title: Particle size control of poly(dl-lactide-co-glycolide) nanospheres for sterile applications.
abstract: 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.
authors.affiliation: Hosokawa Powder Technology Research Institute, 1-9 Shoudai, Tajika, Hirakata, Osaka 573-1132, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Tsukada
authors.forename: Kaori
authors.initials: K
authors.lastname: Hara
authors.forename: Yohei
authors.initials: Y
authors.lastname: Bando
authors.forename: C C
authors.initials: CC
authors.lastname: Huang
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Kousaka
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Kawashima
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Morishita
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsujimoto
mesh_terms: 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
chemical_list: D004655:Emulsions; D008567:Membranes, Artificial; D012997:Solvents; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid