Design, Optimization, Preparation and Evaluation of Solid Dispersions of Albendazole using Factorial Design

To enhance the solubility and dissolution rate of albendazole, a poorly water soluble anthelmintic drug, by preparation of solid dispersions. The dispersion granules were prepared using a hot melting technique which involved preparation of a homogenous dispersion of albendazole in gelucire 44/14 and PEG 8000. A two-factor, four-level (4*2) statistical design was implemented to quantitate the influence of gelucire 44/14 and PEG 8000 on the dissolution profile, where gelucire 44/14 and PEG 8000 were chosen as independent variables, while T10 min (cumulative drug release in 10 minutes) and T60 min (cumulative drug release in 60 minutes) were chosen as dependent variables. The solid dispersions were characterized for their in-vitro dissolution rate. The optimized formulation was further characterized by DSC, XRD and SEM analysis. An appropriate statistical model was arrived at and a significantly enhanced dissolution rate was exhibited with the optimized formulation. DSC and XRD data indicated the amorphous nature of albendazole in solid dispersion. SEM revealed partial loss of drug crystallinity which can bring about significant changes in the drug dissolution rate. In conclusion the statistical model enabled us to understand the effects of formulation variables on the dispersion.

Author(s): Setia Anupama, Goyal Surinder, Shrivastva Birendra and Goyal N

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