Functional Category
Emollient; oleaginous vehicle; solvent.
Applications in Pharmaceutical Formulation
Safflower oil is mainly used as an oleaginous vehicle in oral and topical formulations. It is also used as a component of parenteral fat emulsions for the preparation of parenteral nutrition solutions. Safflower oil has been used as a vehicle in the development of an oral dosage form containing a novel viral-specific inhibitor of the replication of human rhinoviruses.(1) It has also been used as a solvent for a capsule formulation containing a new antilipemic agent; formulations containing safflower oil were found to have the greatest bioavailability in dogs compared with formulations containing PEG 300 or water.(2) A topical lotion containing 3% safflower oil is commercially available, and parenteral fat emulsions containing a mixture of safflower oil 5% and soya oil 5%, or 10% and 10%, respectively, have been administered as part of total parenteral nutrition regimes. Safflower oil is used as a food, being consumed in the form of soft margarine, salad oils, and cooking oils. It is also used in cosmetics products such as soaps, lotions, creams, and hair-care preparations
Description
Refined safflower oil is a clear, viscous, yellow to pale-yellow liquid, with a slight vegetable odor.
Stability and Storage Conditions
Safflower oil thickens and becomes rancid on prolonged exposure to air. It is also sensitive to light. Safflower oil should be preserved in tight, light-resistant containers. Refined safflower oil should be stored in a well-filled, airtight container, protected from light. Parenteral fat emulsions containing safflower oil are destabilized by electrolytes; severe droplet coalescence in the emulsion occurs 3–5 days after the addition of 10% v/v dimethyl sulfoxide, and after 10 days if 5% v/v is added.(3) Parenteral fat emulsions are prone to bacterial and fungal growth. Generally, fat emulsions containing safflower oil or soybean oil show similar growth patterns,(4,5) although growth of Candida albicans has been reported to be higher in safflower oil containing fat emulsions than in other types of emulsion.(6)
Incompatibilities
Safflower oil is incompatible with strong oxidizing agents.
Safety
Safflower oil is an edible oil and generally presents no significant health hazards following eye contact, skin contact, oral ingestion, or inhalation. Skin irritation or allergic reactions, or eye irritation may occur. Ingestion of large doses can cause vomiting. Safflower oil may cause diarrhea. LD50 (mouse, IP): >50 g/kg(7)