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A Study of Water Vapor Transmission Rate of Blister Packs by Usp Standard and Continuous Gravimetric Protocol

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A Study of Water Vapor Transmission Rate of Blister Packs by Usp Standard and Continuous Gravimetric Protocol A STUDY OF WATER VAPOR TRANSMISSION RATE OF BLISTER PACKS BY USP STANDARD AND CONTINUOUS GRAVIMETRIC PROTOCOL By Nikhil Mehrotra A THESIS Submitted to Michigan State University in partial fulfillment of the requirements for the degree of Master of Science Packaging 2010 ABSTRACT A STUDY OF WATER VAPOR TRANSMISSION RATE OF BLISTER PACKS BY USP STANDARD AND CONTINUOUS GRAVIMETRIC PROTOCOL By Nikhil Mehrotra The water vapor transmission rate (WVTR) is essential in determining the shelf life of pharmaceutical products in the package. The WVTR of blister pack was determined by using USP 671 and the continuous gravimetric protocols. The WVTR values from the two protocols were compared and the accuracy was validated. The WVTR of the blister pack determined using the USP 671 protocol was 0.0452 mg/day/blister with a standard error of 0.0010 while the WVTR using the continuous gravimetric protocol was 0.0652 mg/day/blister with a standard error of 0.0067. The WVTR were compared using t-statistic for unequal sample size with unequal variance and no significant difference was detected. The accuracy of the two protocols was compared through the pooled variance of the data -4 points. USP 671 standard protocol had a pooled variance of 4.99 x 10 while for -5 the continuous gravimetric protocol it was 2.13 x 10 . Therefore the continuous gravimetric protocol showed higher accuracy than the USP standard protocol. Several recommendations have been suggested for the USP standard protocol in order to make the protocol more accurate: for the WVTR of the blister pack, the unsteady state should be considered and excluded from the calculation, Monitoring of the humidity and temperature is critical, Chamber size and the time of equilibrium for the specific relative humidity needs to be outlined. To my ddearear family and friends iii ACKNOWLEDGEMENT I would like to express my gratitude to Dr. Maria Rubino, my major advisor for her support, supervision and guidance through out the course of my Master’s degree. She gave me an opportunity to work in the field of my interest and made me a part of industry projects, the experience of which would help me in my career. Her support and guidance was always there whenever I needed. I would also link to thank my other committee members, Dr. Susan Selke for her suggestions which helped me a lot in my research and Dr. Sarat Dass for his help and advice in carrying out the statistical analysis for the research. I would like to thank the faculty and staff of The School of Packaging for their help. I would like to thank Dr. A.F. Veno and Marcelo Mancheno from TA Instruments for their complete support and suggestions in solving the troubleshooting for the instrument. I am grateful to my family for taking all the efforts and pain to send me to U.S for my Masters. There unconditional love and support helped me in reaching my goal. I am also thankful to my friends at MSU for two years that were full of fun, joy and happiness. I would also like to thank my friends back in India for there support and wishes for me. I would special like to thank GOD for showing me the right path in my life and everything I achieved. Nikhil Mehrotra iv TABLE OF CONTENTS LIST OF TABLES ……………………………………………………………………...vii LIST OF FIGURES ……………………………………………………………..……..viii . Chapter 1: INTRODUCTION ………………………………………...……….…….....1 1.1 Background……………………………………………………….…………….…...1 1.2 Motivation.……………………………………………………………...………...... 2 1.3 Goals and Objectives……………………………………………………………....4 References…………………..………………………………………………...……….. 5 Chapter 2: LITERATURE REVIEW ……………………………………….……..…..6 2.1 Introduction....………………………………………………………………...….....6 2.2 Unit Dose Packaging...................................................................................... 6 2.3 Blister Packaging….........................................................................................7 2.4 Mass Transfer in Polymer Systems………………………………………………8 Sorption………………...……………………………………………………......8 Diffusion…………………………………..………………………………….....10 Permeation……………………..…………………………………............…...11 2.5 Fickian Characteristics…………………….…………………………………..….12 2.6 Parameters Affecting Permeability………………………………………………13 Polymer Properties………….…………………………………….…………..13 Temperature Dependence………………….……………………...………...14 2.7 Methods for Measuring Permeability……………………………………………15 Isostatic…………………………………..…………………………………..…15 Quasi-Isostatic……………………..…………………………………………..17 2.8 Standard Protocol to Study Water Vapor Transmission Rate of a Blister Packs……….………………………………………….…..………….19 References……………………………………………………..……………………....20 Chapter 3: MATERIALS AND METHODS …………………………………...……23 3.1 Materials………………………..……………………………………………….….23 Blister Package Materials…………..……..…………..…………………….…...23 3.2 USP Standard protocol……………………………………….……….……...…..25 3.2.1 Materials…………….…....………………………………………….…..25 3.2.2 Method………………………...…………………………………….…...26 3.2.3 Statistical Analysis……………………………...…….…………..…….29 Kernel Smoother……………………………………………………......29 Analysis of Variance………………………………………………........30 3.3 Continuous Gravimetric Protocol...……………………………………………...32 3.3.1 Materials………………………………………………………………....32 3.3.2 Method…………………………………………………………….……..35 Quantification of Instrumental Noise……………………………....….35 Water Vapor Transmission Rate Experiment…....................……..………………………...……..36 v 3.3.3 Statistical Analysis……………………………………………………...38 Least Square Method of Regression………………………………....38 Two tailed t-satistic for Unequal Variance and Unequal Sample Size……………………………………….……38 Pooled Variance……………………………………………………..….40 References…………………………………………………………………………..…41 Chapter 4: RESULTS AND DISCUSSION ……………………...…………………42 4.1 USP 671 Standard Protocol..…………………………………………………....43 4.1.1 Average Weight Gain by the Control Blister Pack……………….....45 4.1.2 Determination of WVTR for the Blister Pack…………………..…….48 4.2 Continuous Gravimetric Protocol..……………………………………………...50 4.2.1 Evaluation of Instrumental Noise……………………………………..50 4.2.2 Equilibrium Time for the Control Blister Pack…..............................54 4.2.3 Determination of WVTR for the Blister Pack…………....…...…...…55 4.3 Comparison of the WVTR Obtained by the USP Standard and Continuous Gravimetric Protocol.....………………………………………...….57 4.4 Estimation of the Accuracy of USP Standard and Continuous Gravimetric Protocol…..……………………………………..…….58 4.5 Recommended Changes for the USP Standard Protocol……..…….……....58 References…………………………………………………………………………….62 Chapter 5: CONCLUSION ……………………………………...……………..…....63 Conclusion.……………………………………………………………………………63 Future Work …………………….…………………………………………………….66 APPENDIX A …………………………………………………………………..……...67 APPENDIX B …………………………………………………………………..……...71 vi LIST OF TABLES Table 3.1: Different classes of blister packs based on USP standard ……….28 Table 4.1: Description of Kernel smoother statistical technique for bucket-1……………….………………………………………..…..46 Table 4.2: The average WVTR and standard error for three buckets at 23 °C,75%RH with ANOVA results.…………………………………………………..49 Table 4.3: Regression analysis of the instrumental noise and drifting ...........................................................................53 Table 4.4: Water vapor transmission rate in two filled blister pakcs……………………………….……...……...56 Table 4.5: The average WVTR and standard error for three buckets at 23 °C and 75%RH ……...……...………………….60 Table A1: Weights of eight samples in the bucket-1, 2 and 3 for 36 days…………………………………………………………......69 Table A2: Weights of each of the eight filled blister packs of bucket-4 for 36days………………………………………………...69 Table A3: Weights of each of the eight filled blister packs of bucket-5 for 36days……………………………………………..….70 Table A4: Weights of each of the eight filled blister packs of bucket-6 for 36days………………………………………………...70 vii LIST OF FIGURES Figure 2.1: Experimental setup for the isostatic method...……………………...16 Figure 2.2: Permeant flow vs. time for an isostaic method………….………….16 Figure 2.3: Experimental setup for the quasi isostatic approach………………17 Figure 2.4: Permeated mass vs. time for a quasi isostatic method………………………………….……………..18 Figure 3.1(a): Diagram of the empty blister cavity and filled blister cavity with desiccant…………………………………….24 Figure 3.1(b): A tablet with 10 cavities …….………………………………………..24 Figure 3.2: Temperature and humidity recorders from LogTag………………..26 Figure 3.3: Experimental Setup for the USP standard protocol………………..27 Figure 3.4: Three different zones of the rubotherm magnetic suspension balance with schematic of gas flow……………….......32 Figure 3.5: The coupling/decoupling action between the electromagnet and suspension magnet at different operating conditions…………34 Figure 3.6: Quantity vs. time variation in a Quasi-isostatic process…………...37 Figure 4.1: Relative humidity in bucket 1, 2, 4 and 5 or 36 days ……………...44 Figure 4.2: Temperature in bucket 1, 2, 4 and 5 for days………………………45 Figure 4.3: Percentage weight gain vs. time by the control blister packs at 23 °C and 75%RH, over a period of 36 days…….………47 Figure 4.4: Percentage weight gain over a period of 36days in bucket 4, 5 and 6 ……..……………………………...………….…48 Figure 4.5: Percentage weight change of the Standard weight for 4,000 minutes………………...….…………………………………51 Figure 4.6: Quantification of noise for rubotherm SGA-100 gravimetric analyzer…………………………….………….52 Figure 4.7: Percentage weight gain for control blister at 23 °C, 75% RH for 14,000 minutes……………...………………...54 viii Figure 4.8: Percentage weight gain by the desiccant for 14,000 minutes at 23 °C, 75%RH…………...….…………..….…55 Figure 4.9: Average
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