SURINERTS® SUGAR SPHERES
SURINERTS® SUGAR SPHERES are inert microgranules made of Pharmaceutical Grade sucrose and corn starch. They are intended to be used by Pharmaceutical Companies, as cores in sustained and controlled release formulations in solid-oral dosage forms.
Being SURINERTS® critical excipients they should guarantee first –rate features; as a matter of fact, IPS SURINERTS® can guarantee:
• Perfect sphericity
• Accurate size uniformity
• Smooth surface (no holes , porosity or cracks)
• Minimum humidity content
• Low friability
• Total compliance with USP, EP, BP and JP
IPS has set up a proper advanced production method which guarantees no fine powder in the finished sugar spheres products. This method is called “Dust Free”, and the D.F. letters are reported in the CoA of Sugar Spheres.
IPS SURINERTS® SPHERES are manufactured in compliance with Good Manufacturing Practices for Bulk Pharmaceutical Excipients.
IPS has 59 rotating pans and two rooms in which modern automatized sieves are working, together with many other semi-automatic sieves.
The Plant has been designed for a continuous production on 2/3 daily shifts, 6 days per week. Shut down periods are scheduled in August (2 weeks) and during New Year shut down (1 week). During this time a periodically maintenance of the equipment is performed.
Total capacity for Spheres is of about 450 Mtons/year.
Thanks to the innovative systems applied in our new production facilities (separation of production premises and sieving areas, different air pressure in production areas and corridors are designed to avoid any possible cross contamination) IPS can manufacture different kind of pellets and spheres (not only sugar spheres, but Tartaric Acid pellets as well).
Surinerts® are supplied with very homogeneous parameters and narrower specification’s limits than the ones reported in the official Pharmacopoeia.
Certificate of Analysis
IPS has obtained the Drug Master files # 32181 for Sugar Spheres.