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DEVELOPMENT of a NYSTATIN-LOADED MICELLAR SYSTEM for ORAL MUCOADHESION by NANCY OWUSU AKYERE SARPONG Submitted in Fulfilment Of

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DEVELOPMENT of a NYSTATIN-LOADED MICELLAR SYSTEM for ORAL MUCOADHESION by NANCY OWUSU AKYERE SARPONG Submitted in Fulfilment Of DEVELOPMENT OF A NYSTATIN-LOADED MICELLAR SYSTEM FOR ORAL MUCOADHESION By NANCY OWUSU AKYERE SARPONG Submitted in fulfilment of the requirements for the degree of Magister Scientiae in the Faculty of Science at the Nelson Mandela University Supervisor: Prof G Kilian Co-supervisor: Mr Y Kadernani Co-supervisor: Prof S Roux 2019 i Declaration I, NANCY SARPONG, Student nr: 212277901, hereby declare that the work on which this dissertation is based is my own work (except where acknowledgements have been made) and that neither the work as a whole, or any part of thereof has been, is being, or is to be submitted for another degree at this or any other university. J NANCY OWUSU AKYERE SARPONG Signed on this 11 day of January 2019 at the Nelson Mandela University ii Dedication I would like to dedicate this treatise to my family, the Gwimo family, the Masika family and the Sarpong family. Thank you for your prayers, encouragement and sacrifices. Without you, this work would not have been possible. You have proven that it does indeed take a village to raise a child. iii Acknowledgements I wish to extend gratitude to the following people and institutions for contributing towards the success of this treatise. My supervisor Prof Kilian, for your constant guidance, support and the long chats. My co-supervisors Mr Kadernani and Prof Roux, for their invaluable input and constant support. The nanoscience platform and the Department of Science and Technology, for funding the research. My colleagues Lana, Jethro, Amy, Yasmin, Yumna, Lauren and Vuyi for your wealth of knowledge and for the constant laughter and jokes. Arista and Jean for always being available to teach me new things when I needed them. Mama Cynthia and Vuyelwa from the Pharmacy Department, for their encouragement and support and for always helping me find equipment in the lab. The staff of the Department of Pharmacy, for their support and motivation. Hyacinthe Tonga, for spending late nights at the labs and bringing supper whenever it was necessary. Wimana Gwimo for being my lab partner, my typing buddy and my support system. Patricia Masika, for the daily check-ups, phone calls, laughter and being my shoulder to cry on. My family, for the constant jokes and the support that you have accorded me throughout my academic career. iv Summary Oropharyngeal Candidiasis (OPC) is an opportunistic fungal infection that affects mostly infants and immunocompromised patients. In recent years, the disease has been on the rise due to an increased life span, the HIV pandemic and the increased use of broad spectrum antibiotics. OPC may be treated using a nystatin suspension, which is not as effective as it could be due to the mechanism by which the suspension is applied to the affected tissue. This research aims to improve the effectiveness of nystatin, for the treatment of OPC, by proposing a nystatin loaded micellar system incorporated into a mucoadhesive system for drug delivery. This will ensure that nystatin is gradually released from the film, thus increasing retention time of nystatin at the affected area. In this study, a mixture design was developed, which was used to determine the most appropriate solvent system for nystatin solubilization. Optimisation of the micelle formulation was achieved by using the central composite rational design (CCRD). The two factors that were taken into consideration were the temperature of the hydration medium (water) and the length of time the micellar solution was exposed to the temperature environment of the rotary evaporator. The responses that were investigated were the mean particle size, mean polydispersity index (PDI), mean zeta potential, change in mean particle size and change in mean PDI. The optimal micelle formulation was characterised for size, stability, morphology and drug encapsulation efficiency. The micelles were found to be spherical and stable with an acceptable size range. However, their drug encapsulation efficiency was low. The mucoadhesive film was formulated and characterised for physical characteristics, pliability, percentage swelling index and drug release profile. The film was found to be highly pliable and evenly distributed with a smooth surface; no bumps or bubbles were visible. The film was able to swell to up to 550 %. In vitro studies showed that nystatin was gradually released from the film. Key words: central composite rotational design, mucoadhesive film, oropharyngeal candidiasis, polymeric micelles, response surface methodology v Table of Contents Page ACKNOWLEDGEMENTS ......................................................................................... III SUMMARY ................................................................................................................ IV LIST OF TABLES ..................................................................................................... XII LIST OF FIGURES ................................................................................................. XIV LIST OF ABBREVIATIONS ................................................................................... XVII CHAPTER 1 .............................................................................................................. 1 Introduction ............................................................................................................. 1 1.1 BACKGROUND ............................................................................................... 1 1.2 PROBLEM STATEMENT ................................................................................ 2 1.3 AIM AND OBJECTIVES .................................................................................. 3 1.3.1 Aim. ..................................................................................................... 3 1.3.2 Objectives. .......................................................................................... 3 CHAPTER 2 .............................................................................................................. 4 Literature Review .................................................................................................... 4 2.1 OROPHARANGEAL CANDIDIASIS (OPC) ..................................................... 4 2.1.1 Introduction. ........................................................................................ 4 2.1.2 The different forms of OPC infections. ................................................ 5 2.1.3 Candida associated lesions. ................................................................... 6 2.1.4 Treatment of OPC. .............................................................................. 9 2.2 NYSTATIN ..................................................................................................... 12 2.2.1 Introduction. ...................................................................................... 12 2.2.2 Pharmacological actions. .................................................................. 12 2.2.3 Physical properties of nystatin. ......................................................... 13 vi 2.3 NANOTECHNOLOGY/ NANOSCIENCE ....................................................... 14 2.3.1 Introduction. ...................................................................................... 14 2.3.2 Nanoparticles for drug delivery. ........................................................ 15 2.3.3 Polymeric micelles. ........................................................................... 16 2.3.4 Formation of polymeric micelles. ....................................................... 17 2.4 MUCOADHESION ......................................................................................... 18 2.4.1 Introduction. ...................................................................................... 18 2.4.2 Mucous membrane. .......................................................................... 19 2.4.3 Mechanism of mucoadhesion. .......................................................... 20 2.4.4 Theories of mucoadhesion. ............................................................... 21 2.4.4.1 Adsorption theory. ................................................................ 21 2.4.4.2 Diffusion theory. .................................................................... 22 2.4.4.3 Electrostatic theory. .............................................................. 22 2.4.4.4 Fracture theory. .................................................................... 23 2.4.4.5 Wetting theory. ..................................................................... 23 2.4.5 Mucoadhesive polymers. .................................................................. 23 2.4.6 Polymer factors affecting mucoadhesion. ......................................... 24 2.4.6.1 Molecular weight. .................................................................. 24 2.4.6.2 Concentration of active polymer. .......................................... 25 2.4.6.3 Flexibility of polymer chains. ................................................. 25 2.4.6.4 Cross linking density and swelling. ....................................... 25 2.4.6.5 pH and charge. ..................................................................... 25 2.5 CONCLUSION ............................................................................................... 26 CHAPTER 3 ............................................................................................................ 27 Methodology .........................................................................................................
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