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FDA issues Guidance for Reformulating drug product containing Carbomers manufactured with Benzene

FDA has issued a guidance to address the safety concerns associated with requirement of reformulation of drug products using carbomers synthesized with benzene. Goal of this guidance is to give clear recommendations for reformulation of such product, what documentation is required and less burdensome regulatory pathway, which otherwise may fall under Scale Up and Post-approval changes (SUPAC) guidelines.

Carbomers are acrylic acid polymers, used widely in formulation, as binder, gel forming agents, suspending agent and fillers. Some of these polymers use benzene as part of their manufacturing process.

FDA States that  “Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid using these carbomers”

FDA recommends that applicant to use alternate grade of polymer (if the current grade of Polymer uses benzene for manufacturing) that is manufactured without benzene and has similar polymer chemistry and physical properties (such as Viscosity and Rheology).

The guidance provides details on requirement of the data (including, In vitro release, CMC and Additional Bioequivalence studies). It also provides Regulatory Pathways, CBE-30 Supplement and Prior Approval Supplement, depending on impact on Quality, type of dosage forms and functionality of polymer in the formulation.

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