Functional Category
Oleaginous vehicle.
Applications in Pharmaceutical Formulation
Olive oil has been used in enemas, liniments, ointments, plasters, and soap. It has also been used in oral capsules and solutions, and as a vehicle for oily injections including targeted delivery systems.(1) It has been used in topically applied lipogels of methyl nicotinate.(2) It has also been used to soften ear wax.(3) Olive oil has been used in combination with soybean oil to prepare lipid emulsion for use in pre-term infants.(4) Olive oil is used widely in the food industry as a cooking oil and for preparing salad dressings. In cosmetics, olive oil is used as a solvent, and also as a skin and hair conditioner. Types of products containing olive oil include shampoos and hair conditioners, cleansing products, topical creams and lotions, and sun-tan products.
Description
Olive oil is the fixed oil obtained by cold expression or other suitable mechanical means from the ripe drupes of Olea europaea. It occurs as a clear, colorless or yellow, transparent oily liquid. It may contain suitable antioxidants. Refined olive oil is obtained by refining crude olive oil such that the glyceride content of the oil is unchanged. A suitable antioxidant may be added.
Stability and Storage Conditions
When cooled, olive oil becomes cloudy at approximately 108C, and becomes a butterlike mass at 08C. Olive oil should be stored in a cool, dry place in a tight, wellfilled container, protected from light. For refined oil intended for use in the manufacture of parenteral dosage forms, the PhEur 6.2 requires that the bulk oil be stored under an inert gas.
Incompatibilities
Olive oil may be saponified by alkali hydroxides. As it contains a high proportion of unsaturated fatty acids, olive oil is prone to oxidation and is incompatible with oxidizing agents.
Safety
Olive oil is used widely as an edible oil and in food preparations and products such as cooking oils and salad dressings. It is used in cosmetics and topical pharmaceutical formulations. Olive oil is generally regarded as a relatively nonirritant and nontoxic material when used as an excipient. Olive oil is a demulcent and has mild laxative properties when taken orally. It has been used in topical formulations as an emollient and to sooth inflamed skin; to soften the skin and crusts in eczema; in massage oils; and to soften earwax.(3) There have been isolated reports that olive oil may cause a reaction in hypersensitive individuals. However, these incidences are relatively uncommon.(5–7) Olive oil is an infrequent sensitizer and does not appear to be a significant allergen in the USA, possibly due to the development of oral tolerance.