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Immediate release pharmaceutical granule compositions and a continuous process for making them
专利权人:
Jean Paul Remon
发明人:
Jean Paul Remon,Chris Vervaet
申请号:
US12815781
公开号:
US08337897B2
申请日:
2010.06.15
申请国别(地区):
US
年份:
2012
代理人:
摘要:
A pharmaceutical or veterinary granule composition in the form of a mixture consisting essentially of: (i) at least one drug classifiable as Class II or Class IV of the Biopharmaceutical Classification System, wherein said drug (i) constitutes from 0.5% to 20% by weight of the composition, and excipients, said pharmaceutical or veterinary granule composition providing a drug release of at least 70% within 10 minutes in water, (ii) a first excipient being a maltodextrin representing from 40% by weight to 80% by weight of said composition, (iii) a wetting amount of a second excipient being a polyethylene glycol having a weight number molecular weight between 300 and 5,000, said second excipient comprising a solid fraction and a liquid fraction, and representing from 15% to 40% by weight of said composition, and optionally one or more pharmaceutically acceptable fillers selected from the group consisting of hydrocolloids, glidants, lubricants, surfactants and diluents, wherein the weight ratio of said first excipient (ii) to said second excipient (iii) is in a range from 1:1 to 5:1.
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