Prajapati Devang, Hakim Masuma, Patel Margi, Ansari Mohammad Javed, Alfarraj Saleh, Chauhan Sanjay, Bhatt Vaibhav, Yadav Virendra Kumar, Sahoo Dipak Kumar, Thummar Kashyap, Patel Ashish
Graduate School of Pharmacy, Gujarat Technological University (GTU), Gandhinagar, India.
Department of Life Sciences, Hemchandracharya North Gujarat University, Patan, India.
Cell Biochem Funct. 2025 Feb;43(2):e70049. doi: 10.1002/cbf.70049.
The present study aimed to optimize a mouth-dissolving film (MDF) made from Pongamia pinnata stem bark extract to increase patient compliance and accelerate oral disease therapy. Several stem bark extracts were prepared, and karanjin was used as an herbal marker for the extracts. The ethanolic extract showed the maximum yield (12.10% ± 0.09%) and cytotoxic activity against human oral cancer (KB 3-1) and embryonic kidney cell lines. The MDF formulation was focused on incorporating a fixed amount of the extract and varying concentrations of HPMC E5 polymer, along with evaluating the performance of plasticizers like PEG 400 and propylene glycol (PG). An optimized formulation was determined based on disintegration time, wetting time, and folding endurance. The formulation consisted of HPMC E5 as a film-forming polymer, PG as a superior plasticizer, ascorbic acid as an antioxidant, and other ingredients contributing to solubility, dispersion, sweetening, and appearance. High-performance thin-layer chromatography-mass spectrometry analysis confirmed higher levels of karanjin in the optimized formulation, ensuring its successful incorporation and stability. Taste masking evaluations indicate a favorable taste profile and a high potential for patient compliance. The stability study displayed no significant changes in the physical characteristics of the film, affirming its stability and quality. In conclusion, the developed herbal-based optimized MDF presents a promising drug delivery system, offering enhanced patient compliance, taste masking, and stability. The MDF holds great potential for effective treatment and management of oral diseases, providing convenience and improved therapeutic outcomes.
本研究旨在优化由水黄皮茎皮提取物制成的口腔崩解膜(MDF),以提高患者依从性并加速口腔疾病治疗。制备了几种茎皮提取物,并将羽扇豆醇用作提取物的草药标志物。乙醇提取物显示出最高产量(12.10%±0.09%)以及对人口腔癌(KB 3-1)和胚胎肾细胞系的细胞毒性活性。MDF制剂着重于加入固定量的提取物和不同浓度的羟丙基甲基纤维素E5聚合物,同时评估聚乙二醇400和丙二醇(PG)等增塑剂的性能。基于崩解时间、润湿时间和耐折性确定了一种优化制剂。该制剂由作为成膜聚合物的羟丙基甲基纤维素E5、作为优质增塑剂的PG、作为抗氧化剂的抗坏血酸以及其他有助于溶解性、分散性、甜味和外观的成分组成。高效薄层色谱-质谱分析证实优化制剂中羽扇豆醇含量更高,确保了其成功加入和稳定性。掩味评估表明其味道良好,患者依从性潜力高。稳定性研究显示膜的物理特性无显著变化,证实了其稳定性和质量。总之,所开发的基于草药的优化MDF呈现出一种有前景的药物递送系统,具有更高的患者依从性、掩味性和稳定性。该MDF在口腔疾病的有效治疗和管理方面具有巨大潜力,提供了便利性并改善了治疗效果。