Design and Characterization of Fast Dissolving Buccal Films of Paroxetin

[摘要] Depressive Disorder medications are pharmacological agents that are used to treat Major Depressive Disorder disease. The intention of the present study is to design and characterization of fast dissolving buccal films of Paroxetin. Films were prepared by using different polymers like HPMC E15, PVA, PVP and Glycerol as plasticizer and saccharin as a sweetening agent and vanillin as a flavoring agent. Buccal films were prepared using solvent casting technique. The major problem with Paroxetine was it belongs to class Ⅱ in BCS classification and have low solubility in biological fluids. In order to enhance the solubility of Paroxetine solid dispersion of Paroxetine were prepared by melting technique at different drug carrier (PEG 4000) weight ratios and evaluated. No interaction was found between the drug and the polymers which was obtained by FTIR studies. The buccal films were evaluated for Folding endurance, weight variation, Drug content, Thickness, permeation study and in-vitro drug release study. Dissolution profile were studied by using USP dissolution apparatus type I, pH 6.8 simulated saliva were used as dissolution media. The influence of variable like polymer type, and their concentration, on Paroxetine release profile was studied. The formulation was optimized on the basis of various evaluation parameters like drug content and In-vitro drug release. Formulation F3 successfully gave the fast release of drug within 12 minutes. Stability studies were as per ICH guide lines and result indicated that the selected formulation was stable.

[学科分类] 药学

[关键词] Paroxetine;HPMC E15;PVA;PVP;PEG 4000;Solvent casting method.