Earlier this week the US Patent and Trademark Office (PTO) gave Fuisz the green light for tablet and capsule designs intended to address esophageal transit failure. The condition can affect a wide range of patients, including children and the elderly and those taking bisphosphonates or receiving cancer treatment, and create significant compliance issues.
Fuisz's pills are designed to be less likely to adhere to mucosal surfaces than existing oral dosage forms which - the company claims - accelerate esophageal transit by as much as 80 per cent.
CEO Joseph Fuisz told in-Pharmatechnologist.com that his firm came up with the new designs – including its ‘Saturn’ pill which is shaped to minimize contact with the esophageal tract - after working on the problem for a long time.
“We’ve been active in orally dissolving dosage forms, and we even developed a liquid at one point that was used in the place of water when swallowing tablets with improved results. But none of these efforts has made material incursions on the sold dosage form market.
“That got us thinking about tablets and caplets themselves. Intuitively, you might imagine a streamlined shaped is optimal. What we demonstrated in the lab and in clinical trials is that the big driver of esophageal transit failure is contact patch surface area.
Fuisz first told us about the pill designs in 2011 when it was still working to gain a US patent for the technology.
With this now in place the firm is looking for drug manufacturers interested in adopting the new tablets according to Fuisz, who said that own brand producers rather than contractors are the most likely to be interested.
“We have been waiting for this patent to issue to commence active business development. As a family business, we are pretty open-minded to partnership structure but I would expect individual pharma companies to be the likely partners. I think CMO’s tend to trail in innovation adoption, on the whole.”
One thing likely to be of interest is Fusiz claim that drugmakers which adopt the new tablet designs will not see a significant increase in production costs or in capital expenditure on manufacturing technology.
“This is a great advantage for Saturn is that it does not add manufacturing costs to the dosage form. This is more critical today than ever. Generally Saturn will not even require formulation change. You simply tablet the Saturn with different die tooling.”