Polydextrose

• USP–NFPolydextrose

Litesse; polydextrosum; Sta-Lite; E1200

Randomly bonded condensation polymer of D-glucose with minor amounts of sorbitol and citric acid · [68424-04-4]

(C6H10O5)n

Diluent (filler)

Typical concentrations: — · Dosage forms: Solid

In foods polydextrose is used as a low-calorie bulking agent, humectant and source of soluble dietary fibre, replacing sugar and fat. In pharmaceuticals it is used as a bulking agent and binder in tablets, in chewable and sugar-free formulations, and as a component of film coatings. Use levels depend widely on the function, from a few percent as a binder to a major part of the formulation as a bulking agent.

A white to light cream, amorphous, hygroscopic powder that is almost odourless and has a neutral to slightly tart taste; it is not sweet. It is a polydisperse polymer with a wide molecular-weight distribution and only a small fraction of free glucose and sorbitol.

Composition

approximately 90% glucose, 10% sorbitol and 1% citric acid (by weight, before polymerisation); 1→6 glycosidic bonds predominate

Energy value

about 1 kcal/g (≈ 4 kJ/g)

Solubility

very soluble in water (solutions of about 80% w/w can be made); limited solubility in ethanol

pH

2.5–7.0 (10% w/v solution), depending on whether the grade has been neutralised

Hygroscopicity

hygroscopic amorphous powder

Stable under normal conditions but hygroscopic; it absorbs moisture and may cake when exposed to humid air. Store in a well-closed container in a cool, dry place.

Incompatible with strong oxidising agents. The acidic unneutralised grades may affect acid-sensitive drugs, and residual reducing end groups can give some browning with amines on heating.

Made by heating a melt of glucose with about 10% sorbitol and 1% citric acid under vacuum, which causes random polycondensation; the product may then be purified and neutralised (for example with potassium hydroxide) and dried.

Polydextrose is only partly fermented in the colon and is regarded as non-toxic. Like other poorly digested carbohydrates, large single doses can cause a laxative effect and flatulence. JECFA has not specified an ADI.

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

Approved in the USA as a direct food additive and accepted as a food additive in Europe (E1200). Used in oral pharmaceutical products.

Dextrin; inulin; maltodextrin.

Because it is not sweet, polydextrose is usually combined with an intense sweetener in sugar-free products. Its hygroscopicity should be considered when it is used in solid dosage forms, and low-moisture packaging may be needed.