Catalent's Zydis technology is used to manufacture orally disintegrating tablets (ODTs) which rapidly dissolve in the mouth within seconds, and offer a water-free alternative to traditional tablets.
At a press day last week, Catalent explained how it is hoping to use the platform to administer vaccines sublingually, increasing patient compliance and reducing manufacturing costs.
"We are generally seeing poor compliance with injections, certainly in the UK and the same in US, as the recent measles outbreak shows," Rob Smith - R&D Director at Catalent Pharma Solutions - said.
Emerging Market Opportunity
But while an ODT form would aid immunisation programmes in Western countries, bringing this platform to emerging markets would be game changing.
"Many vaccines struggle to get to the end user in developing countries," he said. "Liquid vaccines need [temperature-stable] shipping, refrigeration, clean needles, so oral vaccines have always been a kind of holy grail of the industry."
Furthermore, its typically cheaper to formulate a Zydis tablet than an injectable, he added. "They are not sterile so not got all the elements normally associated with running a sterile facility - HVAC, microbiological testing, etc."
He continued, adding that "while the shelf life is longer and the cost of goods smaller [ODT] have not got the complex supply chain needed for a frozen or refrigerated product."
R&D
While Zydis technology is used in over 20 products on the market, Zydis vaccines are still in the development stage.
Catalent is investigating an influenza vaccine internally, and according to Smith the programme "stimulated far more t-cells than we originally thought" and demonstrated improved immunity in mice without using an adjuvant.
The company has also just been awarded a grant as part of the EU's research and innovation framework, Horizon 2020, in order to work on developing the platform for a potential HIV vaccine.
Big Vaccine Makers
As to how industry has responded to the idea, Smith told in-Pharmatechnologist.com, one of the challenges is to get beyond the consortium that currently controls the vaccine market.
"We are not seeing barriers, but there is a perception that they are there," he said. "The Big Pharmas have their vial products and are well established, and we're trying to break into that with emerging technologies," he said, adding these established processes could become redundant if Zydis takes off.
However, Catalent's VP of Global Marketing Elliott Berger was certain the mindset would change once Big Pharma sees a product breakthrough.
"This is a huge market and they have an established way of doing things," he told us. "In order to disrupt their own big infrastructure like this they need to be sure it works, it's stable and robust, and that it can be proven in a regulatory setting."
Presently Catalent has worked with one Big Pharma firm on a potential Zydis vaccine, and is in talks with another aboyt installing equipment into one of their facilities.
"They will get there eventually, but it is going to take a certain amount of disruption and investment," Berger added.