Polydextrose

Category

Coating agents; Diluents; Humectants; Binders; Fillers

Molecular Formula

(C6H12O6)x

Molecular Weight

1200-2000 (average)

Grade

Pharmceutical Excipients

Description

Polydextrose occurs as an odorless, off-white to light tan powder with a bland, slightly sweet to slightly tart taste, dependent upon grade. Polydextrose is also available as a clear, light yellow to colorless liquid (70% dry substance), which is odorless with a slightly sweet taste.

UNII

VH2XOU12IE

Chemical Name

Polydextrose

CAS Number

68424-04-4

Synonyms

E1200; Litesse; polydextrose A; polydextrose K; STA-Lite.

Administration route

Oral

Dosage Form

Oral tablets

Stability and Storage Conditions

Polydextrose powder is hygroscopic and absorbs significant amounts of moisture at relative humidities greater than 60%. Under dry storage conditions, and in original sealed packaging, polydextrose powders can be expected to retain stability for at least 3 years. Solution grades have a shorter shelf-life of 3 to 6 months (dependent upon grade) at an ambient temperature of 25℃, although this can be extended to 12 months through the use of refrigeration.The bulk material should be stored in a cool, dry place in well closed containers.

Source and Preparation

Polydextrose is prepared by the bulk melt polycondensation of glucose and sorbitol in conjunction with small amounts of foodgrade acid in vacuo. Further purification steps are then involved to generate a range of products with improved organoleptic properties by the removal of acidity and flavor notes generated during the condensation reaction. A partially hydrogenated version of polydextrose, which is suited for high inclusion rates, for sugar-free applications, and where Maillard reactions are not required, is also available.

Applications

Polydextrose is used in pharmaceutical formulations and food products. In food products it is used as a bulking agent; it also has texturizing and humectant properties.

Safety

Polydextrose is used in oral pharmaceutical applications, food products, and confectionery, and is generally regarded as a relatively nontoxic and nonirritant material. However, excessive consumption of non-digestible carbohydrates, such as polydextrose, can lead to gastrointestinal distress. After evaluating a series of clinical studies, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Commission Scientific Committee for Food (EC/SCF) concluded that polydextrose was better tolerated than other digestible carbohydrates such as polyols. The committee concluded that polydextrose has a mean laxative threshold of approximately 90 g/day (1.3 g/kg body-weight) or 50 g as a single dose. LD50 (mouse, oral): >30 g/kg LD50 (rat, oral): >15 g/kg

Incompatibilities

Incompatible with oxidizing agents, strong acids, and alkalis, forming a brown coloration and depolymerizing.