FAQ

Frequently asked questions about SURINERTS® pharmaceutical inert cores, Sugar Spheres, Tartaric Acid Pellets, applications, technical specifications, quality and development support

SURINERTS® and Products

SURINERTS® develops and manufactures pharmaceutical inert cores and pellets for pharmaceutical companies and CDMOs, supporting projects intended for regulated pharmaceutical markets.

In the SURINERTS® context, pharmaceutical inert cores are cores used as a base in oral pharmaceutical formulations. Their physical characteristics, including sphericity, surface uniformity, particle size and mechanical strength, are important for subsequent drug layering and coating processes.

SURINERTS® Sugar Spheres are also identified as nonpareils / starter pellets. They are inert cores used as a base in pharmaceutical formulations and for subsequent drug layering and coating processes.

SURINERTS® Sugar Spheres are inert microgranules manufactured from pharmaceutical-grade sucrose and maize starch under controlled production conditions.

Sugar Spheres are used as inert cores and starter pellets in solid oral pharmaceutical formulations, providing a substrate for subsequent drug layering and functional coating processes, including sustained and controlled-release formulations.

SURINERTS® 100% Tartaric Acid Pellets are inert cores for pharmaceutical use, composed of 100% tartaric acid and manufactured according to Good Manufacturing Practices for bulk pharmaceutical excipients.

Tartaric Acid Pellets are designed to support dissolution enhancement of poorly soluble basic APIs through localized acidification. They are also suitable for multiparticulate drug delivery systems requiring acidic micro-environment control.

Sugar Spheres are neutral inert cores composed of pharmaceutical-grade sucrose and maize starch, while Tartaric Acid Pellets are composed of 100% tartaric acid and can also provide a localized acidifying function within the formulation. The most suitable core depends on the formulation, API characteristics, particle size requirements and manufacturing process. SURINERTS® can support the technical evaluation of the most appropriate standard, special or customized solution.

Drug Layering and Core Characteristics

Yes. Suitability for subsequent drug layering and functional coating processes is considered during core selection, together with parameters such as particle size distribution, sphericity, flowability and mechanical resistance.

No. SURINERTS® supplies inert cores and excipients only and does not perform API drug layering activities on customer products.

High sphericity and surface uniformity support efficient coating processes, homogeneous drug layering and consistent product performance. Surface characteristics are also controlled to avoid porosity, cracks and holes.

These characteristics help minimize particle breakage during handling, transportation and high-shear manufacturing processes. SURINERTS® products are also designed to withstand fluid bed processing.

Both SURINERTS® Sugar Spheres and 100% Tartaric Acid Pellets have a specified friability of less than 1.0%.
Yes. SURINERTS® inert cores can be used as starter cores in multiparticulate oral dosage forms involving drug layering and functional coating. The selection of the most appropriate core depends on the formulation, particle size and manufacturing process requirements.
Yes. SURINERTS® inert cores are designed to provide the sphericity, surface uniformity and mechanical resistance required for subsequent drug layering and coating processes, including fluid-bed processing. Core selection should also consider particle size distribution, flowability and the specific formulation requirements.

Particle Size, Mesh and Customization

SURINERTS® Sugar Spheres are available in standard and special sizes ranging from 300 µm to 1700 µm, with different mesh ranges available.

SURINERTS® Tartaric Acid Pellets are available in standard and special sizes ranging from 300 µm to 1000 µm.

Yes. The SURINERTS® portfolio includes standard, special and customized solutions. When standard products do not fully meet project requirements, the feasibility of a customized solution can be evaluated.

Selection is based on the required mesh size, application requirements and manufacturing process. Technical evaluation may include particle size distribution, sphericity, flowability, mechanical resistance and suitability for subsequent drug layering or functional coating processes.

For the available Tartaric Acid Pellet sizes, IPS guarantees a PSD ≥ 90%.

Stability, Quality and Regulatory Documentation

SURINERTS® Sugar Spheres have a declared stability of 5 years when stored under monitored conditions. SURINERTS® Tartaric Acid Pellets have a declared stability of 3 years under monitored conditions.

Yes. SURINERTS® products are compliant with current USP and Ph. Eur. editions.

Yes. SURINERTS® Sugar Spheres are supported by Drug Master File No. 32181 – Active Type IV, while SURINERTS® 100% Tartaric Acid Pellets are supported by Drug Master File No. 32545 – Active Type IV. These Drug Master Files are available to support regulatory submissions involving the corresponding SURINERTS® excipients.

Each released product batch is supplied with a Certificate of Analysis reporting chemical and microbiological results. Regulatory Data Sheets are also available for SURINERTS® Sugar Spheres and 100% Tartaric Acid Pellets, together with relevant technical documentation and Drug Master File information to support supplier qualification and regulatory assessment.

Analytical and microbiological quality controls are carried out throughout the manufacturing process. Analytical testing is performed both by the internal Analytical Laboratory and by external validated laboratories. Certificates of Analysis are issued by Quality Control and approved by Quality Assurance.

SURINERTS® products are manufactured at the IPS production facility in San Giuliano Milanese, Italy. Manufacturing is carried out under controlled production and quality processes, with analytical and microbiological controls performed throughout the manufacturing process.

Development and Industrial Supply

Yes. The development process may include technical and regulatory assessment, particle size and mesh selection, formulation compatibility evaluation, identification of the most appropriate standard, special or customized solution, and feasibility assessment for customized production when required.

Yes. SURINERTS® supports pharmaceutical manufacturers from initial material selection through to routine industrial supply, with consistent product specifications, batch traceability and appropriate quality documentation.

Yes. SURINERTS® supplies pharmaceutical manufacturers and CDMOs in international markets, supporting projects from initial material selection and development through to routine industrial supply.

Explore IPS Certifications:

ISO Certificate 9001:2015

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ISO Certificate 14001:2015

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Halal - EIA

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Explore SURINERTS® Products:

Sugar Spheres

Inert starter cores for drug layering and modified-release formulations

Tartaric Acid Pellets

Functional pellets for pharmaceutical formulations

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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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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

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