Stabilized controlled release substrate having a coating...

A - Human Necessities – 61 – K

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A61K 9/36 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01) A61K 31/522 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2061824

A stabilized solid controlled release dosage form having a coating derived from an aqueous dispersion of ethylcellulose is obtained by overcoating a substrate including a therapeutically active agent with an aqueous dispersion of ethylcellulose and then curing the coated substrate at a temperature and relative humidity elevated to a suitable level above ambient conditions until the coated dosage form attains a stabilized dissolution profile substantially unaffected by exposure to storage conditions of elevated temperature and/or elevated relative humidity.

Une forme posologique solide, stabilisée, à libération prolongée, avec un enrobage dérivé d'une dispersion aqueuse d'éthylcellulose, est obtenue par revêtement d'un substrat renfermant un agent thérapeutique avec une dispersion aqueuse d'éthylcellulose, puis par réticulation du substrat ainsi enrobé, à une température et à une humidité relative amenées à un niveau assez élevé au-dessus des conditions ambiantes pour que la forme posologique enrobée acquière un profil de dissolution stabilisé, qui ne dépende pratiquement pas de son exposition à des conditions de stockage à température élevée et (ou) à humidité relative élevée.

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