Abstract
Propranolol is a beta-blocker used for treatment of infantile haemangioma in pediatric population. Due to lack of dosage forms containing adequate doses for children, tablet splitting is sometimes the only option for dose adjustment. The aim of this study was to compare different methods of tablet splitting in regard to mass variation/loss, content uniformity and dissolution properties of propranolol in order to find the optimal approach for dose adjustment for pediatric population. Uncoated tablets of propranolol (40 mg) were split into quarters using different approaches: tablet splitter, knife and by hand. Obtained quarters were subjected to the tests for subdivided scored tablets and content uniformity (Ph. Eur. 9.0), weight loss (FDA) and the dissolution rate (USP42-NF37). Hand scored tablets did not meet the criteria of Ph. Eur. tests for subdivided scored tablets, compared to two other methods. Weight loss was the highest for tablets obtained by the tablet-splitter as well as variations in drug content after splitting, while tablets scored by other methods met the requirements. Regarding dissolution rate after splitting, the acceptance criterion was fulfilled. Similarity with whole tablets’ dissolution profiles was found in the case of quarters obtained by using a tablet-splitter. Presented results indicate that different methods for tablet splitting significantly affect the uniformity of doses, directly influencing the drug effect. Considering that the tablets scored by knife meet the requirements of all executed tests, when necessary, this method of tablet splitting is considered to be the most appropriate for dose adjustment in pediatric population.
Published Version
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