Formac Pharmaceuticals and WR Grace say their silica platform can improve the formulation selection process for poorly soluble APIs (active pharmaceutical ingredients).
The companies last year formed an alliance which saw Grace provide a range of mesoporous silica’s for Formac’s early phase testing service.
And following the first-in-human trials of the technology, the firms are now confident they can find effective delivery formulations for researchers having absorption difficulties with their orally delivered chemical compounds.
CEO Laurent Schueller told Outsourcing-Pharma: “This could definitely speed up time to market for our clients. One of the main things in drug development is finding the right formulation that ensures the API is efficient.”
However Scheuller said formulation often takes a back seat in early phase because companies want to make sure their compounds work before spending time and money on perfecting the delivery.
“Because of this, companies often use several formulations in early phase studies,” he added. “The problem is firms end up switching from formulation to formulation through the process, and this is time consuming and costly.
“If you get it right from the start there is no need to switch. That’s what our programme can do.”
He added the platform could help speed up the regulatory process, because using the same formulation ensures the same API exposure for the patient through the entire development process.
“We have consulted with some regulatory bodies, for instance with the Belgium authorities, however we are still yet to discuss this with the EMA (European Medicines Agency) and the US FDA (Food and Drug Administration). This will come in due time,” Scheuller said.
The service is currently aimed largely at chemical compounds delivered as capsules. However R&D (research and development) director Michiel Van Speybroeck told Outsourcing-Pharma that tablets are on the horizon in future development.
“It’s basically a delivery platform for poorly water soluble APIs, which means you can now absorb poorly hydrophilic silica materials with typical porosity, where a compound may not otherwise be able to form itself into crystals,” he said.
He said that though this makes the platform perfect for capsules, Formac and Grace are still to find a way to produce tableted forms which require less excipients to work.
“It’s mainly about maximising the performance. Using a lot of excipients will dilute the formulation,” he said.
“In reality, we could produce tablets at this stage but we first need to optimise the way we do this before we can actually focus on it.”
As for the type of company Formac aims its service offering at, Van Speybroeck said: “If it’s a poorly soluble chemical entity, then we would consider it. We look to both Big Pharma as well as medium enterprises.”
Schueller added that the programme has a wide spectrum of target firms, from early phase developers up to generics companies looking to re-formulate existing products to improve their efficacy.
However, he stressed the company is only working with chemical compounds at the moment.
When asked about the potential for testing biological drugs he replied: “We have had a few bio firms interested, but we don’t see any added value for products like peptides and antibodies at present.
“But I think this is an emerging technology, and there is an obvious need to improve all poorly soluble molecules.”