| abstract |
A process for preparing a stabilized bioadhesive composition extruded in the hot melt state comprising an alkaline labile drug, an alkaline matrix forming polymer and an acid component, the process comprising the steps of: a) wet or dry granulate at least a water-swellable or water-soluble alkaline thermoplastic polymer; an antioxidant; at least one bioadhesive polymer; at least one acid component; and, optionally, one or more hydrophobic polymers, one or more hydrophilic polymers, one or more additional excipients or a combination thereof to form a mixture of excipients having a solution pH of 7 or less; b) mixing the mixture of excipients with an alkaline labile drug to form a bioadhesive thermoplastic hydrophilic composition; and c) extruding the hydrophilic composition in the hot melt state to form the hot melt extruded bioadhesive composition. |