8008-74-0

clear yellow viscous liquid

Sesame oil is obtained from the ripe seeds of one or more cultivated varieties of Sesamum indicum Linne′ (Fam. Pedaliaceae) by expression in a hydraulic press or by solvent extraction. The crude oil thus obtained is refined to obtain an oil suitable for food or pharmaceutical use. Improved color and odor may be obtained by further refining.

The seeds by expression yield a fixed oil consisting essentially of the glycerides of oleic and linoleic acids with small amounts of stearin, palmitin and myristin. Liquid fatty acids are present to about 70%, solid fatty acids 12 to 14%.

Aroma characteristics at 100%: roasted nutty,sesame, peanut, hazelnut-like with some ashy coffee nuances.

Taste characteristics of extract at 650 ppm: nutty, roasted, pyrazine, cocoa and coffee, with a slightly smoky, savory nuance. Taste characteristics at 0.1%: roasted nutty, ashy coffee, sesame with a fatty, oily peanut-like note.

The major use of sesame oil in pharmaceutical formulations is as a solvent in the preparation of sustained-release intramuscular injections of steroids, such as estradiol valerate, hydroxyprogesterone caproate, testosterone enanthate, and nandrolone decanoate, or other oil-soluble drug substances, such as the decanoates or enanthate esters of fluphenazine. The disappearance of sesame oil from the injection site, following subcutaneous or intramuscular administration to pigs, has been reported to have a half-life of about 23 days. The in vitro drug release rates from oily depot formulations containing sesame oil intended for intra-articular administration have been reported.
Sesame oil may be used as a solvent in the preparation of subcutaneous injections, oral capsules, rectal suppositories, and ophthalmic preparations; it may also be used in the formulation of suspensions and emulsions. Multipleemulsion formulations, in which sesame oil was one of the oil phases incorporated, have been investigated as a prolonged-release system for rifampicin; microemulsions containing sesame oil have been prepared for the transdermal delivery of ketoprofen. Sesame oil has also been included in self-microemulsifying drug delivery systems, and fast-disintegrating lyophilized dry emulsion tablets for oral administration. It has also been used in the preparation of liniments, pastes, ointments, and soaps. A sesame paste (tahini), composed of crushed sesame seeds in sesame oil, has been investigated as a novel suspending agent.
Sesame oil is additionally used as an edible oil and in the preparation of oleomargarine.

Sesame oil is mainly used in intramuscular and subcutaneous injections; it should not be administered intravenously. It is also used in topical pharmaceutical formulations and consumed as an edible oil.
Although it is generally regarded as an essentially nontoxic and nonirritant material, there have been rare reports of hypersensitivity to sesame oil, with sesamin suspected as being the primary allergen. Anaphylactic reactions to sesame seeds have also been reported. However, it is thought that the allergens in the seeds may be inactivated or destroyed by heating as heat-extracted sesame seed oil or baked sesame seeds do not cause anaphylactic reactions in sesame seed-allergic individuals.
LD50 (rabbit, IV): 678 mg/kg

Sesame oil is more stable than most other fixed oils and does not readily become rancid; this has been attributed to the antioxidant effect of some of its characteristic constituents. The PhEur 6.3 permits the addition of a suitable antioxidant to sesame oil.
Sesame oil may be sterilized by aseptic filtration or dry heat. It has been reported that suitable conditions for the sterilization of injections containing sesame oil are a temperature of 170℃ for 2 hours; it has been suggested that 150℃ for 1 hour is inadequate. However, it has been demonstrated that dry heat sterilization of sesame oil at 150℃ for 1 hour was sufficient to kill all added Bacillus subtilis spores.
Sesame oil should be stored in a well-filled, airtight, lightresistant container, at a temperature not exceeding 40℃. Sesame oil intended for use in the manufacture of parenteral dosage forms should be stored under an inert gas in an airtight glass container.

Sesame oil may be saponified by alkali hydroxides.

Included in the FDA Inactive Ingredients Database (IM and SC injections; oral capsules, emulsions, and tablets; also topical preparations). Included in parenteral (IM injections) and nonparenteral (oral capsules) medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.