Pharmaceutical Sugar Spheres
Inert microgranules made of pharmaceutical grade sucrose and corn starch
- Drug Master File No.: 32181 – Active IV
Application
Pharmaceutical companies use SURINERTS® Sugar Spheres as pharmaceutical starter pellets and inert cores in sustained and controlled release formulations in solid oral dosage forms.
Project Design
- Surface: Roughness and sphericity to ensure uniform drug layering and coating; no porosity, cracks or holes
- Reproducibility: Reliable and reproducible uniformity for batch-to-batch consistency
- Different Particle sizes: to support different pharmaceutical formulation and processing requirements
- Minimum Humidity Content
- Low friability and hardness to withstand fluid bed processing;
Product Specifications
SURINERTS® Sugar Spheres are neutral inert pellets manufactured for pharmaceutical use, ensuring consistent performance and high process reliability.
Manufactured using pharmaceutical-grade sucrose and maize starch under controlled production conditions.
Available in standard and special sizes (from 300 µm to 1700 µm). Other sizes can be customized.
< 1.0%
5 years stored in monitored conditions
Available Sizes
A wide range of standard and special particle sizes is available to ensure uniformity and meet different pharmaceutical formulation and drug layering requirements.
| Standard Size | MESH | Size |
|---|---|---|
| #14 | 1180 – 1700 µm | |
| #16 | 1000 – 1400 µm | |
| #18 | 850 – 1180 µm | |
| #20 | 710 – 1000 µm | |
| #25 | 600 – 850 µm | |
| #30 | 500 – 710 µm | |
| Standard Sizes on request | #40 | 355 – 500 µm |
| #45 | 300 – 425 µm | |
| Special Sizes | #12/14 | 1400 – 1700 µm |
| #14/16 | 1180 – 1400 µm | |
| #16/18 | 1000 – 1180 µm | |
| #18/20 | 850 – 1000 µm | |
| #20/25 | 710 – 850 µm | |
| #25/30 | 600 – 710 µm | |
| #30/35 | 500 – 600 µm | |
| Special Sizes on request | #35/40 | 425 – 500 µm |
| #40/45 | 355 – 425 µm |
Quality
GlossaryQuality is our main concern. SURINERTS® products are fully compliant with current USP and EP 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 stringent quality controls, both analytical and microbiological, performed throughout the entire production process.
In-process controls are performed at all manufacturing steps. All analytical tests are carried out both by an internal Analytical Laboratory and by external validated laboratories.
Technical Documentation
SURINERTS® Sugar Spheres are supported by an FDA Drug Master File (DMF No. 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.
FDA Drug Master File available to support regulatory submissions:
FDA Drug Master File
Sugar Spheres · DMF No. 32181 · Type IV · Active
Technical Data
Press to download technical data sheet
Ask for information
If you need more information on the products, fill out the form below.
SURINERTS® is the pharmaceutical division of IPS , specialized in pharmaceutical-grade Sugar Spheres and Tartaric Acid Pellets. Our inert cores support drug layering, functional coating and multiparticulate oral dosage forms. Quality, regulatory support and reliable industrial supply for pharmaceutical manufacturers.
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Contacts
Headquarters
Via Civesio, 6
20097 San Donato Milanese (MI) – Italy
Manufacturing plant
Via Tirso, 7/11
20098 San Giuliano Milanese (MI) – Italy
E- Mail
info@surinerts.it
Phone and Fax
+39 02.9880416