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FDA Cautions Against Use of Phthalates as Drug Excipients
The FDA is warning drugmakers to avoid using two types of phthalates as excipients because of safety concerns, according to a new draft guidance. Dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) are sometimes used in coatings of solid oral drugs to create slow- or extended-release formulations. They are also commonly used in plastics intended to make products more flexible.
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