초록 |
A new spinning oil film(SOF) solid-in-oil-in-oil emulsion process was developed to produce uniform-sized protein loaded biodegradable microspheres. A thin SOF on a cylindrical rotor was used to shear droplets from a nozzle tip to control droplet size. The resulting microspheres with low polydispersity(6%) produced a low burst(6-11%) release even at high loadings(13-18% encapsulated solids, 8-12% protein). The SOF process had a high yield and did not require the presence of water or surfactants. Amorphous protein and crystalline excipient solids were encapsulated into 3 different polymers, giving a homogenous drug distribution throughout the microspheres, and an essentially complete protein encapsulation efficiency (average=99%). In contrast, large burst release was observed for polydisperse microspheres produced by a conventional emulsification technique, particularly for microspheres smaller than 25μm in diameter, which gave 93% burst at 15% loading. |