Objective: The main objective of this study was to compare the taste-masking efficiency of LYOMATRIX Technology which was utilized in the development of Paracetamol Oral Solution (Taste Masked) i.e., NEXPAR with marketed suspension product to see any improvement in taste and therapeutic efficacy in paediatric population.

Methods: Children from the age of 2-12 years with fever of non-serious origin were randomized to receive either of the treatments. The paracetamol dose selected was 15mg/kg body weight. Armpit temperature was measured at various time-points till 24 hours. A second dose was administered only when at 6 hours the body temperature was still found to be 101.3^oF; or the child was not responding to the treatment. At the end of the study, parents were asked to subjectively rate the efficacy of the product. The primary endpoints were to; compare the taste acceptability; area under the temperature-time curve; and to compare reduction in fever after administration of two different formulations from baseline at various time points post-dosing. Secondary efficacy endpoints included a variety of objective and subjective measures.

Results: Statistically significant differences in all the primary endpoints were in favour of NEXPAR. Most of the secondary endpoints also showed some significant differences. Both agents were equally well tolerated. Significantly more parents in the NEXPAR group rated the drug as very efficacious.

Conclusion: NEXPAR was found to have better taste and greater formulation acceptance by the children, ensuring better compliance, correct dosing and better absorption of the drug resulting in better therapeutic outcome.

Keywords: Fever, Taste-mask, Bitter taste, Paediatric, Paracetamol, LYOMATRIX Technology, Solution, Suspension.

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Sangeeta Choudhury

Pulse Pharmaceuticals Pvt. Ltd.,

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