Фармацевтическая Пелле

Pharmaceutical pelletBrief 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 Celphere.Celphere are drug-free starter cores which are coated by a suspension or a solution of Active Ingredients. We are the first one and only one whoacquired the "Official Production License" in China.As critical pharmaceutical adjuvant for controlled or sustained release drug delivery technologies, Celpherecan be used as cores for the manufacture of sustained & controlled-release pellets for both western and Chinese traditional medicines.Celphere are inert pellets composed by sucrose and starch, which offer an excellent quality: a homogeneous population ofCelphere with a high sphericity. We are the first one and only one who get the "Official Production License" forCelphere in China. The main advantage of using Celphereis to produce pellets with a uniformity of drug content in the final dosage form (capsules).Characteristics: l Appearance: White or kind of white near circular pellets. l Density: Can be adjusted as per the product’s characteristics l Standard: Conform to USP/NF Chemical specificationsLoss on drying< 4.00 %Sulphated ash £ 0.20 %Heavy metals £ 5 ppmStarch content < 92 %Specific rotation < +61°O.V.I. AbsentPhysical propertiesTrue density * 1.550 – 1.590 g/cm3 (vary with the particle size)Surface area (BET) * > 0.100 m²/gCarr index < 10 %Flow time < 10 s for 100 gMicrobiological specificationsTotal aerobic bacteria count <100/gSalmonella Absent/1gEscherichia coli Absent/1gMoulds <100/g Size Specifications Product ID Granule-diameter (µm) P1 300-500 P2 500-710 P3 600-800 P4 700-900 P5 900-1120 General informationPackaging: 25 kg cardboard drums, tightly closed, with two polyethylene liners.Storage conditions: in original sealed drums, protected from humidity, at a temperature between 15°C to 30°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.