Formulation and Optimization of Solid Dispersions by BoxBehnken Design. Box-behnken Design - An effective tool in Solid Dispersion

      Аннотация: The objective of this study was to prepare and evaluate solid dispersion of poorly water soluble drug Telmisartan, a candidate mainly from the class II category of BCS classification, to increase solubility and for enhancement of bioavailability. The solid dispersions were prepared by physical mixture method using PEG 6000, Eudrajit L 100 and PVP K 30 as a carrier. A Box Behnken design has been applied to study the effect of independent variables i.e. PEG 6000, Eudrajit L 100 and PVP K 30 on dependent variables i.e. % Cumulative Drug Release and time required for cumulative drug release . Response surface plots and counter plots were drawn and optimum formulations were selected based on feasibility search method. Validation of optimized study performed using three confirmatory runs indicated very high degree of prognostic ability of response surface methodology, with mean percentage error as +0.02. Optimized solid dispersion formulations were prepared and its effect on % Cumulative Drug Release and time was evaluated. Optimized solid dispersions were evaluated for % CDR and Time for CDR, FTIR, DSC, SEM and in vitro drug release study.

Ключевые слова: Solid Dispersion, BCS classification, Telmisartan, Box Behnken design, PEG 6000, EUD L 100, PVP K 30, Physical Mixture method.