ORALLY DISPERSIBLE DRUG FORMULATIONS

摘要

Pharmaceutical dosage forms, particularly dosage forms in granular form having good palatability and capable of rapidly and completely dispersed in the mouth when orally administered.

主权项

1) A method of making an orally dispersible formulation comprising:
i) adding an active ingredient to a high speed mixer and shearing said active ingredient at a first rate; ii) adding a granulating solution comprising a solvent and a coating agent to said high speed mixer while shearing said active ingredient to form a wet mixture; iii) shearing said wet mixture in said high speed mixer at a second rate greater than said first rate; iv) adding a diluent and a disintegrating agent and optionally other excipients (e.g. buffering agents, flavors, flavor enhancers) to said wet mixture while shearing said mixture at said second rate until a first granular mixture forms; and v) drying said first granular mixture.