Drug granule coatings that impart smear resistance during...

A - Human Necessities – 61 – K

Patent

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A61K 9/20 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2551825

A drug formulation is disclosed comprising granules having a substrate and a coating, said granule substrate comprising a solubilizing surfactant or a low solubility therapeutic drug, or both, and said granule coating comprising a hydrophilic polymer. Also disclosed is a drug formulation consisting of a tablet core made by mechanical compression, wherein said tablet core comprises granules having a substrate and a coating, said granule substrate comprising a solubilizing surfactant or a low solubility therapeutic drug, or both, and said granule coating comprising a hydrophilic polymer. Also disclosed is a dosage form for oral administration of topiramate, comprising a tablet core and an osmotic delivery system. Methods for controlling topiramate release patterns by altering the composition of the topiramate dosage form are also disclosed.

L'invention concerne une formulation pharmaceutique qui comprend des granulés ayant un substrat et un revêtement. Le substrat comporte un tensioactif solubilisant ou un médicament thérapeutique à faible solubilité, ou les deux, et le revêtement comporte un polymère hydrophile. L'invention concerne aussi une formulation pharmaceutique qui comprend un noyau de comprimé élaboré par compression mécanique, ledit noyau comportant des granulés à substrat et revêtement. Le substrat de granulé comporte un tensioactif solubilisant ou un médicament thérapeutique à faible solubilité, ou les deux, et le revêtement de granulé comporte un polymère hydrophile. L'invention concerne également une forme pharmaceutique de topiramate pour administration orale, à noyau de comprimé et système de délivrance osmotique. L'invention concerne enfin des procédés de contrôle de profil de libération de topiramate par modification de la composition de la formulation de topiramate.

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