Polysorbates: High Purity for Demanding Drug Formulations
Performance Materials offers the two most widely used types of
polysorbates—polysorbate 20 and polysorbate 80—under its J.T.Baker® brand. Each
type is now available in both high-purity and Super Refined®* grades,
manufactured under cGMP conditions.
high-purity grade polysorbates offer low levels of impurities to ensure high
performance in formulations, the proprietary flash chromatographic Super
Refined® process has been shown to remove even more polar and oxidative
impurities, such as peroxides and aldehydes, that can degrade active
pharmaceutical ingredients (APIs).
are used in a variety of biotechnology and small molecule drug formulations to
improve solubilization and stability. The surface activity of polysorbates
serves to stabilize proteins, by reducing the alteration or aggregation of
proteins during manufacturing, distribution and storage. When formulated with
poorly soluble drugs, polysorbates provide improvements in solubilization. In
addition, the enhanced stability of emulsions with polysorbates is widely
Higher Purity Provides Improved Drug
Stability and Shelf-Life
of fatty acid esters of polyoxyethylene sorbitan, polysorbates are surfactants
which are amphiphilic and non-ionic. The largest fatty acid component dictates
the general type of polysorbate—polysorbate 20 is based on lauric acid, while
polysorbate 80 is based on oleic acid. These structures provide high
hydrophilic-lipophilic balance (HLB) numbers and low critical micelle
concentration values, the factors responsible for their common use in drug
formulations. The choice between polysorbate types depends on their specific
interaction with APIs or other excipients.
Baker ® brand polysorbates are vegetable-based, with a non-peanut origin,
providing low endotoxin and other impurities. These high-purity materials can
provide robust formulation by improving oxidative stability and shelf life. The
low endotoxin and peroxide level is critical for formulation of
state-of-the-art cGMP subdivision processes in FDA-registered ISO
9000-certified facilities, Avantor offers polysorbates in a variety of
container sizes, packaged under nitrogen to ensure premium product integrity.
These products meet the rigorous multicompendial requirements of the National
Formulary (NF), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) or
Japanese Pharmaceutical Excipients (JPE).