FDA approves drug containing Lubrizol's Carbopol polymer
The FDA has recently approved a drug product containing Lubrizol’s Carbomer Homopolymer as a tablet ingredient
The FDA has recently approved a drug product containing Lubrizol’s Carbomer Homopolymer as a tablet ingredient. The decision represents a significant milestone for Lubrizol's business.
Carbomer Homopolymer is the latest USP/NF nomenclature for non-benzene crosslinked acrylic acid polymers. The same drug product was granted EU approval late in 2009.
Dr Ed Greenberg, global director of marketing and technology for Lubrizol's pharmaceutical ingredients business said: ‘The drug approval enables our newest Carbopol polymers to be listed as approved excipients in the FDA's Inactive Ingredient Guide (IIG) for use in controlled release tablets along with other Lubrizol polymers previously included on the list.’
Carbopol polymers are non-absorbable excipients used in a variety of pharmaceutical formulations. The polymers function as rheology modifiers or controlled release agents in liquid, semisolid and solid dosage forms.