Glossary

Technical definitions for pharmaceutical inert cores, starter pellets, drug layering, particle characteristics and regulatory documentation

Active Pharmaceutical Ingredient (API): the component of a pharmaceutical product intended to provide pharmacological activity or another direct therapeutic effect. SURINERTS® supplies pharmaceutical inert cores and excipients and does not perform API drug layering activities on customer products.
Analytical and Microbiological Quality Control: testing activities used to evaluate chemical, physical and microbiological product characteristics against defined specifications. SURINERTS® performs analytical and microbiological quality controls throughout manufacturing. Analytical tests are carried out both by an internal Analytical Laboratory and by external validated laboratories.
Batch-to-Batch Reproducibility: the ability to maintain consistent product characteristics from one manufacturing batch to another. Controlled particle size, physical characteristics and manufacturing conditions support reproducible behaviour during subsequent pharmaceutical processing.
Certificate of Analysis (CoA): a document reporting analytical results for a specific product batch and demonstrating the batch results against the applicable specifications. SURINERTS® product batches are released with a Certificate of Analysis reporting chemical and microbiological results. Certificates of Analysis are issued by Quality Control and approved by Quality Assurance.
Controlled Release: a modified-release approach in which the formulation is designed to control the release of an API over time according to specific formulation requirements. SURINERTS® Sugar Spheres are used as inert cores in controlled-release pharmaceutical formulations.
Current Good Manufacturing Practices (cGMP):
the term used particularly in the United States to emphasize compliance with current Good Manufacturing Practice requirements and up-to-date manufacturing and quality systems.
Drug Layering: a pharmaceutical process in which an Active Pharmaceutical Ingredient is deposited onto the surface of a starter pellet or inert core. SURINERTS® supplies the cores used as substrates for subsequent drug layering but does not perform API drug layering on customer products.
Drug Master File (DMF): a confidential submission to the U.S. Food and Drug Administration containing detailed information about facilities, processes or materials used in pharmaceutical manufacturing. A DMF can support pharmaceutical regulatory submissions and is not, by itself, an FDA approval of a product.
European Pharmacopoeia (Ph. Eur. / EP): the official reference for quality standards for medicines and pharmaceutical ingredients in its signatory states. SURINERTS® products are declared compliant with current European Pharmacopoeia editions.
Extended Release / Prolonged Release: terms used for modified-release dosage forms designed to make the API available over an extended period compared with a conventional immediate-release formulation. “Extended release” is commonly used in the United States, while “prolonged release” is widely used in European regulatory terminology.
Flowability: the ability of particulate material to flow under defined handling or processing conditions. In pharmaceutical manufacturing, flowability can influence material transfer, processing behaviour and production consistency.
Fluid Bed Processing: a pharmaceutical processing technique in which particles are suspended and moved by an upward stream of air while operations such as layering, coating or drying are performed. SURINERTS® inert cores are designed with low friability and suitable mechanical characteristics to withstand fluid bed processing.
Formulation Compatibility: the technical evaluation of whether the characteristics of an inert core are appropriate for the requirements of a specific pharmaceutical formulation and manufacturing process. This evaluation may consider particle size distribution, sphericity, flowability, mechanical resistance and suitability for subsequent drug layering or functional coating. It does not imply universal compatibility with every API.
Friability: the tendency of a particle or pellet to abrade, fragment or break when subjected to mechanical stress. Low friability helps maintain particle integrity during handling, transportation and manufacturing. SURINERTS® Sugar Spheres and 100% Tartaric Acid Pellets have a specified friability of less than 1.0%.
Functional Coating: a coating applied to a pharmaceutical pellet to provide a defined function within the final formulation. Core characteristics such as particle size, surface properties and mechanical resistance may be evaluated according to the requirements of subsequent functional coating processes.
Functional Core: a pharmaceutical starter core that provides a specific formulation-related function in addition to serving as a physical substrate for subsequent processing. Tartaric acid cores are an example because they can provide localized acidification within the formulation.
Good Manufacturing Practices (GMP): a system of manufacturing and quality principles intended to ensure that pharmaceutical products and materials are consistently produced and controlled according to appropriate quality standards.
Localized Acidification: the creation of an acidic micro-environment within or around a pharmaceutical pellet. SURINERTS® Tartaric Acid Pellets are designed to provide localized acidification to support the dissolution of poorly soluble basic APIs.
Mechanical Strength: the ability of a pellet or inert core to resist mechanical stresses encountered during handling and pharmaceutical processing. Adequate mechanical strength helps minimize particle breakage during manufacturing operations.
Mesh Size: a sieve-based designation used to classify particles according to their size. In pharmaceutical pellet specifications, mesh ranges correspond to defined particle-size intervals expressed in micrometres (µm).
Modified Release: a pharmaceutical release approach in which the rate, timing and/or location of API release is intentionally different from that of a conventional immediate-release dosage form. Modified-release formulations may include extended, prolonged or delayed release systems.
Multiparticulate Drug Delivery System: a pharmaceutical dosage system composed of multiple small individual units, such as pellets or beads, rather than a single unit. Individual pellets may contain layered API and functional coatings and can subsequently be incorporated into pharmaceutical dosage forms.
Nonpareil: in pharmaceutical pellet technology, a term commonly used for spherical starter cores, particularly sugar-based cores used as substrates for subsequent layering processes. SURINERTS® Sugar Spheres are identified as nonpareils / starter pellets.
Particle Size: the physical dimension of an individual particle or pellet. Particle size is an important parameter in pharmaceutical pellet processing because it can influence subsequent layering, coating and manufacturing operations.
Particle Size Distribution (PSD): the distribution of particle sizes within a batch of material. A controlled PSD helps ensure uniformity and reproducibility during pharmaceutical manufacturing. For available SURINERTS® Tartaric Acid Pellet sizes, IPS guarantees a PSD ≥ 90%.
Pharmaceutical Excipient: a substance other than the Active Pharmaceutical Ingredient that is used in the manufacture of a pharmaceutical product or drug delivery system. Excipients may support manufacturing, stability, product performance or other characteristics of the final formulation.
Pharmaceutical Inert Core: a solid pharmaceutical core used as a substrate for subsequent formulation processes such as drug layering and coating. Important characteristics include particle size, sphericity, surface uniformity, mechanical strength and friability. SURINERTS® inert core solutions include Sugar Spheres and 100% Tartaric Acid Pellets.
Quality Assurance (QA): the overall quality system designed to provide confidence that manufacturing and quality activities are performed according to established requirements. SURINERTS® Certificates of Analysis are approved by Quality Assurance after Quality Control activities.
Quality Control (QC): the operational activities used to verify that materials and products meet defined quality specifications through testing and evaluation. SURINERTS® Certificates of Analysis are issued by Quality Control following analytical and microbiological testing.
Regulatory Data Sheet: a product-specific document providing regulatory information relevant to the qualification and use of a pharmaceutical material. Regulatory Data Sheets are available for SURINERTS® Sugar Spheres and 100% Tartaric Acid Pellets.
Solid Oral Dosage Form: a pharmaceutical dosage form intended for oral administration in solid form. SURINERTS® inert cores are designed for applications involving solid oral pharmaceutical formulations and advanced oral dosage forms.
Sphericity: the degree to which a particle approaches a spherical shape. High sphericity is an important characteristic of pharmaceutical starter pellets because it supports uniform drug layering and coating and contributes to consistent processing.
Starter Pellet / Starter Core: a pre-manufactured pharmaceutical pellet or core used as the starting substrate for building a layered pellet formulation. An API-containing layer and, when required, additional functional coatings can subsequently be applied to the starter core.
Sugar Sphere: a spherical pharmaceutical starter core primarily composed of sucrose and starch. SURINERTS® Sugar Spheres are inert microgranules manufactured using pharmaceutical-grade sucrose and maize starch and are used as cores in solid oral pharmaceutical formulations.
Surface Roughness: the microscopic irregularity of a particle surface. Surface roughness is relevant to pharmaceutical pellet processing because surface characteristics can influence the application and uniformity of subsequent drug layers and coatings.
Surface Uniformity: the consistency of the external surface of a pharmaceutical pellet. A uniform surface supports homogeneous drug layering and coating. SURINERTS® cores are designed with controlled surface characteristics and without unwanted porosity, cracks or holes.
Sustained Release: a formulation approach designed to release an API over a longer period than a conventional immediate-release formulation. SURINERTS® Sugar Spheres can be used as inert cores in sustained-release solid oral formulations.
Tartaric Acid Pellet: a pharmaceutical pellet composed of tartaric acid and used as a core in pharmaceutical formulations. SURINERTS® 100% Tartaric Acid Pellets are designed to support dissolution enhancement of poorly soluble basic APIs through localized acidification and are suitable for multiparticulate systems requiring acidic micro-environment control.
Type IV Drug Master File: an FDA Drug Master File category used for information concerning an excipient, colorant, flavour, essence or materials used in their preparation. SURINERTS® Sugar Spheres are supported by DMF No. 32181 – Active IV, while SURINERTS® 100% Tartaric Acid Pellets are supported by DMF No. 32545 – Active IV.
United States Pharmacopeia (USP): a compendium containing official quality standards for pharmaceutical substances, drug products and excipients in the United States. SURINERTS® products are declared compliant with current USP editions.

Explore IPS Certifications:

Explore SURINERTS® Products:

Sugar Spheres

Inert starter cores for drug layering and modified-release formulations

Tartaric Acid Pellets

Functional pellets for pharmaceutical formulations

Ask for information

If you need more information on the products, fill out the form below.

Product / Theme

Name

Company

Country

Request

I declare that I have read and accepted the Privacy Policy

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.

Products

Legal menu

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

Glossary

ISO Certificate 9001:2015

ISO Certificate 14001:2015

Halal - EIA