Names and synonyms
USP NF Name
Glyceryl distearate
EP Name
Glycerol distearate (type I)
UNII Code (FDA)
73071MW2KM
Preferred Substance Name (FDA)
GLYCERYL DISTEARATE
Handbook of Pharmaceutical Excipients
Glyceryl palmitostearate
Chemical description
Consists of esters of palmitic (C16) and stearic (C18) acids, the diester fraction being predominant
Key characteristics
Product form
Powder
Melting range (°C)
50 – 60
HLB
2
Main functionalities
Coating agent for taste masking. Lubricant and flow aid for capsule filling with powders. Modified release matrix former for tablets. Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.
Main formulation technologies
Tablet compression (direct and wet granulation). Powder-filled capsules. Melt processes: granulation, extrusion, coating, prilling, spray congealing. Nanoparticle formulation.
