CURRENT REGULATORY SITUATION AND PROPOSED USE OF RAMAN SPECTROSCOPY AS A MONITORING TECHNIQUE FOR CONTENT UNIFORMITY IN SCORED TABLET PARTITION

Abstract

Among the various pharmaceutical forms, the most common solid ones are tablets. These may have a score on the surface to facilitate partition, a common practice, especially in treating children and elderly patients. Research has shown that the partition can interfere with the dosage of a tablet and compromise the entire therapeutic approach. Some regulatory bases and pharmacopeias recognize the practice of splitting tablets and require tests to evaluate the uniformity of the unit dose of a scored tablet.
Therefore, this work proposes to assess the impact of scored tablet splitting using the most common methods for this purpose through the tests proposed in the main pharmacopeias, presenting Raman as an alternative technique. Thus, a narrative bibliographic review was performed using different databases and regulatory agencies’ websites. Some regulatory bases allow the tablets to split with the recommendations, and the pharmacopeias propose its evaluation through the unit dose uniformity
test. The studies revealed that the division using tablet splitters is more accurate, followed by manual, knife, and scissors. On the other hand, Raman proved to be liable for the proposed evaluation. Given the lack of this issue, there is a need for more detailed regulation. On the other hand, Raman proved to be liable for the proposed evaluation. Given the lack of this issue, there is a need for more detailed regulation. At the same time, higher productivity in the characterization of substances in comparison to other techniques.