Diclofenac sodium is an NSAID (Non-Steroidal anti-inflammatory widely used in the treatment of pain, migraine, and inflammation). It has been observed that Diclofenac undergoes extensive first-pass metabolism when administered using conventional dosage forms through the oral route. The aim of this study is to formulate and evaluate pre-compression, postcompression factors and release kinetics of buccal mucoadhesive tablets formulated by a 23 factorial method that can prevent the first-pass metabolism of the drug thereby increasing its bioavailability. This formulation increases patient compliance by reducing its dosing frequency. In these formulations, two polymers polyvinyl pyrrolidine (PVP K30) and Chitosan are used in varying proportions. Eight different formulations were prepared by varying concentrations of the polymers. The buccal mucoadhesive tablets formulated have been evaluated for their general appearance, thickness, hardness, weight variation, friability and other in vitro tests such as swelling and dissolution studies. The evaluation studies demonstrated that formulation F8 showed better properties as a buccal mucoadhesive formulation compared to other formulations.

中文翻译：

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使用 23 种析因设计双氯芬酸钠口腔粘膜粘附片的配方和评价

双氯芬酸钠是一种 NSAID（非甾体抗炎药，广泛用于治疗疼痛、偏头痛和炎症）。已经观察到，当通过口服途径使用常规剂型给药时，双氯芬酸经历广泛的首过代谢。本研究的目的是制定和评估通过 23 阶乘法配制的口腔粘膜粘附片的预压缩、压缩后因素和释放动力学，可以防止药物的首过代谢，从而提高其生物利用度。该配方通过降低给药频率来提高患者的依从性。在这些配方中，两种聚合物聚乙烯吡咯烷 (PVP K30) 和壳聚糖以不同的比例使用。通过不同浓度的聚合物制备了八种不同的配方。已对配制的口腔粘膜粘附片剂的一般外观、厚度、硬度、重量变化、脆碎度和其他体外测试（如溶胀和溶解研究）进行了评估。评估研究表明，与其他制剂相比，制剂 F8 作为口腔粘膜粘附制剂显示出更好的特性。