Comparative analysis of carbomer polymers for pharmaceutical and cosmetic practice

Abstract

The aim of the study. Given the wide range of carbomers, their manufacturing technologies, solvent systems for their synthesis, differences in name and regulation, there is a need to systematize this group of excipients for the pharmaceutical and cosmetic industries. When using carbomers in the pharmaceutical development of medicines, the results of additional studies on the compliance of quality with pharmacopoeial indicators should be provided in registration materials.

Materials and methods. As materials used were data from the official websites of the Ministry of Health of Ukraine, the FDA and Lubrizol; Pharmacopoeias of the United States (USP/NF), Europe (Ph. Eur) and Japan (JPE); scientific publications. Methods of information retrieval, systematization of theoretical and practical material were used.

Results. As a result of studying the official regulatory documents it has been found that the US Pharmacopoeia (USP/NF) contains monographs called “Carbomer Copolymer”, “Carbomer Interpolymer” and “Carbomer Homopolymer”, which are classified into types A, B, C for polymers synthesized without the use of benzene, and monographs “Carbomer934”, “Carbomer 934Р”, “Carbomer940”, “Carbomer941”, “Carbomer1342” – for polymers synthesized using benzene. The Pharmacopoeia of Europe (Ph. Eur) contains a monograph “Carbomers” of a general nature, the requirements of which are met only in “Carbomer Homopolymer” polymers synthesized without the use of benzene by USP/NF. The Japan Pharmacopoeia (JPE) contains the monograph “Carboxyvinyl Polymer”, which includes carbomers synthesized both with and without benzene.

Conclusions. The USP/NF pharmacopoeial quality requirements are met in the trademarks of carbomers: Carbopol 71G NF, Carbopol 971P NF, Carbopol 974P NF, Carbopol 980 NF, Carbopol 981 NF, Carbopol 5984 EP, Carbopol 934 NF, Carbopol 934P NF, Carbopol 940 NF, Carbopol 941 NF, Carbopol 1342 NF, Carbopol Ultrez 10 NF, Carbopol ETD 2020 NF, Pemulen TR-1 NF, Pemulen TR-2 NF, Noveon AA-1 USP. Only 6 brands of carbomers meet the requirements of the European Pharmacopoeia: Carbopol 71G NF, Carbopol 971P NF, Carbopol 974P NF, Carbopol 980 NF, Carbopol 981 NF, Carbopol 5984 EP.