Optimization of Aceclofenac Solid Dispersion Using Box-Behnken Design: in-vitro and in-vivo Evaluation
Furqan A. Maulvi, Vaishali T. Thakkar, Tejal G. Soni and Tejal R. Gandhi
Affiliation: Maliba Pharmacy College, Uka Tarsadia University, Bardoli – Mahuva Road, Tarsadi, Dist. Surat 394 350, Gujarat, India.
Keywords: Aceclofenac, Analgesic, Anti-inflammatory, Avicel 200, Box-Behnken Design, HPMC E-5.
The study investigates the combined influence of three independent variables in preparation of aceclofenac ternary
solid dispersion (SD) by kneading method. A 3-factor, 3-level Box-Behnken design was used. Independent variables
selected were microcrystalline cellulose (Avicel 200 = X1), hydroxypropyl methylcellulose-5 cps (HPMC E-5 = X2), and
ratio of drug to polymer mixture (X3). Fifteen batches were prepared and evaluated for angle of repose and percentage
drug release at 5 minutes (Q5). The transformed values of variables were subjected to multiple regression analysis to establish
a second-order polynomial equation. Contour plots were constructed to evaluate the effects of X1, X2 and X3 on Q5
and angle of repose. Model was validated for accurate prediction of Q5 and angle of repose (AR) by performing checkpoint
analysis. The computer optimization process and contour plots predict the levels of independent variables as X1=
+0.5, X2 = -1 and X3 = +0.35 for maximized response of Q5 with better flow property. The stability study during 6 months
confirms that aceclofenac exhibits high stability in solid dispersion. In vivo studies indicate that optimized ternary solid
dispersion provides rapid pharmacological responses in mice and rats compared to marketed formulation.
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