Clobazam orally dissolving strips were prepared by solvent casting method. A full 32 factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm2), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of C max (95.87%), t max (71.42%), AUC0−t (98.125%), and AUC0−∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.
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机译：通过溶剂浇铸法制备氯巴沙姆口腔溶解片。完整的3 2 析因设计用于优化，使用不同浓度的成膜聚合物和崩解剂作为自变量，崩解时间，累积药物释放百分比和拉伸强度作为因变量。另外，还评估了制备的膜的表面pH，耐折性和含量均匀性。选择了表现出最大的体外药物释放，令人满意的体外崩解时间和抗张强度的优化薄膜制剂进行生物利用度研究，并与兔子的参考产品（product 5片）进行了比较。通过Design-expert软件选择制剂（F6），该制剂表现出DT（24 sec），TS（2.85 N / cm 2 ）和体外药物释放（96.6％）。统计评估表明测试膜（F6）和参考产品的生物利用度参数之间无显着差异。 C max（95.87％），t max（71.42％），AUC0-t（98.125％）和AUC0-∞（99.213％）的平均比率值（测试/参考）表明，这两个公式显示出可比的血浆水平-时间资料。
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