Dr. Jason Teckoe, technical director, Colorcon delves into evolving ingredient regulations and the future of digital technologies.
Colorcon
FILM COATINGS - 1
The pharmaceutical industry is at a crossroads, facing both regulatory changes and rapid technological advancement. Colour ingredients, long used in oral solid dosage forms for functionality and patient appeal, are under increasing regulatory scrutiny. At the same time, artificial intelligence (AI) is emerging as a tool to accelerate formulation design, process optimisation and regulatory compliance.
There has been significant discussion around the regulation of colour ingredients. How is this shaping industry priorities?
Over the past few years, we’ve seen heightened attention on excipients like titanium dioxide (TiO₂), which sparked debates across Europe about safety, labelling and patient perception. While the most recent rulings have reaffirmed TiO₂’s continued use in medicines, the discussion has highlighted the importance of transparency and science-based evaluation.
For industry, this means being proactive. Companies must monitor regulatory developments closely, validate excipients against evolving standards, and—importantly—communicate clearly to patients and healthcare professionals about why these ingredients are used. It’s not just about compliance; it’s about trust.
Beyond compliance, what role do colour ingredients continue to play in formulation?
Colours in pharmaceutical coatings are not just aesthetic. They help with product identification, reduce medication errors and enhance patient adherence by making medicines easier to recognise and swallow.
What we’re seeing now is a stronger demand for “clean label” solutions, inspired by the nutritional sector, as well as a push toward alternative opacifiers or natural pigments. The challenge is ensuring that these alternatives perform as reliably as established ingredients, particularly in terms of stability and manufacturability.
Turning to technology, AI is a hot topic. How do you see it impacting pharmaceutical development?
AI has huge potential across the lifecycle of oral solid dosage forms. For example, predictive modelling can simulate how excipients will behave under different conditions, reducing the need for multiple rounds of physical testing. That accelerates development and supports more sustainable practices by cutting down material use.
In coatings and packaging, AI tools are being explored to predict shelf life under variable moisture conditions, or to optimise film thickness for efficiency and quality. Combined with digital twins of manufacturing processes, this opens the door to faster scale-up and more consistent production.
What is Colorcon doing to support customers in this changing landscape?
We see our role as a partner, helping customers navigate both regulatory complexity and the shift toward digital solutions. On the regulatory side, our global team tracks developments closely and provides customers with clear guidance, documentation and risk assessments.
Digitally, we’ve invested in platforms like MyColorcon, which gives formulators on-demand access to regulatory and technical data; the Answer Center, a searchable knowledge hub; and HyperStart, our digital tool that accelerates coating development by predicting optimal formulations. These resources are designed to give customers faster answers, reduce uncertainty and make their development processes more efficient.
What should companies keep in mind as they adapt to these changes?
Flexibility is key. Whether it’s adjusting to regulatory updates on excipients or integrating AI into workflows, companies that build adaptability into their strategy will be best positioned. This isn’t about replacing proven practices overnight, but about adding new layers of intelligence and resilience to how we develop medicines.
Looking ahead
As regulatory scrutiny continues and digital technologies advance, the pharmaceutical industry faces both challenge and opportunity. For colour ingredients, science-led dialogue remains central; for AI, the focus is on practical application to improve speed, quality and compliance.
The future of pharmaceutical development lies in balancing tradition with innovation—ensuring patients receive safe, effective and trusted therapies in an evolving landscape.