FORMULATION OPTIMIZATION OF HYDRODYNAMICALLY BALANCED ORAL CONTROLLED RELEASE BIOADHESIVE TABLETS OF TRAMADOL HYDROCHLORIDE

The directly compressible floating‐bioadhesive tablets of tramadol were formulated using varying amounts Carbopol 971P (CP) and hydroxypropylmethylcellulose (HPMC), along with other requisite excipients. In vitro drug release profile, floatational characteristics and ex vivo bioadhesive strength using texture analyzer were determined, and systematically optimized using a 32 central composite design (CCD). The studies indicated successful formulation of gastroretentive compressed matrices with excellent controlled release, mucoadhesion and hydrodynamic balance. Comparison of the dissolution profiles of the optimized formulation, with optimal composition of CP:HPMC :: 80.0:125.0, with that of the marketed controlled release formulation other indicated analogy of drug release performance with each other. Validation of optimization study using eight confirmatory experimental runs indicated very high degree of prognostic ability of CCD with mean ± SEM of −0.06% ± 0.37.Further, the study successfully unravels the effect of the polymers on the selected response variables.