Seeing inside medicines
How uncovering the microstructure of inhaled therapies is leading to an exciting new commercial venture jointly with the University of Manchester, and a faster path to drug development.
Respiratory disease remains one of the world’s most pressing long-term health challenges. With over 339 million people affected by asthma, and chronic respiratory illnesses poised to become the third leading cause of death by 2030, the need for effective, affordable, and scalable treatments is growing rapidly.
Daily inhaled therapies are the cornerstone of care. For patients, especially in low-income health systems, access to affordable alternatives can be life-changing. Generic drugs offer that potential: lower-cost versions of branded medicines, designed to match their efficacy and safety.
But when it comes to inhalers, proving that generics truly measure up is far from straightforward.
The equivalence equation
To bring a generic inhaled therapy to market, pharmaceutical companies must prove bioequivalence – that their drug delivers the same dose of the active ingredient to the lungs as the original medicine, with the same clinical effect. While this process is well established for tablets, inhalers pose a much greater scientific challenge.
“Inhalers are incredibly complex,” explains Darragh Murnane, Professor of Pharmaceutics at the University of Hertfordshire. “The particle size, how those particles are blended, how they behave when the patient breathes them in – all of this is dictated by the medicine’s microstructure. But until recently, we’ve been flying blind. We couldn’t see inside these products in any meaningful way.”
This lack of visibility has consequences. The average generic drug costs around $25 million to develop. A generic inhaler can cost over four times that – up to $100 million – largely due to lengthy and expensive clinical trials to demonstrate bioequivalence. Fewer generics reach the market, fewer patients benefit, and healthcare systems bear the financial burden.
Decoding medicine microstructures
Professor Murnane’s mission to “see inside medicines” began in 2016 with the £1.9m EPSRC-funded INFORM 2020 project. Over several years, his team explored the microstructure of dry powder inhalers – how particles smaller than five microns interact, agglomerate, and influence drug delivery. Their aim was to understand not just what medicines contain, but how internal architecture shapes performance.
At the heart of the challenge was a problem of scale. “These particles are smaller than the width of a human hair, yet they hold the key to drug delivery,” says Professor Murnane. “We needed new ways of imaging, analysing, and ultimately understanding them.”
The breakthrough came with the adaptation of X-ray computed micro-tomography (microCT), a technique traditionally used in engineering, to image pharmaceutical powders in three dimensions without disturbing their structure.
This allowed the team, working with collaborator Philip Withers, Professor of Materials Science at the University of Manchester, to characterise the elusive microstructures of the powders, providing unique insight into formulation performance and addressing a key technical gap identified by the US Food and Drug Administration (FDA).
From lab to impact: the founding of InformiX Pharma
That foundational research led to the creation of spinout company InformiX Pharma, co-founded by Professor Murnane and Dr Parmesh Gajjar, an X-ray imaging scientist and Visiting Researcher at the University of Manchester.
By seeing inside medicines in 3D, we can begin to create digital twins – virtual models that mirror both the product and its manufacturing process. We can visualise individual particles in raw materials, map how the drug is distributed throughout a blend, and detect structural failures. This level of insight helps us accelerate product development.
Professor Darragh Murnane,
Professor of Pharmaceutics
The FDA has already recognised InformiX’s techniques as a potential solution to the global challenge of in vitro equivalence testing. To scale its offering, InformiX Pharma drew on support from the University of Hertfordshire’s Healthcare Technologies Capability Connector (HTCC), part of a Research England-funded initiative supporting innovation and commercialisation in health tech. With HTCC support, the company launched a commercial testing service for the pharmaceutical industry.
“You wouldn’t build a house without a structural plan,” says Professor Murnane. “We shouldn’t be building medicines that way either. By understanding the internal architecture of a medicine from the outset, we can design it with manufacturability in mind – avoiding costly redesigns later and accelerating the journey from discovery to delivery.”
Professor Murnane
Professor of Pharmaceutics
I am a pharmaceutical technologist with a particular interest in drug delivery to the airways including the lung, nose and the mouth-throat cavities. My academic interests lie in using chemical engineering, physical and analytical chemistry to understand the link between patient physiology and drug targetting. This extends to developing formulation analysis tools to aid identification of medicines and formulation performance.
The focus of my research in recent years has been in achieving improvments in specificity of localised respiratory and topical drug delivery. This has extended to investigations into patient use of inhaled therapies and has led to a number of collaborations with clinicians and pharmaceutical companies in the last 5 years on PhD and post-doctoral projects as well as collaborative commercially-funded research.