Patent ID: 8173152

Claim:
A process for preparing a stabilized bioadhesive hot-melt extruded composition comprising the steps of: a) wet or dry granulating at least one water swellable or water soluble alkaline matrix-forming material; at least one acidic component; and optionally one or more antioxidants, one or more hydrophobic polymers, one or more hydrophilic polymers, one or more other excipients, or a combination thereof to form an excipient mixture having a solution pH of 7 or less; b) mixing the excipient mixture with an alkaline labile drug to form a bioadhesive thermoplastic hydrophilic composition; and c) hot-melt extruding the hydrophilic composition to form the bioadhesive hot-melt extruded composition, wherein the matrix-forming material is thermoplastic, bioadhesive, or both.