Project 7: Design and formulation of nanomicelles for the treatment of diabetic eye diseases

Diabetes is a highly prevalent disease that affects nearly 10% world population and is characterized by severe acute and chronic complications. Affectation of ocular structures may lead to retinopathy, papilopathy, glaucoma, cataracts and corneal damage, with an increased risk of loss of vision. Current pharmacological strategies involve prevention of sorbitol accumulation, vascular proliferation and inflammatory conditions, and delivery of growth factors for healing.

Most treatments for diabetic eye conditions rely on systemic (oral) or intravitreal administration, and there is still a demand of efficient ocular dosage forms that can be administered in a comfortable way for the patient. Recently, nanomicelles (<100 nm) have been pointed out as advantageous delivery systems for both anterior and posterior segment ocular drug delivery, being able to prolong the permanence of the formulation in the cornea and overcome a variety of barriers. The aim of this Thesis project is to develop nanomicelles that can be topically administered and can deliver active substances to the posterior eye segment, mainly for the prevention or treatment of deleterious effects due to sorbitol accumulation, vascular proliferation and inflammatory conditions.

This project aims to address this challenge through the design of nanomicelles that can be topically administered and can deliver active substances to the posterior eye segment, mainly for the prevention or treatment of deleterious effects caused by diabetes. Research and experimental work will involve the development of strategies for triggering the self-assembly of amphiphilic copolymers and drug loading that are compatible with ocular administration, the characterization of the drug-loaded nanomicelles and their capability to accumulate into the cornea and diffuse to inner eye structures, strategies for the optimization of the formulations, scale-up and in vivo assessment in animal models.

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

  • Selection of copolymers and drug candidates. Development of strategies for triggering the self-assembly of amphiphilic copolymers and drug loading that are compatible with ocular administration. The formulation will be progressively optimized. Encapsulation of the drug candidate, and physical stability of the drug-loaded nanomicelles against dilution and sterilization will be tested.
  • Assessment of ocular safety, capability to accumulate into the cornea and diffuse to inner eye structures. The assays will be carried out according to the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).
  • Strategies for the optimization of the formulations, scale-up and in vivo assessment in animal models will be implemented.
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