Functional Category
Tablet binder; tablet and capsule diluent
Applications in Pharmaceutical Formulation
Dextrates is a directly compressible tablet diluent used in chewable, nonchewable, soluble, dispersible, and effervescent tablets.(1–3) It is a free-flowing material and glidants are thus unnecessary. Lubrication with magnesium stearate (0.5–1.0% w/w) is recommended.(4) Dextrates may also be used as a binding agent by the addition of water, no further binder being required.(4) Tablets made from dextrates increase in crushing strength in the first few hours after manufacture, but no further increase occurs on storage.(5)
Description
Dextrates is a purified mixture of saccharides resulting from the controlled enzymatic hydrolysis of starch. It is either anhydrous or hydrated. In addition to dextrose, dextrates contains 3–5% w/w maltose and higher polysaccharides. Dextrates comprises white spray-crystallized free-flowing porous spheres. It is odorless with a sweet taste (about half as sweet as sucrose)
Stability and Storage Conditions
Dextrates may be heated to 508C without any appreciable darkening of color. Dextrates should be stored in a well-closed container in conditions that do not exceed 258C and 60% relative humidity. When correctly stored in unopened containers, dextrates has a shelf-life of 3 years.
Incompatibilities
At high temperatures and humidities, dextrates may react with substances containing a primary amino group (Maillard reaction).(8,9) Also incompatible with oxidizing agents
Safety
Dextrates is used in oral pharmaceutical formulations and is generally regarded as a relatively nontoxic and nonirritant material.