SPLIT-HALF TABLETS: A COMPLETE REVIEW FOR ANALYTICAL TESTING

  • LAKSHMI NARASIMHA RAO KATAKAM Department of Analytical Chemistry, Analytical Research and Development, Saptalis Pharmaceuticals LLC, Hauppauge, New York 11788, USA.

Abstract

A solid oral dosage form (as a tablet) which is an immediate or extended-release dosage form which necessitates the scoring bisect of the tablet. This review discusses the quality attributes and interpretations for the split studies of the various tablet formulations using the analytical techniques. Each method of analysis for the evaluation of split-half tablets in terms of its critical quality attributes discusses in detail explanation of analytical methodology and challenges in formulation development. The results for quantitative analytical evaluation in terms of finished product/stability testing and release of the split-half drug product against the acceptance criterion and also discusses the flowchart guidance for the investigation of out of specification results. The present article provides an insight into the complete analytical evaluation of split-half drug product testing according to the requirements of tablet scoring as per US food and drug administration.

Keywords: Split-half tablet, Analytical testing, Calculation formulae, Acceptance criteria, Investigation of results

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How to Cite
LAKSHMI NARASIMHA RAO KATAKAM. “SPLIT-HALF TABLETS: A COMPLETE REVIEW FOR ANALYTICAL TESTING”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 9, July 2019, pp. 27-38, https://innovareacademics.in/journals/index.php/ajpcr/article/view/34601.
Section
Review Article(s)