School of Pharmacy and Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Iran J Basic Med Sci. 2014 May;17(5):344-50.
This study dealt with the wet agglomeration process in which a small quantity of binder liquid was added into a suspension of crystals, directly in the stirring vessel where the crystallization took place. The purpose of this investigation was evaluation of the effect of temperature on the agglomeration process in order to gain insight into the mechanism of the formation of the agglomerates.
Carbamazepine was used as a model drug and water/ethanol and isopropyl acetate were used as crystallization system and binder liquid, respectively. The agglomeration of crystals was carried out at various temperatures and the agglomerates were characterized in terms of size, morphology, density and mechanical strength.
Evaluation of the agglomerates along the course of agglomeration shows that the properties of the particles change gradually but substantially. Higher temperature of the system during agglomeration process favors the formation of more regular agglomerates with mechanically stronger and denser structure; this can be explained by the promotion effect of temperature on the agglomeration process.
With optimized wet agglomeration temperature, spherical, dense, and strong agglomerates can be obtained.
本研究涉及湿团聚过程,其中在结晶发生的搅拌容器中直接向晶体悬浮液中加入少量粘结剂液体。本研究的目的是评估温度对团聚过程的影响,以便深入了解团聚体形成的机理。
采用卡马西平作为模型药物,水/乙醇和异丙基乙酸酯分别作为结晶体系和粘结剂液体。在不同温度下进行晶体团聚,根据粒径、形态、密度和机械强度对团聚体进行表征。
在团聚过程中对团聚体进行评价表明,颗粒的性质逐渐但显著地发生变化。在团聚过程中,较高的体系温度有利于形成更规则的团聚体,具有更强的机械强度和更致密的结构;这可以通过温度对团聚过程的促进作用来解释。
通过优化的湿团聚温度,可以获得球形、致密和高强度的团聚体。