Sowjanya J Naga, Rao P Raja
Research Scholar, Osmania University, Hyderabad, Telangana, 500007, India.
Department of Pharmacy, Osmania University, Hyderabad, Telangana, 500007, India.
Heliyon. 2023 Mar 10;9(3):e14292. doi: 10.1016/j.heliyon.2023.e14292. eCollection 2023 Mar.
Fast dissolving oral films(FDOF's) are the popular dosage forms when placed in the oral cavity, disintegrate rapidly and dissolve to release the medication for improving oral absorption. Traditionally plant is used in the treatment of rheumatoid arthritis as Non-steroidal Anti-inflammatory agent along with analgesic properties. The plant extract is reported to be used in low dose as analgesic and anti-inflammatory agent in Rheumatoid Arthritis. No scientific data was reported on plant formulation as FDOF's for treating osteoarthritis. This study aims to formulate fast oral dissolving film(FDOFs) bark extract and evaluate using studies for osteoarthritis. About 14 formulations were prepared using standard Box Behnken design protocol for optimization using the natural film formers, synthetic polymers, super disintegrants, plasticizers as independent variables with folding endurance and disintegration time as dependent variables by solvent casting method. Further the formulation characteristics including physical and mechanical behavior of films and drug release behavior was evaluated. The 3D countour plots and response curves suing the design expert software were investigated which proved that the optimized oral dissolving films of extract with Pullalan gum, HPMC (polymers), Propylene glycol, PEG 400 (Co-solvents) and Croscarmellose sodium (super Disintegrant) are stable and uniform with formulation characteristics. The drug release rates prove that F5 and F13 formulations showed 99.90% drug release within 30 min following first order kinetics with satisfactory mechanical properties. The study results suggest that the fast dissolving oral films of extract is novel, attractive and alternative to the available marketed products resulting in improved patient adherence in treatment of osteoarthritis.
速溶口腔膜（FDOF）是一种受欢迎的剂型，置于口腔中时会迅速崩解并溶解以释放药物，从而改善口服吸收。传统上，该植物被用作治疗类风湿性关节炎的非甾体抗炎药，同时具有止痛特性。据报道，该植物提取物在类风湿性关节炎中以低剂量用作止痛和抗炎剂。目前尚无关于该植物制成FDOF用于治疗骨关节炎的科学数据。本研究旨在制备该植物树皮提取物的速溶口腔膜（FDOF），并使用骨关节炎研究进行评估。采用标准的Box Behnken设计方案，以天然成膜剂、合成聚合物、超级崩解剂、增塑剂为自变量，以折叠耐久性和崩解时间为因变量，通过溶剂浇铸法制备了约14种制剂用于优化。进一步评估了制剂特性，包括膜的物理和机械性能以及药物释放行为。使用设计专家软件研究了三维等高线图和响应曲线，结果证明，含有普鲁兰多糖、羟丙甲纤维素（聚合物）、丙二醇、聚乙二醇400（助溶剂）和交联羧甲基纤维素钠（超级崩解剂）的提取物优化口腔速溶膜具有稳定且均匀的制剂特性。药物释放速率证明，F5和F13制剂在30分钟内按照一级动力学显示出99.90%的药物释放，具有令人满意的机械性能。研究结果表明，该植物提取物的速溶口腔膜是新颖、有吸引力的，并且是现有市售产品的替代品，可提高骨关节炎治疗中患者的依从性。
