Starch-based orodispersible film for diclofenac release

Abstract The form of drug administration affects the success of treatment, since it can influence adherence of the patient to the therapy. The use of orodispersible films has emerged as a way to overcome some drawbacks of conventional methods of drug delivery, especially for patients experiencing difficulty in swallowing. These films are prepared using a matrix that incorporates the drug and contains other substances that confer the properties of the system. The present work describes the use of thermoplastic starch as a carrier for the model drug diclofenac, including film preparation and testing of its orodispersible potential. Preparation of the film employed a microwave oven to gelatinize and plasticize corn starch, with incorporation of the model drug, followed by solvent-casting. The samples were characterized using mechanical tests, analyses of water uptake and water content, and Fourier transform infrared spectroscopy. The results indicated that the film presented promising properties as an alternative system for oral drug administration, with good incorporation and distribution of the drug in the matrix. The material displayed satisfactory mechanical properties, which are crucial for this type of material, due to the need for oral administration and handling before use.

摘要 给药方式可影响治疗成败，因其能够改变患者对治疗方案的依从性。口腔速溶膜（orodispersible films）作为一种新型给药形式，已逐渐成为克服传统药物递送方式诸多弊端的有效途径，尤其适用于存在吞咽困难的患者。此类薄膜以负载药物的基质为基础制备，基质中还添加了赋予体系特定性能的其他辅料。本研究介绍了以热塑性淀粉作为模型药物双氯芬酸载体的应用研究，涵盖薄膜制备及其口腔速溶性能测试两部分内容。薄膜制备过程采用微波炉对玉米淀粉进行糊化与塑化，同时加入模型药物，随后通过溶剂浇铸法成型。对所得样品分别开展力学性能测试、吸水率与含水率分析，以及傅里叶变换红外光谱（Fourier transform infrared spectroscopy）表征。结果表明，该薄膜作为口服给药替代体系具备良好应用前景，药物在基质中负载均匀且分布良好。该材料的力学性能表现优异，这对于这类需经口服给药且使用前需进行操作的制剂而言至关重要。