Dad Haseeb Anwar, Shabbir Asra Shanzeh, Ali Saman, Mahmood Tariq
Zhejiang University College of Pharmaceutical Sciences, Department of Pharmaceutics, Hangzhou, China.
University of Central Punjab Faculty of Pharmacy, Department of Pharmaceutics, Lahore, Pakistan.
Turk J Pharm Sci. 2021 Dec 31;18(6):683-694. doi: 10.4274/tjps.galenos.2021.23080.
The objective of this research was to fabricate, characterize, and optimize fluoxetine laden orodispersible film (ODF), in enhancing dosage forms options for the pediatric population suffering from incapacitating psychotic disorders of selective mutism and obsessive-compulsive disorder, which will be ultimately beneficial in enhancing compliance factor and the quality of pharmacotherapy.
Solvent casting technique was used to formulate the ODF formed by natural hydrophilic polymers matrix of hydroxypropyl methylcellulose E15 and pullulan. Propylene glycol as plasticizing agent imparted satisfactory tenacity and flexibility to ODFs. Fourier transform infrared spectroscopy studies were performed to investigate any potential compatibility, and the results revealed no potential interaction between fluoxetine and excipients. Developed ODFs were evaluated for physicochemical properties, content uniformity, disintegration time, and dissolution time studies. Results: The experimental data.
The experimental data suggested that different polymer concentrations had a complex effect on content uniformity, disintegration time, and cumulative percentage drug release from the ODFs. TF7 was the most optimized formulation with a disintegration time of 10.66 sec and 99.37% drug release within 3 min. Additionally, the most optimized fluoxetine ODF was submitted to a Universal Testing Machine for tensile strength and percentage elongation determination. It was also further evaluated by thermogravimetric analysis, scanning electron microscopy and X-ray diffraction.
Fluoxetine ODFs of good pharmaceutical quality can be prepared on a small scale. Therefore, the perspective of using fluoxetine ODFs for individualized pharmacotherapy to ameliorate the compliance issues in selective mutism and OCD pediatric patients can be considered.
本研究的目的是制备、表征和优化含氟西汀的口腔崩解膜（ODF），以增加针对患有选择性缄默症和强迫症等致残性精神障碍的儿科人群的剂型选择，这最终将有利于提高依从性因素和药物治疗质量。
采用溶剂浇铸技术制备由羟丙基甲基纤维素E15和支链淀粉的天然亲水性聚合物基质形成的ODF。丙二醇作为增塑剂赋予ODF令人满意的韧性和柔韧性。进行傅里叶变换红外光谱研究以调查任何潜在的相容性，结果表明氟西汀与辅料之间没有潜在相互作用。对所制备的ODF进行理化性质、含量均匀度、崩解时间和溶出时间研究。结果：实验数据。
实验数据表明，不同的聚合物浓度对ODF的含量均匀度、崩解时间和药物累积释放率有复杂的影响。TF7是最优化的制剂，崩解时间为10.66秒，3分钟内药物释放率为99.37%。此外，将最优化的氟西汀ODF提交给万能材料试验机测定拉伸强度和伸长率百分比。还通过热重分析、扫描电子显微镜和X射线衍射进行了进一步评估。
可以小规模制备质量良好的氟西汀ODF。因此，可以考虑使用氟西汀ODF进行个体化药物治疗，以改善选择性缄默症和强迫症儿科患者的依从性问题。
