US Pharmacopeia (USP) plans to organize
an invitation only,
Virtual Carbomers Roundtable: Identifying a path forward for benzene containing Carbomer monographs, on
October 27-28, 2022.
The USP Carbomers Roundtable will facilitate dialogue on identifying a path forward for the benzene containing NF Carbomer monographs (Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342) to address increasing stakeholder concern about exposure to benzene when using some drug products.
The overarching goal is to convene global stakeholders (users, makers, regulators, trade associations, and others) to help USP determine the overall approach for addressing benzene limits in these NF Carbomer monographs.
The Roundtable Steering Committee was established at the request of the Chair of the USP Complex Excipients Expert Committee to assist with organizing the Roundtable (agenda, content, speakers, etc.) and identifying impacted stakeholders to share their scientific/technical knowledge on the experience and use of benzene containing Carbomers that can inform the Roundtable Steering Committee's decision.
Anticipated outcomes of the meeting are as follows:
• Understanding of USP <467> Residual Solvents' applicability to excipients and drug products.
• Learning about industry and regulatory successes in switching from benzene containing Carbomers.
• Learning about industry challenges in switching from benzene containing Carbomers.
• Understanding the impact of omission of the NF benzene containing Carbomer monographs on application and nonapplication drug products and time necessary for switching.
• Review of stakeholders' questions, comments, and feedback received that the Steering Committee would consider in the panel discussion.
• Upon conclusion of the Roundtable, the Steering Committee will propose a path forward for the NF benzene containing Carbomer monographs.
If you are an organization or a scientist with expertise in formulating complex dosage forms
using Carbomers that may be impacted by the outcome of the Roundtable and
would like to participate in the roundtable meeting, please write to
Galina Holloway ([email protected]).------------------------------
Otilia Koo Ph.D.
Executive Director
Bristol-Myers Squibb
New Brunswick NJ
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------