11 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: US-based Avantor Performance Materials has introduced a higher purity Super Refined grade of polysorbate products to improve solubilization and stability in a variety of biopharmaceutical and small-molecule drug formulations.
The new Super Refined grade of products is addition to Avantor's two widely used types of polysorbate products, JT Baker brand Polysorbate 20 and Polysorbate 80. These products are commonly used in pharmaceutical formulations such as parenteral, otic, ophthalmic, oral and topical preparations.
Avantor's high-purity and Super Refined grades of JT Baker polysorbates are manufactured under current good manufacturing practices (cGMP) conditions in FDA-registered ISO 9000-certified facilities, and are supported by the company's best-in-class quality systems.
While Avantor's existing high-purity grade of polysorbates offers low levels of impurities for better performance in formulations, the new Super Refined grade takes advantage of a proprietary flash chromatographic process that removes even more polar and oxidative impurities, such as peroxides and aldehydes, which can degrade active pharmaceutical ingredients.
"Pharmaceutical manufacturers are increasingly facing challenges to ensure the stability of their formulations and improve the shelf life of their products," said Mr Paul Smaltz, Avantor's executive VP for pharmaceuticals. "We're pleased to now offer these additional options in our polysorbate products so customers can match the right level of purity to their formulation needs."
The surface activity of polysorbates helps to stabilize proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs, polysorbates provide improvements in solubilization while enhancing the stability of emulsions.