Functional Category
Biodegradable material; coating agent; gelling agent; releasemodifying agent; sustained-release agent; tablet and capsule diluent; tablet and capsule lubricant; taste-masking agent.
Applications in Pharmaceutical Formulation
Glyceryl palmitostearate is used in oral solid-dosage pharmaceutical formulations as a lubricant.(1,2) Disintegration times increase(3) and tablet strength decreases(4) with increase in mixing time. It is used as a lipophilic matrix for sustained-release tablet and capsule formulations.(5,6) Tablet formulations may be prepared by either granulation or a hot-melt technique,(7,8) the former producing tablets that have the faster release profile. Release rate decreases with increased glyceryl palmitostearate content.(5) Glyceryl palmitostearate is used to form microspheres, which may be used in capsules or compressed to form tablets,(9,10) pellets,(11) coated beads,(12) and biodegradable gels.(13) It is also used for taste-masking.(14)
Description
Glyceryl palmitostearate occurs as a fine white powder with a faint odor.
Stability and Storage Conditions
Glyceryl palmitostearate should not be stored at temperatures above 358C. For storage for periods over 1 month, glyceryl palmitostearate should be stored at a temperature of 5–158C in an airtight container, protected from light and moisture.
Incompatibilities
Glyceryl palmitostearate is incompatible with ketoprofen(15) and naproxen.(16)
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(14)