Maltodextrin

• BPMaltodextrin
• Ph. Eur.Maltodextrin
• USP–NFMaltodextrin

Maltodextrinum; hydrolysed starch; Glucidex; Lycatab DSH; Maltrin; Paselli MD

Non-sweet, nutritive saccharide polymer of D-glucose units linked mainly by α-(1→4) bonds, with a dextrose equivalent below 20 · [9050-36-6]

(C6H10O5)n·H2O · ≈ 900–9000

Diluent (filler), Binder

Typical concentrations: — · Dosage forms: Solid

Used as a tablet binder and diluent in wet granulation (typically about 3–10% w/w) and direct compression (often at higher proportions), as a film-coating additive, a viscosity-increasing agent in oral liquids, a carrier for spray-dried and freeze-dried products, and as a carbohydrate source in nutritional products.

A white, hygroscopic powder or granules, odourless and with a bland or slightly sweet taste. Grades are classified by dextrose equivalent (DE), which reflects the degree of starch hydrolysis.

Dextrose equivalent

less than 20 (grades typically 5–20)

pH

4.0–7.0 (20% w/v aqueous solution)

Loss on drying

not more than 6% w/w

Solubility

freely soluble or readily dispersible in water (higher-DE grades dissolve more easily); practically insoluble in ethanol

Stable for at least a year when stored dry and cool. Aqueous solutions can support microbial growth and may need a preservative. Store in a well-closed container in a cool, dry place.

Contains reducing end groups and can take part in Maillard reactions with primary amines; the tendency increases with DE. Incompatible with strong oxidising agents.

Prepared by partial hydrolysis of starch (commonly maize or potato) with acid and/or enzymes, followed by purification, concentration and spray drying.

Digested and absorbed as glucose; regarded as non-toxic and non-irritant. The carbohydrate load should be considered in diabetic patients when large amounts are used.

Observe normal precautions for the quantity handled. Avoid generating dust; eye protection, gloves and a dust mask are recommended.

GRAS listed. Included in the FDA Inactive Ingredient Database (oral capsules, solutions and tablets) and in non-parenteral medicines licensed in Europe.

Dextrates; dextrin; dextrose; corn syrup solids (DE above 20); pregelatinised starch.

Low-DE grades are less hygroscopic, less sweet and give more viscous solutions; higher-DE grades are more soluble and compress better but brown more readily. Choose the DE to suit the process and the drug's reactivity.