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US2693436A - Coating material for tablets and coated tablets - Google Patents

Coating material for tablets and coated tablets Download PDF

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Publication number
US2693436A
US2693436A US213045A US21304551A US2693436A US 2693436 A US2693436 A US 2693436A US 213045 A US213045 A US 213045A US 21304551 A US21304551 A US 21304551A US 2693436 A US2693436 A US 2693436A
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US
United States
Prior art keywords
tablets
coating
parts
sugar
ethyl cellulose
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.)
Expired - Lifetime
Application number
US213045A
Inventor
Arch B Spradling
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.)
Pharmacia and Upjohn Co
Original Assignee
Upjohn Co
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 Upjohn Co filed Critical Upjohn Co
Priority to US213045A priority Critical patent/US2693436A/en
Application granted granted Critical
Publication of US2693436A publication Critical patent/US2693436A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • This invention relates to coated tablets and materials which may be used for coating them to protect their contents and to make them attractive in appearance.
  • the process is slow because many layers have to be applied and there must be drying between applications. This means that as many as sixty to eighty hours may be necessary for drying.
  • An object of this invention is to provide a new and improved coating for tablets and a new and improved coated tablet. Another object is to provide such a tablet with a coating which is more elastic than previouslyknown coatings and which is more resistant to chipping through fracture. Another object is to provide a tablet with a relatively thin coating which can be applied in a shorter time, eliminating extensive and expensive operations. Another object is to provide a thin coating which is sufiiciently opaque to conceal the internal portion of the tablet.
  • a small amount of watersoluble hydroxy ethyl cellulose is added to the syrup which is used in coating the tablets.
  • a coating which is adequate for the tablet and thinner than coating heretofore employed can be applied to the tablet in a relatively short time. This coating is more elastic and adequate coverage can be obtained in fewer processing steps, reducing the amount of material and time required.
  • iinxiris- 0.5 Distilled water 100 Sugar 200
  • the amounts can vary as above pointed out using from from 2 to 7 parts by weight depending upon viscosity. With high viscosity hydroxy ethyl cellulose the lower ranges are employed.
  • the titanium dioxide can be varied from 0.5 to 3 parts by weight.
  • Example About 100,000 compressed tablets which have been given a sealing coat of shellac are placed in a coating pan. These tablets are given four applications of about two pounds each of a subcoating syrup consisting of 3 parts by weight of hydroxy ethyl cellulose, 100 parts by weight of distilled water and 200 parts by weight of sugar. Dusting or filling powder is employed with each coat, as is customary, and the coatings are dried between applications with an air blast.
  • the tablets are rounded by the application of about three pounds of the same solution. During this rounding operation they are tumbled in the pan and dried without the use of an air blast.
  • the color coating is applied to the dried tablets. This consists of 6 parts by weight of hydroxy ethyl cellulose, 0.5 part by Weight of titanium dioxide, coloring material, 100 parts by weight of distilled water and 200 parts by weight of sugar. About nine separate applications are made of this syrup, each application consisting of about two pounds. The quantity is decreased until the last two applications which consist only of enough syrup to wet the surface of all the tablets. An air blast is used continuously until the last three applications.
  • the dried tablets are waxed and polished.
  • a medicinal tablet having a coating thereon comprising intermixed sugar and water-soluble hydroxy ethyl cellulose and titanium dioxide in the proportions oi 200 parts of sugar to 2 to 7 parts of water-soluble hydroxy ethyl cellulose to 0.5 to 3 parts of titanium dioxide and characterized by elasticity and resistance to fracture.
  • a medicinal tablet having a coating thereon comprising intermixed sugar and water-soluble hydroxy ethyl cellulose in the proportions of 200 parts of sugar to 2 to 7 parts of Water-soluble hydroxy ethyl cellulose and characterized by elasticity and resistance to fracture.
  • a composition for coating compressed medicinal tablets or the like comprising a solution in Water of sugar and water-soluble hydroxy ethyl cellulose in the proportion of 200 parts of sugar to 2 to 7 parts of water-soluble hydroxy ethyl cellulose and having suspended therein titanium dioxide.
  • a composition for coating compressed medicinal tablets or the like comprising a solution in water of sugar and Water-soluble hydroxy ethyl cellulose in the propor- 4 tion of 200 parts of sugar to 2 to 7 parts of watersoluble hydroxy ethyl cellulose.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Description

United States Patent O" COATING MATERIAL FOR TABLETS AND COATED TABLETS Arch B. Spradling, Kalamazoo, Mich., assignor to The Upjohn Company, Kalamazoo, Mich., a corporation of Michigan No Drawing. Application February 27, 1951, Serial N0. 213,045
4 Claims. (Cl. 167-82) This invention relates to coated tablets and materials which may be used for coating them to protect their contents and to make them attractive in appearance.
Heretofore tablets have been coated by a lengthy, expensive process which consists in applying a plurality of coatings of sugar syrup with the addition of powdered filler and with intermediate drying between coating applications. During the first portion of a coating process the layers are built up rather fast with sugar syrup and filler. They are dried with an air blast. After the coating has been built up the tablets are shaped with coatings of the syrup and dried with air blast with accompanying tumbling. After the desired shape has been given to the tablets several coatings of colored syrup are added. When these have been dried the tablets are waxed and polished.
Heretofore it has been customary to apply a coating which amounts to approximately one-half the weight of the tablet. It has been diliicult to get a satisfactory coating on corners or sharp edges and it has been therefore necessary to use considerably more coating than would be necessary if the coating could be applied evenly. In fact, on the edges and corners only about 70% as much material is applied as on the rest of the tablet due to the manner in which the coating is applied.
The process is slow because many layers have to be applied and there must be drying between applications. This means that as many as sixty to eighty hours may be necessary for drying.
An object of this invention is to provide a new and improved coating for tablets and a new and improved coated tablet. Another object is to provide such a tablet with a coating which is more elastic than previouslyknown coatings and which is more resistant to chipping through fracture. Another object is to provide a tablet with a relatively thin coating which can be applied in a shorter time, eliminating extensive and expensive operations. Another object is to provide a thin coating which is sufiiciently opaque to conceal the internal portion of the tablet. Other objects and advantages of the invention will be apparent from the following specification:
In carrying out this invention a small amount of watersoluble hydroxy ethyl cellulose is added to the syrup which is used in coating the tablets. After from 2 to 7 parts by weight of such hydroxy ethyl cellulose are added to each 200 parts by weight of sugar in making the syrup, a coating which is adequate for the tablet and thinner than coating heretofore employed can be applied to the tablet in a relatively short time. This coating is more elastic and adequate coverage can be obtained in fewer processing steps, reducing the amount of material and time required.
When such coatings are applied and are thin, the addition of from 0.5 to 3 parts by weight of titanium dioxide to the sugar and hydroxy ethyl cellulose will improve the covering properties. This thinner coat thus gives adequate protection and adequate attractiveness to the tablet.
When such a coating is applied to a tablet the resistance at the corners and sharper edges of the tablets to chipping is increased by a considerable amount. The resistance to fracture may be increased several times. Therefore, it is possible to reduce the amount of coating material and the time to apply it. Savings up to 60% of the man hours involved and 50% of the drying time may be brought about.
In preparing coating solutions in accordance with this invention '100 parts by weight of water are employed with 2,693,436 Patented Nov. 2, T954 No. 25 subcoating syrup:
Parts by weight Hydroxy ethyl cellulose medium viscosity.. 3 0
Distilled water Sugar 200 No. 19 color coating syrup (green):
Hydroxy ethyl cellulose low viscosity 6.0 Titanium dioxide 0.5 PD and C green No. 2 q.s. FD and C yellow No. l q.s. Distilled water 100 Sugar 200.
No. 60 color coating syrup (brown):
Hydroxy ethyl cellulose medium viscosity-" 3.0 Distilled water 100 Brown oxide q.s. Sugar 200 No. 21 color coating syrup (red):
Hydroxy ethyl cellulose low viscosity 6.0 PD and C red No. 1 q.s. Titanium (iinxiris- 0.5 Distilled water 100 Sugar 200 In these examples from 3 to 6 parts by weight of the hydroxy ethyl cellulose are employed, although the amounts can vary as above pointed out using from from 2 to 7 parts by weight depending upon viscosity. With high viscosity hydroxy ethyl cellulose the lower ranges are employed.
The titanium dioxide can be varied from 0.5 to 3 parts by weight.
The following example illustrates a specific application of the invention to the coating of tablets:
Example About 100,000 compressed tablets which have been given a sealing coat of shellac are placed in a coating pan. These tablets are given four applications of about two pounds each of a subcoating syrup consisting of 3 parts by weight of hydroxy ethyl cellulose, 100 parts by weight of distilled water and 200 parts by weight of sugar. Dusting or filling powder is employed with each coat, as is customary, and the coatings are dried between applications with an air blast.
The tablets are rounded by the application of about three pounds of the same solution. During this rounding operation they are tumbled in the pan and dried without the use of an air blast.
Just prior to complete drying another application of syrup is made and the tablets are allowed to dry without any air blast.
The color coating is applied to the dried tablets. This consists of 6 parts by weight of hydroxy ethyl cellulose, 0.5 part by Weight of titanium dioxide, coloring material, 100 parts by weight of distilled water and 200 parts by weight of sugar. About nine separate applications are made of this syrup, each application consisting of about two pounds. The quantity is decreased until the last two applications which consist only of enough syrup to wet the surface of all the tablets. An air blast is used continuously until the last three applications.
The dried tablets are waxed and polished.
About four hours is required for drying the subcoating and the coloring coats.
It will be appreciated by those skilled in the art that the above examples of the syrup and coating procedures have been given by way of illustration only and that variations may be made without departing from the invention. Certain of the variations have been described above. It is not intended that there be any limitation to the specific form of invention described. The invention is defined in the appended claims.
What is claimed is:
1. A medicinal tablet having a coating thereon comprising intermixed sugar and water-soluble hydroxy ethyl cellulose and titanium dioxide in the proportions oi 200 parts of sugar to 2 to 7 parts of water-soluble hydroxy ethyl cellulose to 0.5 to 3 parts of titanium dioxide and characterized by elasticity and resistance to fracture.
2. A medicinal tablet having a coating thereon comprising intermixed sugar and water-soluble hydroxy ethyl cellulose in the proportions of 200 parts of sugar to 2 to 7 parts of Water-soluble hydroxy ethyl cellulose and characterized by elasticity and resistance to fracture.
3. A composition for coating compressed medicinal tablets or the like comprising a solution in Water of sugar and water-soluble hydroxy ethyl cellulose in the proportion of 200 parts of sugar to 2 to 7 parts of water-soluble hydroxy ethyl cellulose and having suspended therein titanium dioxide.
4. A composition for coating compressed medicinal tablets or the like comprising a solution in water of sugar and Water-soluble hydroxy ethyl cellulose in the propor- 4 tion of 200 parts of sugar to 2 to 7 parts of watersoluble hydroxy ethyl cellulose.
References Cited in the file of this patent UNITED STATES PATENTS Number Name Date 2,253,800 Myers et a1 Aug. 26, 1941 2,302,511 Wallach Nov. 17, 1942 2,362,761 Medl Nov. 14, 1944 2,591,742 Thomas Apr. 8, 1952 FOREIGN PATENTS Number Country Date 389,518 Great Britain Mar. 16, 1933 OTHER REFERENCES Hollabaugh et al., Industrial and Engineering Chemistry, pp. 943 to 947.
Mantell, Water Soluble Gums, pp. 152 to 155 (1947).
Rowell, Drug and Cosmetic Ind., vol. 63, No. 4, pp. 459, 460, 549 to 551.
Little et al., Tablet Making, 1949, Pp. 82, 83 and 85.

Claims (1)

1. A MEDICINAL TABLET HAVING A COATING THEREON COMPRISING INTERMIXED SUGAR WATER-SOLUBLE HYDROXY ETHYL CELLULOSE AND TITANIUM DIOXIDE IN THE PROPORTIONS OF 200 PARTS OF SUGAR TO 2 TO 7 PARTS OF WATER-SOLUBLE HYDROXY ETHYL CELLULOSE TO 0.5 TO 3 PARTS OF TITANIUM DIOXIDE AND CHARACTERIZED BY ELASTICITY AND RESISTANCE TO FRACTURE.
US213045A 1951-02-27 1951-02-27 Coating material for tablets and coated tablets Expired - Lifetime US2693436A (en)

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Application Number Priority Date Filing Date Title
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Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2816062A (en) * 1954-05-27 1957-12-10 Univ Illinois Hydroxyethyl cellulose tablet coating
US2925365A (en) * 1957-11-27 1960-02-16 Smith Kline French Lab Coloring solid pharmaceutical forms and compositions therefor
US3054724A (en) * 1960-05-12 1962-09-18 Smith Kline French Lab Coloring discrete solids and compositions therefor
US3097144A (en) * 1960-10-14 1963-07-09 Upjohn Co Heat-cured, polymeric, medicinal dosage film coatings containing a polyvinylpyrrolidone copolymer, polyethenoid acid, and polyethylene glycol
US3132075A (en) * 1960-10-17 1964-05-05 Upjohn Co Solid medicinal dosage forms coated with hydroxyethylcellulose and hydrolyzed styrene-maleic anhydride copolymer
US3293133A (en) * 1963-04-24 1966-12-20 Squibb & Sons Inc Method of imparting color to pharmaceutical solutions
US3361631A (en) * 1963-09-30 1968-01-02 Sandoz Ag Method of sugar coating pharmaceutical tablets
US3395202A (en) * 1963-06-14 1968-07-30 American Cyanamid Co Pigment composition for marking gelating capsules
US3413400A (en) * 1964-08-27 1968-11-26 Geigy Chem Corp Colored pharmaceutical coating compositions
US3421920A (en) * 1965-05-25 1969-01-14 Ciba Geigy Corp Tablet coating containing a linear poly-1,3-beta-glucoside
US3475187A (en) * 1967-06-13 1969-10-28 Rex Lab Inc Edible indelible ink for pharmaceutical pellets
US3798054A (en) * 1970-09-25 1974-03-19 H Kawada Method of sugar coating tablets
EP0023327A2 (en) * 1979-07-31 1981-02-04 Eisai Co., Ltd. Sugar-coated tablet containing fat-soluble pharmaceutical material
US4720378A (en) * 1981-03-09 1988-01-19 Imperial Chemical Industries Plc Coated colored intagliated articles

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB389518A (en) * 1931-09-16 1933-03-16 Henry Dreyfus Improvements in the production of filaments and the like
US2253800A (en) * 1936-01-03 1941-08-26 Myers Medicinal lozenge and process of froducing the same
US2302511A (en) * 1940-03-22 1942-11-17 Sylvania Ind Corp Carbohydrates and process of modifying the absorbability thereof
US2362761A (en) * 1942-06-15 1944-11-14 Hercules Powder Co Ltd Water-soluble cellulose ether composition
US2591742A (en) * 1949-11-22 1952-04-08 Thomas Enteric medicament

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB389518A (en) * 1931-09-16 1933-03-16 Henry Dreyfus Improvements in the production of filaments and the like
US2253800A (en) * 1936-01-03 1941-08-26 Myers Medicinal lozenge and process of froducing the same
US2302511A (en) * 1940-03-22 1942-11-17 Sylvania Ind Corp Carbohydrates and process of modifying the absorbability thereof
US2362761A (en) * 1942-06-15 1944-11-14 Hercules Powder Co Ltd Water-soluble cellulose ether composition
US2591742A (en) * 1949-11-22 1952-04-08 Thomas Enteric medicament

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2816062A (en) * 1954-05-27 1957-12-10 Univ Illinois Hydroxyethyl cellulose tablet coating
US2925365A (en) * 1957-11-27 1960-02-16 Smith Kline French Lab Coloring solid pharmaceutical forms and compositions therefor
US3054724A (en) * 1960-05-12 1962-09-18 Smith Kline French Lab Coloring discrete solids and compositions therefor
US3097144A (en) * 1960-10-14 1963-07-09 Upjohn Co Heat-cured, polymeric, medicinal dosage film coatings containing a polyvinylpyrrolidone copolymer, polyethenoid acid, and polyethylene glycol
US3132075A (en) * 1960-10-17 1964-05-05 Upjohn Co Solid medicinal dosage forms coated with hydroxyethylcellulose and hydrolyzed styrene-maleic anhydride copolymer
US3293133A (en) * 1963-04-24 1966-12-20 Squibb & Sons Inc Method of imparting color to pharmaceutical solutions
US3395202A (en) * 1963-06-14 1968-07-30 American Cyanamid Co Pigment composition for marking gelating capsules
US3361631A (en) * 1963-09-30 1968-01-02 Sandoz Ag Method of sugar coating pharmaceutical tablets
US3413400A (en) * 1964-08-27 1968-11-26 Geigy Chem Corp Colored pharmaceutical coating compositions
US3421920A (en) * 1965-05-25 1969-01-14 Ciba Geigy Corp Tablet coating containing a linear poly-1,3-beta-glucoside
US3475187A (en) * 1967-06-13 1969-10-28 Rex Lab Inc Edible indelible ink for pharmaceutical pellets
US3798054A (en) * 1970-09-25 1974-03-19 H Kawada Method of sugar coating tablets
EP0023327A2 (en) * 1979-07-31 1981-02-04 Eisai Co., Ltd. Sugar-coated tablet containing fat-soluble pharmaceutical material
EP0023327A3 (en) * 1979-07-31 1981-10-21 Eisai Co., Ltd. Sugar-coated tablet containing fat-soluble pharmaceutical material
US4421738A (en) * 1979-07-31 1983-12-20 Eisai Co., Ltd. Sugar-coated tablet containing fat-soluble pharmaceutical material
US4720378A (en) * 1981-03-09 1988-01-19 Imperial Chemical Industries Plc Coated colored intagliated articles

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