Sorbitan Monostearate

Category

Dispersing Agents; Emulsifying Agents; Nonionic Surfactant; solubilizing Agents; Suspending Agents; Wetting Agents

Molecular Formula

C24H46O6

Molecular Weight

431

Grade

Pharmceutical Excipients

Description

Cream solid

UNII

NVZ4I0H58X

Chemical Name

Sorbitan mono-octadecanoate

CAS Number

1338-41-6

Synonyms

Ablunol S-60; Alkamuls SMS; 1, 4-Anhydro-D-glucitol, 6-octadecanoate; anhydrosorbitol monostearate; Arlacel 60; Armotan MS; Atlas 110K; Capmul S; Crill 3; Dehymuls SMS; Drewmulse SMS; Drewsorb 60K; Durtan 6O; Durtan 60K; E491; Famodan MS Kosher; Glycomul S FG; Glycomul S KFG; Hodag SMS; Lamesorb SMS; Liposorb S; Liposorb SC; Liposorb S-K; Montane 60; Nissan Nonion SP-60R; Norfox Sorbo S-60FG; Polycon S60K; Protachem SMS; Prote-sorb SMS; S-Maz 60K; SMaz 60KHS; Sorbester P18; Sorbirol S; sorbitan stearate; sorbitani stearas; Sorgen 50; Span 60; Span 60K; Span 60 VS; Tego SMS

Administration route

Administration of topical preparations, sublingual administration, rectal cavity urethral administration, dental external application and tablet use.

Dosage Form

Inhalation, intramuscular, ophthalmic, oral, topical and vaginal formulations

Stability and Storage Conditions

Gradually saponified under strong acid or strong base; stable in weak acid or weak base. Sorbitan ethoxylate should be packed in airtight containers and stored in a cool, dry place.

Source and Preparation

Sorbitol is dehydrated to 1, 4-Sorbitan, and then obtained by esterification with stearic acid.

Applications

Emulsifiers; nonionic surfactants; solubilizers; wetting agents and dispersing/suspending agents. As a lipophilic nonionic surfactant, sorbitan ester is widely used in cosmetics, food and pharmaceuticals. They are primarily used as emulsifiers in the preparation of creams, emulsions and ointments for topical application. When used alone, sorbitan ester can prepare stable water-in-oil emulsions and microemulsions, but if it is used in combination with polysorbate esters in different proportions, various water-in-oil or oil-in-water emulsions or cream.

Safety

Sorbitan ester is widely used in cosmetics, food, oral and topical pharmaceutical preparations, and is generally considered non-toxic and non-irritating. However, there have been occasional reports of allergic skin reactions to topical agents containing sorbitan cilexetil. Sorbitan ester emits irritating fumes when heated to decomposition temperature. The WHO has determined the acceptable daily intake for humans of sorbitan monopalm, sorbitan monostearate, sorbitan tristearate, sorbitan monolaurate and sorbitan monooleate: 25 mg per kg body weight (based on total sorbitan esters) . Sorbitan monostearate: LD50 (rat, oral): 31g/kg. Moderate ingestion toxicity. Has experimental reproductive effects.