Influence of encapsulation variables on formation of leuprolide-loaded PLGA microspheres

乳状液 PLGA公司 无量纲量 化学 化学工程 纳米技术 热力学 材料科学 纳米颗粒 有机化学 物理 工程类
作者
Jia Zhou,Richard Schutzman,Nian-Qiu Shi,Rose Ackermann,Karl Olsen,Yan Wang,Steven P. Schwendeman
出处
期刊:Journal of Colloid and Interface Science [Elsevier]
卷期号:636: 401-412 被引量:6
标识
DOI:10.1016/j.jcis.2022.11.122
摘要

Emulsion-based solvent evaporation microencapsulation methods for producing PLGA microspheres are complex often leading to empirical optimization. This study aimed to develop a more detailed understanding of the effects of process variables on the complex emulsification processes during encapsulation of leuprolide in PLGA microspheres using a high-shear rotor-stator mixer. Following extensive analysis of previously developed formulation conditions that yield microspheres of equivalent composition to the commercial 1-month Lupron Depot, multiple variables during the formation of primary and secondary emulsion were investigated with the aid of dimensional analysis, including: rotor speed (ω) and time (t), dispersed phase fraction (Φ) and continuous phase viscosity (µc). The dimensionless Sauter mean diameter (d3,2) of primary emulsion was observed to be proportional to the product of several key dimensionless groups (Φ1,We,Re,ω1t1) raised to the appropriate power indices. A new dimensionless group (Θ ) (surface energy/energy input) was used to rationalize insertion of a proportionate time dependence in the scaling of the d3,2. The dimensionless d3,2 of secondary emulsion was found proportional to the product of three dimensionless groups ( [Formula: see text] ) raised to the appropriate power indices. The increased viscosity of the primary emulsion, decreased secondary water phase volume and reduced second homogenization time each elevated encapsulation efficiency of peptide by reducing drug leakage to the outer water phase. These results could be useful for dimensional analysis and improving manufacturing of PLGA microspheres by the solvent evaporation method.
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