Macrogol 15 Hydroxystearate

The PhEur 2005 describes macrogol 15 hydroxystearate as a mixture of mainly monoesters and diesters of 12-hydroxystea-ric acid and macrogols obtained by the ethoxylation of 12-hydroxystearic acid. The number of moles of ethylene oxide reacted per mole of 12-hydroxystearic acid is 15 (nominal value). It contains about 30% free macrogols. 

Macrogol 15 hydroxystearate is a yellowish-white waxy mass at room temperature, which becomes liquid at approximately 30°C. 

Solubilizing capacity of macrogol 15 hydroxystearate [Solutol HS IS, BASF Pic). 

Macrogol 15 hydroxystearate is produced by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxystearic acid. 

Macrogol 15 hydroxystearate is used in parenteral pharmaceutical preparations in concentrations up to 50% to solubilize diclofenac, propanidid, and vitamin Kl. It has also been used in preclinical formulations in preparing supersaturated injectable formulations of water-insoluble molecules. It is generally regarded as a relatively nontoxic and nonirritant excipient. 

Macrogol 15 hydroxystearate is reported to not be mutagenic in bacteria, mammalian cell cultures and mammals. 

Macrogol 15 hydroxystearate is not restricted solely parenteral use, but is also suitable for oral applications. 

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