Sustained release preparation and method for production thereof

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/22 (2006.01) A61K 31/222 (2006.01) A61K 47/32 (2006.01) A61K 47/38 (2006.01) A61P 13/02 (2006.01)

Patent

CA 2632962

Disclosed is a sustained release preparation which comprises an active ingredient having a higher release rate at pH 4 compared to that in pH 1.2 or pH 6.8 and exerts a controlled release of the active ingredient in a pH- independent manner. The sustained release preparation comprises ethyl (-)-2-[4- [2-[[(1S,2R)-2- hydroxy-2-(4-hydroxyphenyl)-1-methylethyl]amino]ethyl]2,5- dimethylphenoxy]acetate hydrochloride as the active ingredient and a polymer capable of forming a gel in a pH-independent manner and contains substantially no pH-controlling agent other than the polymer. The sustained release preparation can release the active ingredient in a pH-independent manner in the pH range from 1.2 to 6.8 and shows a constant release rate for a prolonged period of time. Therefore, the preparation is useful as a therapeutic agent for frequent urination/incontinence of urine which has a long-lasting effect.

La présente invention concerne une préparation à libération prolongée comprenant une substance active ayant un débit de libération plus élevé à pH = 4 par comparaison à celui à pH = 1,2 ou à pH = 6,8 et exerce une libération régulée de la substance active de manière indépendante par rapport au pH. La préparation à libération prolongée comprend le chlorhydrate de (-)-2-[4-[2-[[(1S,2R)-2-hydroxy-2-(4-hydroxyphényl)-1-méthyléthyl]amino]éthyl]2,5-diméthylphénoxy]acétate d~éthyle en tant que substance active et un polymère capable de former un gel de manière indépendante par rapport au pH et ne contient pratiquement aucun agent de régulation du pH autre que le polymère. La préparation à libération prolongée peut libérer la substance active de manière indépendante par rapport au pH dans la gamme de pH de 1,2 à 6,8 et présente un débit de libération constant sur une période prolongée. Par conséquent, la préparation est utile en tant qu~agent thérapeutique ayant un effet durable pour lutter contre l~urination fréquente/l~incontinence urinaire.

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