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Topical Clear Aqueous Nanomicellar Formulations for Age TOPICAL CLEAR AQUEOUS NANOMICELLAR FORMULATIONS FOR AGE-RELATED MACULAR DEGENERATION A DISSERTATION IN Pharmaceutical Sciences and Chemistry Presented to the Faculty of University of Missouri-Kansas City in partial fulfillment of requirements for the degree DOCTOR OF PHILOSOPHY by Meshal Alshamrani Pharm. D. King Abdul-Aziz University, Saudi Arabia, 2013 Kansas City, Missouri 2020 © 2020 MESHAL ALSHAMRANI ALL RIGHTS RESERVED TOPICAL CLEAR AQUEOUS NANOMICELLAR FORMULATIONS FOR AGE-RELATED MACULAR DEGENERATION Meshal Alshamrani, Candidate for the Doctor of Philosophy Degree University of Missouri-Kansas City, 2020 ABSTRACT Disorders affecting the posterior segment of eyes represent a significant burden to healthcare and patients’ wellbeing. Among the back of the eye disorders, age-related macular degeneration (AMD) is one of the major ailments responsible for blindness worldwide. There is currently no effective treatment available to cure AMD completely. Anti-VEGF therapy is currently considered the treatment of choice. However, it is invasive and does not offer substantial long-term relief to AMD patients. Other treatment options include thermal laser photocoagulation and surgery. None of these therapeutic approaches are safe and effective. Hence there is a real need for the development of an alternative therapeutic approach that is safe, effective and non-invasive. The objective of this study is to develop a clear, aqueous drug-loaded nanomicellar formulation utilizing FDA approved polymers, namely Hydrogenated castor oil 40 (HCO-40) and Octoxynol 40(OC-40) as a potential-therapeutics for AMD. Hydrophobic drugs such as curcumin (CUR), celecoxib (CXB), and resveratrol (RSV) were successfully solubilized and entrapped in the core of the nanomicelles. These nanomicellar constructs efficiently utilize their hydrophilic corona and evade the wash-out into the systemic circulation from both the conjunctival and choroidal blood vessels and lymphatics, thus overcoming the dynamic barrier. A design of experiments (DOE) with JMP software was performed to optimize the formulation’s size, drug loading, entrapment efficiency, critical micellar concentration (CMC), polydispersity index (PDI), zeta potential and delineate the effect of drug-polymer interactions. The formulation will be administered in the form of topical eye drops. iii APPROVAL PAGE The faculty listed below, appointed by the Dean of the School of Graduate Studies have examined a dissertation titled “Topical Clear Aqueous Nanomicellar Formulations for Age- Related Macular Degeneration”, by Meshal Alshamrani, candidate for the Doctor of Philosophy degree and certify that in their opinion it is worthy of acceptance. Supervisory Committee Russell B. Melchert, Ph.D., R.Ph, Committee Chair Department of Pharmacology & Pharmaceutical Sciences Hari K. Bhat, Ph.D. Department of Pharmacology & Pharmaceutical Sciences Simon Friedman, Ph.D. Department of Pharmacology& Pharmaceutical Sciences Zhonghua Peng, Ph.D. Department of Chemistry Peter Silverstein, Ph.D. Department of Pharmacology & Pharmaceutical Sciences iv TABLE OF CONTENTS ABSTRACT ................................................................................................................................... iii LIST OF ILLUSTRATIONS ........................................................................................................ xiv LIST OF TABLES ...................................................................................................................... xvii CHAPTER 1. OCULAR ANATOMY, DRUG DELEIVERY AND AGE-RELATED MACULAR DEGENERATION ........................................................................................... 1.1 Ocular Anatomy ........................................................................................................ 1 1.1.1 Anterior Segment of the Eye .............................................................................. 2 1.1.2 Posterior Segment of the Eye ............................................................................. 3 1.2 Ocular Drug Delivery Barriers .................................................................................. 8 1.2.1 Epithelial Tight Junction (ZO) ........................................................................... 9 1.2.2 Reflex Blinking .................................................................................................. 9 1.2.3 Metabolism in Ocular Tissues ............................................................................ 9 1.2.4 Tear Turnover ................................................................................................... 10 1.2.5 Nasolacrimal Drainage ..................................................................................... 10 1.2.6 Efflux Pumps .................................................................................................... 11 1.3 Ocular Drug Delivery Routes .................................................................................. 12 1.3.1 Systemic Route ................................................................................................. 12 1.3.2 Topical Route ................................................................................................... 13 1.3.3 Intravitreal Injection (IVT) and Implants ......................................................... 15 1.3.4 Periocular Injection .......................................................................................... 17 1.3.5 Sub-conjunctival Injection ................................................................................ 18 v 1.4 Age-Related Macular Degeneration (AMD) ........................................................... 17 1.4.1 AMD Background ............................................................................................ 18 1.4.2 AMD Pathogenesis ........................................................................................... 19 1.4.3 AMD Statistics ................................................................................................. 21 1.4.4 Dry AMD ......................................................................................................... 22 1.4.5 Wet AMD ......................................................................................................... 23 1.4.6 Therapies for AMD .......................................................................................... 24 1.4.6.1 Nutritional Therapy ................................................................................... 24 1.4.6.2 Anti-VEGF Therapy .................................................................................. 25 1.4.7 Limitations of Anti-VEGF Therapy ................................................................. 26 1.4.8 Intravitreal Implants ......................................................................................... 27 1.5 The Use of Nanotechnology in AMD...................................................................... 28 1.5.1 Nanoparticles .................................................................................................... 29 1.5.1.1 Emulsion-Solvent Evaporation Method .................................................... 30 1.5.1.2 Double Emulsion and Evaporation Method .............................................. 30 1.5.1.3 Salting-Out Method ................................................................................... 29 1.5.1.4 Nanoprecipitation Method ......................................................................... 29 1.5.2 Microparticles ................................................................................................... 30 1.5.3 Core Materials .................................................................................................. 34 1.5.4 Mechanism and Mechanics of Drug Release ................................................... 34 1.5.4.2 Dissolution ................................................................................................. 34 vi 1.5.4.3 Osmosis ..................................................................................................... 35 1.5.4.3 Erosion ....................................................................................................... 35 1.5.4.4 Applications of Microcapsules and Microspheres ..................................... 35 1.5.6 Nanomicelles .................................................................................................... 36 1.5.7 Liposomes ........................................................................................................ 40 1.5.7.1 Liposomes Preparation .............................................................................. 40 CHAPTER 2. INTRODUCTION .................................................................................................. 43 2.1 Overview ................................................................................................................. 43 2.2 Statement of the Problem and Hypothesis ............................................................... 43 2.2.1 Rationale for Using Statistical Design of Experiments (DOE) ........................ 44 2.2.2 Rational for Using Curcumin (CUR), Celecoxib (CXB), and Resveratrol (RSV) ...................................................................................................................................... 45 2.3 Objectives ................................................................................................................ 46 2.3.1 Optimization of Curcumin (CUR) Nanomicellar Formulation: ......................
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