Sucrose Ester

Sucrose Ester is known as dispersing agent, emulsifying agent, nonionic surfactant, solubiliz-ing agent. This product is available in Arvin Kala’s diverse product portfolio.

Description
Sucrose Ester appears as a white or nearly white powder that is tasteless, odorless, and has a greasy texture. According to USP 40-NF 35 S1 and PhEur 9.2, sucrose Ester is characterized as a blend of sucrose monoesters, predominantly sucrose monopalmitate, with varying amounts of mono-, di-, tri-, and polyesters. The chemical formula of this substance is C₂₈H₅₂O₁₂, and its chemical structure is defined as follows:
Applications in Pharmaceutical Formulation or Technology
Sucrose Ester is utilized to stabilize emulsions, functioning as either a surfactant or cosurfactant. Additionally, it serves as a solubilizing agent and has been noted to enhance the solubility of felodipine in controlled-release formulations. This compound also acts as an absorption enhancer for oral delivery of drugs with poor absorption through the intestinal mucosa. It boasts excellent skin compatibility and has been shown to improve the skin permeation of acyclovir when applied topically in an oil-in-water cream. Sucrose Ester exhibits temperature-dependent viscoelastic gel-forming properties, which are beneficial for creating temperature-sensitive controlled drug delivery systems. It has been used as a matrix-forming agent in tablets, in combination with microcrystalline cellulose, and has demonstrated a slight delay in the release of model drugs like theophylline monohydrate and ibuprofen. In the cosmetic industry, sucrose Ester is found in various products such as creams, lotions, lipsticks, antiperspirants, and bath items. It contributes to good foam quality and provides excellent skin mildness, emolliency, and moisturizing properties. Typically, it is used in cosmetic formulations at concentrations ranging from 0.5% to 5%.
Stability and Storage Conditions
Sucrose Ester should be stored at 15-25°C and protected from humidity.
Method of Manufacture
esters derived from edible tallow, hydrogenated edible tallow, or edible vegetable oils with sucrose. The process of manufacturing these fatty acid methyl esters involves a distillation step. In the preparation of sucrose fatty acid esters, solvents such as ethyl acetate, methyl ethyl ketone, dimethyl sulfoxide, and isobutyl alcohol (2-methyl-1-propanol) may be utilized.
Safety
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has assessed the safety of sucrose fatty acid esters and suggested an acceptable daily intake of up to 30 mg/kg. At higher doses, these esters may exhibit a laxative effect. Sucrose Ester is non-irritating to both skin and eyes. Acute toxicity tests conducted on rats and mice, involving an oral dose of 20 g/kg administered in 10 equally divided doses at 30 to 60-minute intervals, resulted in no fatalities.

LD_50 (mouse, oral): > 2g/kg

Handling Precautions
Take standard precautions based on the specific conditions and amount of material being handled. Avoid creating dust. It is advisable to use eye protection and gloves.

Chemical-physical values

Test Item Unit Specification
Arsenic
ppm
NMT 4.0
Free Sucrose
%
NMT 5.0
Water Content
%
NMT 4.0
Residue on Ignition
%
NMT 2.0
Test Item Unit Specification
Appearance
White crystalline powder
Monoester
%
NLT 74.0
Acid Value
mg KOH/g
NMT 6.0
Lead
ppm
NMT 2.0

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