Daghmash Rawand M, Khanfar Mai S, Darweesh Ruba S
Department of Pharmaceutical Technology, Faculty of Pharmacy, Jordan University of Science and Technology, P.O. Box 3030, Irbid 22110, Jordan.
Pharmaceutics. 2024 Aug 13;16(8):1062. doi: 10.3390/pharmaceutics16081062.
Gummy formulations are defined as gradually or slowly released solid oral dosage forms. Risperidone is an atypical antipsychotic medication used to treat schizophrenia and autism-related irritability. This study presents the development of visually appealing, patient-tailored medicated gummies that act as a novel pharmaceutical form of Risperidone for pediatrics. In this study, two gummy bases were used, one containing Glucomannan and the other containing Gelatin as a gelling agent, where these gummy bases were loaded with coated Risperidone pellets with a controlled release layer. The final products were evaluated for their pH, viscosity, content uniformity, drug content, and dissolution profile. Both formulas showed proper rheology and met content and weight uniformity standards. The release rates for F1 and F2 in the acidic media were 25% and 11%, respectively, after 2 h. At the same time, a full-release profile for Risperidone was noticed in both formulae at pH 6.8 where the release lasts for 24 h. It can be concluded that the chewable semi-solid dosages (gummies) filled with coated pellets are suitable for pediatric patients since pediatrics have drug-related problems which can be solved using high gastro-resistance coated pellets, which also shows a proper release profile for the drug.
软糖制剂被定义为缓释或缓慢释放的固体口服剂型。利培酮是一种非典型抗精神病药物，用于治疗精神分裂症和自闭症相关的易怒症状。本研究展示了开发外观吸引人、针对患者定制的含药软糖，作为利培酮用于儿科的一种新型药物剂型。在本研究中，使用了两种软糖基质，一种含有葡甘露聚糖，另一种含有明胶作为胶凝剂，这些软糖基质中填充了带有控释层的包衣利培酮微丸。对最终产品的pH值、粘度、含量均匀度、药物含量和溶出曲线进行了评估。两种配方均显示出适当的流变学性质，并符合含量和重量均匀度标准。在酸性介质中，F1和F2在2小时后的释放率分别为25%和11%。同时，在pH 6.8时，两种配方中利培酮均呈现完全释放曲线，释放持续24小时。可以得出结论，填充有包衣微丸的可咀嚼半固体剂型（软糖）适用于儿科患者，因为儿科患者存在与药物相关的问题，而使用高胃抗性包衣微丸可以解决这些问题，并且该剂型对药物也显示出适当的释放曲线。
