Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1998-04-15
2000-09-19
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424474, 424480, A61K 920, A61K 928, A61K 936
Patent
active
061208027
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a process for producing multilayer, solid drug forms for oral or rectal administration, and to the drug forms obtainable by the process according to the invention.
Drug forms consisting of several layers, for example laminated or multilayer tablets, which may be coated, are increasingly being used, for example in order to combine active ingredients which are incompatible with one another or to bring about release of initial and maintenance doses in the case of controlled-release drug forms. Drug forms of these types are produced by classical methods. Thus, laminated tablets are produced by dry coating, and multilayer tablets are produced by compressing two or more layers of granules. Special machines are required therefor and resemble in their mode of operation the conventional rotary machines, with at least two filling and compressing stations being required. These conventional processes are therefore elaborate and cost-intensive.
A process for producing tablets which is considerably simpler than the classical multistage, batchwise tabletting process has been known for some time. It comprises taking up the active ingredient in a polymeric binder, extruding the polymer melt containing the active ingredient, and shaping the extrudate emerging from the extruder in a suitable manner, see, for example, EP-A-240 904 and 240 906.
Coextrusion is known in plastics technology and entails the melt streams from a plurality of extruders being combined in a mold so that the required layer structure of various thermoplastics results. The use of coextrusion in the drugs industry is mainly confined to the production of packaging films. In addition, the production of polymer capsules and coated active ingredients in the form of a fish medicine and of an implant is known:
WO-A-89/12442 describes a pharmaceutical dosage form for the medication of fish. As a rule, drugs are administered to fish via the feed, ie. the drug is mixed with the feed. The problem with this was that the drug-containing feed was not accepted by the fish because of its taste. The consequence of this was that a large part of the drug-containing feed remained in the water for a lengthy period, remained unused and could sink. This led to unwanted release of the drug into the water, which naturally led to contamination of the water.
To solve this problem, WO 89/12442 proposes a dosage form which is obtained by coextrusion and which consists of an outer layer which surrounds an inner chamber. The outer layer consists of a starch derivative which contains a suitable animal or vegetable material in order to make the dosage form acceptable to the fish. In addition, the outer layer is impermeable to water and to the active ingredient contained in the inner chamber. The inner chamber contains the active ingredient in a viscous suspension which only partly fills the chamber. This provides an air space which confers on the dosage form the necessary buoyancy for it not to sink but float in the water.
U.S. Pat. No. 5,283,187 describes an implant which comprises as active ingredient a cell suspension which is enclosed in a semipermeable polymer membrane. The implant is produced by coextrusion of the cell suspension with a solution of the polymer in a suitable water-miscible organic solvent. The polymer must be chosen so that it coagulates on extrusion and forms a network of channels so that the membrane becomes semipermeable.
EP-A-303 306 describes a cylindrical implant which has a core of an ethylene/vinyl acetate copolymer with a melt flow index of more than 10 g/10 min and a vinyl acetate content of at least 20% by weight. The core is surrounded by a membrane with a thickness of 50 bis 250 .mu.m which likewise consists of an ethylene/vinyl acetate copolymer. This polymer has, however, a melt flow index of less than 10 g/10 min and a vinyl acetate content of less than 20% by weight. The membrane serves to control the release of the active ingredient contained in the core, a contraceptive, in such a way that the latter is released in
REFERENCES:
patent: 4801460 (1989-01-01), Goertz et al.
patent: 4880585 (1989-11-01), Klimesch et al.
patent: 5283187 (1994-02-01), Aebischer et al.
patent: 5681583 (1997-10-01), Conte et al.
Breitenbach Jorg
Hartl Axel Paul
Hofmann Jurgen
Rosenberg Joerg
Schiessl Michael
BASF - Aktiengesellschaft
Howard S.
Page Thurman K.
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