A Note on the FDA’s Perspective on the Reformulation of Drug Products Containing Carbomer Manufactured using Benzene as Polymerization Solvent

Abstract

The US Food and Drug Administration (FDA) have implemented the guidance for the carbomer that uses benzene as a residual solvent immediately. The course record has been summarized in this authoritative note. The course record covers the carbomer grades, for instance, 934, 934P, 940, 941, and 1342 containing 5000 ppm, which will be disposed of from the USP Monograph. The required solvents for the synthesis of carbomers are described. Therefore, the guidance covers the semisolid, immediate, and modified release oral solid, and Oral suspension formulations containing carbomer. The 1, 2, and 3 levels of progress are depicted with the possible impact on the estimation structure. The managerial necessities concerning the level of progress and required examinations are referred to. The level of progress, required study and the technique for regulatory recording have been portrayed thoroughly. The scale-up and post-approval changes details elaborated for the multiple dosage forms in brief. The future point is to assess the less expensive methods by dissecting the hydration of the polymers.