Monday, 25 August 2014

Formulation Optimization and Evaluation of Orodispersible Tablets of an Antipsychotic Drug Using Solubility Enhancement Technique

Formulation Optimization and Evaluation of Orodispersible Tablets of an Antipsychotic Drug Using Solubility Enhancement Technique: The main objective of this study is to formulate oro dispersible tablets of Olanzapine and to complex Olanzapine with β-cyclodextrin (β-CD) and PVP K 30. Olanzapine is second generation atypical antipsychotic drug. Phase solubility studies demonstrated that addition of water soluble polymer PVP K 30 with β-CD further enhanced solubility of drug compared to β-CD without PVP K 30. Complex was characterized using infrared spectroscopy, differential scanning calorimetry, % drug release study, % drug content and saturated solubility study. A 32 full factorial design was applied to systematically optimize the drug disintegration time. The concentration of Croscarmellose Sodium (X1) and concentration of Kyron T 314 (X2) were selected as independent variables. The disintegration time (Y1) and wetting time (Y2) were selected as dependent variables. The prepared tablets were evaluated for hardness, friability, disintegration time, wetting time and In-vitro drug release. The different formulations showed disintegration time between 19 to 48 seconds. The results indicated that concentration of croscarmellose Sodium (X1) and concentration of Kyron T 314 (X2) significantly affected the disintegration time (Y1) and wetting time (Y2).Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F18 prepared with Croscarmellose Sodium (4.47 %) & Kyron T 314 (3.73 %) was found to be the best formulation with disintegration time 20 sec, wetting time 26 sec and % drug release in 10 min 99.49%.