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Hydroxyethyl cellulose
هیدروکسی اتیل سلولز
1Nonproprietary names
- BPHydroxyethylcellulose
- Ph. Eur.Hydroxyethylcellulose
- USP–NFHydroxyethyl Cellulose
2Synonyms and trade names
Cellosize HEC; cellulose hydroxyethyl ether; HEC; hydroxyethylcellulosum; Natrosol; Tylose H
3Chemical name and CAS Registry Number
Cellulose, 2-hydroxyethyl ether · [9004-62-0]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Gelling agent, viscosity modifier
Typical concentrations: — · Dosage forms: Liquid, Semi-solid
6Applications in pharmaceutical formulation
A non-ionic, water-soluble polymer used mainly as a thickening and suspending agent in ophthalmic and topical products, including gels, lubricating jellies, lotions and artificial tears, usually at concentrations of a few per cent or less. It is also used as a binder and film former in tablets, as a matrix former in sustained-release systems, as a stabiliser in emulsions and in mucoadhesive formulations. It is widely used in cosmetics and toiletries.
7Description
A white, yellowish-white or greyish-white, odourless and tasteless, hygroscopic powder or granules. Grades are distinguished by the viscosity of their aqueous solutions and by the degree of hydroxyethyl substitution.
8Typical properties
- Molar substitution
- typically about 1.5–3.5 (≈ 2.5 for common grades)
- pH
- 5.5–8.5 (1% w/v aqueous solution)
- Viscosity
- wide range of grades, from a few mPa·s to many thousands of mPa·s for 1–2% w/v solutions
- Solubility
- soluble in hot and cold water, without thermal gelation; practically insoluble in acetone, ethanol and most other organic solvents
9Stability and storage conditions
The powder is stable but hygroscopic; store in a well-closed container in a cool, dry place. Aqueous solutions are relatively stable at pH 2–12, but viscosity falls through acid hydrolysis at low pH and oxidative degradation at high pH. Solutions are susceptible to enzymatic (cellulase) degradation and should be preserved.
10Incompatibilities
Compatible with most water-soluble gums and resins and, being non-ionic, tolerates many salts, although very high salt concentrations can salt it out. It is incompatible with zein and may be precipitated by some concentrated solutions of salts such as sodium sulfate.
11Method of manufacture
Prepared by treating purified cellulose with sodium hydroxide to form alkali cellulose, which is then reacted with ethylene oxide. The product is neutralised, washed, dried and milled.
12Safety
Regarded as essentially non-toxic and non-irritant; it is not absorbed from the gastrointestinal tract. It is used in ophthalmic preparations and contact lens solutions without significant irritation.
13Handling precautions
Observe normal precautions for the quantity handled. The fine powder can form explosive dust–air mixtures; avoid generating dust and use eye protection and gloves.
14Regulatory status
Included in the FDA Inactive Ingredient Database (ophthalmic, otic, oral, topical and vaginal preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Ethylhydroxyethyl cellulose; hydroxypropyl cellulose; hypromellose; methylcellulose.
16Comments
Unlike methylcellulose and hypromellose, hydroxyethyl cellulose does not gel on heating, so it can be dissolved directly in hot water. To prevent lumps, disperse the powder in water with good agitation before the pH is raised or before other solutes are added; some grades are surface-treated to delay hydration and ease dispersion.