Patent ID: 6143325
Filing Date: 2000-11-07
Classification: A61K,A61P

Abstract:
A pH-modulated extended release pharmaceutical formulation for the oral administration of nefazodone or a pharmaceutically acceptable salt thereof, wherein the improvements comprise:(a) requiring from about 4 to 16 hours for essentially complete drug release from the formulation as measured using standard USP in vitro dissolution protocols employing test media in the pH 1.2 to 7.0 range;(b) providing, after oral administration, extended blood levels of nefazodone relative to blood levels seen with immediate release formulations and these extended levels are maintained at or above therapeutic levels for up to 24 hours;(c) providing, after oral administration, reduced amounts of nefazodone metabolites, particularly mCPP, while maintaining the blood levels of nefazodone at concentrations comparable to those seen following oral administration with immediate-release formulations; and(d) lacking a significant food effect on oral administration.