General Description
Synonyms:12-Hydroxyoctadecanoic acid polymer with a-hydro-o-hydroxypoly(oxy-1,2-ethanediyl); 12-hydroxystearic acid polyethylene glycol copolymer; macrogoli 15 hydroxystearas; polyethylene glycol15-hydroxystearate; polyethylene glycol 660 12-hydroxystearate;
Solutol HS 15.
Description: Macrogol 15 hydroxystearate is a yellowish-white, almost odorless waxy mass or paste at room temperature, which becomes liquid at approximately 30C.
Chemical Name: 2-Hydroxyethyl-12-hydroxyoctadecanoate
Functions
Dissolution enhancer; nonionic surfactant; solubilizing agent; stabilizing agent
Uses
Macrogol 15 hydroxystearate is frequently used in preclinical testing of drugs, mainly for IV and other parenteral applications.
The solubilizing capacity for some tested drugs (clotrimazole, carbamazepine, 17b-estradiol, sulfathiazole, and piroxicam) increases almost linearly with increasing concentration of solubilizing agent.
This is due to the formation of spherical micelles even at high concentrations of macrogol 15 hydroxystearate.
Similarly, tests have revealed that viscosity increases with increasing amount of solubilizer, but the amount of solubilized drugs does not have any additional influence on the kinematic viscosity.
Lipid nanocapsules comprising macrogol 15 hydroxystearate and soybean phosphatidylcholine containing 3% docetaxel have been successfully prepared by a solvent-free inversion process.
Macrogol 15 hydroxystearate has been used in the manufacture of aqueous parenteral preparations with vitamin A, D, E and K, and a number of other lipophilic pharmaceutical active agents, such as propanidid, miconazole, alfadolone, and alfaxalone.
It is very efficient at solubilizing substances like fat-soluble vitamins and active ingredients of hydrophobic nature.
It is also an excellent solubilizer for parenteral use, at a concentration of 20%, and the water solubility of different drugs may be enhanced by a factor of 10–100, depending on the structure of the drug molecule.
Safety
Macrogol 15 hydroxystearate is used in parenteral pharmaceutical preparations in concentrations up to 50% to solubilize diclofenac, propanidid, and vitamin K1. 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.
Handling Precautions
Observe normal precautions appropriate to the circumstances and quantity of material handled.
Related Substances
Polyethylene glycol.