Continuous Supercritical Anti-Solvent Treatments of Active Pharmaceutical Ingredients：Sulfamerazine and Acetazolamide
Date Issued
2008
Date
2008
Author(s)
Tsai, Feng-Nien
Abstract
The purpose of this study was to apply the continuous supercritical anti-solvent (SAS) process to treat the active pharmaceutical ingredients (APIs)：sulfamerazine and acetazolamide. The aims are to increase dissolution rates of micronized APIs, and to obtain polymorphous APIs after the SAS processes.n this research, the effects of the continuous SAS process parameters were discussed. The operating parameters resulted in various particle sizes, particle size distributions, crystal habits, and polymorphs of the APIs. These parameters included solvent, pressure, temperature, concentration of solution, and solution flow rate of solution. They were systematically studied and the optimum operating conditions were reported.he smallest average particle of sulfamerazine was obtained as 0.61±0.38µm under the following operating conditions：solvent = acetone, P=140bar, T=35℃, solution concentration=30% sat., solution flow rate=0.5mL/min. The crystal habit changed from the original irregular lump to irregular flake. The dissolution rate of sulfamerazine ncreased by 2.9 times after the SAS process. he smallest average particle size of acetazolamide was obtained as 0.36±0.12µm under the following operating conditions：solvent = ethyl acetate, P=100bar, T=35℃, solution concentration=90% sat., solution flow rate=1mL/min. The crystal habit changed from the original irregular lump to bar shape. The dissolution rate of cetazolamide increased by 4.4 times after the SAS process. The original acetazolamide was Form II while polymorph Form I was received from the SAS process using ethanol as the solvent.
Subjects
Supercritical anti-solvent
Sulfamerazine
Acetazolamide
Micronization
Polymorph
Dissolution rate
Type
thesis
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