CA2129254A1 - Improved Method for Manufacturing Freeze Dried Dosages in a Multilaminate Blister Pack - Google Patents

Improved Method for Manufacturing Freeze Dried Dosages in a Multilaminate Blister Pack

Info

Publication number
CA2129254A1
CA2129254A1 CA2129254A CA2129254A CA2129254A1 CA 2129254 A1 CA2129254 A1 CA 2129254A1 CA 2129254 A CA2129254 A CA 2129254A CA 2129254 A CA2129254 A CA 2129254A CA 2129254 A1 CA2129254 A1 CA 2129254A1
Authority
CA
Canada
Prior art keywords
dosages
sheet
freeze dried
improved method
buster
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.)
Granted
Application number
CA2129254A
Other languages
French (fr)
Other versions
CA2129254C (en
Inventor
Patrick Kearney
Andrew Roy Thompson
Richard John Yarwood
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.)
Catalent UK Swindon Encaps Ltd
Original Assignee
Patrick Kearney
Andrew Roy Thompson
Richard John Yarwood
R.P. Scherer Ltd.
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 Patrick Kearney, Andrew Roy Thompson, Richard John Yarwood, R.P. Scherer Ltd. filed Critical Patrick Kearney
Publication of CA2129254A1 publication Critical patent/CA2129254A1/en
Application granted granted Critical
Publication of CA2129254C publication Critical patent/CA2129254C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00—Layered products having a general shape other than plane
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/20—Layered products comprising a layer of metal comprising aluminium or copper
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/304—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/34—Layered products comprising a layer of synthetic resin comprising polyamides
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging

Abstract

An improved method for manufacturing freeze dried pharmaceutical tablets in blister packs is disclosed. Liquid dosages are introduced into a multilayer laminated buster sheet having an impermeable intermediate layer (14) that is positioned between first and second outer layers (16, 18) each of which has substantially the same coefficient of thermal expansion. The properties of the outer layers of the blister sheet are such that there are no inter-layer stresses that will cause curvature of the buster sheet when it is subjected to temperature changes during the freezing and freeze drying sips. Following the introduction of the dosages into the depressions (10) of the blister sheet, the dosages are frozen and freeze dried. A lidding sheet (32) is then attached to the blister sheet to seal the solid dosages into the buster pack.
CA002129254A 1992-12-01 1993-11-30 Improved method for manufacturing freeze dried dosages in a multilaminate blister pack Expired - Fee Related CA2129254C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/985,040 1992-12-01
US07/985,040 US5343672A (en) 1992-12-01 1992-12-01 Method for manufacturing freeze dried dosages in a multilaminate blister pack
PCT/GB1993/002459 WO1994012142A1 (en) 1992-12-01 1993-11-30 Improved method for manufacturing freeze dried dosages in a multilaminate blister pack

Publications (2)

Publication Number Publication Date
CA2129254A1 true CA2129254A1 (en) 1994-06-09
CA2129254C CA2129254C (en) 1999-11-23

Family

ID=25531135

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002129254A Expired - Fee Related CA2129254C (en) 1992-12-01 1993-11-30 Improved method for manufacturing freeze dried dosages in a multilaminate blister pack

Country Status (18)

Country Link
US (2) US5343672A (en)
EP (2) EP0646367B1 (en)
JP (2) JP2568479B2 (en)
KR (1) KR100227315B1 (en)
CN (1) CN1066937C (en)
AT (2) ATE153530T1 (en)
AU (1) AU677030B2 (en)
BR (1) BR9305805A (en)
CA (1) CA2129254C (en)
DE (2) DE69311109T2 (en)
ES (2) ES2118368T3 (en)
FI (1) FI105149B (en)
GR (1) GR3023853T3 (en)
HK (2) HK1007489A1 (en)
HU (1) HU216509B (en)
NO (1) NO303161B1 (en)
NZ (1) NZ258600A (en)
WO (1) WO1994012142A1 (en)

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HU9402091D0 (en) 1994-10-28
AU5654594A (en) 1994-06-22
US5343672A (en) 1994-09-06
EP0710101B1 (en) 1998-05-06
KR950700046A (en) 1995-01-16
KR100227315B1 (en) 1999-11-01
EP0646367A2 (en) 1995-04-05
JP2568479B2 (en) 1997-01-08
JPH08187271A (en) 1996-07-23
DE69318429D1 (en) 1998-06-10
ATE153530T1 (en) 1997-06-15
AU677030B2 (en) 1997-04-10
DE69318429T2 (en) 1998-09-03
ES2102143T3 (en) 1997-07-16
FI943537A (en) 1994-07-27
HUT69435A (en) 1995-09-28
CN1066937C (en) 2001-06-13
NO942805L (en) 1994-07-28
WO1994012142A1 (en) 1994-06-09
FI105149B (en) 2000-06-30
CA2129254C (en) 1999-11-23
JP2796578B2 (en) 1998-09-10
HK1007489A1 (en) 1999-04-16
JPH07508676A (en) 1995-09-28
HU216509B (en) 1999-07-28
HK1013245A1 (en) 1999-08-20
EP0646367B1 (en) 1997-05-28
ES2118368T3 (en) 1998-09-16
NZ258600A (en) 1995-12-21
US5729958A (en) 1998-03-24
FI943537A0 (en) 1994-07-27
EP0646367A3 (en) 1995-07-05
DE69311109D1 (en) 1997-07-03
GR3023853T3 (en) 1997-09-30
EP0710101A1 (en) 1996-05-08
NO303161B1 (en) 1998-06-08
CN1089829A (en) 1994-07-27
ATE165730T1 (en) 1998-05-15
DE69311109T2 (en) 1997-09-25
NO942805D0 (en) 1994-07-28
BR9305805A (en) 1997-02-18

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