Meet the expert: Chris Wells, Applications Team Lead

What does your role as an applications team lead involve? 

Our team look to build an understanding of what our excipients do from a core physico-chemical perspective and what performance benefit, innovation or differentiation they can bring across different formulation types.    

You specialise is inhalation and nasal delivery. What benefits do Croda’s excipients bring to these formulations? 

At Croda, we have a range of excipients that are used in orally inhaled and nasally delivered drug products. These range from solubilisers and stabilisers through to permeation enhancers.  

For example, many of the small molecule drugs used in inhaled and nasal drug products are not very soluble, and they’re often formulated as suspensions, with the active ingredient suspended in the liquid.  

Our excipients, such as Super Refined Polysorbate 80 (Tween 80) not only help improve the solubility of drug molecules but can stabilise the suspension.

This means it ensures that every time you spray from a device, like a decongestant via the nose or for orally inhaled asthma treatments, it gets to where it needs to be, and you get the same dose every time.  

Our ingredients are also used as absorption and permeation enhancers in nasal sprays. These act by improving the drug’s crossing of the nasal membrane, ensuring it gets to where it needs to be in the body. 

Where are you seeing growth? 

Historically, inhalation therapies have focused on local disease areas such as chronic obstructive pulmonary disease (COPD) and asthma, but new innovations are coming that use inhaled and nasal therapeutics to target systemic diseases. 

Both offer fast onset of action, improved bioavailability over oral routes and are non-invasive, making them an exciting alternative to injectables for patients.  

There is also considerable opportunity for delivery, not just for small molecules, but also for peptides, complex biologics and vaccines. These potential uses have seen considerable interest and growth. 

There are still many challenges for new therapies via these routes, such as device formulation, complex physiology and patient compliance. This can make speed to market challenging.  Both routes also have complex pre-clinical and toxicological barriers that can make new products complex to approve.  

Nevertheless, an increasing number of customers are turning to inhalation and nasal routes for delivery of complex therapeutics. 

And Croda’s high-purity excipients and formulation expertise can provide support for customers in this field, offering a more stable drug product, improved efficacy and reducing the potential risk of dose variability. 

Can you tell us about potential new and innovative indications for nasal delivery and how Croda can help support these innovations? 

There is considerable interest in using nasal delivery to target diseases for the central nervous system. For example, for acute diseases where patients require rapid drug absorption, such as epilepsy, migraines and opioid dependency.  

Avanti DDM, n-dodecyl-b-maltoside, can be used in such treatments, acting as a solubiliser, stabiliser and more importantly as an absorption enhancer, providing support for the drug to cross the challenging nasal membrane.  

There’s also considerable research in nasally delivered treatments to target these neurological diseases, as the olfactory epithelium within the nasal cavity acts as a non-invasive method that can bypass the blood-brain barrier.  

This opens exciting possibilities for drug products to treat brain diseases such as Alzheimer’s disease, Parkinson’s disease, strokes and brain tumours. And at Croda we’re working with several customers in this space. 

Another growth area is nasal delivery of vaccines. This is a very active research area, following the COVID-19 pandemic, as you can target the primary route of viral infection within the upper respiratory tract.  

Nasal delivery provides opportunities to target influenzas as well as respiratory infections, whilst overcoming some of the challenges associated with injectables, such as stability, compliance and shelf-life.  

Intranasal vaccine dry powders, for instance, could provide stable vaccine products in countries without cold-store facilities or enable self-administration at home.

Future gazing, what excites you the most about the potential of these applications? 

We are in an incredibly exciting times for inhaled and nasal drug products. The opportunity to deliver drug modalities, such as small molecules, peptides, biologics and nucleic acids unlocks potential for treating disease types from respiratory through to neurological indications.   

From a patient perspective, delivering drugs through oral inhalation or via the nose is non-invasive. It opens the chance for patients to administer treatments at home, or  to reach patients where healthcare storage and supply is challenging.  

I’m also hoping that there will be a paradigm shift in drug formulators towards inhalation and nasal route, from the regulators in particular.  

As drug modalities become more complex, the need for a broader excipient selection becomes increasingly important to treat these diseases.  

With more options in our excipient toolbox, the opportunities to deliver a broader range of drugs via inhalation or nasal route widens, opening the door to target challenging diseases in a way that is non-invasive and offers high levels of acceptance amongst patients.