Names and synonyms
USP NF Name
Hard fat
EP Name
Hard fat
UNII Code (FDA)
8334LX7S21
Preferred Substance Name (FDA)
FAT, HARD
Handbook of Pharmaceutical Excipients
/
Chemical description
Consists of mono-, di- and triglyceride esters of fatty acids (C8 to C18), the triester fraction being predominant
Key characteristics
Product form
Pellets
Melting range (°C)
42– 46
HLB
1
Main functionalities
Matrix-forming agent for protection of APIs sensitive to oxidation, humidity, or light. Consistency agent in oral and topical formulations. Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Melt processes: granulation and capsule molding. Topical emulsion and ointment.
