Meet the expert: Will Small, Research & Technology Specialist

What does your role Research & Technology Specialist with Croda Pharma involve? 

As part of the Pharma Applications team, I work with technical, marketing, commercial, production and regulatory colleagues around the world, supporting our excipients for small molecule and protein delivery in both human and veterinary medicines.  

As a Research & Technology Specialist, my expertise is around understanding our Super Refined excipients which are extremely high-purity versions of common pharmaceutical excipients and being able to demonstrate and understand the benefits they bring to our customers’ formulations. 

Why are quality and purity of excipients so important in product formulations? 

Excipients can impact lots of different aspects of a pharmaceutical formulation, from active ingredient solubility and stability to delivery.  

A lot of excipients in use today were developed several decades ago. We’ve made massive strides in our understanding of them and our analytical capability to study them. But there has also been accelerated innovation in both the types of active ingredients used as well as the delivery system (formulation). 

This means our customers are seeing new types of problems emerge. So, understanding our Super Refined excipients and what they can do has never been more important than it is now.  

What are five key customer benefits of using Croda’s high-purity excipients? 

• Product range: Croda produces a wide range of Super Refined excipients, across many different chemistries and physical forms, and it’s expanding all the time.
• Testing: Croda’s Super Refined excipients undergo additional testing, beyond what is typically required by the major pharmacopoeia. This testing picks up some of the things that hide in plain sight in excipients that can lead to issues for our customers.
• Low batch-to-batch variability: Consistent excipients help to build consistent formulations. 
• They're Super Refined!: The high purity of these excipients brings multiple benefits. Fewer impurities lead to less active and formulation-related stability issues, making formulators lives easier and speeding up time to market in both new and generic product development. Improved stability can enable longer shelf life, while lower odour and taste can help achieve higher patient compliance. 
• Support and collaboration: I love it when our customers need help finding a solution. We can work together to solve their issues, which is incredibly satisfying and a great way to understand more about our excipients.  

Can you give an example of how your team’s work and a Super-Refined excipient helped improve a formulation? 

Docetaxel is an anti-cancer treatment that was developed in the mid-1990s. It is delivered by IV infusion, and contains Polysorbate 80, a common pharmaceutical excipient to solubilise the drug.  

We discovered that the stability of Docetaxel was poor in standard pharma grades of the excipient, but it was really good in our Super Refined excipient.  

When we dug a little deeper, we discovered one of the causes of instability in the standard pharma grade was linked to residual catalyst. The absence of catalyst in the Super Refined Polysorbate 80 therefore, led to much better results.  

Where this gets even more interesting is that the formulation for Docetaxel also contains citric acid, which we now understand is there to help lock up that catalyst. So, the formulation is stable, but only because it contains something that is there to improve the destabilising effect of another excipient!  

I can just imagine going back to when this formulation was being developed, working on this formulation and running into stability issues with my drug in the standard pharma excipient, and adding citric acid, as a remedial measure to prevent that instability. 

Now, just imagine a parallel universe, with Super Refined Polysorbate 80 on the lab bench. No catalyst present, so no active degradation. No need to analyse and characterise any degradation products, and no need to add unnecessary excipients to the formulation.  

That is where our Super Refined excipients can make a difference. Providing a more straightforward formulation journey, with one less excipient on the inventory and a faster route to market.  

What part of working with Super Refined excipients excites you the most?

Even with the advances that have been made in understanding and characterising excipients, there's still a lot to learn. And that's going to be important for us and our customers in the years to come.

For our customers, the drug development process is inherently risky, and failure rates remain high. So anywhere we can help to de-risk the process and make it easier for them is important. And that’s where our Super Refined excipients can be really valuable to them.

Croda can offer high purity across a wide portfolio of excipient chemistries, alongside better batch-to-batch consistency that can bring new innovations to market and help our customers grow their business and market share.