PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Sesame oil
روغن کنجد
1Nonproprietary names
- BPRefined Sesame Oil
- JPSesame Oil
- Ph. Eur.Sesame Oil, Refined
- USP–NFSesame Oil
2Synonyms and trade names
benne oil; gingelly oil; oleum sesami; sesami oleum raffinatum; teel oil
3Chemical name and CAS Registry Number
Refined fixed oil obtained from the seeds of Sesamum indicum L. (a mixture of triglycerides, mainly of oleic and linoleic acids) · [8008-74-0]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Oleaginous vehicle
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Used mainly as a vehicle for intramuscular depot injections of lipophilic drugs, such as steroid hormones and long-acting antipsychotic esters (for example haloperidol and fluphenazine decanoates), where it may form the whole of the vehicle. It is also used as a solvent in oral capsules, in topical and cosmetic products, in emulsions and in self-emulsifying and other lipid-based delivery systems, and widely as an edible oil.
7Description
A clear, pale yellow oil that is almost odourless and has a bland taste. It solidifies to a buttery mass at about −5 °C.
8Typical properties
- Density
- ≈ 0.92 g/cm³
- Iodine value
- ≈ 103–116
- Saponification value
- ≈ 188–195
- Fatty acid composition
- mainly oleic and linoleic acids (each roughly 35–55%), with smaller amounts of palmitic and stearic acids
- Solubility
- miscible with chloroform, ether, light petroleum and carbon disulfide; slightly soluble in ethanol; practically insoluble in water
9Stability and storage conditions
More resistant to oxidative rancidity than most fixed oils because it contains natural antioxidants (lignans such as sesamol and sesamolin). It can be sterilised by dry heat. Store in a well-filled, airtight, light-resistant container, avoiding exposure to excessive heat.
10Incompatibilities
Saponified by alkali hydroxides; may react with strong oxidising agents.
11Method of manufacture
Obtained by expression or solvent extraction of the seeds of Sesamum indicum, followed by refining (degumming, neutralisation, bleaching and deodorisation). Grades for parenteral use meet tighter limits on acid value, water and peroxides.
12Safety
An edible oil that is generally non-toxic and non-irritant. Sesame is, however, a recognised food allergen, and hypersensitivity reactions, including anaphylaxis, have been reported after oral use and after injection of products formulated in sesame oil. Oily intramuscular injections can cause local pain and reactions at the injection site.
13Handling precautions
Observe normal precautions for the quantity handled. Spills are slippery; the oil is combustible.
14Regulatory status
Widely used as an edible oil. Included in the FDA Inactive Ingredient Database (intramuscular and subcutaneous injections, oral capsules and topical preparations) and in parenteral and non-parenteral medicines licensed in Europe.
15Related substances
Almond oil; canola oil; castor oil; corn oil; cottonseed oil; peanut oil; soybean oil.
16Comments
Its good oxidative stability and low tendency to crystallise on cooling make it a preferred vehicle for oily depot injections; benzyl alcohol or benzyl benzoate is often added as a cosolvent or preservative. Patients with sesame allergy should be identified before oily injections are given.