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A Thesis Entitled Physicochemical Compatibility and Stability of 4 A Thesis entitled Physicochemical compatibility and stability of 4% sodium citrate and ethanol when stored in silicone coated and non-silicone coated glass containers by Megha Krishnakumar Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences Industrial Pharmacy ___________________________________________ Dr. Jerry Nesamony, Committee Chair ___________________________________________ Dr. Gabriella Baki, Committee Member ___________________________________________ Dr. Jeffrey G. Sarver, Committee Member ___________________________________________ Dr. Amanda C. Bryant-Friedrich, Dean College of Graduate Studies The University of Toledo May 2020 Copyright 2020 Megha Krishnakumar This document is copyrighted material. Under copyright law, no parts of this document may be reproduced without the expressed permission of the author. An Abstract of Physicochemical compatibility and stability of 4% sodium citrate and ethanol when stored in silicone coated and non-silicone coated glass containers by Megha Krishnakumar Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences Industrial Pharmacy The University of Toledo May 2020 Background: Hemodialysis patients are at high risk of infection because the process of hemodialysis requires frequent use of catheters or insertion of needles to access the bloodstream. Indwelling catheters deliver lifesaving therapy for chronically ill patients but frequently cause infections. Ethanol 20 to 74% concentration has proven efficacy in eradicating various planktonic pathogens as well as microbial organisms embedded in biofilms of indwelling central venous catheters (CVCs). Centre for disease control (CDC) report of emerging infectious diseases suggests 2 million people are infected with bacteria resistant to antibiotics. Objective: Even though 70% sodium citrate and 30% ethanol solution is used routinely as catheter lock, there is a paucity of guidance and methodological approaches to ensure safe and effective admixture storage when compounded in hospitals. The aim of this research project was to investigate the compatibility of 4% sodium citrate and ethanol mixtures (v/v) containing greater than 30% v/v of ethanol for potential use as a catheter lock solution. The influence of light, temperature and type of storage container iii on the physico-chemical compatibility and stability of admixtures was studied over 48hours. Method: Increasing % (v/v) concentrations of 4% sodium citrate was admixed with ethanol. Samples were studied under four conditions: (1) at 25°C with artificial indoor white LED tube light, (2) at 25°C without light wrapped using aluminum foil, (3) at 37°C with artificial indoor white LED tube light, and (4) at 37°C without light wrapped using aluminum foil. Two types of containers were used: (1) silicone-coated and (2) non-coated glass test tubes. Physical compatibility, chemical compatibility and stability were assessed at 0, 8, 24 and 48 hours. Results: Physical compatibility tests indicated that regardless of the storage condition and nature of container 70% volume of ethanol with 4% sodium citrate formed a crystalline precipitate. A statistically significant difference p≤0.05 in chemical compatibility as indicated by the UV/Vis absorbance at 546 nm was observed between sample admixtures incubated in silicone coated and non-coated tubes and storage conditions such as light and temperature influenced chemical compatibility. The stability study data followed a pattern similar to, albeit statistically insignificant, chemical compatibility studies. Samples stored at 37°C without light wrapped using aluminum foil showed better sodium citrate recovery when compared to samples stored at 25°C with artificial indoor white LED tube light. iv Physical and chemical compatibility tests of admixtures prepared with a 50% or higher volume % of 4% sodium citrate and ethanol demonstrated compatibility regardless of the type of container and storage conditions. Chemical stability tests indicated a sodium citrate recovery of 90 to100%. There was no statistically significant difference observed in physico-chemical compatibility and stability between different types of containers, light conditions, and temperature of storage. Conclusions: 70% parts by volume (v/v) ethanol should not be mixed with 4% sodium citrate since this would lead to drug loss and adverse consequences. The admixtures containing 50% or 30% (v/v) ethanol and 4% sodium citrate and were physically and chemically compatible and chemically stable for 48 hours regardless of light and temperature conditions. Pattern plots of physico-chemical compatibility and stability parameters indicated reversible reaction kinetics between sodium citrate and ethanol. Better safety and compatibility outcomes may be expected when ethanol and sodium citrate admixtures are stored at 37°C without light wrapped using aluminum foil v Dedicated to my parents Bindu and Krishnakumar and my younger sister Neha. vi Acknowledgements I would like to acknowledge the faculty at the University of Toledo for sharing knowledge, providing feedback, motivation and support throughout my period as a graduate student. I would like to thank Dr. Mariann D.Churchwell for providing resources, material, advise, and subject matter that was the foundation for this project. I would like to thank Dr. Jerry Nesamony, Dr. Jeffrey G. Sarver and Dr. Gabriella Baki for imparting knowledge and providing subject expertise, which made this work possible. I would also like to thank the College of Graduate Studies for the continued financial support throughout my graduate studies. vii Table of Contents Abstract.............................................................................................................................. iii Acknowledgments............................................................................................................. vii Table of Contents............................................................................................................. viii List of Tables ................................................................................................................... xii List of Figures.................................................................................................................. xiii List of Abbreviations .........................................................................................................xv List of Symbols............................................................................................................... xvii 1 Introduction ..........................................................................................................1 1.1 Central Venous Catheter....................................................................................1 1.2 Pathogenesis of CRBSI......................................................................................2 1.3 IDSA Guidelines on CRBSI ..............................................................................3 1.4 Catheter Lock Solution ......................................................................................4 1.4.1 Flushing, Flushing Regimen & Locking of ALT................................5 1.4.1.1 Flushing................................................................................5 1.4.1.2 Flushing Regimen ................................................................5 1.4.1.3 Locking Volume & Locking Regimen ................................6 1.5 Physicochemical Compatibility & Stability of CLS..........................................6 1.5.1 Physical Stability ...............................................................................8 viii 1.5.2 Chemical Stability..............................................................................8 1.5.3 Microbiological Stability ...................................................................9 1.6 Factors affecting Drug Stability.........................................................................9 1.6.1 pH.....................................................................................................10 1.6.2 Temperature .....................................................................................10 1.6.3 Light.................................................................................................10 1.6.4 Concentration...................................................................................11 1.6.5 Containers ........................................................................................11 2 Sodium Citrate and ethanol Catheter Lock Solution .............................................12 2.1 Pharmacology of Sodium Citrate in CLS ........................................................12 2.2 Pharmacology of Ethanol in CLS ....................................................................13 2.3 Physicochemical properties of Sodium Citrate (API)......................................13 2.4 Sodium Citrate and Ethanol Lock....................................................................16 2.4.1 Heparin VS Sodium Citrate ..............................................................14 2.4.2 Ethanol VS Antimicrobials ..............................................................14 2.4.3 Dosage Form.....................................................................................15 3 Aim of Research ....................................................................................................17
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