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Int J Pharm. 2018 Feb 15;537(1-2):183-192. doi: 10.1016/j.ijpharm.2017.12.011. Epub 2017 Dec 9.

Real time release testing of tablet content and content uniformity.

Author information

1
GSK Research & Development, New Frontiers Science Park, Third Avenue, Harlow, CM19 5AW, UK. Electronic address: daniel.j.goodwin@gsk.com.
2
GSK Global Manufacturing & Supply, Priory Street, Ware, SG12 0DJ, UK.
3
GSK Research & Development, Park Road, Ware, SG12 0DP, UK.
4
GSK Research & Development, Gunnels Wood Road, Stevenage, SG1 2NY, UK.

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.

KEYWORDS:

Compaction force weight control; Content uniformity; Parametric tolerance interval test; Quality by design; Real time relea; Uniformity of dosage units; se testing

PMID:
29229511
DOI:
10.1016/j.ijpharm.2017.12.011
[Indexed for MEDLINE]

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