Reformulating Drug Products Containing Carbomers with Benzene

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About This Webinar:

Meera Raghuram, Director of Regulatory and Sustainability Strategy

Elena Draganoiu, Ph.D., Global Technical Business Development Director, Pharmaceuticals & Nutraceuticals

The U. S. FDA issued a guidance document in December 2023 that provided recommendations for drug product manufacturers on required testing and documentation to support the reformulation of drug products that use carbomers manufactured with benzene.   

In this webinar the Lubrizol Pharmaceutical team discussed what this guidance means for drug product manufacturers and the impact it has on the reformulation of drug products containing benzene-grade carbomers. Our team reviewed regulatory strategy and information on non-benzene grade carbomer excipients to assist drug manufacturers with reformulation efforts and answered questions.

Our Speakers:

• Meera Raghuram, Director of Regulatory and Sustainability Strategy
• Elena Draganoiu, Ph.D., Global Technical Business Development Director, Pharmaceuticals & Nutraceuticals

Key Takeaways: 

1. What the recent FDA guidance on drug products containing carbomers with benzene mean for product manufacturers 
2. The impact this guidance has on the reformulation of drug products containing benzene-grade carbomers
3. What excipient information is available from Lubrizol to assist manufacturers in switching to a non-benzene-grade carbomer