DFE Pharma Norten Hardenberg, Germany

The new ‘Closer to the Formulator’ (C2F) center offers DFE Pharma’s excipient expertise to help pharmaceutical companies achieve ‘first-time right’ formulations

DFE Pharma is a global leader in excipient products and services for usage in the pharmaceutical, biopharmaceutical, and nutraceutical industries. We strive to develop, produce and supply the highest quality functional excipients for oral solid dose, inhalation, and parenteral formulations. Our products play essential roles as fillers, binders, disintegrants, and stabilizing agents in formulations. 

They enable the active ingredients to be dosed and released into the patients' system in a predictable, accurate, and effective manner. With over a century of experience, we are driven by our purpose your medicines, our solutions. Moving to a healthier world. 

DFE Pharma is proud to announce that we have been awarded a Gold Medal by EcoVadis for our sustainability achievements. This prestigious recognition places us in the top 5% of companies globally, highlighting our commitment to environmental and social responsibility.

Assessing nitrosamines in drug products has become one of the top challenges for formulators in the pharmaceutical industry.

During drug product risk evaluation, excipients play a crucial role. Although the risk of nitrosamine presence is low, some excipients contain trace amounts of nitrites. Under specific conditions, these traces can lead to nitrosamine formation within the drug product.

Different studies reveal varying nitrite levels among different excipients and even within the same type from different suppliers. Comparing excipient types and suppliers is essential for risk mitigation during production.

Excipients are a crucial component of the pharmaceutical product formulation, and the industry is constantly having to adapt to changes in demand and technology innovations

As pharmaceutical production moves from batch-wise to continuous manufacturing, individual processing steps, such as blending of the active pharmaceutical ingredient (API) with excipients, have to be re-designed to continuous operations.

Whilst the cost and quality benefits of CM are well documented, successful implementation relies on an in-depth understanding of how raw materials and their mixtures – including excipients – behave in continuous processes. This whitepaper will outline some of the key learnings from DFE Pharma’s excipients in CM processes variability experiments, before setting out DFE Pharma’s Stretch Batch Approach and how it can work in practice.
Ultimately, it will demonstrate why DFE Pharma is fast becoming the pharma industry’s preferred global partner in the robust development of continuous tablet manufacturing processes.