U.S. FDA Approves Generic Drug Product Containing Lubrizol’s Carbopol® Polymer (Carbomer Homopolymer)
CLEVELAND, - The Lubrizol Corporation announces today that the U.S. Food and Drug Administration (FDA) has recently approved a generic drug product containing Lubrizol’s Carbomer Homopolymer Type A, sold under the trade name Carbopol® 971P, as a tablet ingredient. This important development provides even more assurance to drug manufacturers considering the use of Carbopol in both abbreviated and new drug applications.
Explaining the significance of this recent approval, Deb Langer, general manager of Lubrizol’s LifeScience Polymers group, stated, “Carbopol 971P NF Polymer (Carbomer Homopolymer Type A) is a very efficient excipient material used to control the release of the active pharmaceutical ingredient over time in pharmaceutical formulations. Carbopol has already been approved in other drug applications and can be found on the U.S. FDA Inactive Ingredients (IIG) listing. The approval of this generic drug product will allow our customers to formulate using a much higher level of Carbopol, broadening the functionality and benefits to the end user.”
Labeled with the family name, Carboxypolymethylene, Carbopol is already in the FDA’s Inactive Ingredient Guide (IIG) at a maximum potency of 195 mg. Carbomer Homopolymer is the latest USP/NF nomenclature for non-benzene cross-linked acrylic acid polymers. With the upcoming listing, the IIG will specifically note a maximum potency for Carbomer Homopolymer Type A that is significantly larger than the existing 17.5 mg per dose.
Lubrizol’s LifeScience Polymers group is focused on linking science to life through the development of innovative polymer solutions and world-class support services for the healthcare industry. Formulating products for oral solid dosage applications is one of the numerous ways in which LifeScience Polymers meets the needs of the pharmaceutical and medical markets daily.
Further information related to the use of Carbopol polymers in oral solid dosage forms can be reviewed at http://www.lubrizol.com/lifesciencepolymers.
About The Lubrizol Corporation
The Lubrizol Corporation, a Berkshire Hathaway company, is an innovative specialty chemical company that produces and supplies technologies to customers in the global transportation, industrial and consumer markets. These technologies include lubricant additives for engine oils, other transportation-related fluids and industrial lubricants, as well as fuel additives for gasoline and diesel fuel. In addition, Lubrizol makes ingredients and additives for personal care products and pharmaceuticals; specialty materials, including plastics technology and performance coatings in the form of specialty resins and additives. Lubrizol’s industry-leading technologies in additives, ingredients and compounds enhance the quality, performance and value of customers’ products, while reducing their environmental impact.
With headquarters in Wickliffe, Ohio, The Lubrizol Corporation owns and operates manufacturing facilities in 17 countries, as well as sales and technical offices around the world. Founded in 1928, Lubrizol has approximately 7,000 employees worldwide. Revenues for 2011 were $6.1 billion. For more information, visit www.lubrizol.com.
Carbopol® is a registered trademark of The Lubrizol Corporation.
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