Polysorbates 20 and 80 are the most frequently used excipients in biotherapeutics, the\nsafety data for which have been well documented in adults. The polysorbate content in therapeutic\nformulations that are administered to children, however, has been less clearly regulated or defined\nwith regard to safety. In pediatric patients, excessive amounts of polysorbate in biotherapeutics\nhave been linked to hypersensitivity and other toxicity-related effects..............................
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