International Numbering System (INS) for Food Additives: 1200
Food additives Europe numbers: E1200
Functional Category
Coating agent; diluent; granulation aid; humectant; tablet and capsule diluent; tablet binder; tablet filler; viscosity-increasing agent
Applications in Pharmaceutical Formulation
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. Although polydextrose can be used in a wide range of pharmaceutical formulations, its primary use is in solid-dosage forms. In tableting, polydextrose solutions are used as binders in wetgranulation processes. Polydextrose is also used in the manufacture of directly compressible tableting excipients. Polydextrose solutions may also be used, in conjunction with other materials, as a film and tablet coating agent. Polydextrose acts as a bulking agent in the formulation of ‘sugarfree’ confectionery-type dosage forms. In conjunction with isomalt, lactitol, or maltitol, polydextrose can be used in the manufacture of ‘sugar-free’ hard-boiled candies and acacia lozenges or pastilles as a base for medicated confectionery. The combination of high water solubility and high viscosity of polydextrose facilitates the processing of sugar-free candies of excellent quality. Polydextrose is amorphous and does not crystallize at low temperatures or high concentrations, so it can be used to control the crystallization of polyols and sugars and therefore the structure and texture of the final product
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.
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 258C, although this can be extended to 12 months through the use of refrigeration.
Incompatibilities
Incompatible with oxidizing agents, strong acids, and alkalis, forming a brown coloration and depolymerizing
Safety
Polydextrose is used in oral pharmaceutical applications, food products, and confectionery, and is generally regarded as a relatively nontoxic and nonirritant material.(2,3) 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.(4) See also Section 18. LD50 (mouse, oral): >30 g/kg LD50 (rat, oral): >15 g/kg