Functional Category
Dissolution enhancer; emulsifying agent; nonionic surfactant; penetration agent; solubilizing agent; sustained-release agent.
Applications in Pharmaceutical Formulation
Polyoxylglycerides are used as self-emulsifying and solubilizing agents in oral and topical pharmaceutical formulations. They are also used in cosmetic and food products
Description
Polyoxylglycerides are inert liquid or semi-solid waxy materials and are amphiphilic in character. Caprylocaproyl polyoxylglycerides are pale-yellow oily liquids. Lauroyl polyoxylglycerides and stearoyl polyoxylglycerides occur as pale-yellow waxy solids. Oleoyl polyoxylglycerides and linoleoyl polyoxylglycerides occur as amber oily liquids, which may give rise to a deposit after prolonged periods at 208C.
Stability and Storage Conditions
Polyoxylglycerides are very stable and inert. However, preventive measures against the risk of oxidation or hydrolysis may be taken to ensure stability during handling. See Section 15. Polyoxylglycerides should be preserved in their original containers, and exposure to air, light, heat, and moisture should be prevented.
Safety
Polyoxylglycerides are used in oral and topical pharmaceutical formulations, and also in cosmetics and food products. They are generally regarded as relatively nonirritant and nontoxic materials. Caprylocaproyl polyoxylglycerides: LD50 (rat, oral): >22 ml/(kg day).(59) Lauroyl polyoxylglycerides: LD50 (rat, oral): >2004 mg/(kg day).