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1. CA2232356 - METHOD OF PRODUCING MULTI-LAYER MEDICAMENTS IN SOLID FORM FOR ORAL OR RECTAL ADMINISTRATION

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CLAIMS
1. A process for producing multilayer, solid drug forms for oral or rectal administration, which comprises coextrusion of at least two separate compositions which in each case comprise a thermoplastic, pharmacologically acceptable polymeric binder which is soluble or swellable in a physiological environment, and at least one of which contains a pharmaceutical active ingredient, and shaping the coextruded multilayer material to the required drug form, and wherein the mixture of at least two separate compositions has a glass transition temperature below 180°C and said at least two separate compositions are coextruded.
2. The process as claimed in claim 1, wherein the polymeric binder for a layer containing no active ingredient is selected from among hydroxyalkylcelluloses, alkylcelluloses, hydroxyalkylalkylcelluloses, cellulose phthalates, polyacrylates, galactomannans and polylactides.
3. The process as claimed in claim 1 or 2, wherein the polymeric binder for a layer containing active ingredient is selected from among polyvinylpyrrolidones, copolymers of N-vinylpyrrolidone and vinyl esters and hydroxyalkyl acrylates.
4. The process according to any one of claims 1 to 3, wherein an active ingredient which is selected from among ibuprofen, ketoprofen, flurbiprofen, acetylsalicyclic acid, verapamil, paracetamol, nifedipine, caffeine, captopril and vitamins or mixtures of two or more of these active ingredients is used.
5. The process according to any one of claims 1 to 4, wherein to produce closed drug forms the coextrusion is carried out with a concentric annular coextrusion die and the shaping is carried out in a molding calendar or by a hot or cold cut method.
6. The process according to any one of claims 1 to 4, wherein to produce open drug forms the coextrusion is carried out using a slot die and the shaping is carried out by punching.
7. The process as claimed in claim 6, wherein the open drug form is an open multilayer tablet.
8. The process according to any one of claims 1 to 7, wherein the drug form further comprises an outer layer(s), in inner layer and a core, and wherein hydroxypropylcellulose is used as polymeric binder for the outer layer(s), and polyvinylpyrrolidone is used for the inner layer and the core.
9. The process according to any one of claims 5 to 8, wherein ibuprofen atone or ibuprofen/caffeine or vitamins A, C, E are used as active ingredient, with the ibuprofen or the vitamins A and E being located in the core and the caffeine or the vitamin C being located in the outer layer.
10. The process according to any one of claims 1 to 9, wherein the multilayer drug forms are, in a subsequent step, rounded and/or provided with a coating.
11. A multilayer solid drug form for oral or rectal administration obtained by
process as claimed in any one of claims 1 to 10.