Octadecanoic acid, ester with 1,2,3-propanetriol hexadecanoate

Chemical properties

Glyceryl palmitostearate occurs as a fine white powder with a faint odor.

Production Methods

Glyceryl palmitostearate is manufactured, without a catalyst, by the direct esterification of palmitic and stearic acids with glycerol.

Pharmaceutical Applications

Glyceryl palmitostearate is used in oral solid-dosage pharmaceutical formulations as a lubricant. Disintegration times increase and tablet strength decreases with increase in mixing time.
It is used as a lipophilic matrix for sustained-release tablet and capsule formulations. Tablet formulations may be prepared by either granulation or a hot-melt technique, the former producing tablets that have the faster release profile. Release rate decreases with increased glyceryl palmitostearate content.
Glyceryl palmitostearate is used to form microspheres, which may be used in capsules or compressed to form tablets, pellets, coated beads, and biodegradable gels.

Safety

Glyceryl palmitostearate is used in oral pharmaceutical formulations and is generally regarded as an essentially nontoxic and nonirritant material.
LD50 (rat, oral): >6 g/kg

Storage

Glyceryl palmitostearate should not be stored at temperatures above 35°C. For storage for periods over 1 month, glyceryl palmitostearate should be stored at a temperature of 5–15°C in an airtight container, protected from light and moisture.

Incompatibilities

Glyceryl palmitostearate is incompatible with ketoprofen(15) and naproxen.

Regulatory Status

GRAS listed. Included in the FDA Inactive Ingredients Database (oral suspension, oral tablet). Included in nonparenteral preparations licensed in Europe. Included in the Canadian List of Acceptable Non-medicinal Ingredients.