Preparation and characterization of gelatin sponge millispheres from air-in-water-in-oil-type emulsions.
A novel method for the preparation of gelatin sponge millispheres (GSMs) for biomaterials such as embolic agents and cell scaffolds was developed using an air-in-water-in-oil-type emulsion. The droplets, consisting of a foamy gelatin suspension in caprylic triglyceride, were gelled and rinsed with isopropanol. Sonication and depressurization were used during the rinsing process to create interconnected pores. GSMs cross-links created over 4 h at 155 degrees C without any agent were insoluble and had short and long diameters of 1.1 +/- 0.2 mm and 1.3 +/- 0.2 mm, respectively. The residual isopropanol and caprylic triglyceride were <0.05% (w/w) and <1% (w/w) respectively. The level of bacterial endotoxins in the extracts was below 0.025 EU/ml, and no bacterial or fungal growth was found during sterility testing. The GSMs produced using this method were considered to meet the basic requirements of embolic agents.
Yamashita
Noboru
N
Institute for Technology, Astellas Pharma Inc., Yaizu-shi, Shizuoka-ken, Japan. noboru.yamashita@jp.astellas.com
Izumikawa
Satoshi
S
Takagi
Akira
A
Arakawa
Haruyuki
H
Wakasawa
Tatsuyoshi
T
Maruyama
Atsushi
A
D000388:Air; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D004355:Drug Stability; D004655:Emulsions / Q000737:chemistry*; D005780:Gelatin / Q000737:chemistry*; D006358:Hot Temperature; D008855:Microscopy, Electron, Scanning; D009821:Oils / Q000737:chemistry*; D010316:Particle Size; D016062:Porosity; D014867:Water / Q000737:chemistry*
D004304:Dosage Forms; D004655:Emulsions; D009821:Oils; D014867:Water; D005780:Gelatin