Mirabegron sustained-release tablet composition

Abstract

The invention provides a Mirabegron sustained-release tablet composition which contains Mirabegron, a non-polyoxyethylene sustained-release framework material, an antioxidant and a lubricant. The quality of the Mirabegron sustained-release tablet prepared after Mirabegron and the non-polyoxyethylene sustained-release framework material are mixed is qualified and stable, and uniform release speed and high release rate can be achieved.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a composition of mirabegron sustained-release tablets. Background technique [0002] Mirabegron Sustained-release Tablets were developed by Astellas Pharma Inc. in Japan. The Chinese chemical name is (R)-2-(2-amino-1,3-thiazol-4-yl) )-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]phenylacetamide, the trade name is Betanis Tablets, which are multi-standard sustained-release tablets, and the specifications are 25mg, 50mg (in the form of Mirabellon meter). The drug is a selective β-adrenoceptor blocker, used for the treatment of urinary frequency, urgency and urinary incontinence caused by overactive bladder. The drug was approved for marketing in Japan in September 2011 and in the United States in June 2012. [0003] The prescriptions for the original preparations listed in Japan and the United States are: [0004] [0005] The content of related substances after t...

AI Technical Summary

Problems solved by technology

[0009] Chinese patent CN 103655503 A discloses a Mirabegron sustained-release tablet and a preparation method thereof. The composition includes Mirabegron, a skeleton material, an antioxidant, a lubricant, a filler and an adhesive, and protects each The choice of additives, more additives are used, including the porogen polyethylene glycol, which increases the production cost. In addition, the patent also uses polyethylene oxide which is poorly compatible with mirabegron

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