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Table 1 Carbomers, polycarbophil, and carbomer copolymers for use in drug products • Rheology modification at very low concentrations— less than 1 percent—to produce a wide range of vis- cosities and flow properties in lotions, creams, and gels; oral suspensions; and transdermal gel reservoirs. • Suspension of insoluble ingredients in oral and topical liquids and semisolids. • Emulsification of topical oil-in-water systems with essentially no need for surfactants. Lubrizol manufactures all three polymers under GMP standards and offers them in a variety of functional grades suitable for different dosage forms. Table 1 provides an overview of the products and sum- marizes their recommended uses in drug development and manufacture. Polymers manufactured in either ethyl acetate or a cosolvent mixture of ethyl acetate and cyclo- hexane are used in topical products, while the polymers manufactured in ethyl acetate are intended for use in orally administered pharmaceutical products. Product Properties Applicable compendial monograph Route of administration Polymerization solvent Viscosity a (cP) United States (USP/NF) Europe (Ph Eur) Japan (JPE) b Oral Topical Carbopol polymers 971P NF Ethyl acetate 4,000 - 11,000 Carbomer homopolymer type A Carbomers Carboxyvinyl polymer • • 71G NF Ethyl acetate 4,000 - 11,000 Carbomer homopolymer type A Carbomers Carboxyvinyl polymer • • 974P NF Ethyl acetate 29,400 - 39,400 Carbomer homopolymer type B Carbomers Carboxyvinyl polymer • • 5984 EP Cosolvent c 30,500 - 39,400 Carbomer homopolymer type B Carbomers Carboxyvinyl polymer • 980 NF Cosolvent 40,000 - 60,000 Carbomer homopolymer type C Carbomers Carboxyvinyl polymer • 981 NF Cosolvent 4,000 - 10,000 Carbomer homopolymer type A Carbomers Carboxyvinyl polymer • Ultrez 10 NF Cosolvent 45,000 - 65,000 Carbomer interpolymer type A • ETD 2020 NF Cosolvent 47,000 - 77,000 d Carbomer interpolymer type B • Noveon polycarbophil AA-1 USP Ethyl acetate 2,000-12,000 e Polycarbophil • • Pemulen polymers TR-1 NF Cosolvent 10,000-26,500 d Carbomer copolymer type B • TR-2 NF Cosolvent 4,500-13,500 d Carbomer copolymer type A • a Specification at 0.5 weight percent at pH 7.5, unless otherwise noted b Upon request, Lubrizol certifies select lots of product against JPE's Carboxyvinyl Polymer Monograph c Cosolvent is a mixture of ethyl acetate and cosolvent d 1.0 weight percent e 0.2 weight percent 18 July 2016 Tablets & Capsules