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.
Highlights
Functional scoring of a tablet enables patients to manage their drug dose and possibly limit the cost savings for healthcare suppliers [1,2,3,4,5,6,7,8,9,10,11]
This review article demonstrates the complete evaluation of functional scoring that represents labeled fractions of a whole tablet dose concerning the current analytical testing and release practices
Select a minimum of 30 tablets, and proceed as follows for the dosage form designated where different procedures can use for the determination of assay and content uniformity (CU) test, it is necessary to establish a correction factor to be post applied to the results
Summary
Functional scoring of a tablet enables patients to manage their drug dose and possibly limit the cost savings for healthcare suppliers [1,2,3,4,5,6,7,8,9,10,11]. Select a minimum of 30 tablets, and proceed as follows for the dosage form designated where different procedures can use for the determination of assay and CU test, it is necessary to establish a correction factor to be post applied to the results. The tests are intended primarily to perform whether a substance or preparation complies with an established specification for a microbiological character When employed for such purposes, follow the instructions as stated in general monograph, including the number of samples to be taken, and evaluate the results. The tests are intended primarily to perform whether a substance or preparation complies with a demonstrated specification for microbiological quality When used for such determinations, follow the instructions as per general monograph, including the number of samples to be taken for testing, and evaluate the results. If any material reprocessed after additional testing, the investigation should incorporate observations and the signatures of suitable production and quality control personnel (Fig. 5)
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