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Development and Evaluation of Fluoxetine Fast Dissolving Films: An Alternative for Noncompliance in Pediatric Patients
Processes ( IF 3.5 ) Pub Date : 2021-04-28 , DOI: 10.3390/pr9050778
Emőke-Margit Rédai , Paula Antonoaea , Nicoleta Todoran , Robert Alexandru Vlad , Magdalena Bîrsan , Anamaria Tătaru , Adriana Ciurba

The most used pharmaceutical formulations for children are syrups, suppositories, soft chewable capsules, and mini-tablets. Administrating them might create an administration discomfort. This study aimed to develop and evaluate orodispersible films (ODFs) for pediatric patients in which the fluoxetine (FX) is formulated in the polymeric matrix. Six FX fast dissolving films (10 mg FX/ODF), FX1, FX2, FX3, FX4, FX5, and FX6, were prepared by solvent casting technique. In the composition of the ODFs, the concentration of the hydroxypropyl methylcellulose and the concentration of the propylene glycol were varied. Each formulation of fluoxetine ODF was evaluated by determining the tensile strength, folding endurance, disintegration, behavior in the controlled humidity and temperature conditions, and adhesiveness. All the obtained results were compared with the results obtained for six ODFs prepared without FX. The disintegration time of the FX ODFs was of maximum 88 s for FX2. Via the in vitro releasing study of the FX from the ODFs it was noticed that FX1 and FX2 allow a better release of the drug 99.98 ± 3.81% and 97.67 ± 3.85% being released within 15 min. From the obtained results it was also confirmed that FX ODFs were found to follow first-order release kinetic

中文翻译:

氟西汀快速溶解膜的开发和评估:儿童患者不依从性的替代方法

儿童最常用的药物配方是糖浆,栓剂,可咀嚼软胶囊和微型片剂。管理它们可能会导致管理上的不适。这项研究旨在开发和评估针对儿科患者的口腔分散膜(ODF),其中在聚合物基质中配制了氟西汀(FX)。通过溶剂流延技术制备六片FX快速溶解膜(10mg FX / ODF),FX1,FX2,FX3,FX4,FX5和FX6。在ODF的组成中,羟丙基甲基纤维素的浓度和丙二醇的浓度是变化的。通过确定抗张强度,耐折性,崩解性,在受控的湿度和温度条件下的行为以及粘合性来评估氟西汀ODF的每种配方。将所有获得的结果与六种不使用FX制备的ODF的结果进行比较。对于FX2,FX ODF的崩解时间最长为88 s。通过对ODF中FX的体外释放研究,注意到FX1和FX2可以在15分钟内更好地释放99.98±3.81%和97.67±3.85%的药物。从获得的结果还证实,发现FX ODF遵循一级释放动力学。
更新日期:2021-04-29
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