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US20040137140A1 - Pharmaceutical dispensing apparatus and method - Google Patents

Pharmaceutical dispensing apparatus and method Download PDF

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Publication number
US20040137140A1
US20040137140A1 US10/625,813 US62581303A US2004137140A1 US 20040137140 A1 US20040137140 A1 US 20040137140A1 US 62581303 A US62581303 A US 62581303A US 2004137140 A1 US2004137140 A1 US 2004137140A1
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US
United States
Prior art keywords
pharmaceutical
reservoir
fluid drop
component
drop generator
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10/625,813
Inventor
Winthrop Childers
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to US10/625,813 priority Critical patent/US20040137140A1/en
Priority to US10/801,381 priority patent/US20040173147A1/en
Priority to US10/801,380 priority patent/US20040175331A1/en
Priority to US10/801,379 priority patent/US20040173146A1/en
Publication of US20040137140A1 publication Critical patent/US20040137140A1/en
Priority to CN 200480021128 priority patent/CN1826228A/en
Priority to PCT/US2004/023355 priority patent/WO2005009738A2/en
Priority to CN 200480021190 priority patent/CN1826229A/en
Priority to PCT/US2004/023354 priority patent/WO2005009737A1/en
Priority to JP2006521194A priority patent/JP2006528191A/en
Priority to EP04778728A priority patent/EP1648707A2/en
Priority to JP2006521195A priority patent/JP2006528192A/en
Priority to EP04778727A priority patent/EP1648706A1/en
Priority to US11/189,139 priority patent/US20050260273A1/en
Priority to US11/189,582 priority patent/US20050271737A1/en
Priority to US11/189,585 priority patent/US7767249B2/en
Priority to US11/361,438 priority patent/US7707964B2/en
Abandoned legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B12/00Arrangements for controlling delivery; Arrangements for controlling the spray area
    • B05B12/08Arrangements for controlling delivery; Arrangements for controlling the spray area responsive to condition of liquid or other fluent material to be discharged, of ambient medium or of target ; responsive to condition of spray devices or of supply means, e.g. pipes, pumps or their drive means
    • B05B12/084Arrangements for controlling delivery; Arrangements for controlling the spray area responsive to condition of liquid or other fluent material to be discharged, of ambient medium or of target ; responsive to condition of spray devices or of supply means, e.g. pipes, pumps or their drive means responsive to condition of liquid or other fluent material already sprayed on the target, e.g. coating thickness, weight or pattern
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/02Inhalators with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
    • A61M15/025Bubble jet droplet ejection devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B41PRINTING; LINING MACHINES; TYPEWRITERS; STAMPS
    • B41JTYPEWRITERS; SELECTIVE PRINTING MECHANISMS, i.e. MECHANISMS PRINTING OTHERWISE THAN FROM A FORME; CORRECTION OF TYPOGRAPHICAL ERRORS
    • B41J3/00Typewriters or selective printing or marking mechanisms characterised by the purpose for which they are constructed
    • B41J3/407Typewriters or selective printing or marking mechanisms characterised by the purpose for which they are constructed for marking on special material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/70Device provided with specific sensor or indicating means
    • A61J2200/74Device provided with specific sensor or indicating means for weight
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B12/00Arrangements for controlling delivery; Arrangements for controlling the spray area
    • B05B12/14Arrangements for controlling delivery; Arrangements for controlling the spray area for supplying a selected one of a plurality of liquids or other fluent materials or several in selected proportions to a spray apparatus, e.g. to a single spray outlet
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05BSPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B17/00Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups
    • B05B17/04Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods
    • B05B17/06Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations
    • B05B17/0607Apparatus for spraying or atomising liquids or other fluent materials, not covered by the preceding groups operating with special methods using ultrasonic or other kinds of vibrations generated by electrical means, e.g. piezoelectric transducers

Definitions

  • Present invention relates to apparatus and method for manufacturing pharmaceutical doses.
  • compositions in tablet or liquid form are made by pharmaceutical companies in formulations of a predetermined quantity of pharmaceutical units in each dose. Such pharmaceutical doses are frequently available in different strengths, such as 50 mg, 100 mg, etc.
  • a doctor typically prescribes a pharmaceutical or medication for a patient.
  • the doctor when prescribing a particular medication and medication strength, typically takes into account the patient's age, weight, sex, strong versus weak health condition, available dosage types, and the severity of the patient's illness, disease, or condition.
  • the prescription is filled by a pharmacist who provides the selected pharmaceutical or medication in the desired strength and pharmaceutical type.
  • fluid jetting devices based on inkjet printer technology have been used to dispense chemicals onto a substrate.
  • Piezoelectric or thermal jet heads with one or more fluid reservoirs or chambers have been used to dispense a plurality of fluid drops of defined volume onto a medium or substrate.
  • the fluid jetting heads dispense the same constant fluid volume.
  • each pharmaceutical dose contains one of more pharmaceuticals in a single tablet or liquid dose and where the type of pharmaceutical, and the quantity of the selected pharmaceutical may be easily varied to meet a specific prescription or to manufacture a specific pharmaceutical dose.
  • the present invention is a pharmaceutical dispensing apparatus and method which is capable of dispensing variable quantities of one or more pharmaceuticals onto a pharmaceutical receiving medium thereby enabling a pharmaceutical dose to be custom manufactured to the particular needs of a user.
  • the present invention is a method of manufacturing a pharmaceutical dose.
  • the method comprises the steps of:
  • the present method also includes the step of supplying the pharmaceutical component including the step of providing the one pharmaceutical component in a replaceable reservoir fluidically coupled to the fluid drop generator.
  • the step of supplying the pharmaceutical component further comprises the step of providing a plurality of pharmaceutical components each in a separate reservoir, each reservoir fluidically coupled to a different one of a plurality of fluid drop generators.
  • the method also includes the step of providing pharmaceutical component identification data to the controller for each reservoir connected to the fluid drop generators.
  • the method includes the step of controlling the activation of the fluid dispenser to dispense a variably selectable quantity of the one pharmaceutical component through the fluid drop generator to the pharmaceutical receiving medium.
  • the method includes the step of dispensing a barrier component onto the pharmaceutical receiving medium to seal a prior dispensed pharmaceutical component on the pharmaceutical receiving medium.
  • the method includes the step of providing a signal to the fluid dispenser from a remote signal source specifying a selected quantity of specified pharmaceutical component to be dispensed onto one pharmaceutical receiving medium.
  • the signal from the remote source may also specify the selected quantities of a plurality of pharmaceutical components to be dispensed onto the one pharmaceutical receiving medium and patient information.
  • the method includes the steps of weighing the pharmaceutical receiving medium after the quantity of the pharmaceutical component or components have been dispensed onto the medium.
  • the method compares the weight of the pharmaceutical receiving medium with a reference combined weight corresponding to the weight of an empty pharmaceutical receiving medium and the weight of the variably selected quantity of the one pharmaceutical component to verify that the selected quantity of the one pharmaceutical component which has been completely dispensed onto the medium.
  • the invention is an apparatus for manufacturing a pharmaceutical dose.
  • the apparatus includes a reservoir containing one pharmaceutical component, a fluid drop generator fluidically coupled to the reservoir, and a control for activating the fluid drop generator to eject a variably selected quantity of the one pharmaceutical component onto the pharmaceutical receiving medium.
  • the supplying means is preferably a reservoir containing a single pharmaceutical component.
  • the reservoir is fluidically coupled to the fluid drop generator and replaceably mounted in the fluid dispenser.
  • the reservoir is a plurality of reservoirs, each containing a different pharmaceutical component.
  • a plurality of fluid drop generators are provided in the fluid dispenser, with at least one fluid drop generator fluidically coupled to one of the plurality of reservoirs. Further, the plurality of reservoirs are preferably replaceably connected to the fluid dispenser.
  • the apparatus includes a communication means, coupled to the activating means or controller, for coupling a signal from a remote source carried on an external telecommunications network to the controller wherein the remote signal specifies the variably selectable quantity and/or the type of the one or more pharmaceutical components to be dispensed.
  • the apparatus also includes an optional weight detector for detecting and outputting signals corresponding to the weight of the pharmaceutical receiving medium after the pharmaceutical component or components have been dispensed onto the medium.
  • the activating means or controller compares the detected weight with a reference or standard weight corresponding to the desired weight of the medium which has received the complete specified pharmaceutical quantity. Any discrepancies can be use for corrective action or to reject the particular medium.
  • the invention is a replaceable cartridge for an apparatus used to manufacturer a pharmaceutical dose which includes a control receiving data indicative of the pharmaceutical dose and dispensing droplets onto a pharmaceutical receiving medium.
  • the replaceable cartridge includes a reservoir containing at least one pharmaceutical component and a fluid drop generator fluidically coupled to the reservoir.
  • An information storage element may be provided on the replaceable cartridge for providing information concerning at least one parameter of the reservoir, the pharmaceutical dose or the state operative of the fluid drop generator.
  • the invention is a method of generating a custom pharmaceutical dose using a fluid drop generator operated by a controller to eject droplets of a pharmaceutical component from a reservoir onto a pharmaceutical receiving medium.
  • the method includes the steps of providing information to the controller indicative of a particular prescription, and selecting a number of drops from a pharmaceutical component to be ejected from the reservoir through the fluid drop generator in response to the information.
  • This method envisions the selection of one or more of a plurality of fluid drop generators, each ejecting a different pharmaceutical component.
  • the method also includes steps selecting the fluid drop generators in a plurality of different sequences or firing orders for dispensing a plurality of different pharmaceutical components.
  • the pharmaceutical dispensing apparatus and method of the present invention has numerous advantages compared to previous apparatus and methods for manufacturing pharmaceutical dosages, whether in tablet or liquid container form.
  • the present apparatus and method uniquely enable a single pharmaceutical receiving medium, such as a tablet, to be manufactured with variably selected quantities of one or more pharmaceuticals.
  • This enables a doctor or other prescription prescriber, as well as a manufacturer of mass distribution pharmaceutical doses, to custom make a pharmaceutical dose which meets the specific requirements of a particular user or at a particular strength, taking into account various user characteristics, such as age, weight, sex, general health condition, degree of illness, physical condition, etc.
  • the pharmaceutical manufacturer may also be able to use the present apparatus and method to construct a plurality of pharmaceutical doses to suit a wide range of personal characteristics.
  • the present apparatus and method may be used to custom manufacture a single pharmaceutical dose in a single pharmaceutical receiving medium with contains multiple pharmaceuticals. This is ideally suited for users who take multiple pharmaceutical doses or pills in different combinations and at different times during each 24 hour period.
  • the multiple pills or doses can be replaced with a single dose which contains all of the pharmaceuticals the user is to take at a specific time. This can minimize taking the wrong pharmaceutical dose, or missing some of the doses a user is supposed to take at a particular time.
  • the present method and apparatus are also connectable to an external telecommunication network to enable prescription order signals from a prescription prescriber, such as a doctor, to be transmitted, such as to the pharmaceutical manufacturing site.
  • a prescription prescriber such as a doctor
  • the specified quantities of the pharmaceutical or pharmaceuticals which a particular user is to take can be sent directly from the prescriber or doctor to the manufacturing site enabling the prescribed pharmaceuticals to be automatically dispensed into a medium or tablet. This minimizes the potential for error in interpreting the prescriber's instructions as well as minimizing error in the actual selection of the required quantity and type of each pharmaceutical.
  • the present apparatus and method also enables a cartridge carrying fluidically coupled reservoirs and fluid drop generators carrying different pharmaceuticals to be replaceably mounted in the dispensing apparatus. This enables a pharmacy to use the present apparatus and method to create many different pharmaceutical doses, simply by replacing one cartridge with a different cartridge containing a different pharmaceutical(s).
  • the present apparatus and method may also be employed by a pharmacy to manufacture a single type of pharmaceutical dose where the entire apparatus is replaced with a new apparatus containing new quantities of the required pharmaceutical or pharmaceuticals.
  • the present apparatus and method may also be used to dispense a barrier or seal component which forms a seal layer between the different pharmaceuticals in a single pharmaceutical receiving medium. This prevents interaction between the pharmaceuticals before the medium is ingested by a user.
  • FIG. 1 is a block diagram of a pharmaceutical dispensing apparatus utilizing the method of the present invention
  • FIG. 2 is a pictorial representation of a fluid dispenser according to the present apparatus
  • FIGS. 3A and 3B are pictorial representations of the sequential steps in the method of the present invention.
  • FIGS. 4A and 4B are pictorial representations of optional method steps according to the present invention.
  • FIG. 5 is a flow diagram of the sequence of operation of the pharmaceutical dispensing apparatus and method of the invention.
  • the present invention is an apparatus and method for dispensing pharmaceuticals to a pharmaceutical medium for manufacturing a pharmaceutical dose for a patient or user.
  • the apparatus and method make unique use of an automated liquid ejecting device, such as a fluid jet dispenser having at least one pharmaceutical supply in a reservoir or chamber and at least one, and preferably, a plurality of jet heads or droplet generators in an array, each head dispensing a fixed volume of fluid in individual droplets from the reservoir on each activation of the head or drop generator.
  • This arrangement enables the quantity of pharmaceutical(s) to be varied from dose to dose thereby enabling custom doses to be more easily prepared to suit the needs of each specific patient.
  • FIGS. 1 and 2 there is depicted a pharmaceutical dispensing apparatus 10 constructed in accordance with one aspect of the present invention.
  • the apparatus 10 is depicted as a stand-alone apparatus which may be used in a pharmacy or other pharmaceutical dispensing location to automatically prepare custom pharmaceutical doses in response to prescription orders.
  • pharmaceutical is meant to include any type of drug, medication, chemical, or compound which is designed to be taken by a human as a medication to combat an illness or disease or to promote general health.
  • pharmaceuticals as used herein can be any drug, vitamin, or other chemical or compound which is used for health related purposes.
  • the apparatus 10 includes an activating means, such as a controller or control 12 , which may be a computer or central processing unit based device operating a control program stored in a memory, not shown.
  • the controller 12 provides output signals 14 to a fluid dispenser 16 , such as a fluid-jet based device.
  • a fluid dispenser 16 which may incorporate control and structural features of Hewlett-Packard Ink-Jet printer, Model Nos. HP-C1823D and HP51645A, for example, includes at least one reservoir 18 which contains a quantity of a specific type of one pharmaceutical.
  • multiple reservoirs 20 and 22 are also provided in the fluid dispenser 16 .
  • Each reservoir 18 , 20 and 22 may contain the same or different pharmaceutical. Alternately, a single reservoir can contain a plurality of separate compartments.
  • such fluid dispenser 16 include at least one fluid drop generator or jetting head for each reservoir 18 , 20 , and 22 .
  • an array 24 is provided with a plurality of heads or droplet generators divided into subgroups, with each subgroup containing a plurality of heads associated with one specific reservoir 18 , 20 , or 22 .
  • the fluid dispenser 16 is a drop on demand type fluid dispenser, with piezoelectric or thermal fluid drop generators being preferred.
  • FIG. 2 depicts a block diagram of a typical piezoelectric fluid drop generator 24 which is capable of dispensing individual droplets 36 upon each activation of a driver 25 .
  • the piezoelectric driver 25 operating under control signals from the controller 12 supplies activating signals to a disk or layer of piezoelectric material 27 which is mechanically connected to a chamber 29 in one jetting head 24 .
  • the chamber 29 is disposed in fluid communication with one of the reservoirs, such as reservoir 18 , whereby capillary action supplies fluid pharmaceutical from the reservoir 18 to the chamber 29 .
  • the piezoelectric material 27 undergoes stress which results in mechanical movement of the piezoelectric material or element 27 resulting in a pumping action within the chamber 29 which expels individual droplets 36 thought an orifice or outlet 33 in the jetting head 24 .
  • each jetting head 24 be formed of materials that are inert to the pharmaceuticals which are to be dispensed therefrom.
  • the jetting head 24 can be formed of inert materials, such as glass, ceramic, porcelain, inert plastic, etc.
  • the control signals 14 generated by the controller 12 control the selection of the heads or droplet generators 24 connected to a particular reservoir 18 , 20 , and 22 for each dispensing operation, which may include a plurality of fluid drops dispensed by the array of heads 24 connected to the selected reservoir or reservoirs 18 , 20 or 22 .
  • the pictorial representation of a single jetting head 24 in FIG. 2 will be understood to represent all of the jetting heads 24 which form the array 24 of jetting heads in the fluid dispenser 16 of the present invention.
  • Various combinations of jetting heads 24 and reservoirs 18 , 20 and 22 may be utilized.
  • a single jetting head 24 may be associated with a single reservoir 18 , 20 or 22 .
  • a plurality of identical jetting heads 24 may be disposed in fluid communication with a single reservoir 18 , 20 and 22 , with similar groups of jetting heads 24 disposed in fluid communication with other reservoirs 18 , 20 and 22 .
  • the controller 12 is also capable of generating the control signals 14 which simultaneously or consecutively control the number of drops dispensed by each subgroup of heads 24 associated with one or more reservoirs, 18 , 20 , or 22 . This enables, for example, multiple different pharmaceuticals to be dispensed onto a single pharmaceutical receiving medium 26 .
  • the jetting heads 24 may be arranged in any particular spatial arrangement consistent with the shape of the pharmaceutical receiving medium 26 , depending upon the manner in which the various pharmaceuticals are to be dispensed onto the medium 26 , the speed of operation of the dispensing apparatus 10 , etc. Thus, in one aspect, all of the jetting heads 24 in the array may be disposed in a single line. Alternately, various matrices of heads 24 may be provided for each particular reservoir 18 , 20 and 22 .
  • the controller 12 may activate the head or heads 24 associated with one reservoir 18 , 20 and 22 at a single time to dispense the complete variably selected quantity of the pharmaceutical from the single one reservoir 18 , 20 or 22 . If an additional pharmaceutical is to be added to the medium 26 , the controller 12 will then activate the jetting heads 24 associated with a second one of the reservoirs 18 , 20 and 22 to dispense the second pharmaceutical. Alternately, the controller 12 may send control signals to the jetting heads 24 associated with two or more of the reservoirs 18 , 20 or 22 to simultaneously dispense all of the different pharmaceuticals which are selected for dispensing to the single medium 26 . Further details of a preferred sequence of dispensing of one or more pharmaceuticals is discussed hereafter.
  • the number of heads 24 in each subgroup of heads associated with one particular reservoir 18 , 20 , and 22 typically have the same cross section or diameter so as to be able to eject the same known, constant volume of fluid upon each activation, it is possible in the present apparatus 10 to provide the heads 21 in at least one subgroup of heads 24 with a different diameter, either larger or smaller than the diameter of the heads 24 connected to other reservoirs 24 so as to dispense smaller or larger volumes of the pharmaceutical in the associated reservoir 18 , 20 , or 22 upon each activation of the fluid drop generator(s) 16 .
  • the receiving medium 26 may be any suitable media used to receive, store, and transport pharmaceuticals.
  • a porous sugar tablet or even a liquid receiving vial may be employed as the medium 26 .
  • multiple identical pharmaceutical filled mediums 26 can be formed by the apparatus 10 with the same selected quantity and type of pharmaceuticals.
  • a media carrier 28 such as a conveyor, not shown, may be employed to advance new, unfilled media 26 into proximity with the jetting head array 24 as well as moving pharmaceutical filled media 26 away from the jetting head array 24 and to a packaging or unload station, not shown.
  • the entire fluid dispenser 16 may be mounted on a movable carriage, which is traversable in one or more directions with respect to the receiving medium 26 so as to bring the head array 24 into proximity with successive receiving mediums 26 .
  • a weight detector 30 is shown in FIG. 1 as an optional part of the apparatus 10 .
  • the weight detector 30 may be any type of weighting device, such as an electronic scale, which is capable of measuring the weight of each receiving medium 26 , both in an unfilled state and in a filled state.
  • the output signals of the weight detector 30 are input to the controller 12 .
  • the controller 12 compares the measured weight of each filled medium 26 with a pre-stored, established reference or standard weight of a medium 26 and a complete quantity of a selected pharmaceutical to determine that the proper amount of pharmaceutical components have been dispensed to the medium 26 .
  • the controller 12 can thus determine whether or not each medium 26 has been filled with the complete quantity of the selected pharmaceutical. If the detected weight comparison indicates that the medium 26 is too heavy, thereby indicating that too much pharmaceutical has been added to the medium 26 , the controller 12 can activate a suitable reject apparatus, not shown, to reject the particular medium 26 . Alternately, if the detected weight of the filled medium 26 is less than the standard or reference weight, the controller 12 can also generate signals activating the reject apparatus or, using feedback, determine the difference between the standard weight and measured weight of the medium 26 and then re-activate the heads 24 to dispense a selected amount of the pharmaceutical(s) to bring the weight difference to zero.
  • the cartridges 16 containing the reservoirs 18 , 20 , and 22 and heads 24 may be provided in different configurations, such as a single stand-alone, generally permanently attached cartridge 16 or as a replaceable cartridge 16 .
  • the single stand-alone configuration is suitable for a single use of the apparatus 10 where the reservoir or reservoirs 18 , 20 , and 22 are fully charged with pharmaceutical components by the pharmaceutical manufacturer, for example, and then shipped to the dispensing location, such as a pharmacy. When the pharmaceuticals in the reservoirs 18 , 20 , and 22 are exhausted, the apparatus 10 is exchanged for a completely new apparatus 10 .
  • the apparatus 10 may also be constructed with replaceable cartridges 16 . This provides the pharmacy with the ability to resupply pharmaceuticals when the existing supply of pharmaceutical components in any of the reservoirs 18 , 20 , and 22 is exhausted. At the same time, one or more cartridges 16 can be replaced with a different cartridge 16 containing a different pharmaceutical to prepare a different pharmaceutical dose.
  • Each of the plurality of reservoirs 18 , 20 , and 22 may be formed as separate, discrete reservoirs, each fluidically coupled to a head 24 . Alternately, a single reservoir 18 , 20 , or 22 may contain individual, separate compartments defining the separate reservoirs 18 , 20 , and 22 for different pharmaceuticals.
  • FIG. 2 also depicts a data or information storage device 39 which may be associated with each of the reservoirs 18 , 20 and 22 , with only reservoir 18 being shown.
  • the storage device 39 is any type of memory device suitable for storing and outputting information related to parameters of the pharmaceutical contained within the particular reservoir 18 and/or the reservoir itself. This is advantageously used with the standalone, non-replaceable combination of the reservoirs 18 , 20 and 22 or the replaceable configuration reservoirs 18 , 20 and 22 .
  • the storage device 39 may be a memory chip mounted on the reservoir 18 and connected to external contacts which mate with contacts in a connector 41 when the reservoir 18 is mounted in the fluid dispenser 16 and connected electrically or optically with the controller 12 . Once the connection between the contacts on the storage device 39 and the connector 41 is made, the controller 12 is disposed in electrical communication with the storage device 39 for information transfer with the storage device 39 .
  • the data in the information storage device 39 can be in the form of a code identifying the particular pharmaceutical component contained in the reservoir, such as a bar code, etc., which can be read by any suitable reader, including a laser optical reader.
  • electrical contacts or other signal generating devices can be carried on each storage device 39 to provide a code output which can be read by a code reader in the connector 41 or in the controller 12 .
  • the information in the storage device 39 may be such as to enable the controller 12 to digitally determine the type of pharmaceutical in the reservoir 18 as well as other information, such as the quantity of the pharmaceutical remaining the reservoir 18 based on the number of drops dispensed or the number of times that the jetting head(s) 24 coupled to the particular reservoir 18 has been activated.
  • Other parameters which can be stored in the storage device 39 include a date code of manufacture of the pharmaceutical, an inspection date, system coefficients, reservoir size, age of the pharmaceutical, to name just a few.
  • the controller 12 can thereby verify that the proper pharmaceutical component is provided in the appropriate reservoir location or merely identify which pharmaceutical component is present.
  • An example of a fluid dispenser having retrievable reservoir identification information is described in U.S. Pat. No. 6,039,430, assigned to the Assignee of the present invention. The entire contents of this patent are incorporated herein.
  • FIG. 1 Another aspect of the present invention is also shown in FIG. 1 wherein an electrical communication device is provided in the controller 12 or as a separate element electrically connected to the controller 12 .
  • the receiver is coupled to a telecommunication network by various means, including hard conductors, cables, wireless transmission, etc.
  • the telecommunication network may thus comprise an existing telephone communication network, as well as a wireless radio frequency network, cellular telephone network, satellite communication network, the Internet, etc.
  • the receiver is coupled to an antenna for receiving signals from a remote signal source, such as a doctor's office or other prescription issuing authority.
  • signals contain, for example, patient identifying data, as well as the type(s) of pharmaceuticals, the quantity in terms of the number of dosage units to be made, the dosage strength, etc.
  • controller 12 which then activates the fluid dispenser 16 in the appropriate manner to prepare the specified pharmaceutical doses.
  • This automatic system has the advantage of minimizing errors in interpreting a doctor's handwritten prescription order as well as potential errors in manually filling the prescription.
  • At least a portion of the signals received by the receiver may be stored in the memory of the controller 12 for future use by the fluid dispenser 16 .
  • signals specifying patient identification data such as name, address, telephone number, authorized doctor, health insurance provider, etc.
  • patient identification data such as name, address, telephone number, authorized doctor, health insurance provider, etc.
  • signals specifying patient identification data may be transmitted to or otherwise stored in the memory of the controller 12 .
  • Remote signals via a telephone or computer network from the patient to the apparatus 10 may be employed to generate a new order.
  • the pharmacy may take a telephone call or face-to-face verbal instructions from a patient and then input appropriate signals to the controller 12 through push buttons or other input means, including computer inputs to fill a prescription for the patient.
  • step 60 a prescription is generated by a doctor or other prescription generating source. This prescription is transmitted via a communication link 62 in step 64 from the prescription source to the controller 12 via any communication link described above. The prescription is received by a suitable signal receiving element or receiver coupled to the controller 12 in step 66 . The controller 12 then stores the received prescription which specifies the type of pharmaceutical component(s) as well as the quantity of the pharmaceutical component(s) which are to be used in each pharmaceutical dose.
  • Step 68 determines in step 68 if a cartridge containing the required pharmaceutical component or components is installed in the fluid dispenser 16 .
  • Step 68 may include sub-steps in which a plurality of coupled reservoir and fluid drop generators are detected as being installed in the fluid dispenser 16 .
  • step 70 the controller 12 determines the number of drops of the selected pharmaceutical component(s) which are required for each pharmaceutical dose.
  • the controller 12 then generates signals to the cartridge 16 in the fluid dispenser 16 and, specifically, to the fluid drop generator to dispense the selected number of drops of each pharmaceutical component from the reservoir onto the pharmaceutical receiving medium 26 .
  • Step 74 represents a determination made by the controller if the correct number of drops of pharmaceutical component(s) have been dispensed onto the medium 26 .
  • Step 24 can be implemented via the weighing means or scale 30 as well as an indication from the information storage element 36 on each reservoir and fluid drop generator which may contain information specifying the number of drop dispensing signals which have been received from the controller 12 .
  • the fluid dispenser 16 is configured for dispensing a single pharmaceutical component onto each receiving medium 26 , such as a tablet.
  • the head array 24 has been activated by the controller 12 to dispense one and, typically, a plurality of fluid drops 36 onto the medium 26 .
  • the fluid drop 36 of the single pharmaceutical is shown as being deposited on the surface of the receiving medium 26 in a layer 37 .
  • the receiving medium 26 will be formed of a porous material which will allow the fluid pharmaceutical to be absorbed into the interior of the medium 26 .
  • a different subgroup of heads in the head array 24 are activated by the controller 12 to dispense droplets 38 from a different reservoir 18 , 20 , or 22 , as shown in FIG. 2C, over the first dispensed pharmaceutical on the medium 26 .
  • This second component can be a barrier material, such as a clear coat or other inert material which will not interact with the first dispensed pharmaceutical component.
  • the droplets 38 harden or dry to form a barrier layer 40 over the first dispensed droplets 36 and, possibly, over the entire exterior surface of the medium 26 .
  • FIGS. 4A and 4B An optional method sequence is shown in FIGS. 4A and 4B.
  • the pharmaceutical medium 26 has the first pharmaceutical component layer 37 and the barrier layer 40 deposited thereon as described above and shown in FIGS. 3A and 3B.
  • one or more drops 42 of a second pharmaceutical component which can be different from the first pharmaceutical component in layer 37 are dispensed over the barrier layer 40 on the medium 26 in a layer 43 .
  • an optional outermost barrier layer 44 is dispensed from one reservoir 18 , 20 , or 22 over the second pharmaceutical layer 43 , and the initial barrier layer 40 .
  • the apparatus and method can utilize communication signals between a pharmaceutical ordering location, such as a doctor's office, and the pharmaceutical manufacturing location, to automatically generate each prescribed pharmaceutical thereby minimizing potential human errors in interpreting a prescription order and properly filling the prescription order.

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Abstract

An apparatus and method for manufacturing a pharmaceutical dose which dispenses a variable selectable quantity of at least one pharmaceutical onto a pharmaceutical receiving medium. The quantity of the dispensed pharmaceutical(s) are controllably dispensed to customize each pharmaceutical dose to suit the needs of a particular user. The apparatus is coupled by an external telecommunication network to a remote signal source for receiving pharmaceutical quantity and type data for custom manufacturing a pharmaceutical dose. In one aspect, a replaceable cartridge contains a reservoir carrying at least one pharmaceutical component and a fluid drop generator which is mountable in the fluid dispenser. The reservoir may contain a number of separate compartments, each carrying different pharmaceutical component.

Description

    BACKGROUND
  • 1. Field of the Invention [0001]
  • Present invention relates to apparatus and method for manufacturing pharmaceutical doses. [0002]
  • 2. Description of the Art [0003]
  • Pharmaceutical doses in tablet or liquid form are made by pharmaceutical companies in formulations of a predetermined quantity of pharmaceutical units in each dose. Such pharmaceutical doses are frequently available in different strengths, such as 50 mg, 100 mg, etc. [0004]
  • A doctor typically prescribes a pharmaceutical or medication for a patient. The doctor, when prescribing a particular medication and medication strength, typically takes into account the patient's age, weight, sex, strong versus weak health condition, available dosage types, and the severity of the patient's illness, disease, or condition. The prescription is filled by a pharmacist who provides the selected pharmaceutical or medication in the desired strength and pharmaceutical type. [0005]
  • Errors can occur in this process due, for example, to the pharmacist being unable to clearly read the doctor's written prescription. This could cause the pharmacist to inadvertently select the improper strength or the wrong pharmaceutical. It would be desirable to provide a pharmaceutical dispensing apparatus and method which minimizes the occurrence of these problems. [0006]
  • For certain illnesses or physical conditions, people frequently take multiple pharmaceuticals at different times of the day, often in different combinations at different time intervals. Such a process is prone to error by the user by selecting the incorrect pharmaceuticals, or taking the proper pharmaceuticals at the wrong times or in the wrong combination. It would be desirable to provide a pharmaceutical dispensing apparatus and method which simplifies the taking of pharmaceuticals, especially combinations of different pharmaceuticals by providing multiple pharmaceuticals of selected strengths in one dose or pill. [0007]
  • Previously, fluid jetting devices based on inkjet printer technology have been used to dispense chemicals onto a substrate. Piezoelectric or thermal jet heads with one or more fluid reservoirs or chambers have been used to dispense a plurality of fluid drops of defined volume onto a medium or substrate. Typically, the fluid jetting heads dispense the same constant fluid volume. [0008]
  • It would be desirable to provide an apparatus and method for the custom dispensing of pharmaceutical to form pharmaceutical doses where each pharmaceutical dose contains one of more pharmaceuticals in a single tablet or liquid dose and where the type of pharmaceutical, and the quantity of the selected pharmaceutical may be easily varied to meet a specific prescription or to manufacture a specific pharmaceutical dose. [0009]
  • It would also be desirable to provide an apparatus and method which is capable of dispensing variably selectable quantities of pharmaceuticals to a pharmaceutical receiving medium, such as a tablet or a liquid vial. It would be also be desirable to provide an apparatus and method which is capable of dispensing multiple, different pharmaceuticals in varied, selected quantities to a singe pharmaceutical receiving medium. [0010]
  • It would also be desirable to provide an apparatus and method which is automatically responsive to an input prescription or pharmaceutical quantity signal to dispense the prescribed quantity and type of pharmaceutical to a pharmaceutical medium. [0011]
  • It would also be desirable to provide an apparatus and method which is capable of dispensing multiple pharmaceuticals in separate stages to a medium, each separated by a barrier or sealing layer to isolate the different pharmaceuticals from each other in the medium as well as to provide an outer barrier layer to protect the pharmaceuticals in the medium. [0012]
  • It would also be desirable to provide an apparatus and method for dispensing pharmaceuticals which uses replaceable pharmaceutical reservoirs enabling different pharmaceuticals to be dispensed and re-supplied. [0013]
  • SUMMARY OF THE INVENTION
  • The present invention is a pharmaceutical dispensing apparatus and method which is capable of dispensing variable quantities of one or more pharmaceuticals onto a pharmaceutical receiving medium thereby enabling a pharmaceutical dose to be custom manufactured to the particular needs of a user. [0014]
  • In one aspect, the present invention is a method of manufacturing a pharmaceutical dose. The method comprises the steps of: [0015]
  • supplying one fluid pharmaceutical component in a reservoir; [0016]
  • providing a pharmaceutical receiving medium; [0017]
  • fluidically coupling the reservoir to a fluid drop generator; and [0018]
  • activating the fluid drop generator to eject a variably selected quantity of the one pharmaceutical component onto the pharmaceutical receiving medium. [0019]
  • The present method also includes the step of supplying the pharmaceutical component including the step of providing the one pharmaceutical component in a replaceable reservoir fluidically coupled to the fluid drop generator. [0020]
  • In another aspect of the invention, the step of supplying the pharmaceutical component further comprises the step of providing a plurality of pharmaceutical components each in a separate reservoir, each reservoir fluidically coupled to a different one of a plurality of fluid drop generators. [0021]
  • The method also includes the step of providing pharmaceutical component identification data to the controller for each reservoir connected to the fluid drop generators. [0022]
  • In another aspect, the method includes the step of controlling the activation of the fluid dispenser to dispense a variably selectable quantity of the one pharmaceutical component through the fluid drop generator to the pharmaceutical receiving medium. [0023]
  • In yet another aspect, the method includes the step of dispensing a barrier component onto the pharmaceutical receiving medium to seal a prior dispensed pharmaceutical component on the pharmaceutical receiving medium. [0024]
  • In yet another aspect of the present method, the method includes the step of providing a signal to the fluid dispenser from a remote signal source specifying a selected quantity of specified pharmaceutical component to be dispensed onto one pharmaceutical receiving medium. The signal from the remote source may also specify the selected quantities of a plurality of pharmaceutical components to be dispensed onto the one pharmaceutical receiving medium and patient information. [0025]
  • In yet another aspect of the invention, the method includes the steps of weighing the pharmaceutical receiving medium after the quantity of the pharmaceutical component or components have been dispensed onto the medium. The method compares the weight of the pharmaceutical receiving medium with a reference combined weight corresponding to the weight of an empty pharmaceutical receiving medium and the weight of the variably selected quantity of the one pharmaceutical component to verify that the selected quantity of the one pharmaceutical component which has been completely dispensed onto the medium. [0026]
  • In another aspect, the invention is an apparatus for manufacturing a pharmaceutical dose. The apparatus includes a reservoir containing one pharmaceutical component, a fluid drop generator fluidically coupled to the reservoir, and a control for activating the fluid drop generator to eject a variably selected quantity of the one pharmaceutical component onto the pharmaceutical receiving medium. [0027]
  • In this aspect of the invention, the supplying means is preferably a reservoir containing a single pharmaceutical component. Preferably, the reservoir is fluidically coupled to the fluid drop generator and replaceably mounted in the fluid dispenser. [0028]
  • In another aspect, the reservoir is a plurality of reservoirs, each containing a different pharmaceutical component. In this aspect, a plurality of fluid drop generators are provided in the fluid dispenser, with at least one fluid drop generator fluidically coupled to one of the plurality of reservoirs. Further, the plurality of reservoirs are preferably replaceably connected to the fluid dispenser. [0029]
  • In another aspect, the apparatus includes a communication means, coupled to the activating means or controller, for coupling a signal from a remote source carried on an external telecommunications network to the controller wherein the remote signal specifies the variably selectable quantity and/or the type of the one or more pharmaceutical components to be dispensed. [0030]
  • The apparatus also includes an optional weight detector for detecting and outputting signals corresponding to the weight of the pharmaceutical receiving medium after the pharmaceutical component or components have been dispensed onto the medium. The activating means or controller compares the detected weight with a reference or standard weight corresponding to the desired weight of the medium which has received the complete specified pharmaceutical quantity. Any discrepancies can be use for corrective action or to reject the particular medium. [0031]
  • In another aspect, the invention is a replaceable cartridge for an apparatus used to manufacturer a pharmaceutical dose which includes a control receiving data indicative of the pharmaceutical dose and dispensing droplets onto a pharmaceutical receiving medium. The replaceable cartridge includes a reservoir containing at least one pharmaceutical component and a fluid drop generator fluidically coupled to the reservoir. An information storage element may be provided on the replaceable cartridge for providing information concerning at least one parameter of the reservoir, the pharmaceutical dose or the state operative of the fluid drop generator. [0032]
  • In another aspect, the invention is a method of generating a custom pharmaceutical dose using a fluid drop generator operated by a controller to eject droplets of a pharmaceutical component from a reservoir onto a pharmaceutical receiving medium. The method includes the steps of providing information to the controller indicative of a particular prescription, and selecting a number of drops from a pharmaceutical component to be ejected from the reservoir through the fluid drop generator in response to the information. [0033]
  • This method envisions the selection of one or more of a plurality of fluid drop generators, each ejecting a different pharmaceutical component. The method also includes steps selecting the fluid drop generators in a plurality of different sequences or firing orders for dispensing a plurality of different pharmaceutical components. [0034]
  • The pharmaceutical dispensing apparatus and method of the present invention has numerous advantages compared to previous apparatus and methods for manufacturing pharmaceutical dosages, whether in tablet or liquid container form. The present apparatus and method uniquely enable a single pharmaceutical receiving medium, such as a tablet, to be manufactured with variably selected quantities of one or more pharmaceuticals. This enables a doctor or other prescription prescriber, as well as a manufacturer of mass distribution pharmaceutical doses, to custom make a pharmaceutical dose which meets the specific requirements of a particular user or at a particular strength, taking into account various user characteristics, such as age, weight, sex, general health condition, degree of illness, physical condition, etc. The pharmaceutical manufacturer may also be able to use the present apparatus and method to construct a plurality of pharmaceutical doses to suit a wide range of personal characteristics. [0035]
  • In addition, the present apparatus and method may be used to custom manufacture a single pharmaceutical dose in a single pharmaceutical receiving medium with contains multiple pharmaceuticals. This is ideally suited for users who take multiple pharmaceutical doses or pills in different combinations and at different times during each 24 hour period. The multiple pills or doses can be replaced with a single dose which contains all of the pharmaceuticals the user is to take at a specific time. This can minimize taking the wrong pharmaceutical dose, or missing some of the doses a user is supposed to take at a particular time. [0036]
  • The present method and apparatus are also connectable to an external telecommunication network to enable prescription order signals from a prescription prescriber, such as a doctor, to be transmitted, such as to the pharmaceutical manufacturing site. The specified quantities of the pharmaceutical or pharmaceuticals which a particular user is to take can be sent directly from the prescriber or doctor to the manufacturing site enabling the prescribed pharmaceuticals to be automatically dispensed into a medium or tablet. This minimizes the potential for error in interpreting the prescriber's instructions as well as minimizing error in the actual selection of the required quantity and type of each pharmaceutical. [0037]
  • The present apparatus and method also enables a cartridge carrying fluidically coupled reservoirs and fluid drop generators carrying different pharmaceuticals to be replaceably mounted in the dispensing apparatus. This enables a pharmacy to use the present apparatus and method to create many different pharmaceutical doses, simply by replacing one cartridge with a different cartridge containing a different pharmaceutical(s). [0038]
  • The present apparatus and method may also be employed by a pharmacy to manufacture a single type of pharmaceutical dose where the entire apparatus is replaced with a new apparatus containing new quantities of the required pharmaceutical or pharmaceuticals. [0039]
  • In the case of multiple pharmaceuticals injected into a single medium, the present apparatus and method may also be used to dispense a barrier or seal component which forms a seal layer between the different pharmaceuticals in a single pharmaceutical receiving medium. This prevents interaction between the pharmaceuticals before the medium is ingested by a user.[0040]
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The various features, advantages, and other uses of the present invention will become more apparent by referring to the following detailed description and drawing in which: [0041]
  • FIG. 1 is a block diagram of a pharmaceutical dispensing apparatus utilizing the method of the present invention; [0042]
  • FIG. 2 is a pictorial representation of a fluid dispenser according to the present apparatus; [0043]
  • FIGS. 3A and 3B are pictorial representations of the sequential steps in the method of the present invention; [0044]
  • FIGS. 4A and 4B are pictorial representations of optional method steps according to the present invention; and [0045]
  • FIG. 5 is a flow diagram of the sequence of operation of the pharmaceutical dispensing apparatus and method of the invention.[0046]
  • DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • The present invention is an apparatus and method for dispensing pharmaceuticals to a pharmaceutical medium for manufacturing a pharmaceutical dose for a patient or user. The apparatus and method make unique use of an automated liquid ejecting device, such as a fluid jet dispenser having at least one pharmaceutical supply in a reservoir or chamber and at least one, and preferably, a plurality of jet heads or droplet generators in an array, each head dispensing a fixed volume of fluid in individual droplets from the reservoir on each activation of the head or drop generator. This arrangement enables the quantity of pharmaceutical(s) to be varied from dose to dose thereby enabling custom doses to be more easily prepared to suit the needs of each specific patient. [0047]
  • Referring now to the drawings, and to FIGS. 1 and 2 in particular, there is depicted a [0048] pharmaceutical dispensing apparatus 10 constructed in accordance with one aspect of the present invention. The apparatus 10 is depicted as a stand-alone apparatus which may be used in a pharmacy or other pharmaceutical dispensing location to automatically prepare custom pharmaceutical doses in response to prescription orders.
  • For the purposes of this description and the present invention, the term “pharmaceutical” is meant to include any type of drug, medication, chemical, or compound which is designed to be taken by a human as a medication to combat an illness or disease or to promote general health. Thus, pharmaceuticals as used herein, can be any drug, vitamin, or other chemical or compound which is used for health related purposes. [0049]
  • The [0050] apparatus 10 includes an activating means, such as a controller or control 12, which may be a computer or central processing unit based device operating a control program stored in a memory, not shown. The controller 12 provides output signals 14 to a fluid dispenser 16, such as a fluid-jet based device. Such a fluid dispenser, which may incorporate control and structural features of Hewlett-Packard Ink-Jet printer, Model Nos. HP-C1823D and HP51645A, for example, includes at least one reservoir 18 which contains a quantity of a specific type of one pharmaceutical. By way of example only, multiple reservoirs 20 and 22 are also provided in the fluid dispenser 16. Each reservoir 18, 20 and 22 may contain the same or different pharmaceutical. Alternately, a single reservoir can contain a plurality of separate compartments.
  • As is well known, [0051] such fluid dispenser 16 include at least one fluid drop generator or jetting head for each reservoir 18, 20, and 22. Preferably, an array 24 is provided with a plurality of heads or droplet generators divided into subgroups, with each subgroup containing a plurality of heads associated with one specific reservoir 18, 20, or 22.
  • The [0052] fluid dispenser 16 is a drop on demand type fluid dispenser, with piezoelectric or thermal fluid drop generators being preferred. FIG. 2 depicts a block diagram of a typical piezoelectric fluid drop generator 24 which is capable of dispensing individual droplets 36 upon each activation of a driver 25.
  • The [0053] piezoelectric driver 25 operating under control signals from the controller 12 supplies activating signals to a disk or layer of piezoelectric material 27 which is mechanically connected to a chamber 29 in one jetting head 24. The chamber 29 is disposed in fluid communication with one of the reservoirs, such as reservoir 18, whereby capillary action supplies fluid pharmaceutical from the reservoir 18 to the chamber 29. Upon each activation of the driver 25, the piezoelectric material 27 undergoes stress which results in mechanical movement of the piezoelectric material or element 27 resulting in a pumping action within the chamber 29 which expels individual droplets 36 thought an orifice or outlet 33 in the jetting head 24.
  • It is preferred that each jetting [0054] head 24 be formed of materials that are inert to the pharmaceuticals which are to be dispensed therefrom. Thus, the jetting head 24 can be formed of inert materials, such as glass, ceramic, porcelain, inert plastic, etc.
  • The control signals [0055] 14 generated by the controller 12 control the selection of the heads or droplet generators 24 connected to a particular reservoir 18, 20, and 22 for each dispensing operation, which may include a plurality of fluid drops dispensed by the array of heads 24 connected to the selected reservoir or reservoirs 18, 20 or 22. Thus, the pictorial representation of a single jetting head 24 in FIG. 2 will be understood to represent all of the jetting heads 24 which form the array 24 of jetting heads in the fluid dispenser 16 of the present invention. Various combinations of jetting heads 24 and reservoirs 18, 20 and 22 may be utilized. For example, a single jetting head 24 may be associated with a single reservoir 18, 20 or 22. Alternately, a plurality of identical jetting heads 24 may be disposed in fluid communication with a single reservoir 18, 20 and 22, with similar groups of jetting heads 24 disposed in fluid communication with other reservoirs 18, 20 and 22.
  • The [0056] controller 12 is also capable of generating the control signals 14 which simultaneously or consecutively control the number of drops dispensed by each subgroup of heads 24 associated with one or more reservoirs, 18, 20, or 22. This enables, for example, multiple different pharmaceuticals to be dispensed onto a single pharmaceutical receiving medium 26.
  • The jetting heads [0057] 24, whether provided as a single jetting head 24 for each reservoir 18, 20 or 22 or as a plurality of groups of heads 24 for one or more reservoirs 18, 20 or 22, may be arranged in any particular spatial arrangement consistent with the shape of the pharmaceutical receiving medium 26, depending upon the manner in which the various pharmaceuticals are to be dispensed onto the medium 26, the speed of operation of the dispensing apparatus 10, etc. Thus, in one aspect, all of the jetting heads 24 in the array may be disposed in a single line. Alternately, various matrices of heads 24 may be provided for each particular reservoir 18, 20 and 22. The controller 12 may activate the head or heads 24 associated with one reservoir 18, 20 and 22 at a single time to dispense the complete variably selected quantity of the pharmaceutical from the single one reservoir 18, 20 or 22. If an additional pharmaceutical is to be added to the medium 26, the controller 12 will then activate the jetting heads 24 associated with a second one of the reservoirs 18, 20 and 22 to dispense the second pharmaceutical. Alternately, the controller 12 may send control signals to the jetting heads 24 associated with two or more of the reservoirs 18, 20 or 22 to simultaneously dispense all of the different pharmaceuticals which are selected for dispensing to the single medium 26. Further details of a preferred sequence of dispensing of one or more pharmaceuticals is discussed hereafter.
  • Although the number of [0058] heads 24 in each subgroup of heads associated with one particular reservoir 18, 20, and 22 typically have the same cross section or diameter so as to be able to eject the same known, constant volume of fluid upon each activation, it is possible in the present apparatus 10 to provide the heads 21 in at least one subgroup of heads 24 with a different diameter, either larger or smaller than the diameter of the heads 24 connected to other reservoirs 24 so as to dispense smaller or larger volumes of the pharmaceutical in the associated reservoir 18, 20, or 22 upon each activation of the fluid drop generator(s) 16.
  • The receiving [0059] medium 26 may be any suitable media used to receive, store, and transport pharmaceuticals. A porous sugar tablet or even a liquid receiving vial may be employed as the medium 26.
  • Since multiple pharmaceuticals are typically taken by a user over the course of an illness or within a short time period, multiple identical pharmaceutical filled [0060] mediums 26 can be formed by the apparatus 10 with the same selected quantity and type of pharmaceuticals. A media carrier 28, such as a conveyor, not shown, may be employed to advance new, unfilled media 26 into proximity with the jetting head array 24 as well as moving pharmaceutical filled media 26 away from the jetting head array 24 and to a packaging or unload station, not shown. For example, the entire fluid dispenser 16 may be mounted on a movable carriage, which is traversable in one or more directions with respect to the receiving medium 26 so as to bring the head array 24 into proximity with successive receiving mediums 26.
  • A [0061] weight detector 30 is shown in FIG. 1 as an optional part of the apparatus 10. The weight detector 30 may be any type of weighting device, such as an electronic scale, which is capable of measuring the weight of each receiving medium 26, both in an unfilled state and in a filled state. The output signals of the weight detector 30 are input to the controller 12. The controller 12 compares the measured weight of each filled medium 26 with a pre-stored, established reference or standard weight of a medium 26 and a complete quantity of a selected pharmaceutical to determine that the proper amount of pharmaceutical components have been dispensed to the medium 26.
  • The [0062] controller 12 can thus determine whether or not each medium 26 has been filled with the complete quantity of the selected pharmaceutical. If the detected weight comparison indicates that the medium 26 is too heavy, thereby indicating that too much pharmaceutical has been added to the medium 26, the controller 12 can activate a suitable reject apparatus, not shown, to reject the particular medium 26. Alternately, if the detected weight of the filled medium 26 is less than the standard or reference weight, the controller 12 can also generate signals activating the reject apparatus or, using feedback, determine the difference between the standard weight and measured weight of the medium 26 and then re-activate the heads 24 to dispense a selected amount of the pharmaceutical(s) to bring the weight difference to zero.
  • It should be noted that the [0063] cartridges 16 containing the reservoirs 18, 20, and 22 and heads 24 may be provided in different configurations, such as a single stand-alone, generally permanently attached cartridge 16 or as a replaceable cartridge 16. The single stand-alone configuration is suitable for a single use of the apparatus 10 where the reservoir or reservoirs 18, 20, and 22 are fully charged with pharmaceutical components by the pharmaceutical manufacturer, for example, and then shipped to the dispensing location, such as a pharmacy. When the pharmaceuticals in the reservoirs 18, 20, and 22 are exhausted, the apparatus 10 is exchanged for a completely new apparatus 10.
  • The [0064] apparatus 10 may also be constructed with replaceable cartridges 16. This provides the pharmacy with the ability to resupply pharmaceuticals when the existing supply of pharmaceutical components in any of the reservoirs 18, 20, and 22 is exhausted. At the same time, one or more cartridges 16 can be replaced with a different cartridge 16 containing a different pharmaceutical to prepare a different pharmaceutical dose.
  • Each of the plurality of [0065] reservoirs 18, 20, and 22 may be formed as separate, discrete reservoirs, each fluidically coupled to a head 24. Alternately, a single reservoir 18, 20, or 22 may contain individual, separate compartments defining the separate reservoirs 18, 20, and 22 for different pharmaceuticals.
  • FIG. 2 also depicts a data or [0066] information storage device 39 which may be associated with each of the reservoirs 18, 20 and 22, with only reservoir 18 being shown. The storage device 39 is any type of memory device suitable for storing and outputting information related to parameters of the pharmaceutical contained within the particular reservoir 18 and/or the reservoir itself. This is advantageously used with the standalone, non-replaceable combination of the reservoirs 18, 20 and 22 or the replaceable configuration reservoirs 18, 20 and 22. The storage device 39 may be a memory chip mounted on the reservoir 18 and connected to external contacts which mate with contacts in a connector 41 when the reservoir 18 is mounted in the fluid dispenser 16 and connected electrically or optically with the controller 12. Once the connection between the contacts on the storage device 39 and the connector 41 is made, the controller 12 is disposed in electrical communication with the storage device 39 for information transfer with the storage device 39.
  • The data in the [0067] information storage device 39 can be in the form of a code identifying the particular pharmaceutical component contained in the reservoir, such as a bar code, etc., which can be read by any suitable reader, including a laser optical reader. Alternately, electrical contacts or other signal generating devices can be carried on each storage device 39 to provide a code output which can be read by a code reader in the connector 41 or in the controller 12.
  • The information in the [0068] storage device 39 may be such as to enable the controller 12 to digitally determine the type of pharmaceutical in the reservoir 18 as well as other information, such as the quantity of the pharmaceutical remaining the reservoir 18 based on the number of drops dispensed or the number of times that the jetting head(s) 24 coupled to the particular reservoir 18 has been activated. Other parameters which can be stored in the storage device 39 include a date code of manufacture of the pharmaceutical, an inspection date, system coefficients, reservoir size, age of the pharmaceutical, to name just a few.
  • The [0069] controller 12 can thereby verify that the proper pharmaceutical component is provided in the appropriate reservoir location or merely identify which pharmaceutical component is present. An example of a fluid dispenser having retrievable reservoir identification information is described in U.S. Pat. No. 6,039,430, assigned to the Assignee of the present invention. The entire contents of this patent are incorporated herein.
  • Another aspect of the present invention is also shown in FIG. 1 wherein an electrical communication device is provided in the [0070] controller 12 or as a separate element electrically connected to the controller 12. The receiver is coupled to a telecommunication network by various means, including hard conductors, cables, wireless transmission, etc. The telecommunication network may thus comprise an existing telephone communication network, as well as a wireless radio frequency network, cellular telephone network, satellite communication network, the Internet, etc.
  • In the case of a wireless communication network, the receiver is coupled to an antenna for receiving signals from a remote signal source, such as a doctor's office or other prescription issuing authority. These signals contain, for example, patient identifying data, as well as the type(s) of pharmaceuticals, the quantity in terms of the number of dosage units to be made, the dosage strength, etc. These signals are input to the [0071] controller 12 which then activates the fluid dispenser 16 in the appropriate manner to prepare the specified pharmaceutical doses. This automatic system has the advantage of minimizing errors in interpreting a doctor's handwritten prescription order as well as potential errors in manually filling the prescription.
  • At least a portion of the signals received by the receiver may be stored in the memory of the [0072] controller 12 for future use by the fluid dispenser 16. For example, signals specifying patient identification data, such as name, address, telephone number, authorized doctor, health insurance provider, etc., may be transmitted to or otherwise stored in the memory of the controller 12. This would enable, for example, the apparatus 10 to be used whenever a patient desires to refill a prescription. Remote signals via a telephone or computer network from the patient to the apparatus 10 may be employed to generate a new order. Alternately, the pharmacy may take a telephone call or face-to-face verbal instructions from a patient and then input appropriate signals to the controller 12 through push buttons or other input means, including computer inputs to fill a prescription for the patient.
  • An example of this communication sequence is shown in FIG. 5. In [0073] step 60, a prescription is generated by a doctor or other prescription generating source. This prescription is transmitted via a communication link 62 in step 64 from the prescription source to the controller 12 via any communication link described above. The prescription is received by a suitable signal receiving element or receiver coupled to the controller 12 in step 66. The controller 12 then stores the received prescription which specifies the type of pharmaceutical component(s) as well as the quantity of the pharmaceutical component(s) which are to be used in each pharmaceutical dose.
  • The [0074] controller 12 then determines in step 68 if a cartridge containing the required pharmaceutical component or components is installed in the fluid dispenser 16. Step 68 may include sub-steps in which a plurality of coupled reservoir and fluid drop generators are detected as being installed in the fluid dispenser 16.
  • In [0075] step 70, the controller 12 determines the number of drops of the selected pharmaceutical component(s) which are required for each pharmaceutical dose. In step 72, the controller 12 then generates signals to the cartridge 16 in the fluid dispenser 16 and, specifically, to the fluid drop generator to dispense the selected number of drops of each pharmaceutical component from the reservoir onto the pharmaceutical receiving medium 26.
  • [0076] Step 74 represents a determination made by the controller if the correct number of drops of pharmaceutical component(s) have been dispensed onto the medium 26. Step 24 can be implemented via the weighing means or scale 30 as well as an indication from the information storage element 36 on each reservoir and fluid drop generator which may contain information specifying the number of drop dispensing signals which have been received from the controller 12.
  • Referring now to FIGS. 3A and 3B, there is depicted a first method sequence according to the present invention. In this sequence, the [0077] fluid dispenser 16 is configured for dispensing a single pharmaceutical component onto each receiving medium 26, such as a tablet. In FIG. 3A, the head array 24 has been activated by the controller 12 to dispense one and, typically, a plurality of fluid drops 36 onto the medium 26. For clarity in understanding the invention, the fluid drop 36 of the single pharmaceutical is shown as being deposited on the surface of the receiving medium 26 in a layer 37. Although this is possible, typically the receiving medium 26 will be formed of a porous material which will allow the fluid pharmaceutical to be absorbed into the interior of the medium 26.
  • Next, a different subgroup of heads in the [0078] head array 24 are activated by the controller 12 to dispense droplets 38 from a different reservoir 18, 20, or 22, as shown in FIG. 2C, over the first dispensed pharmaceutical on the medium 26. This second component can be a barrier material, such as a clear coat or other inert material which will not interact with the first dispensed pharmaceutical component. The droplets 38 harden or dry to form a barrier layer 40 over the first dispensed droplets 36 and, possibly, over the entire exterior surface of the medium 26.
  • An optional method sequence is shown in FIGS. 4A and 4B. In this aspect of the present inventive method. In FIG. 4A, the [0079] pharmaceutical medium 26 has the first pharmaceutical component layer 37 and the barrier layer 40 deposited thereon as described above and shown in FIGS. 3A and 3B. Next, one or more drops 42 of a second pharmaceutical component, which can be different from the first pharmaceutical component in layer 37 are dispensed over the barrier layer 40 on the medium 26 in a layer 43. Next, an optional outermost barrier layer 44 is dispensed from one reservoir 18, 20, or 22 over the second pharmaceutical layer 43, and the initial barrier layer 40.
  • In summary, there has been disclosed a unique pharmaceutical dispensing apparatus and method which enables pharmaceuticals in tablet, or liquid form to be custom manufactured in different strengths or quantities or in multiple combinations in a single dose to suit the specific requirements of an individual user. Further, the apparatus and method can utilize communication signals between a pharmaceutical ordering location, such as a doctor's office, and the pharmaceutical manufacturing location, to automatically generate each prescribed pharmaceutical thereby minimizing potential human errors in interpreting a prescription order and properly filling the prescription order. [0080]

Claims (30)

What is claimed is:
1. A method of manufacturing a pharmaceutical dose comprising the steps of:
supplying one fluid pharmaceutical component in a reservoir;
providing a pharmaceutical receiving medium;
fluidically coupling the reservoir to a fluid drop generator; and
activating the fluid drop generator to eject a variably selected quantity of the one pharmaceutical component onto the pharmaceutical receiving medium.
2. The method of claim 1 wherein the step of supplying the pharmaceutical component includes the step of providing the one pharmaceutical component in a replaceable reservoir fluidically coupled to the fluid drop generator.
3. The method of claim 1 wherein the step of supplying the pharmaceutical component further comprises the step of providing a plurality of pharmaceutical components each in a separate reservoir, each reservoir fluidically coupled to a different one of a plurality of fluid drop generators.
4. The method of claim 1 wherein the step of providing the pharmaceutical component comprises the step of providing a plurality of pharmaceutical components in a single multiple chamber reservoir.
5. The method of claim 1 further comprising the step of:
providing a pharmaceutical component parameter information storage element on the reservoir.
6. The method of claim 1 further comprising the step of:
providing a control for controlling the activation of the fluid drop generator to dispense a selectable quantity of the one pharmaceutical component.
7. The method of claim 6 further comprising:
providing a signal to the control from a remote signal source specifying a selected quantity of that one pharmaceutical component to be dispensed onto one pharmaceutical receiving medium.
8. The method of claim 1 further comprising the step of:
dispensing a barrier component onto the pharmaceutical receiving medium sealing a prior dispensed one pharmaceutical component on the pharmaceutical receiving medium.
9. The method of claim 1 further comprising the step of:
weighing the pharmaceutical receiving medium after a variably selectable quantity of the one pharmaceutical component has been dispensed onto the pharmaceutical receiving medium to determine the dispensing of the selected quantity of the one pharmaceutical component.
10. The method of claim 9 further comprising the step of:
comparing the weight of the pharmaceutical receiving medium with a reference weight corresponding to the weight of an empty pharmaceutical receiving medium and the weight of the variably selected quantity of the one pharmaceutical component to verify that the variably selected quantity of the one pharmaceutical component has been fully dispensed onto the pharmaceutical receiving medium.
11. The method of claim 1 performed with an apparatus for manufacturing a pharmaceutical dose comprising:
means for supplying one fluid pharmaceutical component in a reservoir;
means for providing a pharmaceutical receiving medium;
means for fluidically coupling the reservoir to a fluid drop generator; and
means for activating the fluid drop generator to eject a variably selected quantity of the one pharmaceutical component onto the pharmaceutical receiving medium.
12. An apparatus for manufacturing a pharmaceutical dose onto a pharmaceutical receiving medium, the apparatus comprising:
a reservoir containing one fluid pharmaceutical component;
a fluid drop generator fluidically coupled to the reservoir; and
a control activating the fluid drop generator to eject a variably selected quantity of the one pharmaceutical component onto the medium.
13. The apparatus of claim 12 wherein the reservoir and the fluid drop generator are provided as an integral replaceable unit.
14. The apparatus of claim 12 wherein the reservoir comprises:
a plurality of reservoirs, each containing a different pharmaceutical component.
15. The apparatus of claim 14 wherein the fluid dispenser comprises:
a plurality of fluid drop generators, at least one separate one of the plurality of fluid drop generators connected to one of the plurality of reservoirs.
16. The apparatus of claim 12 further comprising:
a signal communication receiver coupled to the control and an external telecommunications network, the communication receiver communicating a signal from a remote signal source specifying the variably selectable quantity of the one pharmaceutical component to the control.
17. The apparatus of claim 12 further comprising:
a weight detector for detecting and outputting signals corresponding to the weight of the pharmaceutical receiving medium after the one pharmaceutical component has been dispensed onto the pharmaceutical receiving medium.
18. The apparatus of claim 12 wherein the one reservoir comprises:
a single reservoir includes a plurality of separate compartments, each compartment containing a different pharmaceutical component.
19. The apparatus of claim 12 further comprising:
an information storage element carried on the reservoir and the fluid drop generator, the information storage element electrically connectable to the control and providing communicatable information to the control of at least one parameter of the pharmaceutical component and the fluid drop generator.
20. A replaceable cartridge usable in an apparatus for manufacturing a pharmaceutical dose, the apparatus including a control receiving data indicative of the pharmaceutical dose and dispensing droplets of at least one pharmaceutical component onto a pharmaceutical receiving medium, the replaceable cartridge comprising:
a reservoir containing at least one pharmaceutical component; and
a fluid drop generator fluidically coupled to the reservoir for dispensing droplets from the reservoir to the pharmaceutical receiving medium.
21. The replaceable cartridge of claim 20 further comprising:
an information storage element carried on the reservoir and the fluid drop generator, the information storage element electrically connectable to the control and providing communicatable information to the control of at least one parameter of the pharmaceutical component and the fluid drop generator.
22. The replaceable cartridge of claim 21 wherein the one parameter stored in the information storage element identifies the pharmaceutical component in the reservoir.
23. The replaceable cartridge of claim 21 wherein:
the fluid drop generator is integrally coupled to the reservoir.
24. The replaceable cartridge of claim 23 wherein the information storage element contains information specifying the number of drops to be dispensed by the fluid drop generator.
25. The replaceable cartridge of claim 20 wherein:
the fluid drop generator is integrally coupled to the reservoir.
26. The replaceable cartridge of claim 20 wherein:
the reservoir is a single reservoir including a plurality of separate components, each containing one pharmaceutical component.
27. A method of generating a custom pharmaceutical dose using a fluid drop generator controlled by a controller to eject droplets of a pharmaceutical component onto a pharmaceutical receiving medium, the method comprising the steps of:
providing information to the controller indicative of a selected pharmaceutical dose; and
selecting a number of fluid drops of the pharmaceutical component to be ejected from a reservoir through the fluid drop generator in response to the information.
28. The method of claim 27 wherein the step of selecting a number of drops of the pharmaceutical component further comprises the steps of:
selecting at least one of a plurality of fluid drop generators, each ejecting a different pharmaceutical component.
29. The method of claim 27 wherein the step of selecting a number of drops of a pharmaceutical component further comprises the steps of:
selecting a number of drops of a plurality of different pharmaceutical components in a plurality of different dispensing sequences.
30. The method of claim 27 further comprising the step of:
reading at least one of a pharmaceutical component identification data, a reservoir parameter and a fluid drop generator parameter from an information storage element carried on one of the reservoir and the fluid drop generator.
US10/625,813 2001-06-07 2003-07-22 Pharmaceutical dispensing apparatus and method Abandoned US20040137140A1 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
US10/625,813 US20040137140A1 (en) 2001-06-07 2003-07-22 Pharmaceutical dispensing apparatus and method
US10/801,381 US20040173147A1 (en) 2001-06-07 2004-03-15 Application of a bioactive agent to a delivery substrate
US10/801,380 US20040175331A1 (en) 2001-06-07 2004-03-15 Application of a bioactive agent to a delivery substrate
US10/801,379 US20040173146A1 (en) 2001-06-07 2004-03-15 Application of a bioactive agent to a delivery substrate
EP04778727A EP1648706A1 (en) 2003-07-22 2004-07-21 Dot-topography control of dissolution rate of bioactive agents
CN 200480021190 CN1826229A (en) 2003-07-22 2004-07-21 Dot-topography control of dissolution rate of bioactive agents
PCT/US2004/023355 WO2005009738A2 (en) 2003-07-22 2004-07-21 Application of a bioactive agent to a delivery substrate
CN 200480021128 CN1826228A (en) 2003-07-22 2004-07-21 Application of a bioactive agent to a delivery substrate
PCT/US2004/023354 WO2005009737A1 (en) 2003-07-22 2004-07-21 Dot-topography control of dissolution rate of bioactive agents
JP2006521194A JP2006528191A (en) 2003-07-22 2004-07-21 Application of bioactive agent to delivery substrate
EP04778728A EP1648707A2 (en) 2003-07-22 2004-07-21 Application of a bioactive agent to a delivery substrate
JP2006521195A JP2006528192A (en) 2003-07-22 2004-07-21 Application of bioactive agent to delivery substrate
US11/189,139 US20050260273A1 (en) 2001-06-07 2005-07-25 Applicatin of a bioactive agent in a solvent composition to produce a target particle morphology
US11/189,582 US20050271737A1 (en) 2001-06-07 2005-07-25 Application of a bioactive agent to a substrate
US11/189,585 US7767249B2 (en) 2001-06-07 2005-07-25 Preparation of nanoparticles
US11/361,438 US7707964B2 (en) 2001-06-07 2006-02-24 Pharmaceutical dispensing apparatus and method

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US09/877,896 US6623785B2 (en) 2001-06-07 2001-06-07 Pharmaceutical dispensing apparatus and method
US10/625,813 US20040137140A1 (en) 2001-06-07 2003-07-22 Pharmaceutical dispensing apparatus and method

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US10/028,450 Continuation-In-Part US6962715B2 (en) 2001-06-07 2001-10-24 Method and dosage form for dispensing a bioactive substance
US10/801,380 Continuation-In-Part US20040175331A1 (en) 2001-06-07 2004-03-15 Application of a bioactive agent to a delivery substrate
US10/801,379 Continuation-In-Part US20040173146A1 (en) 2001-06-07 2004-03-15 Application of a bioactive agent to a delivery substrate
US10/801,381 Continuation-In-Part US20040173147A1 (en) 2001-06-07 2004-03-15 Application of a bioactive agent to a delivery substrate
US11/361,438 Continuation US7707964B2 (en) 2001-06-07 2006-02-24 Pharmaceutical dispensing apparatus and method

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US10/625,813 Abandoned US20040137140A1 (en) 2001-06-07 2003-07-22 Pharmaceutical dispensing apparatus and method
US11/361,438 Expired - Fee Related US7707964B2 (en) 2001-06-07 2006-02-24 Pharmaceutical dispensing apparatus and method

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CA2449930A1 (en) 2003-01-23
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EP1395223A2 (en) 2004-03-10
US6623785B2 (en) 2003-09-23
MXPA03011221A (en) 2004-03-18
WO2003005950A3 (en) 2003-07-03
US20070056511A1 (en) 2007-03-15
US7707964B2 (en) 2010-05-04
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WO2003005950A2 (en) 2003-01-23
US20020187248A1 (en) 2002-12-12

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