Brief Introduction:
Drug loaded pellets can be classified by their method of release into sustained-release and controlled-release pellets. The matrix of the drug pellet is a sugar sphere.
Sugar spheres are, therefore, drug-free cores which are coated by a suspension or a solution of active ingredients. As a critical pharmaceutical adjuvant for controlled or sustained release drug delivery technologies, sugar spheres can be used as cores for the manufacture of sustained & controlled-release pellets for both western and Chinese traditional medicines.
Physical properties:
Character: white or off-white, almost circular pellets.
Particle Sizes: 0.355 - 1.40 mm
Specifications: Conforms to standard CP2005
|
Test |
CP2005 |
|
Specific Rotation |
≥+41° |
|
Identification |
Conforms |
|
Loss on Drying % |
≤4.0 |
|
Residue on Ignition % |
≤0.25 |
|
Heavy Metals (ppm) |
≤5 |
|
Microbial Limits |
---- |
|
Total Microbial Count (CFU/g) |
≤1000 |
|
Total Mold and Yeast (CFU/g) |
≤100 |
|
Escherichia coli |
Negative |
Application:
Sugar spheres are inert pellets composed of sucrose and starch, which offer excellent quality, comprising a homogeneous population of sugar spheres with high sphericity. The main advantage of using sugar spheres is to produce pellets with uniformity of drug content in the final dosage form (capsules).
Sugar spheres can also be used for candy products.
Storage:
The product should be stored in closed containers in cool, dry conditions.
