Functional Category
Coating agent; tablet and capsule diluent; tablet binder; viscosityincreasing agent
Applications in Pharmaceutical Formulation
Maltodextrin is used in tablet formulations as a binder and diluent in both direct-compression and wet-granulation or agglomeration processes.(1–7) Maltodextrin appears to have no adverse effect on the rate of dissolution of tablet and capsule formulations; magnesium stearate 0.5–1.0% may be used as a lubricant. It has been used as a carrier in a spray-dried redispersible oil-in-water emulsion to improve the bioavailability of poorly soluble drugs.(8) Maltodextrin may also be used as a tablet film former in aqueous film-coating processes. Maltodextrin grades with a high DE value are particularly useful in chewable tablet formulations. Maltodextrin may also be used in pharmaceutical formulations to increase the viscosity of solutions and to prevent the crystallization of syrups. Therapeutically, maltodextrin is often used as a carbohydrate source in oral nutritional supplements because solutions with a lower osmolarity than isocaloric dextrose solutions can be prepared. At body osmolarity, maltodextrin solutions provide a higher caloric density than sugars. Maltodextrin is also widely used in confectionery and food products, as well as personal care applications.
Description
Maltodextrin occurs as a nonsweet, odorless, white powder or granules. The solubility, hygroscopicity, sweetness, and compressibility of maltodextrin increase as the DE increases. The USP32– NF27 states that it may be physically modified to improve its physical and functional characteristics.
Stability and Storage Conditions
Maltodextrin is stable for at least 1 year when stored at a cool temperature (<308C) and less than 50% relative humidity. Maltodextrin solutions may require the addition of an antimicrobial preservative. Maltodextrin should be stored in a well-closed container in a cool, dry place.
Incompatibilities
Under certain pH and temperature conditions maltodextrin may undergo Maillard reactions with amino acids to produce yellowing or browning. Incompatible with strong oxidizing agents.
Safety
Maltodextrin is a readily digestible carbohydrate with a nutritional value of approximately 17 kJ/g (4 kcal/g). In the USA, it is generally recognized as safe (GRAS) as a direct human food ingredient at levels consistent with current good manufacturing practices. As an excipient, maltodextrin is generally regarded as a nonirritant and nontoxic material.