Why excipients are the unsung heroes of modern medicine

They don’t treat disease. They rarely get a mention on a medicine label. Yet without them, most modern therapeutics simply wouldn’t work. Pharmaceutical excipients – the ingredients that help an active drug substance dissolve, stabilize, and reach patients safely – sit quietly behind nearly every tablet, injectable, and topical treatment on the market.

To understand why these “inactive” ingredients are anything but, Clariant sat down with Bhushan Thekedar, who leads global business development for Clariant’s Health Care business. With a background spanning chemical engineering and a PhD in physics, Bhushan has spent his career at the intersection of science and international business – translating complex formulation challenges into practical solutions for customers around the world.

In the following conversation, Bhushan shares what excipients really do, why quality conversations have changed dramatically in recent years, and what’s next for Clariant’s VitiPure™ and Motusflex™ platforms.

Hello, Bhushan. For someone who’s never heard the word “excipient,” how would you explain what it does?

Bhushan Thekedar: An excipient does not usually treat the disease itself, but it helps make the treatment manufacturable and usable. A poorly soluble API, for instance, might be highly potent in principle, but without a solubilizer to help it dissolve in the body, its potential is difficult to realize. Excipients are often called inactive ingredients, but pharmacologically inactive doesn’t mean functionally unimportant.

Tell us about VitiPure, Clariant’s Health Care excipients range – where did the name and concept come from?

VitiPure represents vitality through purity – purposeful purity. A generic purity number like 99.9% can hide more than it reveals – what matters is which impurities remain and how consistently they’re controlled. Our platform spans three levels: VitiPure for standard pharmacopoeia-grade needs, VitiPure Lex for low-endotoxin applications like injectables and vaccines, and VitiPure Superior for the most sensitive, stability-critical formulations. The goal is helping customers to choose the excipient for the right application with the right price – avoiding overpaying for quality a formulation doesn’t need.

If VitiPure were a crew member on a film set, what role would it play and why?

I’d say VitiPure is the director. Most people never think about the director’s contribution while they’re watching a film – but if it’s inconsistent or poorly balanced, the entire experience suffers, no matter how strong the acting is. VitiPure plays a similar behind-the-scenes role in medicine: the API remains the star of the show, but the excipient creates the environment that allows the API to perform reliably, consistently, and without interference.

You’ve been in this industry long enough to see the conversation shift. What’s changed?

Discussions used to center on three questions: does it meet spec, is it available, and what does it cost. Those questions remain important even today… but they are not the end. Now, formulators, QA teams, and even procurement departments are asking about peroxides, elemental impurities, endotoxins, nitrosamine risk, extractables and leachable, and batch-to-batch variability – questions which never used to get asked in the past. The key shift is moving from, “Does this product meet the monograph?”, to “Is this product sufficiently understood and controlled for my particular application?”

Where do you see excipients heading next; and is Clariant ready for what’s coming?

I see four shifts that are already underway: Application-specific excipient design for biologics and advanced drug delivery. A move from aggregate purity claims to deeper impurity characterization. Earlier collaboration between suppliers and formulators before formulations are locked in. And – especially post-COVID – a heightened focus on supply chain resilience. A technically excellent ingredient has limited value if it is unavailable when required. Clariant’s combination of established chemistry, global manufacturing, and differentiated platforms like VitiPure and Motusflex positions us well – but no company can stand still.

What’s your message to formulators evaluating excipient options today?

Bring us the formulation problem, not only the product name. I encourage customers to describe what they’re observing – poor solubility, oxidation, discoloration, settling – rather than starting from a spec sheet. In addition: Do not select an excipient only because it meets the monograph. Select it because you understand how it fits your medicine. That is where the good formulation begins and very often where the avoidable problems end.

An excipient’s greatest achievement is invisibility – when it performs perfectly, nobody talks about it. But behind every “boring” batch that arrives on time and behaves exactly as expected is a patient who depends on that consistency, whether they know it or not. It’s a reminder that in pharma, reliability isn’t the opposite of innovation – it’s the foundation that makes innovation deliverable at scale.

See the full blog post on Why excipients are the unsung heroes of modern medicine here

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Source: Clariant Health Care, blog post Why excipients are the unsung heroes of modern medicine

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