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Sugar, compressible
شکر قابل تراکم
1Nonproprietary names
- USP–NFCompressible Sugar
2Synonyms and trade names
Di-Pac; Nu-Tab; Sugartab; directly compressible sugar
3Chemical name and CAS Registry Number
Sucrose co-processed with small amounts of other materials such as maltodextrin, invert sugar or starch · [—]
4Empirical formula and molecular weight
C12H22O11 (sucrose) · 342.30 (sucrose)
5Functional category
Diluent (filler)
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used as a directly compressible filler and binder, mainly in chewable tablets and lozenges where its sweetness and pleasant mouthfeel are an advantage. It is typically used at about 20–60% w/w as a diluent and at lower levels as a dry binder, and it also acts as a sweetening agent.
7Description
White, odourless, crystalline or granular powder with a sweet taste. The co-processed agglomerates are more porous than ordinary sugar crystals, which gives better flow and compactibility.
8Typical properties
- Sucrose content
- 95.0–98.0% (dried basis); the remainder is, for example, maltodextrin or invert sugar, and a lubricant may be present
- Loss on drying
- 0.25–1.0% w/w (USP-NF)
- Melting point
- melts with decomposition at about 160–186 °C (sucrose)
- Solubility
- very soluble in water; the starch component, if present, is insoluble
- Sweetness
- similar to sucrose
9Stability and storage conditions
Stable in air at moderate temperatures. It may cake when stored at high relative humidity. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Shares the incompatibilities of sucrose. Hydrolysis to reducing sugars, accelerated by acid and moisture, can lead to Maillard browning with amine drugs; any invert sugar present is already reducing.
11Method of manufacture
Prepared by co-crystallising or agglomerating sucrose with the minor ingredient, for example by spraying a maltodextrin solution onto sucrose and drying, to give porous granules.
12Safety
Generally regarded as non-toxic. As it is mainly sucrose, it is cariogenic and should be used with care in products for diabetic patients.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid creating dust; eye protection is recommended.
14Regulatory status
Sucrose is GRAS listed. Compressible sugar is included in the FDA Inactive Ingredient Database (oral tablets and capsules) and in non-parenteral medicines licensed in Europe.
15Related substances
Sucrose; confectioner's sugar; sugar spheres; dextrates.
16Comments
Tablets made with compressible sugar can harden on storage, especially if exposed to moisture and then dried. A lubricant such as magnesium stearate is usually needed, because sugar-based blends tend to stick to punches.