The effect of process variables on the morphology and release characteristics of protein-loaded PLGA particles

Poly(lactide-co-glycolide) (PLGA 75 :25), IV 0.94 dL/g was chosen as the matrix of the microparticles. Bovine serum albumin (BSA) (Fraction V) as the model drug was incorporated in the microparticles by a W/O/W emulsification and solvent evaporation technique. The effect of the various preparation parameters on particle morphology, drug loading efficiency, and drug release profiles of the resultant microparticles were examined. Particle size varied from 5 to 60 Am. The final morphology of the microparticles varied dramatically with preparation variables such as equipment used to produce the primary emulsion (W1/O) and the water-to-oil ratio (W1/O) in the primary emulsion. In general, the viscosity of the primary emulsion had a significant effect on the porosity of particles produced. The release of BSA showed a strong relationship with the preparation parameters of microparticles, partly due to the morphological effects. For example, microparticles made from the vortex mixer that was used to disperse inner aqueous phase (W1) to oil phase (O) showed a lower burst effect than that made from the homogenizer because of its better surface morphology. W1/O ratio, speed of dispersing the primary emulsion into W2, PLGA concentration, and different matrix materials also affected the drug release profiles. In all the samples studied here, only diffusion-controlled release was observed. (c) 2006 Wiley Periodicals, Inc.