The doctoral dissertation in the field of Pharmacy will be examined at the Faculty of Health Sciences at Kuopio campus.
What is the topic of your doctoral research? Why is it important to study the topic?
Visual impairment is a globally debilitating condition with about 90% of the affected people living in low income settings. Access to low cost quality ocular drugs could help prevent or cure many of these cases. Unfortunately many products like ocular suspension products have not been well studied and there are many gaps in our scientific understanding on how these products are absorbed and reach target locations in the eye. The focus of this research is to help cover some these knowledge gaps using rational well designed studies to help advance the development of improved ophthalmic products.
What are the key findings or observations of your doctoral research?
My doctoral research covers preclinical studies performed to obtain the comprehensive pharmacokinetic parameters of two important ocular drugs: brinzolamide, a topical ophthalmic suspension used for the treatment of glaucoma, and dexamethasone, a corticosteroid used routinely for ocular inflammation. Comparison of modified formulations of these two drugs showed the impact of changes on the absorption, distribution and elimination of these drugs in the eye.
Additionally, the study analysis helped with designing future studies that could minimize the usage of animals while ensuring statistically significant results. The results are expected to advance the development of ophthalmic suspension products using more ideal study designs for comparing formulations.
How can the results of your doctoral research be utilised in practice?
Key gaps remain in the testing recommended by regulatory agencies for ocular suspension products due to the lack of understanding of the in vivo impact of product changes. This continues to be the barrier for the successful development of quality ophthalmic products that can accessed by patients. This research will help pave the way for regulators at the FDA and EMA to update guidelines and support approval of generic and novel products with improved characteristics.
When generics are dispensed at the pharmacy, patients benefit from a health and cost perspective. But even greater benefits can be achieved if we can help safe and effective generic drugs get to market sooner, after patent and statutory exclusivity periods have lapsed, by addressing the scientific and regulatory obstacles. I am passionate about this and appreciate that the University of Eastern Finland gave me the opportunity to perform my doctoral studies in this pursuit.
What are the key research methods and materials used in your doctoral research?
In this research project, the goal was to understand the comprehensive pharmacokinetics of complex ophthalmic suspension products to support ocular drug development. The bioavailability and ocular pharmacokinetics of brinzolamide and dexamethasone was evaluated through pharmacokinetic studies done in rabbit using different dose routes. The impact of formulation changes on the pharmacokinetics of these products was also evaluated through comparative studies. Analysis of the pharmacokinetic variability was done and this data utilized to improve the study design of ocular pharmacokinetic studies through power analysis and effective sample size determination.
The doctoral dissertation of Vatsala Naageshwaran, A.M, M.S., entitled Pharmacokinetics and study size considerations of topical ocular suspensions of brinzolamide and dexamethasone in rabbits (Brintsolamidia ja deksametasonia sisältävien paikallisten silmälääkesuspensioiden farmakokinetiikka kaneissa ja otoskoon arviointi) will be examined at the Faculty of Health Sciences. The Opponent in the public examination will be Professor Thorsteinn Loftsson of the University of Iceland, and the Custos will be Professor Arto Urtti of the University of Eastern Finland.
Doctoral defence
For further information, please contact:
Vatsala Naageshwaran, vnaagesh(a)student.uef.fi, +1-610-350-6769
