Carbopol® 971P NF Polymer

Carbomer Homopolymer Type A USP NF

Applicable synonyms for Carbopol® 971P NF polymer: Carbomer, carboxypolymethylene
Polymerization/residual solvent: Ethyl acetate (ICH Class 3)

Key Features: 

• Bioadhesive agent
• Extended release modifier

Additional Features:

• Thickener and rheology modifier
• Emulsion and suspension stabilizer
• Taste masking agent
• Tablet binder

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
  

Carbopol® 971P 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 A 
• 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 
  

Starting Point Formulations:

• Diclofenac Sodium 100 mg Extended Release
• Diclofenac Sodium 100 mg Extended Release - hypromellose
• Diclofenac Sodium 75 mg Extended Release
• Pentoxifylline 400 mg Extended Release
• Quetiapine Fumarate 200 mg Extended Release
• Tramadol Hydrochloride 100 mg Extended Release
• Verapamil Hydrochloride 240 mg Extended Release
• Ibuprofen and Paracetamol Suspension
• Paracetamol Suspension, 120 mg/5m
• Paracetamol Solution
• Methyl Salicylate, 15% and Menthol, 7% Hydroalcoholic Clear Gel
  

Usage Levels: 

• Oral solid dose – extended release: 5-10 wt%
• Oral solid dose – immediate release: 0.5-3 wt%
• Oral solutions & suspensions: 0.2-1 wt%
• Topical 0.5-3 wt%

Note on controlled drug release with powder and granular polymer grades:

Powder and granular grade Carbopol polymers can be combined in a formulation to achieve desired release profiles. The release rates can be modulated by incorporating powder grades polymers, such as 974P NF, and then blending with Carbopol 71G NF granular polymer.

Note on residual solvent:

Carbopol 971P NF, 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:

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, ocular, and oral toxicology testing for Carbopol 971P 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.