# US 5,343,672 A · Method for manufacturing freeze dried dosages in a multilaminate blister pack

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- Number: US 5,343,672 A
- Document ID: US5343672A
- Status: Granted
- Kind: A
- Application number: 07/985,040
- Filed: 1992-12-01
- Granted: 1994-09-06
- Earliest claimed: 1992-12-01
- Inventors: Patrick Kearney; Andrew R. Thompson; Richard J. Yarwood
- Web page: https://patentgrep.com/patent/US5343672A

## CPC

- B32B 15/08: of synthetic resin
- A61J 1/035: {Blister-type containers (blisters in general B65D75/36)}
- A61K 9/2095: {Tabletting processes}
- B32B 1/00: Layered products having a non-planar shape
- B32B 15/20: comprising aluminium or copper {(B32B15/016 and B32B15/017 take precedence)}
- B32B 27/06: as the main or only constituent of a layer, {which is} next to another layer of {the same or of} a {different material (next to a layer of a particular substance B32B9/045; next to a bituminous or tarry layer B32B11/046; next to a water setting substance layer B32B13/12; next to a metal layer B32B15/08; next to a glass layer B32B17/10; next to a layer formed of natural mineral fibres or particles B32B19/045; next to a wood layer B32B21/08; next to a cellulosic plastic layer B32B23/08; next to a natural or synthetic rubber layer B32B25/08)}
- B32B 27/08: of synthetic resin
- B32B 27/304: {comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF}
- B32B 27/32: comprising polyolefins {(comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30)}
- B32B 27/34: comprising polyamides
- B65D 75/327: {and forming several compartments}
- B32B 2439/80: Medical packaging
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- 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
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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

## Abstract

An improved method for manufacturing freeze dried pharmaceutical tablets in blister packs is disclosed. Liquid dosages are introduced into a multilayer laminated blister sheet having an impermeable intermediate layer that is positioned between first and second outer layers, 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 blister sheet when it is subjected to temperature changes during the freezing and freeze drying steps. Following the introduction of the dosages into the depressions of the blister sheet, the dosages are frozen and freeze dried. A lidding sheet is then attached to the blister sheet to seal the solid dosages into the blister pack.

## Claims

### Claim 1

A method for packaging a freeze-dried dosage formed from a liquid comprising the steps of:
a) forming a first polymeric sheet;
b) forming a second polymeric sheet having substantially the same coefficient of thermal expansion as the first polymeric sheet;
c) forming an aluminum sheet;
d) sandwiching the aluminum sheet between the first and second polymeric sheets to form a multilayer blister film defining a film plane, the multilayer blister film providing a substantially thermally balanced laminate;
e) forming a plurality of depressions in the multilayer blister film;
f) introducing the liquid into the depressions;
g) freezing the liquid, the thermally balanced laminate substantially avoiding warpage of the film plane interposed between the depressions;
h) freeze drying to provide the freeze-dried dosage; and
i) attaching a lidding sheet to the multilayer blister film to seal the depressions thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first and second polymeric sheets are made of the same substances.

### Claim 3 (depends on 2)

The method of claim 2, wherein the first and second polymeric sheets consist essentially of one or more polymers selected from the group consisting of polyethylene, polyamide, polyvinylchloride and polpropylene.

### Claim 4 (depends on 1, 2)

The method of claims 2 or 1, wherein the first and second polymeric sheets have substantially the same thickness.

### Claim 5 (depends on 3)

The method of claim 3, wherein either the first or second polymeric sheet includes a plurality of sublayers.

### Claim 6 (depends on 5)

The method of claim 5, wherein one of the sublayers is a lacquer or priming layer.

### Claim 7 (depends on 5)

The method of claim 5, wherein one of the sublayers is a polymeric substance.