Leveraging elevated temperature and particle size reduction to extract API from various tablet formulations.
Several sample preparation techniques were evaluated for extracting active pharmaceutical ingredient (API) from immediate release (IR) and controlled release (CR) tablet formulations. These techniques utilized either elevated temperature [e.g., accelerated solvent extraction (ASE) and microwave assisted extraction (MAE)] or particle size reduction [e.g., ball mill and homogenizer/Tablet Processing Workstation II (TPWII)]. Results were compared for equivalence to those obtained with the existing standard method for each formulation. For the CR formulations, sample preparation times were significantly reduced when using these techniques compared to the standard method. Advantages and limitations associated with each technique are discussed.
Nickerson
Beverly
B
Pfizer Global Research & Development, Groton/New London Laboratories, Pfizer Inc, Groton, CT 06340, USA. beverly.nickerson@pfizer.com
Arikpo
William B
WB
Berry
Mark R
MR
Bobin
Vincent J
VJ
Houck
Timothy L
TL
Mansour
Hany L
HL
Warzeka
John
J
D004304:Dosage Forms; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013607:Tablets; D013696:Temperature
D004304:Dosage Forms; D004364:Pharmaceutical Preparations; D013607:Tablets