Microspheres-based therapies are highly promising treatments in animal healthcare. As we covered in our earlier article, not only do they offer extended duration of action compared to traditional drug delivery technologies, but they also have better bioavailability, and improved active pharmaceutical ingredient (API) palatability.
However, microspheres can be difficult to bring to market owing to many challenges throughout their development lifecycle. Failing to overcome such challenges draws out timelines, adds unexpected expenses, and can even lead to late programme failure.
So, what setbacks do developers need to be aware of? In this article we focus on four significant challenges faced during early development — API-excipient compatibility, API-microspheres manufacturing process compatibility, drug loading complexities, and particle size exploration.
If you want a breakdown of all challenges in microspheres-based animal health product development, including regulatory and commercial manufacturing complexities, download our eBook.
- API-excipient compatibility
Critical to the success of your drug development programme is ensuring that the API is compatible with available microspheres carriers and excipients. Unfortunately, for injectable microspheres formulations, developers only have a few suitable carriers and excipients to work with.
Developers must therefore identify which microspheres carriers will work with their API. Doing this requires time-intensive literature searching and expensive experimental exploration — which may be near impossible if you do not have the necessary expertise or resources.
- API-microspheres manufacturing process compatibility
It’s not just the carriers and excipients the API needs to be compatible with — it must also tolerate the microspheres manufacturing process. Unfortunately for developers, this process can be quite intensive. Forming the microspheres requires heating the lipid matrix containing the API, which can cause some APIs to degrade. And for injectable microspheres formulations, APIs must withstand a terminal sterilisation step.
It’s therefore critical to extensively characterise your API as soon as possible to determine if it can withstand these conditions before investing significant resources, which again can be challenging without the right tools and know-how.
- Drug-loading complexities
Think your required therapeutic dose isn’t achievable with microspheres? Think again. Many developers grapple with the uncertainty of whether it is possible to achieve the right therapeutic dose with this drug delivery technology, which can lead to prematurely abandoning development projects. Yet, achieving the desired therapeutic dose is often within reach.
Ascertaining if your therapeutic dose is achievable is challenging and requires extensive knowledge of advanced drug-loading techniques. Without this insight, it’s possible that companies could draw the wrong conclusions — leading them to discontinue promising programmes too soon.
- Particle size exploration
Microsphere size directly impacts the therapy’s pharmacokinetics and safety profile. As an example, if the particle size is too large, there is an increased risk of injection site reactions.
Accordingly, companies must determine the optimal particle size range early in development, or risk progressing an infeasible particle size. And once you’ve discovered the ideal range? You must be able to generate them by varying microsphere size in a controlled manner — and understand their effects on various critical quality attributes (CQAs) — both of which can be time-consuming and complicated.
Get to market faster through a partnership
Microspheres can be a promising delivery method for animal health products, but so many challenges and pitfalls can keep developers from progressing in their drug programme.
Luckily, you don’t have to overcome these challenges on your own. You can partner with a contract development and manufacturing organisation (CDMO) that has the experience, licensable technology, and infrastructure to support you from development, pre-clinical research and clinical trials all the way through to regulatory submission and manufacturing. By doing so, you can substantially reduce the risk, time, and costs associated with microsphere development, and get your product to market quicker.
Ready to find out more? Check out our next article to see what you can achieve by partnering with a CDMO for microspheres-based animal health products.
Want to learn more about how to accelerate the path to market for microspheres-based treatments? Download our eBook today.