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WO2017081569A1 - Capsule et procédé de fabrication d'une capsule - Google Patents

Capsule et procédé de fabrication d'une capsule Download PDF

Info

Publication number
WO2017081569A1
WO2017081569A1 PCT/IB2016/056322 IB2016056322W WO2017081569A1 WO 2017081569 A1 WO2017081569 A1 WO 2017081569A1 IB 2016056322 W IB2016056322 W IB 2016056322W WO 2017081569 A1 WO2017081569 A1 WO 2017081569A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
capsule body
locking
diaphragm
side wall
Prior art date
Application number
PCT/IB2016/056322
Other languages
English (en)
Inventor
Tobias Johan LOUW
Original Assignee
Binutra Incorporated
Van Der Walt, Louis Stephanus
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 Binutra Incorporated, Van Der Walt, Louis Stephanus filed Critical Binutra Incorporated
Publication of WO2017081569A1 publication Critical patent/WO2017081569A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

Definitions

  • This invention relates to a digestible pharmaceutical capsule.
  • the invention relates also to a method of manufacturing a digestible pharmaceutical capsule.
  • a digestible pharmaceutical capsule including: a capsule body having a closed end and an open end and a cylindrical side wall extending between the ends; a diaphragm which is at least partially located within the capsule body, the diaphragm having a closed end and an open end and a cylindrical side wall extending between the ends, the capsule being characterised in that at least one of the side wall of the capsule body and the side wall of the diaphragm is resiliently deformable and that the side walls define complementary circumferential locking formations for mechanically locking the diaphragm to the capsule body via engagement of the locking formations, one of the locking formations being the form of a projecting ridge and the other locking formation being in the form of a complementary groove within which the ridge is seated.
  • the side wall of the capsule body may define a circumferential indent defining a first circumferential locking formation in the form of one of the projecting ridge and the complementary groove on one side of the indent and a second circumferential locking formation in the form of a corresponding projecting ridge or groove on the other side of the indent.
  • the first locking formation of the capsule body may comprise the ridge for engagement with the locking formation of the diaphragm in the form of the complementary groove, the second locking formation of the capsule body being in the form of a corresponding groove.
  • the capsule may include an end cap which is located over the capsule body, the end cap having an open end, a closed end and a resiliently deformable cylindrical side wall extending between the ends, the side wall of the end cap defining a circumferential locking formation for mechanically locking the end cap to the capsule body via engagement of the locking formation of the end cap with the second locking formation of the capsule body.
  • the locking formation of the end cap may be in the form of an inwardly-extending ridge which is seated in the groove of the capsule body.
  • the capsule may include an additional diaphragm which is located within the capsule body, the additional diaphragm having a closed end and an open end and a cylindrical side wall extending between the ends.
  • the side wall of the capsule body may define an additional complementary circumferentially locking formation which is longitudinally- spaced from the locking formation thereof and the additional diaphragm may include a complementary circumferential locating formation for mechanical locking of the diaphragm to the capsule body via engagement of the locking formation of the diaphragm with the additional locking formation of the capsule body.
  • a method of manufacturing a digestible pharmaceutical capsule including the steps of: providing a capsule body having a closed end and an open end and a cylindrical side wall extending between the ends, the side wall of the capsule body defining a circumferential locking formation in the form of one of a projecting ridge and a groove; providing a diaphragm having a closed end and an open end and a cylindrical side wall extending between the ends, the diaphragm defining a complementary circumferential locking formation in the form of one of a complementary projecting ridge and a complementary groove for mechanically locking the diaphragm to the capsule body via engagement of the locking formations; and telescopically inserting the diaphragm into the capsule body until the locking formations are mechanically locked via engagement of the locking formations when the ridge is seated within the groove.
  • the method may include providing the side wall of the capsule body with a circumferential indent defining a pair of circumferential locking formations wherein one side of the indent defines the ridge and the other side of the indent defines the groove.
  • the method may include providing an end cap having an open end, a closed end and a resiliently deformable cylindrical side wall extending between the ends, the side wall of the end cap defining a circumferential locking formation; and telescopically locating the end cap over the open end of the capsule body until the locking formation of the end cap is mechanically locked with a corresponding one of the locking formations of the capsule body via engagement of the locking formations.
  • Figure 1 shows a sectional side view of a digestible pharmaceutical capsule in accordance with the invention
  • Figure 2 shows enlarged detail "A" of Figure 1 ;
  • Figure 3 shows an exploded view of the capsule of Figure 1 ;
  • FIGS. 4A and 4B show, in sequence, the manner in which the capsule is assembled
  • Figures 5A - 5C show fragmentary sectional views of a region of the side walls of the capsule body and the diaphragm of the capsule of Figure 1 , illustrating the resistance to movement of the locking formations thereof when engaged; and Figure 6 shows a sectional side view of another embodiment of a digestible pharmaceutical capsule in accordance with the invention.
  • a digestible pharmaceutical capsule in accordance with the invention is designated generally by the reference numeral 10.
  • the capsule 10 is in the form of a hard shell gelatine capsule comprising, broadly, a capsule body 12, a diaphragm 14 and an end cap 16.
  • the capsule 10 defines a first chamber 18 and a second chamber 20 for holding substances therein.
  • the capsule body 12 has an open end 22 and a closed end 24 and a cylindrical side wall 26 extending between the ends.
  • the side wall 26 is resiliently deformable and defines a circumferential indent which defines a first locking formation in the form of a circumferential inwardly-extending ridge 28 at an inner side of the indent and a second locking formation in the form of a corresponding circumferential outwardly-facing groove 30.
  • the diaphragm 14 is located within the capsule body and has an open end 32, a closed end 34 and a cylindrical side wall 36 which extends between the ends.
  • the cylindrical side wall of the diaphragm is resiliently deformable and defines a circumferential indent providing a locking formation in the form of a circumferential outwardly-facing groove 38 and a corresponding inwardly-extending circumferential ridge 40 at an inner side of the indent.
  • the end cap 16 has a closed end 42, an open end 44 and a resiliently deformable cylindrical side wall 46 which extends between the ends.
  • the cylindrical side wall 46 defines a circumferential indent which defines a locking formation in the form of an inwardly-extending circumferential ridge 50 and a corresponding outwardly-facing groove 48 at an outer side of the indent.
  • the locking formations in the form of circumferential ridges and complementary circumferential grooves provide for location and locking of the diaphragm to an inner side of the capsule body location and locking of the end cap to an outer side of the capsule body by engagement of the complementary locking formations wherein the ridges are seated within the complementary grooves.
  • the invention extends to a method of manufacturing the capsule 10 which includes providing the capsule body 12, the diaphragm 14 and the end cap 16, telescopically inserting the diaphragm into the capsule body (see Figure 4A) until the locking formations are mechanically locked by engagement of the locking formations when the circumferential ridge 28 of the capsule body is received and seated within the circumferential groove 38 of the diaphragm (see Figure 4B) and telescopically locating the end cap 16 over the open ends of the capsule body and the diaphragm (see Figure 4B) and pushing the end cap onto the capsule body until the circumferential ridge 50 of the end cap is received and seated within the circumferential groove 30 of the capsule body.
  • the diaphragm is mechanically locked to an inner side of the capsule body while the end cap is mechanically locked to an outer side of the capsule body.
  • the joint formed by the overlapping walls and engaged locking formations of the diaphragm, capsule body and end cap is braced and thus strengthened by the locking of the end cap onto the capsule body.
  • the lower chamber 20 will typically have a gas and/or a liquid contained therein which is prone to expansion at elevated temperatures while the capsule itself may be subjected to lower ambient pressures, for example, during air travel. This may result in a pressure differential between ambient pressure and internal pressure within a chamber of the capsule which may tend to exert a force on the diaphragm for displacement of the diaphragm relative to the capsule body in a direction for separating the diaphragm from the capsule body thereby potentially compromising the hermetic seal of the chamber 20.
  • FIG. 6 of the drawings another embodiment of a capsule in accordance with the invention is designated by the reference numeral 100.
  • the capsule 100 is similar to the capsule 10, with the only difference being that the capsule 100 comprises three chambers 70.1 , 70.2 and 70.3 defined by two diaphragms 14 which are mechanically locked by complementary locating formations to an inner side of an elongated capsule body 112.
  • the capsule 100 comprises three chambers 70.1 , 70.2 and 70.3 defined by two diaphragms 14 which are mechanically locked by complementary locating formations to an inner side of an elongated capsule body 112.
  • features of the capsule 100 which are the same as and/or similar to features of the capsule 10, are designated by the same and/or similar reference numerals.
  • the locking formations of the capsules 10 and 100 assist in maintaining the structural integrity of the capsules and also assist in ensuring uniformity in the structure of capsules. More specifically, the locking formations provide for uniform location of the diaphragm(s) and end cap relative to the capsule body of each capsule in a batch manufacturing process thereby ensuring that the volumes of the chambers remain constant throughout the batch. This is a significant benefit for ensuring optimal volumetric consistency in the chambers of capsules manufactured in a batch process. It will be appreciated that diaphragms inserted too deep into a capsule body will besides reducing the volume of the chamber for holding a substance, also affect the structural integrity of the capsule as the pressure within the chamber is increased with a reduction in volume.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une capsule pharmaceutique digestible 10 en gélatine qui comprend un corps 12 de capsule, une membrane 14 et un capuchon d'extrémité 16. La capsule délimite une première et une seconde chambre destinées à contenir des substances. Le corps 12 de capsule est déformable élastiquement et délimite un renfoncement circonférentiel comprenant une crête 28 s'étendant vers l'intérieur et une rainure correspondante 30 tournée vers l'extérieur. La membrane 14 est déformable élastiquement et délimite un renfoncement circonférentiel comprenant une rainure 38 tournée vers l'extérieur et une crête correspondante 40 s'étendant vers l'intérieur. Le capuchon d'extrémité 16 délimite un renfoncement circonférentiel comprenant une crête 50 s'étendant vers l'intérieur et une rainure correspondante 48 tournée vers l'extérieur. Dans un état assemblé, la crête 28 du corps de capsule est logée dans la rainure 38 de la membrane tandis que la crête 50 du capuchon d'extrémité est logée dans la rainure 30 du corps de capsule, verrouillant ainsi mécaniquement les composants les uns aux autres.
PCT/IB2016/056322 2015-11-13 2016-10-21 Capsule et procédé de fabrication d'une capsule WO2017081569A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA2015/08387 2015-11-13
ZA201508387 2015-11-13

Publications (1)

Publication Number Publication Date
WO2017081569A1 true WO2017081569A1 (fr) 2017-05-18

Family

ID=58695939

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2016/056322 WO2017081569A1 (fr) 2015-11-13 2016-10-21 Capsule et procédé de fabrication d'une capsule

Country Status (1)

Country Link
WO (1) WO2017081569A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4196565A (en) * 1977-05-20 1980-04-08 S. A. Capsugel AG Method for producing a joined capsule filled with viscous material
US20100209389A1 (en) * 2007-10-19 2010-08-19 Mcinnes Clinton Wesley Multi-Compartmented Container
WO2015082983A1 (fr) * 2013-12-03 2015-06-11 Capsugel Belgium Nv Articles de forme galénique à compartiments multiples

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4196565A (en) * 1977-05-20 1980-04-08 S. A. Capsugel AG Method for producing a joined capsule filled with viscous material
US20100209389A1 (en) * 2007-10-19 2010-08-19 Mcinnes Clinton Wesley Multi-Compartmented Container
WO2015082983A1 (fr) * 2013-12-03 2015-06-11 Capsugel Belgium Nv Articles de forme galénique à compartiments multiples

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