The journey SPI Pharma made into developing a game changing patient-centric drug delivery platform.
For pharmaceutical manufacturers, some of the most important considerations when it comes to developing medicines is how patients are going to respond to the physical act of taking them. If it’s a tablet, what does it taste like? Could there be swallowability issues? Is it dissolvable?
This last question is an area in which ingredients supplier, SPI Pharma, specialises in. When it comes to oral dose products like tablets, the effective delivery of those drugs is key if patients are going to comply with their treatment regime.
This idea of patient centricity is what brought SPI Pharma to develop its latest excipient platform –UltraBurst - for orally dispersible tablets (ODTs).
SPI Pharma started developing UltraBurst in the middle of 2020. The company looked at its original platforms for ODTs and found that it could improve upon that technology with a rapid disintegration “flash” platform. In other words, it could take traditional ODT formulations and aim to make them dissolve in under 10 seconds – what SPI Pharma classes as “flash” disintegration.
“The innovation in UltraBurst is that it takes the current excipient platform and moves the disintegration time to a faster range than what’s currently on the market,” Bill McCarthy, global marketing manager of excipients and drug delivery systems, SPI Pharma said.
What this means is that 50-200mg tablets can see disintegration times range from four to nine seconds compared to the usual 12-15 seconds. For larger tablets of 500mg, UltraBurst can help reduce disintegration time from 80-90 seconds with conventional platforms, to just 12 seconds.
For formulators, the three most important characteristics of ODTs are disintegration time, tablet robustness and organoleptic properties – or the feel of a tablet in the mouth. McCarthy explains that whilst there are several ODT excipient platforms available on the market, those that are able to provide “flash” disintegration are very expensive and are limited to just a few suppliers.
“What we saw was an opportunity to create an excipient preformulation that could keep tablet robustness and good mouthfeel, but enable faster disintegration time,” McCarthy says.
McCarthy tells me that SPI Pharma often works with its customers to improve their formulations and that the company had developed several examples of Flash ODTs to demonstrate their expertise and range of capabilities in the space. After their customers saw the examples they had been working on, and showed continued interest, SPI Pharma knew that they had a product that would be welcomed onto the market.
The development of UltraBurst makes sense for a company that has been in the orally dispersible dose market for decades.
“It’s where we play,” McCarthy says. “One of our major product groups - mannitol excipients - is widely used in these types of dose forms. We also have a major business selling antacid actives for chewable and meltaway tablets, and we launched the first directly compressible, ODT excipient platform- Pharmaburst, in 2003.”
Perhaps more importantly however, is the role these types of dosage forms play in improving medicines, helping to increase compliance, resulting in better efficacy. Simply put, patients prefer tablets that dissolve immediately. Faster disintegration results in a better experience for a patient and makes it a more appealing product than one that takes longer to dissolve. More so, the patient friendly nature of an ODT means that for anyone with difficulty swallowing, it can be their preferred dosage form.
It isn’t simply a better patient experience that it offers though.
“Very rapid disintegration also creates possibilities for designing formulations with enhanced oral mucosa or sublingual uptake of the drug - which could open possibilities for formulations with enhanced bioavailability,” McCarthy explains.
And whilst this isn’t something SPI Pharma has validated with UltraBurst, the company is currently exploring those types of formulations.
Of course, making drug delivery more patient focused is a welcome effort but only if the formulations that are being produced through UltraBurst are able to retain their API (active pharmaceutical ingredient) stability.
“Achieving content uniformity for low dose micronized actives requires understanding of the API characteristics and how these interact with the excipient platform,” McCarthy says.
“Larger tablets and tablets with higher drug loadings can be challenging since achieving faster disintegration times becomes more difficult as the tablet size increases or API properties mask the functionality of the excipient platform. Fortunately, UltraBurst is designed to overcome these challenges as it relies on multiple mechanisms to promote tablet disintegration.”
In a time when manufacturing costs can form a significant part of a developer’s overall costs, the need for affordable processes is evident. SPI Pharma has designed UltraBurst to support low manufacturing costs through direct compression manufacturing – a method which removes the need for granulation by having tablets compressed directly from their powdered active drug substance and the excipients.
Developing and launching a product in the midst of a global pandemic was certainly a challenge for SPI Pharma.
“We had to adjust to digital just like everyone. This was particularly challenging as we have development labs in India and the production facility in Michigan, USA,” McCarthy says.
“Tech transfer and scale up usually would have some element of in-person collaboration. We had to manage without that. Luckily, we have developed a robust new product development process and running that process was the key, even if it had to be done virtually.”
*UltraBurst and Pharmaburst are trademarks of SPI Pharma