Numerous technologies are available to mask the bitterness of APIs but their use in paediatric formulation is limited by the excipient’s toxicity, which is different for children compared with adults. So there is a need for formulation based on simple and well-known excipients.
Acetaminophen or paracetamol is one of the most common medications used to treat infants for pain and fever. Its bitterness often leads to complex formulations, needed to improve acceptability by a child’s palate. While testing several directly compressible (DC) excipients in a first study on the formulation of chewable acetaminophen tablets containing sucralose, it was observed that all DC polyols were able to give a pleasant texture, but surprisingly some formulations based on directly compressible maltitol from Roquette (SweetPearl P300DC) were judged less bitter. Therefore, masking the bitterness of acetaminophen by incorporating only a well-accepted intense sweetener (sucralose) and a bulk sweetener (maltitol), both of which are commonly used in paediatric medicines, is of significant interest.
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