Background to the project

Over 40% of new drug (small molecule) substances currently being discovered by the pharmaceutical industry exhibit extremely low aqueous solubility, which frequently constrains bioavailability and the clinical performance of the compound. For example, drugs for HIV are particularly limited by this issue resulting in compromised formulations, often with increased toxicity and side effects.

Of various approaches to solve the challenge of poor solubility, the concept of solid dispersion and co-crystallisation is receiving much interest. Solid dispersion is a system where drug is dispersed at molecular level in hydrophilic polymer matrix. Co-crystals are solid phase structures which combine a challenging drug substance with one (or more) ‘guest’ molecule(s). Through careful selection of guest molecules, co-crystals offer improved physico-chemical properties, especially the solubility and dissolution of the drug constituent.

However the controlled, reproducible and scaled manufacture of these systems remains problematic. Most of the existing manufacturing processes involve solvents which poses major challenge from health and environmental perspectives.

The University of Bradford (UoB) previously signed an MoU with the Institute of Chemical Technology (ICT) focusing on collaborative research and exchange of staff and students.  Improved drug delivery using green technology was identified as a key area considering the complementary strengths and interests of our leading laboratories - the Centre for Green Technology, ICT Mumbai and the Centre for Pharmaceutical Engineering Science and Centre for Advanced Material Engineering at the University of Bradford.  LFHE organised a programme and subsequent follow up meetings in a six month period, which provided opportunity for interactions between academics and resulted in this proposal.

Need for project

Along with major issue of poor drug solubility pharmaceutical companies are also focusing efforts to reduce carbon foot print by adopting green technologies utilising supercritical fluid, microwave, ultrasound and melt extrusion. FDAand EMEAencourageprocess innovation through better process understanding. It also emphasises on quality assurance through its Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives (ICH Q8 guideline link).Highly competitive pharmaceutical sector needs support to overcome these issues and supply of competent graduates. Through this project we attempt to bring together unique complimentary teams with multidisciplinary areas across the two countries. These two centres have state of art infrastructure, expertise and strong industrial linkages globally.

Strong research group in this area will provide human resource which has the required skills and knowledge for the programme, along with providing commercially viable solutions to address the issue of poorly soluble drugs.

© Polymer IRC 2013