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

  • Rada Santosh Kumar GITAM Institute of Pharmacy, GITAM (Deemed to be University)
  • P. Swetha

Abstract

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.

Downloads

Download data is not yet available.

Author Biography

P. Swetha

GITAM Institute of Pharmacy, GITAM (Deemed To Be University) Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India.

Statistics
215 Views | 184 Downloads
How to Cite
1.
Santosh Kumar R, Swetha P. Stability Matrix Designs: A Boon For Stability Testing of Pharmaceutical Drug Products. JDDT [Internet]. 30Aug.2019 [cited 18Jun.2021];9(4-s):839-43. Available from: https://jddtonline.info/index.php/jddt/article/view/3396

Most read articles by the same author(s)

1 2 3 > >>