Use of a swelling intermediate layer for controlling the release profile of a solid pharmaceutical form for peroral administration and pharmaceutical form containing said layer

摘要

Use of a swellable intermediate layer comprising a swellable material from the starch, starch derivatives e.g. pre-gelled starch, sodium-carboxyethyl starch, sodium-starchglycolate and cellulose, for releasing the solid medicament formulation for pre-oral application in a continuously extended manner. The formulation comprises a substrate containing active substance, the swellable intermediate layer and a retardant coating layer for adjusting the release profile of the active substance, where the retardant coating layer allows the complete release of the substance towards the end. Use of a swellable intermediate layer comprising a swellable material from the starch, starch derivatives like pre-gelled starch, sodium-carboxyethyl starch, sodium-starchglycolate, cellulose, cellulose ether such as hydroxypropylmethylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, sodium-carboxymethylcellulose, carrageenan, alginate, pectin, xanthane and their derivatives, guar gum, tragant and/or polyvinylpyrrolidone, for releasing the solid medicament formulation for pre-oral application in an continuously extended manner. The formulation comprises a substrate containing active substance, the swellable intermediate layer and a retardant coating layer for adjusting the release profile of the active substance, where the retardant coating layer allows the complete release of the substance towards the end. Independent claims are also included for: (1) a solid medicament formulation for pre-oral application in a continuously extended manner and for adjusting release profile of the active substance, which permits an essentially complete release towards end in effective quantity; and (2) a delayed release of solid medicament formulation.