Applied Clinical Research, Clinical Trials and Regulatory Affairs

Satish Chandra
Tawam Hospital
Al Ain
UAE

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Tablet Scoring and its Regulatory Perspective

Author(s): V. Yugender Reddy, M.P. Venkatesh, T.M. Pramod Kumar.

Graphical Abstract:


Abstract:

The objective of this paper is to provide insight and better understanding of the regulations for the scored tablet in regulated markets and World Health Organization. Splitting of tablets is done for various reasons; but is associated with certain problems such as inaccurate split resulting in change of dose, enhanced drug degradation due to atmospheric exposure, change in dissolution rate and extent. The accuracy of split is not uniform even with the use of commercial tablet cutters. Often patients with impaired vision, and lack of skilled experience have difficulty during splitting tablets. Accurate dosing may not be possible with splitting of tablets, especially with potent drugs. Tablet splitting may reduce the cost of therapy and may accommodate dose changes as required, but impact on the overall quality of medication used in therapy.

Keywords: Dissolution, score, splitting, tablet.

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Article Details

VOLUME: 1
ISSUE: 2
Year: 2014
Page: [107 - 110]
Pages: 4
DOI: 10.2174/2213476X01666141107192108
Price: $58