Formable film for cold-form, blister-type pharmaceutical packaging
OwnerStephen Franzyshen, Christine Creeganinventors
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Abstract
Cold-formable film composite structures useful for pharmaceutical blister packaging may be constructed from a first polyester surface layer that has a low extractables level, an aluminum layer adhered to the first surface layer, and an additional layer adhered to the aluminum layer. A second surface layer may be adhered to the additional layer. Blister packs may be prepared from such composite structures by cold-forming the structures such that the first polyester surface layer is inside the blister, facing the pharmaceutical. The use of a low-extractables material on the inside surface of the blister minimizes the potential for contamination of the pharmaceutical within the package.
Claims28
A film composite structure comprising a first surface layer, said first surface layer comprising a biaxially oriented polyester film layer having an extractables level less than 15,000 ppm by weight, the composite structure further comprising:
- (a) a first adhesive layer on said first surface layer;
- (b) an aluminum layer on said adhesive layer;
- and
- (c) an additional layer over said aluminum layer;
- wherein the film composite structure is a cold-formable structure suitable for non-contaminating contact with a pharmaceutical product.
A pharmaceutical product container comprising a film composite structure comprising a first surface layer, said first surface layer comprising a biaxially oriented polyester film layer having an extractables level less than 15,000 ppm by weight, the composite structure further comprising:
- (a) a first adhesive layer on said first surface layer;
- (b) an aluminum layer on said adhesive layer;
- and
- (c) an additional layer over said aluminum layer;
- wherein the film composite structure is a cold-formable structure suitable for non-contaminating contact with a pharmaceutical product;
- and
- wherein the film composite structure comprises a blister, surrounded by a flange, having a concave inner surface defining a cavity adapted to receive said pharmaceutical product, the first surface layer of the structure forming the concave inner surface.
A method for forming a pharmaceutical product container comprising a film composite structure comprising a first surface layer, said first surface layer comprising a biaxially oriented polyester film layer having an extractables level less than 15,000 ppm by weight, the composite structure further comprising:
- (a) a first adhesive layer on said first surface layer;
- (b) an aluminum layer on said adhesive layer;
- and
- (c) an additional layer over said aluminum layer;
- wherein the film composite structure is a cold-formable structure suitable for non-contaminating contact with a pharmaceutical product;
- and
- wherein the film composite structure comprises a blister, surrounded by a flange, having a concave inner surface defining a cavity adapted to receive said pharmaceutical product, the first surface layer of the structure forming the concave inner surface;
- the method comprising:
- (a) providing a complementary pair of die elements;
- (b) positioning said composite structure between said elements;
- and
- (c) pressing said die pair elements in complementary engagement without applying external heating to said composite structure to cold-form said composite structure, thereby forming said cavity.
Dependencies are inferred from the claim text.