Weldon School of Biomedical Engineering, Purdue University, West Lafayette, IN, 47907, USA.
Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN, 47907, USA.
Pharm Res. 2023 Nov;40(11):2677-2685. doi: 10.1007/s11095-023-03568-z. Epub 2023 Aug 17.
Biodegradable poly(lactide-co-glycolide) (PLGA) microparticles loaded with either risperidone or naltrexone were prepared from an emulsification homogenization process. The objective of this study was to determine the impact the post-treatment temperature has on the properties and subsequent performance of the microparticles.
The post-treatment temperature of an ethanolic solution was characterized from 10 ~ 35ºC for the naltrexone and risperidone micropartilces.
The wash temperature resulted in a typical triphasic in vitro release pattern at low wash temperatures or a biphasic pattern consisting of an elevated release rate at higher post-treatment temperatures. The post-treatment temperature largely influences the particle morphology, residual solvent levels, glass transition temperature, and drug loading and is molecule dependent, whereby these characteristics subsequently influence the drug release rate.
The study highlights the importance of both the post-treatment process and control during manufacturing to obtain a formulation within the desired product profile.
载有利培酮或纳曲酮的可生物降解聚(乳酸-共-乙醇酸)(PLGA)微球是通过乳化匀浆工艺制备的。本研究的目的是确定后处理温度对微球性能和随后性能的影响。
用乙醇溶液在 10 至 35℃的条件下对纳曲酮和利培酮微球进行后处理温度特性描述。
洗涤温度导致在低洗涤温度下出现典型的三相体外释放模式,或在较高后处理温度下具有较高释放速率的两相模式。后处理温度在很大程度上影响颗粒形态、残留溶剂水平、玻璃化转变温度和药物负载,并且与分子有关,这些特性随后影响药物释放速率。
该研究强调了后处理过程和制造过程中的控制的重要性,以获得具有所需产品特性的配方。