SUGAR SPHERES
Inert microgranules made of pharmaceutical grade sucrose and corn starch
Application
Pharmaceutical companies use Surinerts as cores in sustained and controlled release formulations in solid-oral dosage forms.
Project Design
- Surface: roughness and sphericity to ensure uniform application; no porosity, cracks or holes;
- Reproducibility: Reliable and reproducible uniformity for batch-to-batch consistency;
- Different Particle sizes: for different pharmaceutical dosages;
- Minimum humidity content;
- Low friability and hardness to withstand fluid bed processing;
Product Specifications
SURINERTS – SUGAR SPHERES
Sugar Spheres are neutral pellets for pharmaceutical use
Drug Master File N.: 32181 – Active IV
Composition: sucrose (C12, H22, O11) 62.5-92.0% , corn starch (C6,H10,O5)n 37.5-8.0%
Size: Available in standard and special sizes (from 300 µm to 1700 µm / 50#-12#). Other sizes can be customized.
IPS guarantees, for any available size PSD ≥ 90 %
Friability < 1.0%
Stability: 5 years stored in monitored conditions
Available Sizes
Quality
Quality is our main concern. Surinerts® products are fully in compliance with: USP and EP current editions. Certificates of Analysis are issued by our Quality Control and approved by our Quality Assurance.
We are able to guarantee high quality standards thanks to our severe quality controls, both analytical and microbiological, performed during the entire production process.
In-process controls are performed throughout all manufacturing steps. All the analytical tests are carried out both by an internal Analytical Laboratory and by external validated laboratories.
Technical Documentation
Our pellets have been registered by FDA. Surinerts Sugar Spheres DMF has been filed with number: 32181.
All product batches are released with a Certificate of Analysis reporting all the Chemical and Microbiological results.
A complete Regulatory Data Sheet is available for Surinerts Sugar Spheres