Banov Daniel, Liu Yi, Ip Kendice, Shan Ashley, Vu Christine, Zdoryk Oleksandr, Bassani August S, Carvalho Maria
Professional Compounding Centers of America (PCCA), Houston 77099, TX, USA.
Institute for Pharma Technology, School of Life Sciences, University of Applied Sciences und Arts Northwestern Switzerland, 4132 Muttenz, Switzerland.
Pharmaceutics. 2023 Nov 20;15(11):2642. doi: 10.3390/pharmaceutics15112642.
The paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.
适合儿科患者的药物制剂匮乏,因此需要定制的复方药物。本研究旨在全面分析新型专利无水口服载体SuspendIt Anhydrous的物理性质,该载体专为配制儿科口服液体制剂而设计。使用了广泛的测试方法,包括沉降体积、粘度、在模拟胃液中分散后的液滴大小、显微镜检查和含量均匀度测量,以评估无水载体的性质。结果表明,该载体在不同条件下表现出一致的物理性质,并随时间保持稳定。这可归因于其配方中辅料的独特组合,这些辅料不仅能保持其粘度,还能赋予触变性。粘性、触变性和自乳化特性的独特组合使得药物能够快速再分散、具有沉降稳定性、剂量准确、具有潜在的药物溶解性、分散性,并能促进胃肠道分布和吸收增强。此外,该载体对13种无水混悬液表现出长期的沉降稳定性和含量均匀度。这些结果表明,无水口服载体可作为儿科制剂的通用基质,有可能填补儿科药物递送方面的重要空白。未来的研究可以进一步探讨其与其他药物在不同临床场景下的相容性、稳定性和性能。