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Applied Drug Research, Clinical Trials and Regulatory Affairs

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ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

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Mini-Review Article

Safety of Soluplus® in Pediatrics

Author(s): Georg Schmitt*

Volume 9, Issue 1, 2022

Published on: 21 December, 2022

Article ID: e161122210943 Pages: 3

DOI: 10.2174/2667337109666221116092457

Price: $65

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Abstract

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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