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Glycofurol
گلیکوفورول
1Synonyms and trade names
Glycofurol 75; tetraglycol; tetrahydrofurfuryl alcohol polyethylene glycol ether; α-(tetrahydrofuranyl)-ω-hydroxypoly(oxyethylene)
2Chemical name and CAS Registry Number
α-[(Tetrahydro-2-furanyl)methyl]-ω-hydroxypoly(oxy-1,2-ethanediyl) · [31692-85-0]
3Empirical formula and molecular weight
C5H9O(CH2)O(C2H4O)nH; n mainly 1–2 · 190.24 (n = 2)
4Functional category
Solvent, humectant
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
5Applications in pharmaceutical formulation
Used mainly as a water-miscible solvent in parenteral products for intravenous or intramuscular injection, at concentrations of up to about 50% v/v. It has also been investigated as a solvent and penetration enhancer in nasal, rectal and topical formulations and in in-situ forming implants.
6Description
A clear, colourless, almost odourless liquid with a bitter taste that produces a warm sensation on the tongue. Glycofurol 75 is the grade in which most of the material has n = 1 or 2.
7Typical properties
- Density
- ≈ 1.07–1.09 g/cm³ at 20 °C
- Solubility
- miscible with water, ethanol, glycerin, propylene glycol and polyethylene glycol 400; immiscible with arachis oil and light petroleum
- Viscosity
- low to moderate; somewhat more viscous than water
8Stability and storage conditions
Stable if stored under nitrogen in a well-closed container, protected from light, in a cool, dry place. As a polyether it may slowly form peroxides on exposure to air.
9Incompatibilities
Incompatible with oxidising agents.
10Method of manufacture
Prepared by reacting tetrahydrofurfuryl alcohol with ethylene oxide, followed by purification to remove tetrahydrofurfuryl alcohol and other impurities.
11Safety
Glycofurol is irritant when used undiluted, but is tolerated in parenteral products when diluted to about 50% v/v or less. At high doses it has central nervous system depressant and diuretic effects in animals.
12Handling precautions
Observe normal precautions for the quantity handled; eye protection and gloves are recommended.
13Regulatory status
Has been used in parenteral medicines licensed in some European countries. It is not widely used in products marketed in the USA.
14Related substances
Polyethylene glycol; propylene glycol; tetrahydrofurfuryl alcohol.
15Comments
Glycofurol is a useful co-solvent for poorly water-soluble drugs in injections, but the content of residual tetrahydrofurfuryl alcohol and peroxides should be controlled, and the product checked for precipitation of the drug on dilution with aqueous infusion fluids.