Polydextrose
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.
| Supplier | CD Formulation |
|---|---|
| Product # | PE0401 |
| Pricing | , Inquire for price |
| product1 | Pharmaceutical Excipients |
| Molecular Formula | (C6H12O6)x |
| Molecular Weight | 1200-2000 (average) |
| 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. |
| Synonyms | E1200; Litesse; polydextrose A; polydextrose K; STA-Lite. |
| CAS Number | 68424-04-4 |
| Category | Coating agents; Diluents; Humectants; Binders; Fillers |
| UNII | VH2XOU12IE |
| Chemical Name | Polydextrose |
| Grade | Pharmceutical Excipients |
| 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. |