Gelucire® 44/14

A nonionic water-dispersible surfactant for lipid-based formulations to solubilize and increase oral bioavailability of poorly water-soluble APIs. Self-emulsifies in aqueous media forming a fine dispersion, i.e., microemulsion (SMEDDS).

DOCUMENTATION

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Names and synonyms

USP NF Name

Lauroyl Polyoxyl-32 glycerides

EP Name

Lauroyl Macrogol-32 glycerides

UNII Code (FDA)

H5ZC52369M

Preferred Substance Name (FDA)

LAUROYL PEG-32 GLYCERIDES

Handbook of Pharmaceutical Excipients

Polyoxylglycerides

Chemical description

Consists of a small fraction of mono, di- and triglycerides and mainly PEG-32 (MW 1500) mono- and diesters of lauric acid (C₁₂)

Key characteristics

Product form

Waxy solid

Melting range (°C)

42.5 – 47.5

HLB

CMC (mg/L, 25°C)

72 ± 53

Main functionalities

Solubilizer for poorly-soluble APIs and bioavailability enhancer. Single excipient formulation system: self-emulsifies in aqueous fluid into microemulsion—LFCS Type III (SMEDDS). Wetting agent. Lipid binder in melt processes. Safety of use is inferred by extensive toxicological evaluations and precedence of use in approved pharmaceutical products.

Main formulation technologies

Self-emulsifying lipid formulation for oral applications. Melt processes: granulation and capsule molding. Wet granulation and compression.

Gelucire® 44/14

Names and synonyms

Key characteristics

Main functionalities

Main formulation technologies

Thermorheogram

Oral range of products

PRODUCT DOCUMENTATION