Demanding Formulations Call for Higher Purity Grade Polysorbates

Avantor Performance Materials has introduced a higher purity Super Refined grade of polysorbate products to improve solubilisation and stability in a variety of biopharmaceutical and small-molecule drug formulations.

The new Super Refined grade products join Avantor’s current high-purity versions of the two most widely used types of polysorbate products: J.T.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 J.T.Baker polysorbates are manufactured under cGMP conditions, in FDA-registered ISO 9000-certified facilities.

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 APIs.

“Pharmaceutical manufacturers are increasingly facing challenges to ensure the stability of their formulations and improve the shelf life of their products,” said Paul Smaltz, Avantor Executive Vice President 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 stabilise proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs, polysorbates provide improvements in solubilisation while enhancing the stability of emulsions.

J.T.Baker polysorbates are vegetable-based, with a non-peanut origin, providing low endotoxin and other impurities, which is critical for formulation of biopharmaceuticals. The products meet the rigorous multi-compendial requirements of the National Formulary (NF), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) or Japanese Pharmaceutical Excipients (JPE).

The new Super Refined polysorbates are available in bottle sizes ranging from 200 ml to 4 l and are packaged under nitrogen to ensure premium product integrity.

Information on Avantor’s J.T.Baker polysorbates is available on the Surfactants and Detergents product page and in the Technical Literature Library product profiles section for pharmaceuticals at www.avantormaterials.com.

Avantor Performance Materials, Inc., +1 610 573 2600, info@avantormaterials.com, www.avantormaterials.com.