Particle size control of poly(dl-lactide-co-glycolide) nanospheres for sterile applications.
Parameters affecting the particle sizes of poly(DL-lactide-co-glycolide) (PLGA) nanospheres produced by the Emulsion Solvent Diffusion (ESD) method were evaluated in this study, so that suitable PLGA nanospheres could be prepared to pass through a membrane filter with 0.2 microm pore size and used as a sterile product. Experimental results demonstrated that the particle sizes of PLGA nanospheres could be reduced by the following efforts. (1) Increase stirring rate of poor solvent. (2) Decrease feed rate of good solvent. (3) Increase poor solvent ratio. (4) Increase the temperature of poor solvent. (5) Decrease polyvinyl alcohol concentration in poor solvent. (6) Increase ethanol concentration in good solvent. (7) Decrease PLGA concentration in good solvent. After optimization, PLGA nanospheres with a mean particle size of 102-163 nm and the 100-98% of filtration fraction could be produced and passed the bacteria challenge tests. This study found PLGA nanospheres can be efficiently prepared as a sterile product.
Tsukada
Yusuke
Y
Hosokawa Powder Technology Research Institute, 1-9 Shoudai, Tajika, Hirakata, Osaka 573-1132, Japan.
Hara
Kaori
K
Bando
Yohei
Y
Huang
C C
CC
Kousaka
Yasuo
Y
Kawashima
Yoshiaki
Y
Morishita
Ryuichi
R
Tsujimoto
Hiroyuki
H
D004058:Diffusion; D004339:Drug Compounding; D016503:Drug Delivery Systems / Q000379:methods; D004655:Emulsions; D005374:Filtration; D019344:Lactic Acid / Q000737:chemistry*; D008567:Membranes, Artificial; D054118:Nanospheres; D010316:Particle Size; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011312:Pressure; D012997:Solvents; D013242:Sterilization; D013499:Surface Properties
D004655:Emulsions; D008567:Membranes, Artificial; D012997:Solvents; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid