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Taste-masked multiparticulate pharmaceutical compositions comprising a drug-containing core particle and a solvent-coacervated membrane
专利权人:
APTALIS PHARMA LIMITED
发明人:
LAI JIN-WANG,QIAN KEN,VENKATESH GOPI
申请号:
NZ60196905
公开号:
NZ601969A
申请日:
2005.10.13
申请国别(地区):
NZ
年份:
2014
代理人:
摘要:
ABSTRACT - 601969 The disclosure relates to a taste-masked multiparticulate pharmaceutical composition comprising: (a) a drug-containing core particle, and (b) a solvent-coacervated membrane on said drug-containing core particle comprising a combination of a water-insoluble polymer and a gastrosoluble, organic or inorganic pore-former at a ratio ranging from about 95/5 to about 50/050, said membrane having a thickness of from about 5% to about 50% by weight based on the weight of the coated particle and an average particle size of not more than about 400&mum, wherein said composition has the following properties: (1) said composition has acceptable taste-masking when the composition is placed in the oral cavity for at least about 60 seconds and (2) said composition releases not less than about 60% of the dose in 30 min when tested for dissolution using United States Pharmacopoeia Apparatus ! (Baskets @ 100 rpm in 900 mL of pH 1.2 buffer), and wherein said water insoluble polymer is selected from the group consisting of ethylcellulose, cellulose acetate, cellulose acetate butyrate, polyvinyl acetate, neutral methacrylic ester copolymer, ammonio-methacrylate copolymers and mixtures thereof, and said gastrosoluble organic or inorganic pore-former is selected from the group consisting of calcium carbonate, calcium phosphate, calcium saccharide, calcium succinate, calcium tartrate, ferric acetate, ferric hydroxide, ferric phosphate, magnesium carbonate, magnesium citrate, magnesium hydroxide, magnesium phosphate, and mixtures thereof. Also disclosed is a method of manufacturing the taste-masked multi-particulate composition comprising the above features.
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