PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Sorbitan monolaurate (Span 20)
اسپن 20
1Nonproprietary names
- BPSorbitan Laurate
- Ph. Eur.Sorbitan Laurate
- USP–NFSorbitan Monolaurate
2Synonyms and trade names
Sorbitan laurate; sorbitani lauras; Span 20; Arlacel 20; Crill 1; E493
3Chemical name and CAS Registry Number
Sorbitan monododecanoate (partial esters of sorbitol and its mono- and dianhydrides with lauric acid) · [1338-39-2]
UNII 6W9PS8B71J · PubChem CID 11046239
4Empirical formula and molecular weight
C18H34O6 · 346.5
5Functional category
Surfactant, emulsifier
Typical concentrations: — · Dosage forms: Semi-solid
6Applications in pharmaceutical formulation
A lipophilic nonionic surfactant used as an emulsifier, solubiliser and wetting agent in creams, emulsions and ointments for topical use, and in oral and other preparations. Of the sorbitan esters it is the most hydrophilic and is often combined with polysorbates to obtain the required HLB. Typical concentrations: emulsifier used alone in water-in-oil emulsions 1–15%; in combination with hydrophilic emulsifiers in oil-in-water emulsions 1–10%; to increase the water-holding capacity of ointments 1–10%; solubiliser for poorly soluble actives in lipophilic bases 1–10%; wetting agent for insoluble actives in lipophilic bases 0.1–3%.
7Description
A yellow to amber, viscous oily liquid with a faint characteristic odour and a bland taste. It is a mixture of esters of lauric acid with sorbitol anhydrides, the main component being sorbitan monolaurate.
8Typical properties
- HLB
- 8.6
- Physical form
- viscous liquid at room temperature
- Solubility
- insoluble but dispersible in water; soluble or dispersible in mineral and vegetable oils and in ethanol
- Density
- about 1.0 g/cm³
9Stability and storage conditions
Gradual soap formation occurs with strong acids or bases; the esters are stable in weak acids and bases. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents. Like other nonionic surfactants, it may reduce the activity of some preservatives such as parabens.
11Method of manufacture
Prepared by dehydration of sorbitol to sorbitan (a mixture of cyclic anhydrides) followed by esterification with lauric acid, or by a one-step reaction of sorbitol and lauric acid at high temperature with a catalyst.
12Safety
Sorbitan esters are widely used in cosmetics, foods and oral and topical pharmaceuticals and are generally regarded as non-toxic and non-irritant, although hypersensitivity skin reactions have occasionally been reported after topical use.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.
14Regulatory status
Accepted as a food additive in Europe (E493). Included in the FDA Inactive Ingredient Database (oral and topical preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Polysorbate 20; sorbitan monooleate (Span 80); sorbitan monostearate (Span 60); sorbitan trioleate.
16Comments
Blending a sorbitan ester with its corresponding polysorbate allows the HLB to be matched to the oil phase; for example, mixtures of Span 20 and polysorbate 20 cover an HLB range of about 8.6–16.7. Commercial products vary in fatty-acid and ester distribution, so specify the grade.