[go: up one dir, main page]

WO1988001160A1 - Gelule et dipositif d'insertion revelant une tentative d'ouverture - Google Patents

Gelule et dipositif d'insertion revelant une tentative d'ouverture Download PDF

Info

Publication number
WO1988001160A1
WO1988001160A1 PCT/US1986/002642 US8602642W WO8801160A1 WO 1988001160 A1 WO1988001160 A1 WO 1988001160A1 US 8602642 W US8602642 W US 8602642W WO 8801160 A1 WO8801160 A1 WO 8801160A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
chamber
hard
hard capsule
cooperational
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.)
Ceased
Application number
PCT/US1986/002642
Other languages
English (en)
Inventor
Raymond J. Hughes
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
Publication of WO1988001160A1 publication Critical patent/WO1988001160A1/fr
Priority to KR1019880700433A priority Critical patent/KR880701538A/ko
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61J3/072—Sealing capsules, e.g. rendering them tamper-proof

Definitions

  • the present invention relates to methods for making hard cap and body type capsules and insert devices, and more particularly to improved method for making plural chamber hard capsule and cooperational tamper evident ingestible disintegratable capsule ohamber.insert device, and to the steps for inserting the device therein.
  • the unified United States Pharmacopeia XX and National Formulary XV are recognized as official compendia in numerous statutes, among which are the federal Food, Drug, and Cosmetic Act and the Poison Prevention Packaging Act, and which include certain standards and re-izirements of the federal Consumer Product Safety Commission. These statutes and their regulations include such definitions and standards by reference.
  • package means the immediate container or wrapping in which any household substance is contained for consumption, use, or storage by indi ⁇ viduals in or about the household, ...
  • the stability parameters of a drug dosage form can be influenced by en ⁇ vironmental conditions of storage ( ... ), as well as the package components. (USP XX - P. 1023).
  • such excess, scrap, or waste material is shredded or granulated or pulverized and agglomerated or otherwise suitably composited, and processed and formed to provide the desired coopera ⁇ tional disintegratable capsule chamber insert device for insertion into a plur ⁇ al chamber capsule, and by this means to form a tamper-evident plural chamber capsule.
  • FIGS. 1 and 2 are a plan view and longitudinal section view taken along line 2-2, respectively, of a plural chamber capsule cooperational disintegratable insert device assembly, with removable, withdrawable, temporary retention cover 13 in place;
  • FTG. 3 is a- longitudinal section view of the plural chamber capsule coopera ⁇ tional insert device taken along the line' 2-2 of FIG. 1, having the removable, ' withdrawable, temporary flexible retention cover 13 removed;
  • FIG. - is a perspective illustration of a plural chamber capsule cooperational disintegratable insert device assembly having a withdrawable, temporary flexi ⁇ ble retention cover 13 in place; the insert device positioned after lateral flexure and resultant fragmentation, by insertion into a corresponding coop ⁇ erational capsule chamber body part, and prior to removal or withdrawal of the temporary flexible retention cover 13;
  • FIG. 5 is a perspective illustration of a plural chamber capsule cooperational fragmented disintegratable insert device in place after lateral flexure and. result4 t fragmentation and insertion within a corresponding capsule chamber, and after removal of the temporary withdrawable flexible retention cover 13;
  • FIGS. 6 and are an elevational and sectional view through line 7-7, respect ⁇ ively, of a plural chamber hard capsule mas ⁇ e by combining two sep.arate coop ⁇ erational capsules of different sizes, one capsule within the other; the inner capsule being a dissimilar irregular figure in transverse cross section general outline;
  • FIGS. 8.and 9 are an elevational and sectional view through the line 9-9, re ⁇ spectively, of a plural chamber hard capsule made by combining two cooperation ⁇ al capsules of different sizes, one within the other; the inner capsule being a dissimilar octagon in transverse cross section general outline;
  • FIGS. 10 and 11 are an elevational and sectional view through line 11-11, re- spectively, of a plural chamber hard capsule made by combining two separate cooperational capsules of different sizes, one within the other; the inner capsule being a dissimilar trapezoid in transverse cross section general outlin
  • FIGS. 12 and 13 are a plan and longitudinal section view through line 13-13, respectively, of a plural chamber hard capsule inner chamber wall forming film insert strip.
  • the cooperational disin ⁇ tegratable plural chamber capsule insert device assembly consists of highly glissant friable tablets, or otherwise composited and formed granules, pellets, or particles 10, separated by highly glissant interstitial filler or separator strips 12 having bending stress point fracture dimples, cruciform scores, notches, or depressions I at interstitial intersections, with a highly gliss ⁇ ant removable, withdrawable temporary flexible retention cover 13 overlaying the insert device assembly, which is flat in general profile outline prior to lateral flexure, to provide, upon bending, an appropriate curvature and frag ⁇ mentation of the insert device for its insertion into a corresponding coopera- tional capsule cha ⁇ mber 15; and which insert device bears upon a flexible sup- porting base mat or tray 11.
  • the plural chamber capsule coopera ⁇ tional insert device proper is ingestible for humans and other animals and is made of methylcellulose, gelatin, starch, or other suitable material or com ⁇ bination thereof, with appropriate additives such as diluents, binders, disin ⁇ tegrators, glidants, lubricants, and FDA or equivalent approved food coloring as may be necessary or desired to formulate the components of the plural cham ⁇ ber capsule cooperational insert device.
  • Such basic ingredient materials and additives are commonly used in the manu acture of pharmaceutical capsules.
  • the removable, withdrawable temporary retention cover 13 is made of flexible material such as plastic or metal and is re-usable after withdrawal following insertion of the cooperational insert device into the corresponding capsule chamber 15.
  • the plural chamber capsule cooperational insert de ⁇ vice assembly is made in a configuration and of appropriate dimensions to fit within and cooperate with, and to conform to the corresponding configuration, curvature, and dimensions of a cooperational chamber 15 of a plural chamber capsule FIGS, and 5, upon bending or flexure, and insertion and containment of the insert device FIG. 1 therein.
  • the present invention provides means to make a plural chamber hard capsule FIG. 6 consisting of two separately formed component capsules in cooperational combination, which are of different appropriate sizes and which are dissimilar in transverse cross section; i. e., the larger outer component capsule 21 is circular or elliptical in general outline and the smaller inner component cap ⁇ sule 22 is irregular in general outline; e. g., having at least one general outline segment in the form of an arc, curve, crescent, notch, ' ,or angular breaks.
  • the inner component capsule 22 is inserted, aligned, and fixed in place by suit ⁇ able means in appropriate position relative to the outer component capsule 21, forming thereby at least one smaller chamber 15 and the larger chamber 23; the smaller chamber 15 being provided by the resultant formation of, and within, a space between the inner surface of the outer component capsule 21 wall and a noncontiguous outer surface area of the inner component capsule 22 wall.
  • FIGS. 8 and 9 are views in ele ⁇ vation and transverse cross section along line 9-9 respectively
  • the present invention provides means to make a plural chamber hard capsule FIG. 8 consist ⁇ ing of two separately formed component capsules in cooperational combination, which .are of different appropriate sizes and which are dissimilar in transverse cross section, i. e., the larger outer component capsule 21 is circular or elliptical in general outline and the smaller inner component capsule -Z is equilateral; octagonal, for example, in general outline.
  • the inner component capsule 2 is inserted, aligned, and fixed by suitable means in place in appro ⁇ priate position relative to the outer component capsule 21, forming thereby at least one smaller chamber 15 and larger chamber 23; the smaller chamber 15 be ⁇ ing provided by the resultant formation of, and within, a space between the in ⁇ ner surface of the outer component capsule 21 wall and a noncontiguous outer surface area of the inner component capsule 2k wall.
  • the pre ⁇ sent invention provides a means to make a plural chamber hard capsule FIG. 10, consisting of two separately formed component capsules in cooperational combin ⁇ ation, which are of different appropriate sizes and which are dissimilar in transverse cross section; i. e., the larger outer component capsule 21 is circular or elliptical in general outline and the smaller inner component cap ⁇ sule 25 is nonequilateral; trapezoidal, for example, in general outline.
  • the inner component capsule 25 is inserted, aligned, and fixed by suitable means in place in appropriate position relative to the outer component capsule 21, forming thereby at least one smaller chamber 15 and larger chamber 23, the smaller chamber 15 being provided by the resultant formation of a space be ⁇ tween the inner surface of the outer component capsule 21 wall and a noncon ⁇ tiguous outer surf ce area of the inner component-capsule 25 wall.
  • FIGS 12 and 13 are views in plan and longitudinal section along line 13-13, respectively, provides a means whereby a pre-formed strip of hard capsule form ⁇ ing film FIG. 12, made methylcellulose, gelatin, or other suitable material, is positioned within the cleft of a plural chamber hard capsule cleft dipping pin (not shown) prior to dipping said dipping pin in a dipping solution; said strip of pre-formed hard capsule forming film FIG. 12 being of appropriate dimensions and configuration to fit and cooperate within the periphery of the dipping pin cleft, and having readily detachable means of temporary retention therein; e. g.
  • notch 26, ridge, crimp, crease, groove, hole, or combination thereof at or near the periphery of the hard capsule film strip, and having an appropriate corresponding opposite formation on one or both sur ⁇ faces of the dipping pin cleft wall (not shown) to retain said hard capsule forming film strip FIG. 12 in position for and during dipping and drying stages of. the plural chamber hard capsule film forming operation; and providing also a means of attachment, e. g., a notch or notches 27, a hole or holes, or a com ⁇ bination thereof, at appropriate locations at or near the edges of the pre ⁇ formed hard capsule film strip FIG.
  • a plural chamber hard capsule FIG. 5 is made tamper evident when, after insertion of a cooperational disintegratable ingestible insert device into a clear, transparent, or translu ⁇ cent capsule chamber 15, the temporary retention cover 13 is withdrawn, the re ⁇ sulting effect of the provision of the curved space made by said withdrawal, together with a relatively high degree of glissance of the components 10, 11, and 12 of the capsule insert device FIG. 3 is to provide a means whereby, after the cooperational insert device FIG.
  • the disintegrat ⁇ ed cooperational device FIG. 3 therefore, will not be capable of integrated - re-insertion into the capsule chamber 15 in its original assembled structure, pattern, or design.
  • inner component capsule means one or more than one inner component of a cooperational capsule combination consisting of an outer capsule and inner capsule assembly, each of the assembly members being separately formed, for making plural chamber hard capsules of the type used for containing medicaments; and each of said inner component members having a trans ⁇ verse cross section which is dissimilar to a corresponding cross section of the larger, outer capsule component member in general outline.

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)

Abstract

Gelule et dispositif d'insertion (10) de gelule résistant à une tentative d'ouverture, ainsi que procédé pour fabriquer des gelules du type à plusieurs chambres et à capuchon et corps durs, constituées chacune d'au moins deux gelules formées séparément et coopérant les unes avec les autres, de sections transversales dissemblables, qui sont en position fixe les unes par rapport aux autres, et dont au moins une gelule constitutive interne (21) est positionnée à l'intérieur d'une gelule externe. On obtient ainsi des gelules à plusieurs chambres, chaque gelule possédant au moins dans la partie corps une chambre (15) transparente, claire ou translucide contenant un médicament ou toute autre substance ou dispositif désirés, et au moins une autre chambre transparente, claire, ou translucide destinée à contenir un dispositif associé d'insertion (10) de gelule, ingérable et décomposable, qui est visible de l'extérieur pour l'utilisateur ou le comsommateur voyant, constituant ainsi une gelule révélant une tentative d'ouverture. Ce dispositif est utile pour prévenir la contamination des médicaments sous forme de gelules.
PCT/US1986/002642 1986-08-19 1986-12-08 Gelule et dipositif d'insertion revelant une tentative d'ouverture Ceased WO1988001160A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1019880700433A KR880701538A (ko) 1986-08-19 1988-04-19 댐퍼가 명백한 캡슐 및 삽입기구

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US89814086A 1986-08-19 1986-08-19
US898,140 1986-08-19

Publications (1)

Publication Number Publication Date
WO1988001160A1 true WO1988001160A1 (fr) 1988-02-25

Family

ID=25409006

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1986/002642 Ceased WO1988001160A1 (fr) 1986-08-19 1986-12-08 Gelule et dipositif d'insertion revelant une tentative d'ouverture

Country Status (6)

Country Link
EP (1) EP0303640A1 (fr)
JP (1) JPH01501843A (fr)
KR (1) KR880701538A (fr)
CN (2) CN86209770U (fr)
AU (1) AU1248388A (fr)
WO (1) WO1988001160A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5154962A (en) * 1988-11-30 1992-10-13 Minnesota Mining And Manufacturing Company Indicia-receptive low adhesion backsize
US5379922A (en) * 1993-08-27 1995-01-10 Paradoski; Ronald I. Tubular container with an adjustable opening
WO2009017716A3 (fr) * 2007-07-27 2009-07-30 Depomed Inc Formes médicamenteuses de rétention gastrique pulsatile
US8377062B2 (en) 2009-12-17 2013-02-19 Stryker Trauma Gmbh Therapeutic agent capsule for implants
US8435239B2 (en) 2009-12-17 2013-05-07 Stryker Trauma Gmbh Encapsulated screw locking system
CN103706509A (zh) * 2013-12-19 2014-04-09 丹东金丸集团有限公司 胶囊生产系统用涂油机
EP3167869A1 (fr) * 2015-11-16 2017-05-17 Capsugel Belgium NV Forme posologique orale inviolable
CN111251521A (zh) * 2018-12-03 2020-06-09 沈欣 液态珠丸的制造模具和制造方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2568094A (en) * 1947-11-12 1951-09-18 Carl S Smith Method and apparatus for forming filled capsules
US3924736A (en) * 1974-03-28 1975-12-09 Container Corp Tamperproof display package
US4522666A (en) * 1982-11-09 1985-06-11 Warner-Lambert Company Apparatus and method for sealing capsules by application of vacuum and steam thereto
US4557505A (en) * 1984-01-05 1985-12-10 Minnesota Mining And Manufacturing Company Stress-opacifying tamper indicating tape

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2568094A (en) * 1947-11-12 1951-09-18 Carl S Smith Method and apparatus for forming filled capsules
US3924736A (en) * 1974-03-28 1975-12-09 Container Corp Tamperproof display package
US4522666A (en) * 1982-11-09 1985-06-11 Warner-Lambert Company Apparatus and method for sealing capsules by application of vacuum and steam thereto
US4557505A (en) * 1984-01-05 1985-12-10 Minnesota Mining And Manufacturing Company Stress-opacifying tamper indicating tape

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5154962A (en) * 1988-11-30 1992-10-13 Minnesota Mining And Manufacturing Company Indicia-receptive low adhesion backsize
US5379922A (en) * 1993-08-27 1995-01-10 Paradoski; Ronald I. Tubular container with an adjustable opening
WO2009017716A3 (fr) * 2007-07-27 2009-07-30 Depomed Inc Formes médicamenteuses de rétention gastrique pulsatile
US8377062B2 (en) 2009-12-17 2013-02-19 Stryker Trauma Gmbh Therapeutic agent capsule for implants
US8435239B2 (en) 2009-12-17 2013-05-07 Stryker Trauma Gmbh Encapsulated screw locking system
US9549767B2 (en) 2009-12-17 2017-01-24 Stryker European Holdings I, Llc Encapsulated screw locking system
CN103706509A (zh) * 2013-12-19 2014-04-09 丹东金丸集团有限公司 胶囊生产系统用涂油机
EP3167869A1 (fr) * 2015-11-16 2017-05-17 Capsugel Belgium NV Forme posologique orale inviolable
WO2017084777A1 (fr) * 2015-11-16 2017-05-26 Capsugel Belgium N.V. Forme posologique orale inviolable
US10470975B2 (en) 2015-11-16 2019-11-12 Capsugel Belgium Nv Tamperproof oral dosage form
CN111251521A (zh) * 2018-12-03 2020-06-09 沈欣 液态珠丸的制造模具和制造方法

Also Published As

Publication number Publication date
CN86209770U (zh) 1987-11-18
AU1248388A (en) 1988-03-08
EP0303640A1 (fr) 1989-02-22
KR880701538A (ko) 1988-11-03
CN87105670A (zh) 1988-05-04
JPH01501843A (ja) 1989-06-29

Similar Documents

Publication Publication Date Title
US4883182A (en) Tamper evident capsule and insert device
US5009894A (en) Arrangement for and method of administering a pharmaceutical preparation
US4158411A (en) Dispensing package
US5511665A (en) Child-resistant package
US5469968A (en) Peel-peel-push childproof packaging structure
US5529188A (en) Child resistant carded type blister folder
ES2277650T3 (es) Contenedor para dispensar.
US4928840A (en) Tamper proof encapsulated medicaments
US2996431A (en) Friable tablet and process for manufacturing same
ES2182729T3 (es) Envase de tiras.
US7337906B2 (en) Pharmaceutical treatment blister card
US5595758A (en) Soft-shelled gelatin encapsulated particles
DE3905851A1 (de) Arzneimittelpackung
JPH08501046A (ja) 薬剤パッケージング
US20040069674A1 (en) Product packaging material for individual temporary storage of pharmaceutical products
CA2366327A1 (fr) Carte personnelle de distribution de medicaments
WO1995002395A1 (fr) Formes posologiques encapsulees
WO1988001160A1 (fr) Gelule et dipositif d'insertion revelant une tentative d'ouverture
US7622137B2 (en) Dosage forms contained within a capsule or sachet
AU2017245390A1 (en) Beverage cartridge containing pharmaceutical actives
EP0305506B1 (fr) Conditionnement pour administrer une preparation pharmaceutique
CN101293582A (zh) 安全型泡罩包装
ES2286810T3 (es) Contenedores para dispensar.
SK3496A3 (en) A gelatin capsule
WO1994025011A1 (fr) Systeme d'apport medicamenteux

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU BB BG BR DK FI HU JP KP KR LK MC MG MW NO RO SD SU

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CF CG CH CM DE FR GA GB IT LU ML MR NL SE SN TD TG