Glycerol monostearate (GMS) is insoluble in water and soluble in hot ethanol. Therefore, in most formulations of solid lipid nanoparticles (SLNs) using GMS via ultrasonication and high pressure homogenization, requires heating up the organic phase (lipid + drug) to 75 C, which is the approximate melting point of lipid. Meanwhile, the aqueous phase (surfactant + water) is heated up 5 C above the temperature from the organic phase. These 2 phases are then mixed to form emulsions and eventually SLNs are formed. My question is, is there a way to dissolve GMS at room temperature without heating it up above 25 C? Or if heating is required, how can we make sure the GMS in solubilized form is stable for at least a day without precipitation / crystallization occurs?
GMS is soluble in hot ethanol, ether, chloroform, hot acetone, mineral oil, and fixed oils. Use a volatile organic solvent, add the other excipients and remove the organic solvent. To assess the stability of your formulation, you need to monitor the physical and chemical stability in time.
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