ES2118368T3 - Procedimiento de fabricacion de dosis liofilizadas en envase de burbujas. - Google Patents

Procedimiento de fabricacion de dosis liofilizadas en envase de burbujas.

Info

Publication number
ES2118368T3
ES2118368T3 ES94902027T ES94902027T ES2118368T3 ES 2118368 T3 ES2118368 T3 ES 2118368T3 ES 94902027 T ES94902027 T ES 94902027T ES 94902027 T ES94902027 T ES 94902027T ES 2118368 T3 ES2118368 T3 ES 2118368T3
Authority
ES
Spain
Prior art keywords
bubble
doses
freeze
leaf
dry
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
ES94902027T
Other languages
English (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 Pharma Solutions Inc
Original Assignee
Catalent Pharma Solutions Inc
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 Catalent Pharma Solutions Inc filed Critical Catalent Pharma Solutions Inc
Application granted granted Critical
Publication of ES2118368T3 publication Critical patent/ES2118368T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • 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
    • 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
    • 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
    • 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 non-planar shape
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Composite Materials (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Laminated Bodies (AREA)
  • Medicinal Preparation (AREA)
  • Wrappers (AREA)
  • Compounds Of Alkaline-Earth Elements, Aluminum Or Rare-Earth Metals (AREA)
  • Seasonings (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

SE DESCRIBE UN METODO MEJORADO PARA FABRICAR TABLETAS FARMACEUTICAS HELADAS EN SECO EN PAQUETES DE BURBUJA. LAS DOSIS DE LIQUIDO SE INTRODUCEN EN UNA HOJA DE BURBUJA LAMINADA MULTICAPA QUE TIENE UN CAPA INTERMEDIA IMPERMEABLE (14) QUE ESTA SITUADA ENTRE LA PRIMERA Y SEGUNDA CAPAS EXTERIORES (16, 18) CADA UNA DE LAS CUALES TIENE SUSTANCIALMENTE EL MISMO COEFICIENTE DE EXPANSION TERMICA. LAS PROPIEDADES DE LAS CAPAS EXTERIORES DE LA HOJA DE BURBUJA SON TALES QUE NO HAY TENSIONES ENTRE LAS CAPAS QUE CAUSEN LA CURVATURA DE LA HOJA DE BURBUJA CUANDO SEA SOMETIDA A CAMBIOS DE TEMPERATURAS DURANTE LOS PASOS DE CONGELACION Y HELADO EN SECO. DESPUES DE LA INTRODUCCION DE LAS DOSIS EN LAS DEPRESIONES (10) DE LA HOJA DE BURBUJA, LAS DOSIS SON CONGELADAS Y HELADAS EN SECO. UNA LAMINA PARA TAPAR (32) ES UNIDA ENTONCES A LA HOJA DE BURBUJA PARA CERRAR HERMETICAMENTE LAS DOSIS SOLIDAS EN EL PAQUETE DE BURBUJA.
ES94902027T 1992-12-01 1993-11-30 Procedimiento de fabricacion de dosis liofilizadas en envase de burbujas. Expired - Lifetime ES2118368T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US07/985,040 US5343672A (en) 1992-12-01 1992-12-01 Method for manufacturing freeze dried dosages in a multilaminate blister pack

Publications (1)

Publication Number Publication Date
ES2118368T3 true ES2118368T3 (es) 1998-09-16

Family

ID=25531135

Family Applications (2)

Application Number Title Priority Date Filing Date
ES94203739T Expired - Lifetime ES2102143T3 (es) 1992-12-01 1993-11-30 Procedimiento perfeccionado de fabricacion de dosis secadas en estado congelado en un envase de burbuja multilaminar.
ES94902027T Expired - Lifetime ES2118368T3 (es) 1992-12-01 1993-11-30 Procedimiento de fabricacion de dosis liofilizadas en envase de burbujas.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES94203739T Expired - Lifetime ES2102143T3 (es) 1992-12-01 1993-11-30 Procedimiento perfeccionado de fabricacion de dosis secadas en estado congelado en un envase de burbuja multilaminar.

Country Status (17)

Country Link
US (2) US5343672A (es)
EP (2) EP0710101B1 (es)
JP (2) JP2568479B2 (es)
KR (1) KR100227315B1 (es)
CN (1) CN1066937C (es)
AT (2) ATE165730T1 (es)
AU (1) AU677030B2 (es)
BR (1) BR9305805A (es)
CA (1) CA2129254C (es)
DE (2) DE69311109T2 (es)
ES (2) ES2102143T3 (es)
FI (1) FI105149B (es)
GR (1) GR3023853T3 (es)
HU (1) HU216509B (es)
NO (1) NO303161B1 (es)
NZ (1) NZ258600A (es)
WO (1) WO1994012142A1 (es)

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ATE153530T1 (de) 1997-06-15
KR100227315B1 (ko) 1999-11-01
FI943537A0 (fi) 1994-07-27
JPH07508676A (ja) 1995-09-28
HK1007489A1 (en) 1999-04-16
WO1994012142A1 (en) 1994-06-09
HU9402091D0 (en) 1994-10-28
DE69318429D1 (de) 1998-06-10
NZ258600A (en) 1995-12-21
EP0646367A3 (en) 1995-07-05
HK1013245A1 (en) 1999-08-20
FI943537L (fi) 1994-07-27
US5729958A (en) 1998-03-24
JPH08187271A (ja) 1996-07-23
KR950700046A (ko) 1995-01-16
CA2129254C (en) 1999-11-23
EP0710101B1 (en) 1998-05-06
CA2129254A1 (en) 1994-06-09
HUT69435A (en) 1995-09-28
JP2568479B2 (ja) 1997-01-08
DE69311109D1 (de) 1997-07-03
ES2102143T3 (es) 1997-07-16
ATE165730T1 (de) 1998-05-15
DE69318429T2 (de) 1998-09-03
CN1089829A (zh) 1994-07-27
HU216509B (hu) 1999-07-28
US5343672A (en) 1994-09-06
FI105149B (fi) 2000-06-30
CN1066937C (zh) 2001-06-13
AU5654594A (en) 1994-06-22
GR3023853T3 (en) 1997-09-30
NO942805L (no) 1994-07-28
BR9305805A (pt) 1997-02-18
EP0646367B1 (en) 1997-05-28
EP0646367A2 (en) 1995-04-05
DE69311109T2 (de) 1997-09-25
NO942805D0 (no) 1994-07-28
JP2796578B2 (ja) 1998-09-10
EP0710101A1 (en) 1996-05-08
NO303161B1 (no) 1998-06-08
AU677030B2 (en) 1997-04-10

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