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Health Care Excipients - Solubilizers for High-Risk Applications


In recent years, the number of sensitive pharmaceutical drug delivery systems approved by the U.S. Food and Drug Administration has increased significantly and is expected to increase further as the overall drug market expands and new therapies for both chronic and rare diseases enter the pipeline.

How can Clariant help you to get a solution for these kinds of formulations? We offer a wide range of low bioburden and low elemental impurities excipients for sensitive APIs and formulations:

  • PEGs
  • PEG-Derivatives

With these extended product specifications, Clariant can assist you in creating your individual formulation risk assessment.


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Related products

  • VitiPure CO 35 LEX
    VitiPure CO 35 is a non-ionic solubiliser and emulsifying agent for the human and veterinary pharmaceutical industries. It is made by reacting castor oil with ethylene oxide in a molar ratio of 1:35. At room temperature it appears as pale-yellow oily liquid. It forms clear solutions in water. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in high-risk applications.
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  • VitiPure® CO 35 Superior
    VitiPure® CO 35 Superior is a non-ionic solubilizer and emulsifying agent for human and veterinary pharmaceutical markets. It is manufactured by ethoxylating castor oil in a molar ratio of 1:35. VitiPure® CO 35 Superior is then purified with a patented process to reduce residual impurities yielding transparent almost colorless oily liquid which forms clear solutions in water. Typically used in sensitive applications where final formulations need to be colorless, or the API is sensitive to residual impurities. And where the end formulation needs to have low microbial load with low endotoxins.
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  • VitiPure HCO 40 LEX
    VitiPure HCO 40 is versatile non-ionic solubilizer and emulsifier enhancing the solubility and bioavailability of hydrophobic APIs and fat-soluble vitamins. VitiPure HCO 40 is obtained by reacting 40 moles of ethylene oxide with 1 mole of hydrogenated castor oil. At the room temperature it appears as white to yellowish paste. VitiPure HCO 40 is suitable for SEDDS and SMEDDS. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in high-risk applications.
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  • VitiPure L 20 LEX
    VitiPure L 20 is a non-ionic, hydrophilic emulsifier, co-emulsifier and solubilizer. It is an oily, yellow or brownish-yellow, clear or slightly opalescent liquid with a faint odor. VitiPure L 20 can be used in various pharmaceutical formulations. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in high-risk applications.Generic name: Polysorbate 20
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  • VitiPure LEX 300
    VitiPure LEX 300 are low molecular weight polyethylene glycols with stringent control of microbial load & low in endotoxins for pharmaceutical high-risk formulations. They are colorless and tasteless liquid at room temperature. They are readily soluble in common solvents such as water, ethanol, acetone, glycols etc.
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  • VitiPure LEX 400
    VitiPure LEX 400 are low molecular weight polyethylene glycols with stringent control of microbial load & low in endotoxins for pharmaceutical high-risk formulations. They are colorless and tasteless liquid at room temperature. They are readily soluble in common solvents such as water, ethanol, acetone, glycols etc.
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  • VitiPure® Meglumine LEX
    VitiPure® Meglumine LEX improves the solubility and bioavailability of APIs. Meglumine is a multi-talented functional excipient which is used as a counter-ion to form a salt with the API, or as a standard excipient to modify the pH to enhance the API solubility and stability. Traditionally, Meglumine is used as a counter-ion in contrast media. Applications include oral solid, and liquid formulations. And, widely used in sensitive formulations where low bioburden and low endotoxin grade is required.
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  • VitiPure O 80 LEX
    VitiPure O 80 is a non-ionic, hydrophilic emulsifier, co-emulsifier, solubilizer and suspension stabilizer used widely in various biopharmaceutical formulations. It appears as amber liquid in room temperature with a faint characteristic odor. VitiPure O 80 has a broad working pH range and offers good skin tolerance. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in high-risk applications. Generic name: Polysorbate 80
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  • VitiPure® O 80 Superior
    VitiPure® O 80 Superior is a non-ionic solubilizer and emulsifying agent for human and veterinary pharmaceutical markets. It is manufactured by ethoxylating sorbitan mono-oleate in a molar ratio of 1:20. VitiPure® O 80 Superior is then purified with a patented process to reduce residual impurities yielding a transparent almost colorless oily liquid. Typically used in sensitive formulations where final formulations need to be colorless, or the API is sensitive to residual impurities. And, where the end formulation needs to have low microbial load with low endotoxins.
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