Applicable synonyms for Carbopol® 71G NF polymer: carbomer homopolymer type A, carbomer homopolymer
Polymerization/residual solvent: ethyl acetate (ICH Class 3)
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.
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.
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.
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.
|Recommended Retest Date||2 years after manufacturing date|
|Recommended Storage||In airtight containers, protected from moisture and excessive temperature|