Time-release laminar pharmaceutical composition

Details Time-release laminar pharmaceutical composition Time-release laminar pharmaceutical composition

1998-04-13

2001-10-23

Bawa, Raj (Department: 1619)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Specially adapted for ruminant animal

Reexamination Certificate

active

06306428

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to laminar forms of medication made from rolled or folded polymer films which contain an active substance.
BACKGROUND OF THE INVENTION
Rolling-up polymer films which contain active substances, to produce forms of medication, is known. EP 0 209 212, EP 0 086 997, and EP 0 122 574 describe embedding active substances in polymer films for delayed release. These films are processed individually or in comminuted form into capsules, or compressed into tablets. Delayed release is essentially determined by the type of film and by the size of its surface area. At the beginning of active substance release, the entire film surface is soon in contact with the digestive fluids, and therefore is available to release the active substance.
EP-A 010 987 describes rolling-up a film which contains an active substance, for the administration of veterinary medications to ruminants, where the primary form is supposed to unroll after administration and expand to form an enlarged secondary form. The purpose of the volume expansion is so that the medication remains in the rumen for a longer time. The release of the active substance then also takes place from the entire surface area of the film, which is accessible to the digestive juices. A laminate which is produced with a pressure-sensitive adhesive, in accordance with EP-A 363 187, is also supposed to act in a similar manner. This is also described in EP-A 350 188.
It has also been proposed to introduce rolled-up films which contain active substances into body cavities, e.g., EP-A 447 719, specifically for therapy of middle-ear infections, or, according to JP-Abstract 82-90967 (Derwent), intravaginally for administration of spermicides as a contraceptive. In these cases, only local release of active substance is intended, and here again, one can assume that the film roll will soon expand because it absorbs moisture, and that the active substance will be released from the loosened film laminate.
A form of medication which floats in the stomach is described in EP-A 326 816. Here, polymer films enriched with the active substance are processed to produce various shapes, which are supposed to have an extended dwell time in the stomach because of the use of porous materials in them, along with other materials, or inclusion of air. As a further development of this idea, DE 4419818 mentions rolled films which remain in the stomach for an extended period of time because they unfold, and are intended to pass through the pylorus passage only with difficulty because of their size, which is greater than 5 cm
2
. Here again, the entire surface area of the film becomes available for active substance release after the film has unfolded or expanded.
SUMMARY OF THE INVENTION
An object of the present invention to make available a time-release pharmaceutical composition comprising: a core which contains an active substance, and a film sheath, or a sponge-like matrix structure. Controlled active substance release is accomplished with 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 its entire surface area in the rolled or folded state, and that 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 that at least 30% of the active substance contained in it is released in the rolled or folded state.


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