|
|
ETHOCEL ProductsPharmaceutical manufacturers use ETHOCEL* polymers as binders, fillers, granulation aids, protective and controlled release coatings, taste masks and flavor fixatives. ETHOCEL Premium polymers are recognized and used globally for many different functional purposes in pharmaceutical products. ETHOCEL polymers are among a very small number of water-insoluble polymers that are approved and accepted globally for pharmaceutical applications. In fact, ethylcellulose is currently used in hundreds of commercialized pharmaceutical products. ETHOCEL Premium polymers are essentially tasteless, odorless, noncaloric, and physiologically inert. They form strong, tough films at low concentrations. ETHOCEL polymers alone provide an attractive range of physical properties and can be blended with other materials to achieve intermediate characteristics. ETHOCEL Premium polymers are most frequently used in controlled release and solid dosage formulations. They are also useful as granulation binders, as film-formers to improve tablet integrity and appearance, and in taste masking of bitter actives. ETHOCEL Premium polymers meet the requirements of the Food Chemicals Code, the International Codex Alimentarius, the U.S. National Formulary (NF), the Japanese Standards of Pharmaceutical Ingredients (JSPI), and the European Pharmacopoeia (EP). Refer to the product's Certificate of Analysis for a statement of compliance to the current version of each of these regulatory documents. In addition, ETHOCEL Premium polymers are produced in compliance with the FDA Current Good Manufacturing Practices codes: 21 CFR 172.868, 21 CFR 73.1, 21 CFR 73.1001, and 21 CFR 573.420. ETHOCEL Premium polymers and facilities are Kosher certified. ETHOCEL* Premium Polymers for Pharmaceutical Applications
|
||||||||||||||||||||||||||