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).
생산 방법
Dextrates is produced by controlled enzymatic hydrolysis of starch. The product is spray-crystallized, and may be dried to produce an anhydrous form.
Pharmaceutical Applications
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.Dextrates may also be used as a binding agent by the addition of water, no further binder being required. Tablets made from dextrates increase in crushing strength in the first few hours after manufacture, but no further increase occurs on storage.
Safety
Dextrates is used in oral pharmaceutical formulations and is generally regarded as a relatively nontoxic and nonirritant material.
저장
Dextrates may be heated to 50°C without any appreciable darkening of color. Dextrates should be stored in a well-closed container in conditions that do not exceed 25°C and 60% relative humidity. When correctly stored in unopened containers, dextrates has a shelf-life of 3 years.
비 호환성
At high temperatures and humidities, dextrates may react with substances containing a primary amino group (Maillard reaction).(8,9) Also incompatible with oxidizing agents.
Regulatory Status
GRAS listed. Included in the FDA Inactive Ingredient Database (oral; tablets, chewable and sustained action). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
