ORALLY DISINTEGRATING WATER SOLUBLE ANALGESIC FORMULATIONS AND METHODS FOR PRODUCTION THEREOF

摘要

A water soluble analgesic composition in the form of an orally disintegrating tablet, wafer, pellet, or lozenge includes a plurality of granules is provided. Each of the granules includes a substrate core and a coating disposed on the substrate core forming an agglomerated product, the coating including a salt of an analgesic, but substantially no particles of a non-salt form of the analgesic. The composition may be created by a method including the steps of: (i) providing a first solution comprising a base, (ii) adding an analgesic to the first solution to create a second solution including a salt of the analgesic, (iii) filtering the second solution to remove residual particles of the analgesic to create a filtered second solution, (iv) spray drying the filtered second solution onto a substrate to form an agglomerated product having a plurality of granules, and (v) compressing, molding, or otherwise forming the agglomerated product, optionally with other excipients, into an orally disintegrating tablet, wafer, pellet, or lozenge.