Automated sample preparation of protein solid dosage forms: Novel application for the tablet processing workstation.

Abstract

Biological macromolecule solid dosage forms represent the frontier of orally administered pharmaceuticals. Analysis of these drug products poses new challenges compared to traditional small molecule tablets. In this study we demonstrate the first, to our knowledge, automated Tablet Processing Workstation (TPW) sample preparation of large molecule tablets. Tablets containing a modified version of human insulin were tested for content uniformity and the automated method was successfully validated for recovery, carryover and displayed manual method equivalency in repeatability and in-process stability. Per TPW's ability to process one sample sequentially, the total analysis cycle time is, in fact, increased. In lieu, a net gain in scientist productivity is realized by enabling continuous operation reducing analytical scientist labor time by 71% compared to manually conducted sample preparation.