Project 4: Development of a bioadhesive ocular drug delivery system

There is a clear unmet clinical need for efficient, safe, non-invasive and patient-friendly strategies for the treatment of prevalent diseases of the posterior segment of the eye. With a uniquely qualified, and outstanding collaborative network of European and global experts, from academic, clinical and industrial sectors, the ORBITAL project is an integrated and complementary network of expertise in materials science, nanotechnology, animal modelling, enhanced in-vitro testing, in-vivo ocular modelling, analytical chemistry and drug discovery.

ORBITAL will target the growing challenge of posterior segment diseases (PSD) of the eye, such as Age Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR), by building an intersectoral consortium with extensive experience in generating innovative technologies. This project aims to contribute to these challenges through the development of polymers suitable for the preparation of permeation enhancing nanoparticle-loaded bioadhesive / bioresponsive (such as mucoadhesive) tabs which will then will be studied for their bioadhesion, drug-loading, biodegradability and nanoparticle release capabilities. These polymers will undergo physical and chemical characterisation and a range of materials will be tested for suitability. As part of the network, industrial clinical and medical expertise is available so that drugs to assist in the definition of the target drug release profiles. Secondments to Rowan University, Ocupharm (an industrial placement) and Department of Pharmaceutics at Complutense University of Madrid, in Spain.

The main phases of the research can be summarised as follows:

• Formulation and characterisation of bioadhesive / bioresponsive tabs for incorporation of nanoparticles.
• Permeation enhancing nanoparticles will be formulated into a bioadhesive / bioresponsive tab which will encapsulate the specific model drug compounds. Formulations will be designed with components which will give adequate properties to the final formulation to be administered in the eye.
• Safety and efficacy of the novel platforms and nanomaterials.
• The resultant formulations will be fully characterised and biological evaluation of these nanomaterials will be carried out on ocular cell lines and cytotoxicity evaluation will be fully determined. Safety profiles will be determined and the sustained and controlled release of the nanoparticles from the bioadhesive / bioresponsive tab evaluated