Ensuring
active ingredients
work as intended
Success Story: Ensuring APIs work as intended
2023 | Aspirin, ibuprofen, or metformin, most people think of the active ingredient when they think of medicine. Yet up to 90% of a drug consists of inactive additives and excipients. And just as often, it’s these excipients that ensure the active molecule reaches its intended destination in the body.
Key Features
Far more than just excipients
Thanks to advances in data analysis, medicine, and analytical chemistry, there are more drug candidates today than ever before in human history. However, many of these potential active components lack the properties required to fully unfold their therapeutic effect as medicines. Only the combination with suitable excipients in an appropriate dosage form leads to the desired result.
Excipients improve solubility and absorption in the body, enable specific manufacturing processes, or modify taste. Their functions are as diverse as the materials themselves. Pharmaceutical excipients are subject to safety and quality regulations as stringent as those for active ingredients, making their development equally complex and time-consuming.
Polyglyceryl esters of fatty acids (PGFS) for the pharmaceutical industry – an Austrian-German co-development
The pharmaceutical application of PGFS is the result of years of joint research by the Research Center Pharmaceutical Engineering (RCPE) GmbH and the German company IOI Oleo GmbH. Although polyglyceryl esters have been approved for use in food since 1979 and are already employed in the cosmetics industry, they have so far played only a minor role as excipients in pharmaceuticals. That is about to change.
“As natural, well-tolerated substances, lipids are almost a logical choice for pharmaceuticals,” explains Priv.-Doz. Dr. Salar Bezhadi, Key Researcher at RCPE. “However, while their potential is undisputed, conventional lipid-based excipients show one major drawback: complex crystallinity and the resulting instability.”
One aspect of crystallinity is polymorphism, which refers to variations in crystalline configuration despite identical chemical composition, depending on conditions such as pressure or temperature. These polymorphic forms can differ—sometimes significantly—in their physicochemical properties.
The PGFAs developed at RCPE and synthesized by IOI Oleo in Witten, however, do not exhibit this behavior. “This gives both manufacturers and patients exactly what they need: absolute reliability,” says Dr. Thomas Rillmann of IOI Oleo.
An excipient is not just excipient
Modern commercial excipients are high-tech products. Depending on the application and process, their specific composition is adapted to achieve the best possible outcome. “In pharmaceuticals, there is no one-size-fits-all solution,” notes Priv.-Doz. Dr. Salar-Behzadi. “Whether spray drying, melt extrusion, or 3D printing—each process poses entirely individual demands on the materials.”
It’s a challenge that can only be mastered collaboratively. The continuous partnership between RCPE and IOI Oleo GmbH enables an interdisciplinary research team of pharmaceutical scientists, chemists, and process engineers based in Graz. The introduction of this new excipient class to a broader professional audience is currently in preparation.
RCPE
As a K1 Competence Center, RCPE remains a pioneer in pharmaceutical engineering, driving groundbreaking innovations and sustainable production practices with global relevance.
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Contact
Dr. Caroline Schober