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Formulation and Evaluation of Dermatological Products For FORMULATION AND EVALUATION OF DERMATOLOGICAL PRODUCTS FOR TOPICAL DELIVERY by MAHIMA MANIAN Copyright 2016 Mahima Manian All Rights Reserved FORMULATION AND EVALUATION OF DERMATOLOGICAL PRODUCTS FOR TOPICAL DELIVERY by MAHIMA MANIAN Approved: Ajay. K. Banga, Ph.D. Date Dissertation Committee Chair Martin. J. D’Souza, Ph.D. Date Dissertation Committee Member Grady. J. Strom, Ph.D. Date Dissertation Committee Member Ayyappa Chaturvedula, Ph.D. Date Dissertation Committee Member Piyush Jain, Ph.D. Date Dissertation Committee Member Hewitt. W. Matthews, Ph.D. Date Dean, College of Pharmacy ii DEDICATION This dissertation is dedicated to my better half Sai for his unconditional love and encouragement, to my family, who have incessantly motivated me to pursue my dreams and to my besties for their constant love and support. iii ACKNOWLEDGEMENTS Thank you God for everything! This journey would have been incomplete without the guidance and friendship of Dr.Ajay.K.Banga. He will always be the ‘bestest’ advisor, who continues to inspire and motivate me to be a better human being and scientist. I would like to thank my committee members, Drs. D’Souza, Strom, Chaturvedula and Jain for their guidance and helpful discussions. I would also like to thank the members of the Department of Pharmaceutical Sciences for providing the required technical and professional assistance throughout my Ph.D. for which I am truly grateful. A big shout-out to my lab colleagues and friends, you have been my second family in Atlanta, our talks and laughter will always remain unforgettable. iv Table of Contents CHAPTER 1 .................................................................................................................. 1 INTRODUCTION ................................................................................................................... 1 CHAPTER 2 .................................................................................................................. 6 REVIEW OF LITERATURE ................................................................................................. 6 Background ............................................................................................................................. 6 Factors influencing percutaneous absorption: ......................................................................... 7 Vehicle effects ......................................................................................................................... 8 In vitro permeation and drug distribution ............................................................................... 9 Modulation and enhancement of topical drug delivery ......................................................... 11 Advantages of topical and transdermal drug delivery ........................................................... 12 CHAPTER 3 ................................................................................................................ 14 INVESTIGATION OF THE DERMAL ABSORPTION AND IRRITATION POTENTIAL OF SERTACONAZOLE NITRATE ANHYDROUS GEL ................................................. 14 Abstract ................................................................................................................................. 14 Introduction ........................................................................................................................... 15 Materials and Methods .......................................................................................................... 17 Results ................................................................................................................................... 24 Discussion ............................................................................................................................. 30 Conclusion ............................................................................................................................. 34 CHAPTER 4 ................................................................................................................ 36 EVALUATION OF THE IN VITRO PERCUTANEOUS ABSORPTION AND RHEOLOGICAL BEHAVIOR OF TOPICAL MENTHOL FORMULATIONS ................ 36 Abstract ................................................................................................................................. 36 v Table of Contents (continued) Introduction ........................................................................................................................... 37 Materials and Methods .......................................................................................................... 40 Results ................................................................................................................................... 46 Discussion ............................................................................................................................. 54 Conclusion ............................................................................................................................. 59 CHAPTER 5 ................................................................................................................ 60 EFFECT OF DIFFERENT VEHICLES ON THE IN VITRO RELEASE OF DICLOFENAC SODIUM ............................................................................................................................... 60 Abstract: ................................................................................................................................ 60 Introduction ........................................................................................................................... 61 Material and Methods ........................................................................................................... 63 Results ................................................................................................................................... 68 Discussion ............................................................................................................................. 79 Conclusion ............................................................................................................................. 81 CHAPTER 6 ................................................................................................................ 82 FORMULATION AND EVALUATION OF A POSITIVELY CHARGED NANOEMULSION FOR THE TOPICAL DELIVERY OF MINOXIDIL ......................... 82 Abstract ................................................................................................................................. 82 Introduction ........................................................................................................................... 83 Materials and Methods .......................................................................................................... 85 Results ................................................................................................................................... 90 Discussion ............................................................................................................................. 96 vi Table of Contents (continued) Conclusion ........................................................................................................................... 100 CHAPTER 7 .............................................................................................................. 101 SUMMARY AND CONCLUSION .................................................................................... 101 REFERENCES .......................................................................................................... 105 vii LIST OF TABLES Table 1. Anhydrous gel composition Table 2. Details of TS experiment and parameter estimation Table 3. Composition (% w/w) of menthol in different vehicles Table 4. Composition (% w/w) of menthol gels containing different percentages of carbomer, propylene glycol and ethanol Table 5. Average damping factor values for menthol gel formulations Table 6. Composition of different semi-solid formulations containing 1% diclofenac sodium Table 7. Commercially available membranes and their dimensions Table 8. Recovery of DS from standard solutions after passing through different membranes Table 9. Comparison of flux values for different batches having the same composition Table 10. Flux values for inter-day and intra-day reproducibility Table 11. Comparison of flux values for different dosage strengths of all formulations containing DS Table 12. Composition of the o/w nanoemulsion formulations containing minoxidil Table 13. MNX permeation and skin uptake after 24h of passive diffusion using control solution or F9 NE viii LIST OF FIGURES Figure 1.Schematic representation of the concentration-depth profile during the tape stripping experiment. Shaded region (i.e., stratum corneum) was stripped while drug concentration left in remaining stripped skin was recorded at end of experiment Figure 2.Amount of SN in tape strips and stripped skin following unsteady-state conditions (5 min) Figure 3.Amount of SN in tape strips and stripped skin following steady-state conditions (24 h) Figure 4. (a) Average SN concentration-depth profile following application of the formulation for 5 min and 24 h; (b) Sample fit for application of formulation for 24 h: markers are observed data and solid line is fit; (c) Sample fit for application of formulation for 5 min: markers are observed data and solid line is fit. Figure 5.Simulated
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