Development, evaluation and optimization of extended release buccal tablets prepared using progressive hydration technology

Abstract

Extended release Buccoadhesive buccal tablet for delivery of Nisoldipine were developed using Progressive hydration technology. Technology involves Carbopol 972P (CP), Hypromellose K15M (HPMC) and Polycarbophil (PC) in different amounts. Experiments were designed based on 32 full factorial design to explore effects of CP and HPMC on buccoadhesive strength (BAS) and drug release. Both polymers were found to have effect on swelling index, BAS and drug release which was confirmed by level of significance (p < 0.05). Using quadratic terms a linear second order model that describes a twisted plane of responses were also drawn for elucidation of effect of polymers. Three check points were also taken into account to validate the polynomial equation. Results show that polymers drastically change the drug release mechanism which was confirmed by model fitting into dissolution profile. By customizing the formulation by optimizing the ratio of polymers, desired release (90%) was obtained in the sixth hour and good BAS were obtained for batch F10. Keywords: Buccoadhesive; Nisoldipine; Factorial design; Polynomial equation