Dextrates

• USP–NFDextrates

Emdex; dextrates hydrated; dextrates anhydrous; spray-crystallised dextrose–oligosaccharide mixture

Dextrates (purified mixture of saccharides from controlled enzymatic hydrolysis of starch; mainly dextrose) · [39404-33-6]

Polymer, mixture or material of variable composition — no single molecular formula applies.

Diluent (filler)

Typical concentrations: — · Dosage forms: Solid

Used as a directly compressible tablet filler and binder, particularly in chewable, effervescent and orally disintegrating tablets, where its sweet taste and cool mouthfeel are useful. It usually forms a large part of the tablet weight. It is also used as a sweetener in powders and granules.

Free-flowing, porous, white spherical particles made up of aggregates of microcrystals, with a sweet taste. It is a mixture of dextrose (about 92% or more) with a small amount of higher glucose oligosaccharides, and is available in hydrated and anhydrous forms.

Dextrose equivalent

93.0–99.0 (dried basis)

Loss on drying

7.8–9.2% (hydrated); not more than 2.0% (anhydrous)

pH

3.8–5.8 (20% w/v aqueous solution)

Solubility

freely soluble in water; insoluble in ethanol and common organic solvents

Heat of solution

negative, giving a cooling sensation in the mouth

Stable under normal conditions, but it takes up moisture at high relative humidity and may cake. Store in a well-closed container in a cool, dry place.

As a reducing sugar mixture it can undergo Maillard reactions with drugs containing primary amine groups, which causes browning. Incompatible with strong oxidising agents.

Starch is hydrolysed under controlled enzymatic conditions and the resulting dextrose-rich syrup is spray-crystallised to give porous agglomerated particles; part of the product is dried to give the anhydrous form.

Non-toxic and non-irritant; it is metabolised like dextrose. Its sugar content should be taken into account for patients with diabetes and when assessing cariogenic potential in chewable products.

Observe normal precautions for the quantity handled. Avoid generating dust; eye protection and gloves are recommended.

Included in the FDA Inactive Ingredient Database (oral tablets) and in non-parenteral medicines.

Dextrin; dextrose; glucose, liquid; maltodextrin; sucrose.

Tablets made with dextrates often increase in hardness for some hours after compression. It needs a lubricant, and tablet properties are sensitive to storage humidity, so moisture-protective packaging may be needed.