Carbopol® 71G NF Polymer

Carbomer Homopolymer Type A USP NF

Applicable synonyms for Carbopol® 71G NF polymer: carbomer homopolymer type A, carbomer homopolymer
Polymerization/residual solvent: ethyl acetate (ICH Class 3)

Key Features: 

• Extended release agent
• Direct compressible

Additional Features:

• Bioadhesive agent 
• Efficient tablet binder

Recommended for Use in the Following Dosage Forms:

• Extended release oral solid doses
  

Recommended for Use in the Following Markets / Routes of Administration:

• Oral drug delivery
  

Carbopol^® 71G 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:

• Pentoxifylline 400 mg Extended Release
• Tramadol Hydrochloride 100 mg Extended Release
  

Key Differentiator: 

The unique feature of Carbopol 71G NF polymer is its free-flowing granular form, allowing for tablet manufacturing by direct compression. Direct compression plays a key role in the pharmaceutical industry as it is the most economical as well as the shortest and most direct way to produce an oral tablet. However, in order to achieve a robust final dosage form, a direct compression formulation requires an excipient like Carbopol 71G NF that exhibits good flowability and compressibility.

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 Carbopol 971P NF or 974P NF, and then blending with Carbopol 71G NF granular polymer.

Note on Residual Solvent:

Carbopol 71G 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 71G 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.