Maltodextrin

Category

Coating Agents; Tablet and Capsule Diluent; Tablet Binder; Viscosity increasing Agents; Filler; Stabilizer; Thickening Agents; Surface polish, etc

Molecular Formula

(C6H10O5)n·H2O

Molecular Weight

900-9000

Grade

Pharmceutical Excipients

Description

Maltodextrin occurs as a nonsweet, odorless, white powder or granules. The solubility, hygroscopicity, sweetness, and compressibility of maltodextrin increase as the DE increases.

UNII

7CVR7L4A2D

Chemical Name

Maltodextrin

CAS Number

9050-36-6

Synonyms

Cargill Dry

Administration route

Oral

Dosage Form

Oral tablets and granules

Stability and Storage Conditions

Maltodextrin is stable for at least 1 year when stored at a cool temperature (<30℃) 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.

Source and Preparation

Maltodextrin is prepared by heating and treating starch with acid and/or enzymes in the presence of water. This process partially hydrolyzes the starch, to produce a solution of glucose polymers of varying chain length. This solution is then filtered, concentrated, and dried to obtain maltodextrin.

Applications

Maltodextrin is used in tablet formulations as a binder and diluent in both direct-compression and wet-granulation or agglomeration processes.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. 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.

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.

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.