| 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 85/15 to about 65/15 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 (2) a plurality of rapidly-dispersing microgranules with an average particle size of not more than about 400 µm comprising (i) a sugar alcohol or a saccharide or a combination thereof and (ii) a disintegrant, each having an average particle diameter of not more than about 30 µm, wherein the ratio of said sugar alcohol, saccharide or combination thereof to said disintegrant in the rapidly-dispersing microgranules is from about 90/10 to about 99/10. |
