Functional Category
Tablet and capsule diluent; therapeutic agent; tonicity agent; sweetening agent.
Applications in Pharmaceutical Formulation
Dextrose is widely used in solutions to adjust tonicity and as a sweetening agent. Dextrose is also used as a wet granulation diluent and binder, and as a direct-compression tablet diluent and binder primarily in chewable tablets. Although dextrose is comparable as a tablet diluent to lactose, tablets produced with dextrose monohydrate require more lubrication, are less friable, and have a tendency to harden.(1–3) The mildly reducing properties of dextrose may be used when tableting to improve the stability of active materials that are sensitive to oxidation. Dextrose is also used therapeutically and is the preferred source of carbohydrate in parenteral nutrition regimens
Description
Dextrose occurs as odorless, sweet-tasting, colorless crystals or as a white crystalline or granular powder. The JP XV describes dextrose as dextrose anhydrous; the PhEur 6.3 specifies dextrose as either dextrose anhydrous or dextrose monohydrate; and the USP 32 specifies dextrose as dextrose monohydrate.
Stability and Storage Conditions
Dextrose has good stability under dry storage conditions. Aqueous solutions may be sterilized by autoclaving. However, excessive heating can cause a reduction in pH and caramelization of solutions.(4–7) The bulk material should be stored in a well-closed container in a cool, dry place.
Incompatibilities
Dextrose solutions are incompatible with a number of drugs such as cyanocobalamin, kanamycin sulfate, novobiocin sodium, and warfarin sodium.(8) Erythromycin gluceptate is unstable in dextrose solutions at a pH less than 5.05.(9) Decomposition of B-complex vitamins may occur if they are warmed with dextrose. In the aldehyde form, dextrose can react with amines, amides, amino acids, peptides, and proteins. Brown coloration and decomposition occur with strong alkalis. Dextrose may cause browning of tablets containing amines (Maillard reaction).
Safety
Dextrose is rapidly absorbed from the gastrointestinal tract. It is metabolized to carbon dioxide and water with the release of energy. Concentrated dextrose solutions given by mouth may cause nausea and vomiting. Dextrose solutions of concentration greater than 5% w/v are hyperosmotic and are liable to cause local vein irritation following intravenous administration. Thrombophlebitis has been observed following the intravenous infusion of isoosmotic dextrose solution with low pH, probably owing to the presence of degradation products formed by overheating during sterilization. The incidence of phlebitis may be reduced by adding sufficient sodium bicarbonate to raise the pH of the infusion above pH 7. LD50 (mouse, IV): 9 g/kg(10) LD50 (rat, oral): 25.8 g/kg