Pemulen™ TR-1 NF Polymer

(Carbomer Copolymer Type B USP NF)

Applicable synonyms for Pemulen™ TR-1 NF Polymer: carbomer, carboxypolymethylene 
Polymerization/Residual solvent: Cosolvent mixture of ethyl acetate and cyclohexane

Key features: 

• Emulsifier
• Thickener/rheology modifier

Additional features:

• Bioadhesive agent

Recommended for use in the following dosage forms:

• Semisolids & gels

Recommended for use in the following markets / routes of administration:

• Topical drug delivery
• Ophthalmic drug delivery

Pemulen™ TR-1 NF polymer meets the limits cited in the current edition of the following monographs: 

• United States Pharmacopeia/National Formulary (USP/NF) monograph for Carbomer Copolymer Type B

Starting Point Formulations:

• Methyl Salicylate, Menthol, Thymol, Eucalyptus Oil Compound Emulgel
• Nimesulide, Methyl Salicylate and Menthol Cream 

Usage levels: 

• Topical emulsions: 0.2-0.4 wt%
• Other topical: 0.5-3 wt%

Note on toxicity testing:

The toxicity of carbomers has been summarized by the Cosmetic Ingredient Review Expert Panel in their assessment of the safety of the carbomers for cosmetic ingredients. This assessment and subsequent toxicology testing have demonstrated a low toxicity and irritation potential. Lubrizol has supporting data for dermal and ocular toxicology testing for Pemulen TR-1 NF polymer. Bulletin 2 provides a summary of all toxicology studies for Lubrizol’s pharmaceutical grade polymers.

Additionally, Lubrizol has filed a Type V DMF with FDA. A letter of authorization (LOA) can be issued for FDA drug applications.