Safety of Soluplus® in Pediatrics

This paper provides information on the risk and acceptability of the polymeric solubilizer Soluplus® as an excipient in pediatric formulations. The assessment was performed based on safety data available from the manufacturer and publicly available data sources. Soluplus® is virtually non-toxic in rats and dogs after oral administration, consistent with its negligible systemic exposure. The non-toxic dose levels established in animals translate into a substantial Human Equivalent Dose (>300 mg/kg). Clinical safety data in adult subjects further support the presumed safe use of Soluplus® in pediatric clinical formulations. Based on existing data, additional toxicology studies in juvenile animals are not warranted. Overall, the use of Soluplus® as an excipient in pediatric oral clinical formulations in 300 mg or 30 mg/kg can be considered reasonably safe.

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Schmitt Georg*, Safety of Soluplus® in Pediatrics, Applied Drug Research, Clinical Trials and Regulatory Affairs 2022; 9(1)
https://dx.doi.org/10.2174/2667337109666221116092457

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