These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Real time release testing of tablet content and content uniformity.
    Author: Goodwin DJ, van den Ban S, Denham M, Barylski I.
    Journal: Int J Pharm; 2018 Feb 15; 537(1-2):183-192. PubMed ID: 29229511.
    Abstract:
    A comprehensive commercial control strategy for tablet content and content uniformity focussed on the unit operation of compression is presented and is proposed to enable real time release for these critical quality attributes. The control strategy is based on process understanding, process control through compaction force weight control on the tablet press, periodic checks of mean and individual tablet weight combined with at-line testing of tablet content by near infrared (NIR). The application of the at-line NIR tablet content method is discussed and an acceptance criteria based on a parametric tolerance interval test (PTIT) is proposed. Sample handling limitations and spectral acquisition time for the NIR content method limit the sample size, however the chosen PTIT assures an appropriate level of batch coverage. Data are presented for ten commercial-scale batches that demonstrates the control strategy delivered the quality standard for content and content uniformity.
    [Abstract] [Full Text] [Related] [New Search]