Carbopol® 5984 EP Polymer

Carbomer Homopolymer Type B USP NF

Applicable synonyms for Carbopol^® 5984 EP NF polymer: carbomer, carboxypolymethylene
Polymerization/residual solvent: cosolvent mixture of ethyl acetate and cyclohexane

Key Features:

• Thickener and rheology modifier 

Additional Features:

• Bioadhesive agent
• Emulsion and suspension stabilizer

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
  

Carbopol^® 5984 EP NF Polymer Meets the Limits Cited in the Current Edition of the Following Monographs: 

• United States Pharmacopeia/National Formulary (USP/NF) monograph for Carbomer Homopolymer Type B
• European Pharmacopeia (Ph. Eur.) monograph for Carbomers
• India Pharmacopeia (IP) monograph for Carbomers
• China Pharmacopeia (ChP) monograph for Carbomer Homopolymer
• Japanese Pharmaceutical Excipients (JPE) Monograph for Carboxyvinyl Polymer 

Usage Levels:

• 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, oral, and ophthalmic toxicology testing for Carbopol 5984 EP 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.