Anuradha Patel*, Ajay Nair, Parixit Prajapati, Dr. Anil Jadhav
Department of Pharmaceutics, Smt. B.N.B Swaminarayan Pharmacy College, Salvav, Vapi, Gujarat, India.
A B S T R A C T
The aim of this study is to improve the solubility and oral bioavailability of Avanafil a recently approved second generation type 5 phosphodiestrase inhibitor used for the treatment of erectile dysfunction by employing cyclodextrin complexation technique. The inclusion complex was prepared by Kneading method. Differential scanning calorimetry, X-ray powder diffraction, and Fourier transform infrared spectroscopy is used to evaluate the complexation of Avanafil with hydroxypropyl-β-cyclodextrin (HP-β-CD) and the formation of true inclusion complexes. The inclusion complex containing Avanafil and Hydroxypropyl β-Cyclodextrin (1:1 molar ratio) is formulated into Orodispersible tablet by direct compression method using different superdisintegrant i.e. Croscarmellose, Crospovidone and Sodium Starch Glycolate. A 32 full factorial design was applied to systematically optimize the drug disintegration time. The concentration of Sodium Starch Glycolate (X1) and concentration of Croscarmellose sodium (X2) were selected as independent variables. The Disintegration time (Y1) and Wetting time (Y2) were selected as dependent variables. The prepared tablets will be evaluated for various post compression parameters like hardness, friability, disintegration time, wetting time, weight variation, thickness, drug content and in-vitro dissolution. Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F10 prepared with Starch Glycolate (14.83%) & croscarmellose (8.09%) was found to be the best formulation with disintegration time 21 sec, wetting time 27 sec and % drug release in 10 min 97.45%.
Keywords: Avanafil, Orodispersible tablet, Hyroxy propyl beta cyclodextrin, Sodium strach glycolate, Croscarmellose sodium, Disintegration time, Wetting time, Full factorial design