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TASTE-MASKED PHARMACEUTICAL COMPOSITIONS WITH GASTROSOLUBLE PORE-FORMERS
专利权人:
INC.;APTALIS PHARMATECH
发明人:
LAI, JIN-WANG,VENKATESH, GOPI M,QIAN, KEN KANGYI
申请号:
NZ58975005
公开号:
NZ589750A
申请日:
2005.10.21
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
The disclosure relates to a pharmaceutical composition comprising a plurality of taste-masked particles, wherein the task-masked particles comprise: (a) a drug-containing core particle; and (b) a taste-masking membrane on said drug-containing core particle comprising a combination of a water-insoluble polymer and a gastrosoluble inorganic or organic pore-former at a ratio ranging from about 95/5 to about 50/50 having a thickness of from about 5% to about 50% based on the weight of the coated particle and an average particle size of not more than about 400 microns wherein the composition exhibits acceptable taste-masking when the composition is placed in the oral cavity for 60 seconds and the composition releases not less than about 60% of the dose in 30 min when tested for dissolution using United States Pharmacopoeia Apparatus 2 (paddles at the rate of 50 rpm in 900 mL of pH 1.2 buffer); and (c) a plurality of rapidly-dispersing microgranules with an average particle size of not more than about 400 microns comprising (i) a disintegrant and (ii) a sugar alcohol or a saccharide or a combination thereof, wherein each of said disintegrant or sugar alcohol or saccharide is present in the form of particles having an average particle diameter of not more than about 30 microns; wherein the pharmaceutical composition is an orally disintegrating tablet.
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