Solubility and oral bioavailability enhancement: Gelucire® 48/16 pellets

Gelucire 48/16 is a non-ionic surfactant recommended for use in Lipid-Based Formulations (LBFs) to increase aqueous solubility and oral bioavailability of poorly soluble active ingredients. It is a PEG 32 ester lipid excipient comprising a mixture of stearic and palmitic acid monoesters and diesters. Its high Hydrophilic-Lipophilic Balance (HLB) enhances the solubility of hydrophobic and lipophobic active ingredients. It is solid at ambient temperature with a melting point of 48°C, making it suitable for capsule filling and melt processes.

Gelucire 48/16 pellets in lipid-based formulations for solubility enhancement

Gelucire 48/16 is a pure water-soluble surfactant that can be used in different types of lipidbased formulations. It forms a micellar solution when used alone in a simple binary formulation with an active ingredient or in combination with a low concentration (< 6%) of a miscible solvent, such as Transcutol HP.

Micellar solutions are nanosystems (2-10 nm) which encapsulate the active ingredient within micelles. The size of micelles can change depending on the properties of the active ingredient. Gelucire 48/16 can be combined with oils, surfactants and solvents, to form type III formulations, provided the excipients are miscible. Gelucire 48/16 is miscible with up to 18% Lauroglycol 90 and 14–30% Capryol 90, which are water insoluble surfactants available from Gattefossé.

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