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.
