Noveon® Polycarbophil

Applicable synonyms for Noveon® AA-1 Polycarbophil USP: polycarbophil
Polymerization/Residual  solvent: Ethyl acetate (ICH Class 3)

Key features:

• Bioadhesion agent
• Thickener/rheology modifier

Additional features:

• Suspension and emulsion stabilizer
• Taste masking agent

Recommended for use in the following dosage forms:

• Semisolids & gels
• Solutions & suspensions
• Extended release oral solid doses

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

• Oral drug delivery
• Topical drug delivery
• Ophthalmic drug delivery
• Oral care

Noveon® AA-1 Polycarbophil USP meets the limits cited in the current edition of the following monographs:

• United States Pharmacopeia/National Formulary (USP/NF) monograph for Polycarbophil

Usage levels: 

• Oral solutions & suspensions: 0.2-1 wt%
• Topical: 0.5-3 wt%

Note on residual solvent:

Noveon AA-1 Polycarbophil USP, as well as all oral-grade Carbopol polymers, is solely polymerized in ethyl acetate, which is a toxicologically preferred class III solvent. 

Note on toxicity testing:

Lubrizol has supporting data for dermal, ocular, and oral toxicology testing for Noveon® AA-1 Polycarbophil USP. 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.