Orally disintegrating tablets and methods of manufacture

摘要

A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of rapidly dispersing microgranules prepared by granulating a sugar alcohol or a saccharide or a mixture thereof having an average particle size less than about 30 microns and a disintegrant, and a taste-masked microcapsule containing at least one drug, the microcapsule being prepared by granulating a pharmaceutically acceptable formulation comprising at least one drug in a therapeutically effective amount and at least one polymeric binder that improves resilience of the microgranules, wet milling the granulated mass, and microencapsulating the milled granules to provide microcapsules.

主权项

1. A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of:
rapidly dispersing microgranules comprising a sugar alcohol or a saccharide or a mixture thereof having an average particle size not more than about 30 microns, and a disintegrant, and taste-masked microcapsules containing at least one drug, prepared by granulating a pharmaceutically acceptable formulation comprising the at least one drug in a therapeutically effective amount and at least one polymeric binder imparting resilient characteristics to the resulting microcapsules, wet milling the granulated mass, and coating the milled granules with one or more polymers to provide taste-masked microcapsules, wherein not less than 60% of the at least one drug from said tablet dissolves in about 60 minutes when dissolution tested using USP Apparatus 2 (paddle at 50 RPM, 900 mL of 0.1N HCl at 37° C.).