Quotient Clinical, the business unit of the UK’s Quotient Bioresearch that specialises in early-stage drug-development services, is collaborating with dosage-solutions expert Capsugel to address the drug-delivery challenges of poorly soluble molecules with limited oral bioavailability.

The partnership, which integrates Quotient’s RapidFACT real-time clinical manufacturing and testing service with Capsugel’s lipid-based formulation expertise and manufacturing capability, aims to fast-track the clinical evaluation of drlipid-based drug-delivery systems in humans while optimising the relevant molecules for downstream development.

Up to 70% of the pharmaceutical industry’s development pipeline consists of molecules with poor solubility, Quotient Clinical and Capsugel say.

As part of the collaboration, Quotient will be using Capsugel’s CFS liquid capsule-filling and -sealing technology at the Quotient facility in Nottingham. The UK-based company will also have access to formulation expertise at Capsugel’s Development Centre in Strasbourg.

Empowering RapidFACT

Mark Egerton, managing director of Quotient Clinical, said the partnership would “further empower” the RapidFACT service by ensuring that selected drug products could be rapidly scaled up and transitioned into downstream development, “further reducing timelines to critical development milestones”.

According to Keith Hutchison, senior vice president of R&D at Capsugel, the company’s expertise in poorly soluble drugs – including predictive modelling technology based on an “extensive database” of lipid formulations – as well as its “deep knowledge” of capsules and Licaps liquid-filling and -sealing technology are “perfect complements to Quotient’s ability to accelerate the generation of human clinical data”.

Quotient Clinical was set up in 2009 after Quotient Bioresearch took over an early-stage clinical research facility in Edinburgh, Scotland from Charles River Laboratories.

This facility was consolidated with Pharmaceutical Profiles, a Nottingham, UK provider of specialist Phase I drug development services acquired by Quotient in December 2008.