Stable packaging system for moisture and oxygen sensitive pharmaceutical dosage forms
AssigneeAscent Pharmaceuticals, Inc.
InventorsSridhar Gumudavelli, Sudhakar Vidiyala, Madhava Reddy
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Abstract
The invention describes a blister packaging system, and method of making the system, capable of establishing and maintaining arid and anaerobic conditions for packaging pharmaceutical products that are sensitive to oxygen and/or moisture. The blister packaging system encompasses, for example, a scaffold of several interconnected cavities intended for product and one or more reservoirs comprising an oxygen scavenger and/or a desiccant. Furthermore, the concentration of the components is maintained at a level that prevents establishment of equilibrium conditions.
Claims17
A packaging system for a pharmaceutical product that is sensitive to oxygen and/or moisture comprising:
- a blister pack comprising:
- (i) a blister sheet comprising of an array of interconnected cavities connected through channels that allows the exchange of air between them;
- (ii) wherein one or more of the cavities serve as a reservoirs holding an oxygen scavenger and/or a desiccant at concentrations high enough to provide higher equilibration time for oxygen and/or moisture;
- (iii) further wherein one or more of the cavities comprise at least one pharmaceutical product that is sensitive to oxygen and/or moisture;
- and
- (iii) a frangible lidding sealed to the sheet protecting the product in the cavity.
A blister package for an oxygen and/or moisture sensitive pharmaceutical product comprising:
- (i) a shaped film comprising:
- (A) a plurality of cavities configured to each hold a single unit dose of the pharmaceutical product, and
- (B) at least one airflow channel, and
- (C) at least one reservoir;
- wherein the at least one airflow channel connects each of the plurality of cavities to the at least one reservoir;
- (ii) a frangible lidding sealed to the shaped film so that the unit dose is substantially confined between said frangible lidding and said at least one cavity;
- (iii) an absorbent confined between the reservoir and the frangible lidding;
- (iii) optionally a backing film;
- and
- (iv) single unit doses of an oxygen and/or moisture sensitive pharmaceutical product confined between the cavities and the frangible lidding.
Dependencies are inferred from the claim text.