The research work was aimed to formulate and evaluate gastroretentive mucoadhesive film of calcium channel blocker, Lacidipine for treatment of gastroparesis. Box-Behnken design was used for preparation of optimized formulation using solvent casting method. In this design, different concentrations of mucoadhesive polymers HPMC E15, Eudragit RL100, and Eudragit RS100 were considered as independent variables and its effect on responses like percent drug release, swelling index at 12 h, and folding endurance of the film were examined. Drug and polymer compatibility studies were performed using Fourier transform infrared spectroscopy and differential scanning calorimetry. Optimized formulation was evaluated for organoleptic properties, weight variation, thickness, swelling index, folding endurance, drug content, tensile strength, percent elongation, drug release, and percent moisture loss. The results revealed that the film possessed considerable flexibility and smoothness, and in vitro drug release was found to be 95.22% ± 0.93% at the end of 12 h. Scanning electron microscopy imaging of film displayed smooth, uniform, and porous surface texture. The dissolution followed Higuchi's model and Hixson Crowell model displayed non-Fickian drug release mechanism. Furthermore, the film was incorporated in capsule and the presence of capsule showed no effect on the drug release profile. In addition, no change was observed in the appearance, drug content, swelling index, folding endurance, and drug release upon storage at 25°C ± 2°C and 60% ± 5% relative humidity for 3 months. Collectively, the study revealed that gastroretentive mucoadhesive film of Lacidipine could serve as an effective and alternate site-specific targeted delivery in the management of gastroparesis.

中文翻译：

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拉西地平口服胃滞留膜治疗胃轻瘫。

本研究旨在配制和评价钙通道阻滞剂拉西地平治疗胃轻瘫的胃滞留粘膜粘附膜。Box-Behnken 设计用于使用溶剂浇注法制备优化配方。在此设计中，不同浓度的粘膜粘附聚合物 HPMC E15、Eudragit RL100 和 Eudragit RS100 被视为自变量，并检查其对药物释放百分比、12 小时溶胀指数和薄膜耐折性等响应的影响。使用傅立叶变换红外光谱和差示扫描量热法进行药物和聚合物相容性研究。优化配方的感官特性、重量变化、厚度、溶胀指数、耐折性、药物含量、拉伸强度、伸长率、药物释放和水分损失百分比。结果表明，该薄膜具有相当大的柔韧性和光滑度，体外药物释放在 12 小时结束时为 95.22% ± 0.93%。薄膜的扫描电子显微镜成像显示出光滑、均匀和多孔的表面纹理。溶出遵循 Higuchi 模型和 Hixson Crowell 模型显示非 Fickian 药物释放机制。此外，将薄膜掺入胶囊中，胶囊的存在对药物释放曲线没有影响。此外，在25°C±2°C和60%±5%相对湿度下储存3个月后，外观、药物含量、溶胀指数、耐折度和药物释放均未观察到变化。总的来说，