Gelucire® 43/01

A glyceride with an intermediate melting point used as a matrix agent for sensitive APIs and a viscosity-increasing agent in oral and topical formulations.

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.