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Leveraging elevated temperature and particle size reduction to extract API from various tablet formulations.

作者信息

Nickerson Beverly, Arikpo William B, Berry Mark R, Bobin Vincent J, Houck Timothy L, Mansour Hany L, Warzeka John

机构信息

Pfizer Global Research & Development, Groton/New London Laboratories, Pfizer Inc, Groton, CT 06340, USA.

出版信息

J Pharm Biomed Anal. 2008 Jun 9;47(2):268-78. doi: 10.1016/j.jpba.2008.01.006. Epub 2008 Jan 11.

Abstract

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.

摘要

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