Applications of Polysorbates – by KLK Kolb

KLK Kolb excipients, marketed under the Hedjuvan brand, are all produced at the Hedingen facility in Switzerland. These versatile excipients find extensive use in human, veterinary and biopharmaceutical industry. As surfactants, they play a crucial role in surface-to-surface interactions, including shear protection, solubilizing, and emulsifying. This makes them essential for maximizing the efficacy of active ingredients and optimizing the yield of biotechnical processes. As a result of this versatility, Hedjuvan excipients are utilized in nearly every dosage form, including tablets, capsules, syrups, ointments, injections, and more.

See the polysorbate products of KLK Kolb:

Applications of Polysorbates

Polysorbates are among the most widely used excipients for solubilization and emulsifying in drugs for both human and veterinary pharmaceuticals across various dosage forms.

KLK Kolb has an extensive track record in producing polysorbates for various markets, particularly the pharmaceutical sector. By manufacturing all intermediates and final products at our Swiss site in Hedingen, we ensure unique advantages, maintaining complete control over quality, storage, documentation, and audit trails. Consistent production parameters and reliable raw material sourcing result in outstanding batch-to-batch consistency.

KLK Kolb´s Polysorbates are primarily bio-based from renewable sources, except for the ethylene oxide, which is of synthetic origin. All polysorbates are manufactured according to GMP EXCIPACT standards.

Added Value for Your Formulation by KLK Kolb Polysorbates

A well-established purification step results in a product with a significantly lower impurity profile (e.g., ethylene oxide, dioxane, peroxides, ash content), meeting the stringent requirements of related monographs.

This is crucial for various drug product formulations, ensuring excellent product stability over its shelf life.

Additional Microbiological Testing

In addition to meeting monograph requirements, we determine the microbiological load for selected products in ever batch before release and show them on the CoA.

DEG/EG values on CoA

Currently, there are uncertainties due to potential contamination of excipients by DEG/EG. To provide our customers with assurance on this matter, the content of DEG/EG in each batch of Hedjuvan-PS20 and Hedjuvan-PS80 is specified on the certificate of analysis.

Registrations

Polysorbate 20 and Polysorbate 80 are registered with the Chinese authority (NMPA), and access to the related CDMF can be granted. Additionally, a CEP is available at the EDQM. We are happy to support you during your registration process by providing access to the necessary documents.

We would be happy to support you during your registration process by giving access to the related documents.

Overview of Possible Functions and Dosage Forms

• Emulsifying agent in oral liquids
• Lubricant in tablets and capsules
• Glident and/or anticaking agent in tablets and capsules
• Suspending and/or viscosity increasing agent for semisolids, topicals and suppositories
• Wetting and/or solubilizing agents
• Virus inactivation in blood treatment

All Hedjuvan Polysorbates are manufactured in Switzerland according to GMP-EXCiPACT.

Find the Hedjuvan products here:

• Hedjuvan-PS20
• Hedjuvan-PS60
• Hedjuvan-PS80

See the full brochure on Excipients – Hedjuvan here

(click the picture to download the brochure)

Source: KLK Kolb, brochure “Excipients – Hedjuvan“

FIND ALL HEDJUVAN PRODUCTS HERE

Read also the additional articles:

• Applications of Sorbitan Esters
• Applications of Macrogols / Polyethylene Glycols
• Applications of Macrogol Lauryl Ether (Polidocanol)