Orodispersible tablets of bitter active principles

摘要

The invention concerns coated granules including (A) at least one amine-containing pharmacological active principle, preferably as an acid addition salt, the pharmacological active principle being complexed by low cation-exchange resin containing carboxylic acid groups (COO″), and (B) at least 15 wt. %, based on the total weight of the active principle/low cation-exchange resin complex, of at least one hydrophilic adsorbent, the mixture of the components (A) and (B) being coated with a gastrosoluble polymer. The invention also concerns a method for preparing such granules, as well as orodispesible tablets containing such granules.

主权项

1. A coated granule formed by coating a granule with a coating comprising a gastrosoluble polymer, said granule being formed by granulating a mixture comprising:
(A) fluoxetine or acid addition salts thereof, said fluoxetine being complexed by a weak cation-exchange resin comprising carboxylic acid groups (COO−); and (B) a hydrophilic adsorbent comprising at least 15% by weight, relative to the total weight of the complex, of microcrystalline cellulose and at least 5% by weight, relative to the total weight of the complex, of colloidal silica; wherein said coated granule masks the taste of the fluoxetine; and wherein said coated granule has dissolution kinetics in acid medium that conform to the specification of the USP monograph for fluoxetine tablets.