Sugar Spheres

Product Description

Sugar Sphere ◆ Brief definition: Drug loaded pellets can be classified by their method of release into sustained-release, controlled-release pellets. The matrix of the drug pellet is sugar spheres. Sugar spheres are drug-free cores which are coated by a suspension or a solution of Active Ingredients. We are the first one and only one who get the "Official Production License" in China. As 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. Sugar spheres are inert pellets composed by sucrose and starch, which offer an excellent quality: a homogeneous population of sugar spheres with a high sphericity. We are the first one and only one who get the "Official Production License" for sugar sphere in China. The main advantage of using sugar spheres is to produce pellets with a uniformity of drug content in the final dosage form (capsules). ◆Characteristics:  Appearance: White or kind of white near circular pellets.  Density: Can be adjusted as per the product’s characteristics  Standard: Conform to USP/NF ◆Chemical specifications Loss on drying 4.*0 % Sulphated ash 0.*0 % Heavy metals 5 ppm  Starch content < *2 % Specific rotation < **1° ***** Absent ◆Physical properties True density * 1.**0 – 1.**0 g/cm3 (vary with the particle size) Surface area (BET) * > 0.**0 m²/g Carr index < *0 % Flow time < *0 s for **0 g ◆Microbiological specifications Total aerobic bacteria count **0/g Salmonella Absent/1g Escherichia coli Absent/1g Moulds **0/g ◆ Size Specifications Product ID Granule-diameter (µm) P1 ******0 P2 ******0 P3 ******0 P4 ******0 P5 *******0 ◆General information Packaging: *5 kg cardboard drums, tightly closed, with two polyethylene liners. Storage conditions: in original sealed drums, protected from humidity, at a temperature between *5°C to *0°C. Shelf life: 3 years guaranteed. Samples kept for 5 years and records available for 6 years. Certificate of analysis and Material Safety Data Sheet attached to each delivery.