Stability Matrix Designs: A Boon For Stability Testing of Pharmaceutical Drug Products.

摘要

Long term stability is done in a matrix approach after manufacturing of drug for ensuring the stability of drugs. Using the matrix basic design which is useful for testing 3 lots under one storage condition can be expanded to multiple presentation of products or multiple storage conditions. The design shows full testing at the end points 0 and 36 months and shows partial testing at the interim time points 3, 6, 9, 12, 18 24 min . With the assistance of a statistical search algorithm, the test points are selected . 37.5  reduction in analytical testing, while permitting a reliable interim expiry estimate. Based on 12 months stability data it is provided by the proposed matrix design. The matrix approach obtained by expiration dating periods is typically more conservative than the approaches derived from the full testing estimate. The comparison of expiration dating estimate for meter dose inhaler and capsules is presented using the matrixed and full testing approaches.