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Open AccessArticle

Pediatric Safety of Polysorbates in Drug Formulations

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F. Hoffmann-La Roche, Ltd., 4070 Basel, Switzerland
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Pharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche, Ltd., 4070 Basel, Switzerland
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Formerly Employed by F. Hoffmann-La Roche, Ltd., 4070 Basel, Switzerland
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Lonza AG, Drug Product Services, 4057 Basel, Switzerland
*
Author to whom correspondence should be addressed.
Children 2020, 7(1), 1; https://doi.org/10.3390/children7010001
Received: 15 November 2019 / Revised: 17 December 2019 / Accepted: 18 December 2019 / Published: 20 December 2019
Polysorbates 20 and 80 are the most frequently used excipients in biotherapeutics, the safety data for which have been well documented in adults. The polysorbate content in therapeutic formulations that are administered to children, however, has been less clearly regulated or defined with regard to safety. In pediatric patients, excessive amounts of polysorbate in biotherapeutics have been linked to hypersensitivity and other toxicity-related effects. To determine safe levels of polysorbates for young patients, we have developed the progressive pediatric safety factor (PPSF), an age- and weight-based tool that estimates the amount of parenterally administered polysorbates 20 and 80 in formulations that will avoid excipient-related adverse events. Compared with existing modalities for calculating maximum acceptable doses of excipients for initial clinical trials in pediatrics, the PPSF is far more conservative, thus constituting an added margin of safety for excipient exposure in the most sensitive subpopulations—i.e., neonates and infants. Further, the PPSF may be applied to any relevant excipient, aiding pharmaceutical developers and regulatory authorities in conservatively estimating the safety assessment of a biotherapeutic’s formulation, based on excipient levels. View Full-Text
Keywords: polysorbate; excipient; safety factor; pediatric; toxicology; pharmaceutical; formulation polysorbate; excipient; safety factor; pediatric; toxicology; pharmaceutical; formulation
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MDPI and ACS Style

Kriegel, C.; Festag, M.; Kishore, R.S.; Roethlisberger, D.; Schmitt, G. Pediatric Safety of Polysorbates in Drug Formulations. Children 2020, 7, 1.

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