Time-release laminar pharmaceutical composition
AssigneeRoehm GmbH Chemische Fabrik
InventorsKlaus Lehmann, Hans-Ulrich Petereit
Life of this patent
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Abstract
A time-release laminar pharmaceutical composition, comprised of rolled or folded layers of a polymer film, that contain a pharmaceutically active substance, in which the outer surface area of the polymer film which contains the active substance, and which is accessible to the digestive juices, amounts to at most 25% of the entire surface area in the rolled or folded state, and the rolled or folded layers adhere to one another in such a way that the laminar form of medication maintains its rolled or folded form for a period of at least one hour in the release test according to USP 23, Method A, apparatus 2, at 37° C. and 50 rpm, in artificial gastric juice, and at least 30% of the active substance contained in it is released in the rolled or folded state.
Claims12
A laminar time-release pharmaceufical composition comprising:
- a polymer film containing a pharmaceutically active agent absorbed therein, wherein
- the polymer film is rolled or folded to form a laminar structure in which the rolled or folded layers of the polymer film adhere to one another and form successive layers of the laminar structure, and the area of the outer surface of the laminar structure is at most 25% of the surface area of the polymer film, and
- the rolled or folded layers adhere to one another so that the laminar structure does not unroll or unfold for a period of at least one hour during a release test according to USP 23, Method A, apparatus 2, at 37° C. and 50 rpm, in artificial gastric juice, and
- at least 30% of the active agent is released before the laminar structure unrolls or unfolds, and
- the laminar time-release pharmaceutical composition dissolves or decomposes under the conditions of the digestive tract.
Dependencies are inferred from the claim text.