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Hydrogen Peroxide Formation by Zinc Oxide in Ointments

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Hydrogen Peroxide Formation by Zinc Oxide in Ointments HYDROGEN PEROXIDE FORMATION BY ZINC OXIDE IN OINTMENTS DISSERTATION Presented in Partial Fulfillment of the Requirements for the Degree Doctor of Philo sopty in the Graduate School of the Ohio State University Hy HECTOR ANTONIO LOZADA, B.3. in Phar., M.S. in Phar. The Ohio State University 195S Approved by Adviser College of Pharmacy ii TABLE OF CONTENTS PAGE ACKNOWLEDGEMENTS............................................ iv PURPOSE OF THE RESEARCH.................................... v INTRODUCTION................................................ 1 ZINC OXIDE.................................................. 5 ZINC OXIDE AS A PHOTOSENSITIZER............................. 10 ULTRAVIOLET L I G H T ......................................... IA INFRARED ABSORPTION S P E C T R A ......... 16 SCME PROPERTIES OF THE OINTMENT B A S E S ....................... 19 WHITE OIN T M E N T ........................................ 19 HYDROPHILIC OINTMENT................................... 20 POLYETHYLENE GLYCOL OINTMENT ......................... 21 HYDROUS WOOL F A T ...................................... 24 AQUAPHOR .............................................. 26 CHOLESTEROL............................................ 26 HYDROGEN PEROXIDE.......................................... 28 APPARATUS AND MATERIALS.................................... 32 EXPERIMENTAL................................................ 37 PREPARATION OF S A M P L E S ................................. 37 IRRADIATION OF S A M P L E S ................................. 39 METHOD OF ASSAY........................................ 40 EXPERIMENTAL RE S U L T S ................................... 43 DISCUSSION.................................................. 66 CONCLUSIONS................................................ 84 iii TABLE OF CONTENTS (CONT»D. ) PAGE CONTEMPLATED FUTURE RESEARCH................................. 86 BIBLIOGRAPHY................................................. 87 AUTOBIOGRAPHY............................................... 91 iv ACKNOWLEDGEMENTS My deepest and sincere appreciation to Dr. Earl P. Guth, Professor, College of Pharmacy, for the guidance and assistance offered to me during the course of this research. His efforts have to a large extent contributed to the successful completion of this work. I also want to make grateful acknowledgement to Dean Luis Torres Diaz, University of Puerto Rico - College of Pharmacy, for his efforts in securing the financial assistance necessary for the continuation of my studies for the degree Doctor of Philosophy. Sincere appreciation is extended to Dr. Loyd E. Iferris and Dr. John W. Nelson, College of Pharmacy, for their invaluable assistance. I also wish to acknowledge all the graduate students in the College of Pharmacy for their cooperation, with special gratitude to V&lter Morozowich. Finally, all my love and devotion goes to ray dear wife, Lillian, for her moral support and understanding. v PURPOSE OF THE RESEARCH Considerable work has been done in connection with the ability of photosensitized zinc oxide to produce hydrogen peroxide from water and oxygen. Blubaugh, Mathias, Minardi, Reese, and Young (6 , 4» 5» 3» 7) contributed a good deal of knowledge in applying this phenomenon to pharmaceutical preparations containing zinc oxide or calamine. None of these investigators, however, worked with ointment bases containing zinc oxide. The main objectives of this investigation were - 1. To determine whether the official formula for Zinc Oxide Ointment would produce hydrogen peroxide under the conditions described in this investigation. 2. To compare the amount of hydrogen peroxide produced by the official formula with the amount produced by using hydrous wool fat, aquaphor, hydrophilic ointment, and polyethylene glycol ointment as bases. 3. To determine the effect of temperature on hydrogen peroxide formation. 4. To determine any relation between hydrogen peroxide production and time of exposure to ultraviolet irradiation. 5. To report any changes in hydrogen peroxide production when using sodium formate as additive. 6. To report other information disclosed during the course of the investigation. HYDROGEN PEROXIDE FORMATION BY ZINC OXIDE IN OINTMENTS INTRODUCTION Ointments constitute one of the earliest types of medication employed by man. They were popular remedies in ancient Babylon and Egypt. Fats of animals mixed with such things as resins, waxes, and powdered herbs were very commonly used dermatological preparations in ancient times. The Papyrus Ebers, which dates from about the sixteenth century before Christ, shortly prior to the time of Moses, contained a formula for a greaseless ointment which was made from Hartshorn beaten up with incense and flour and mixed with sweet ale. Ointments are defined by the Pharmacopeia of the United States (l) as ”semi-solid preparations usually containing medicinal substances and intended for external application to the body.” Zinc oxide is one of the most popular and frequently used ingre­ dients in the treatment of dermatological conditions of varied nature. It is official in the Pharmacopeia of the United States (l) and is also an ingredient of such official preparations as Calamine, Calamine Lotion, Zinc Oxide Paste, Zinc Gelatin, Phenolated Calamine Lotion, Coal Tar Ointment, and Zinc Oxide Ointment. The National Formulary (2) includes it in its formulas for Calamine Ointment, Zinc Oxide Paste with Salicylic Acid, Compound Resorcinol Ointment, and Zinc Compounds and Eugenol Cement. Among all these formulas, one of the most frequently used is that of Zinc Oxide Ointment. It has been used for many years as an astringent, protective and mildly antiseptic external preparation. 1 Physicians all over the country continue to prescribe this kind of preparation for treatment of skin conditions, although sometimes they make sane changes in the official base by substituting for it other fats, glycols, or emulsion type bases. Reese, Mathias, Minardi, Blubaugh, and Young (3, 4* 5> 7) have studied the “Formation of Hydrogen Peroxide in Calamine Lotions," "The Effect of Various Phenols on the Formation of hydrogen Peroxide by Zinc Oxide," "The Effect of Time on the Hydrogen Peroxide Production by Calamine Lotions," "A General Study of the Effects of lipids Upon the Quantity of Peroxides Produced by Fhotosensitized Zinc Oxide," and "The Effect of Selected Rienols on the Formation of Hydrogen Peroxide by Calamine liniment N. F. IX," respectively. All these researchers worked with water suspensions of zinc oxide or with emulsions containing zinc oxide as a major ingredient. None of these studies were concerned with ointments containing zinc oxide. This study deals with this type of preparation. Reese (3) found considerable variation in the production of hydrogen peroxide by different formulations of calamine lotion. This amount of peroxide was related to the kind of ingredients present in the formula. Seme substances were found to increase the peroxide. Among these were polyethylene glycols, sorbitan esters, propylene glycol alginates and the two already known, glycerine and phenol. They all showed a pronounced effect on the production of hydrogen peroxide, with phenol being the most efficient of those studied. large amounts of ferric oxide were reported to be detrimental to the production of hydrogen peroxide unless there are ’’additives” present in the lotions. Fluorescent and incandes­ cent lamps were found to stimulate peroxide production. Sunlight proved to be an excellent promoter of peroxide formation even in cloudy weather. The formation of hydrogen peroxide was not linear with respect to time, two hours yielding less than five times the amount formed in fifteen minutes. Reese also found that lotions which are bacteriostatic may be produced by adding 1 per cent of phenol and/or irradiation with ultra­ violet light. The phenol and the peroxide so formed appeared to have complemental synergism rather than additive action. Mathias (4) reported significant difference in the amount of hydrogen peroxide produced by several commercial brands of calamine lotions upon irradiation with ultraviolet light. With one exception, he found no significant difference in the amount of peroxide produced by irradiation of a lotion prepared with native calamine and one made with prepared calamine. In his study of the effect of adding phenol, resorcinol, resorcinol monoacetate, and pyrogallol to the suspension, he concluded that the number of hydroxyl groups may have an effect upon the quantity of hydrogen peroxide produced by ultraviolet light. An increase in hydroxyl groups in the phenol brings an increase in ability to produce peroxide. Nevertheless, there appeared to be an optimum quantity of phenols beyond which there is no increase in hydrogen peroxide production. An increase of concentration beyond this limit showed a decrease in peroxide formation. Minardi (5) studied the effect of time on the hydrogen peroxide production of calamine lotions. He concluded that after a period of fourteen weeks no significant increase is obtained upon irradiation with ultraviolet light. Another of his findings was the fact that sodium carboxymethylcellulose and/or dioctyl sodium sulfosuccinate retarded the photochemical reaction by which hydrogen peroxide is produced from zinc oxide and water. Blubaugh (6 ), working with lipids, found that the addition of fixed oils greatly reduced the amount of peroxides produced by photo­ sensitized zinc oxide. Although he found a considerable variation in the reduction produced
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