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Dextrose
گلوکز، دکستروز
1Nonproprietary names
- BPGlucose Monohydrate
- JPGlucose Hydrate
- Ph. Eur.Glucose Monohydrate
- USP–NFDextrose
2Synonyms and trade names
corn sugar; D-glucose; dextrose monohydrate; anhydrous dextrose; glucose; glucosum monohydricum; grape sugar; Roferose; Tabfine D-100
3Chemical name and CAS Registry Number
D-(+)-Glucopyranose monohydrate (also used in anhydrous form) · [50-99-7]
4Empirical formula and molecular weight
C6H12O6·H2O (anhydrous: C6H12O6) · 198.17 (monohydrate); 180.16 (anhydrous)
5Functional category
Diluent (filler), Tonicity-adjusting agent, Sweetening agent
Typical concentrations: — · Dosage forms: Solid, Sterile (parenteral/ophthalmic), Liquid
6Applications in pharmaceutical formulation
Used as a tablet diluent and binder, especially in chewable tablets, and directly compressible grades are available. It is a sweetener and bulking agent in oral solutions and syrups, and a tonicity agent in parenteral and other solutions, where a 5% w/v solution is approximately isotonic. It is also given therapeutically as an energy source, for example in intravenous infusions.
7Description
Colourless crystals or a white, crystalline or granular powder; odourless, with a sweet taste roughly 70–80% that of sucrose. It is available as the monohydrate and in anhydrous form.
8Typical properties
- Melting point
- about 83 °C (monohydrate); about 146 °C (anhydrous α-form)
- Water content
- 7.0–9.5% w/w (monohydrate)
- Specific rotation
- +52.5° to +53.3° (anhydrous basis, at equilibrium)
- Osmotic behaviour
- a 5% w/v solution is approximately iso-osmotic with serum
- Solubility
- freely soluble in water (about 1 in 1); sparingly soluble in ethanol
9Stability and storage conditions
Stable when stored dry. Solutions can be sterilised by autoclaving, but excessive heating lowers the pH and causes yellowing (caramelisation) with formation of 5-hydroxymethylfurfural; solutions are most stable at about pH 4. Store in a well-closed container in a cool, dry place.
10Incompatibilities
As a reducing sugar it browns with compounds containing primary amine groups (Maillard reaction). Dextrose solutions have been reported to be incompatible with several drugs, such as cyanocobalamin, kanamycin sulfate, novobiocin sodium and warfarin sodium, so compatibility should be checked before admixture.
11Method of manufacture
Produced by complete acid or enzymatic hydrolysis of starch, usually maize starch, followed by purification and crystallisation; crystallisation below about 50 °C gives the monohydrate and at higher temperature the anhydrous form.
12Safety
Non-toxic when taken orally, although the sugar content matters for patients with diabetes and for dental health. Concentrated (hypertonic) solutions given intravenously can cause thrombophlebitis, and rapid infusion can cause hyperglycaemia and fluid and electrolyte disturbances.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid dust; eye protection is recommended.
14Regulatory status
GRAS listed. Included in the FDA Inactive Ingredient Database (injections; oral capsules, solutions, syrups and tablets; inhalation and other routes) and in parenteral and non-parenteral medicines licensed in Europe.
15Related substances
Dextrates; fructose; glucose, liquid; invert sugar; maltodextrin; sucrose.
16Comments
Directly compressible dextrose tablets may harden on storage, and the monohydrate can lose water when dried at higher temperatures, so drying conditions for granules should be controlled. The anhydrous form is preferred in some solid products and the monohydrate in solutions; the amount should always be calculated on the appropriate basis.