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MONTANOX™: Polysorbates, hydrophilic solubilizers and emulsifiers

MONTANOX™

MONTANOX™: Polysorbates, hydrophilic solubilizers and emulsifiers

The MONTANOX™ range is composed of different grades of polysorbates that can be used to solubilize active pharmaceutical and/or biological ingredients and to formulate oil-in-water emulsions for oral, topical and injectable products.

The triple action of polysorbates

MONTANOX™ products are polyethoxylated sorbitan esters.
These hydrophilic surfactants play a triple role: They are used as emulsifiers to formulate oil in water emulsions but also as solubilizers for active ingredients with low solubility and also as antiaggregants for biological active ingredients.
MONTANOX™ products are stable in acidic or basic media and in the presence of electrolytes and are compatible with other surfactants.
They can be combined with MONTANE™ to produce highly stable emulsions.

A suitable grade for every application

The MONTANOX™ range is composed of monoesters of lauric, stearate or oleic fatty acids. They each have a degree of ethoxylation of 20 and are characterized by their HLB (Hydrophilic-Lipophilic Balance).
There are two pharmaceutical grades: PPI and PHA PREMIUM.

  • The PPI grade is designed for injectable administration and products are manufactured according to the Good Manufacturing Practices “GMP part II” and comply with the EP, USP and JP or JPE pharmacopoeia.
  • The PHA PREMIUM grade is designed for oral and topical administration and products are manufactured according to IPEC’s GMPs and comply with the EP and USP pharmacopoeia.
Nom Commercial Nom Chimique HLB EO Voie d'Administration
MONTANOX™20 PPI Polysorbate 20 17 20 Injectable/Orale/Topique
MONTANOX™80 PPI Polysorbate 80 15 20 Injectable/Orale/Topique
MONTANOX™80 API* Polysorbate 80 15 20 Injectable/Orale/Topique
MONTANOX™80 LPI** Polysorbate 80 15 20 Injectable/Orale/Topique
MONTANOX™20 PHA PREMIUM Polysorbate 20 17 20 Orale/Topique
MONTANOX™60 PHA PREMIUM Polysorbate 60 15 20 Orale/Topique
MONTANOX™80 PHA PREMIUM Polysorbate 80 15 20 Orale/Topique

*API: very low water quantity
** LPI: grade with low pH

 

All the regulatory and quality documents required for registration are available on request.

Applications

SEPPIC also offers MONTANOX™ in grades designed for the nutrition and cosmetics markets.

Resources