Transmucosal Nasal Drug Delivery: Systemic Bioavailability of ...

More documents

Recommendations

Info

11 References Tschirch, F.T., K. Gopfert, J.M. Frohlich, G. Brunner and D. Weishaupt 2006 Low-dose intranasal versus oral midazolam for routine body MRI of claustrophobic patients. Eur Radiol. U.Haas, J.M., R.Schreckenberger, H.J.Bardenheuer, E.Martin 1998 Prämedikation und präoperative Nahrungskarenz in der Kinderanästhesie. Der Anaesthesist 47:838-843. Uygur-Bayramicli, O., R. Dabak, T. Kuzucuoglu and B. Kavakli 2002 Sedation with intranasal midazolam in adults undergoing upper gastrointestinal endoscopy. J Clin Gastroenterol 35(2):133-7. Van Asselt, D.Z.B., F.W.H.M. Merkus, F.G.M. Russel and W.H.L. Hoefnagels 1998 Nasal absorption of hydroxocobalamin in healthy elderly adults. British Journal of Clinical Pharmacology 45(1):83- 86. van den Berg, M.P., J.C. Verhoef, S.G. Romeijn and F.W. Merkus 2004 Uptake of estradiol or progesterone into the CSF following intranasal and intravenous delivery in rats. Eur J Pharm Biopharm 58(1):131-5. van der Lubben, I.M., J.C. Verhoef, G. Borchard and H.E. Junginger 2001 Chitosan and its derivatives in mucosal drug and vaccine delivery. Eur J Pharm Sci 14(3):201-7. Visser, S.A., F.L. Wolters, J.M. Gubbens-Stibbe, E. Tukker, P.H. Van Der Graaf, L.A. Peletier and M. Danhof 2003 Mechanism-based pharmacokinetic/pharmacodynamic modeling of the electroencephalogram effects of GABAA receptor modulators: in vitro-in vivo correlations. J Pharmacol Exp Ther 304(1):88-101. Wang, R., Y. Fang, F. Pei, J. Li, X. Chen, L. Xu and Z. Zhang 2004 Study on the bioequivalence of salmon calcitonin nasal spray in Chinese healthy volunteers. Zhongguo Linchuang Yaolixue Zazhi 20(1):45-48. Weinbroum, A.A., O. Szold, D. Ogorek and R. Flaishon 2001 The midazolam-induced paradox phenomenon is reversible by flumazenil. Epidemiology, patient characteristics and review of the literature. Eur J Anaesthesiol 18(12):789-97. Winther, B., S. Brofeldt, H. Gronborg and N. Mygind 1983 Pathology of naturally occurring colds. Eur J Respir Dis Suppl 128 (Pt 1):345-7. Wolfe, T.R. and T. Bernstone 2004 Intranasal drug delivery: an alternative to intravenous administration in selected emergency cases. J Emerg Nurs 30(2):141-7. Woodley, J. 2001 Bioadhesion: new possibilities for drug administration? Clin Pharmacokinet 40(2):77-84. Xu, W., Y. Shen, Z. Jiang, Y. Wang, Y. Chu and S. Xiong 2004 Intranasal delivery of chitosan-DNA vaccine generates mucosal SIgA and anti-CVB3 protection. Vaccine 22(27- 28):3603-12. Yanagihara, Y., M. Ohtani, S. Kariya, K. Uchino, T. Hiraishi, N. Ashizawa, T. Aoyama, Y. Yamamura, Y. Yamada and T. Iga 2003 Plasma concentration profiles of ketamine and norketamine after administration of various ketamine preparations to healthy Japanese volunteers. Biopharm Drug Dispos 24(1):37-43. Yu, S., Y. Zhao, F. Wu, X. Zhang, W. Lu, H. Zhang and Q. Zhang 2004 Nasal insulin delivery in the chitosan solution: in vitro and in vivo studies. Int J Pharm 281(1-2):11-23. Zerrouk, N., G. Corti, S. Ancillotti, F. Maestrelli, M. Cirri and P. Mura 2006 Influence of cyclodextrins and chitosan, separately or in combination, on glyburide solubility and permeability. Eur J Pharm Biopharm 62(3):241-6. Zhang, X., Q.Y. Zhang, D. Liu, T. Su, Y. Weng, G. Ling, Y. Chen, J. Gu, B. Schilling and X. Ding 2005 Expression of cytochrome p450 and other biotransformation genes in fetal and adult human nasal mucosa. Drug Metab Dispos 33(10):1423-8. Katja Suter-Zimmermann Page 186 of 188 University of Basel, 2008
12 Curriculum vitae 12 Curriculum vitae Personal Data Name Date and place of birth Native place Nationality Katja Suter-Zimmermann November 29, 1978; Aarau AG Suhr AG, Oberbözberg AG Swiss Education 1985 - 1989 Primarschule, Leutwil AG 1989 - 1990 Mittelstufe, Dürrenäsch AG 1990 - 1994 Bezirksschule Seengen AG 1994 - 1998 Neue Kantonsschule Aarau AG (Matura Type D) 1998 - 2003 Studies in pharmaceutical sciences, University of Basel; Master’s degree; Master’s thesis “Midazolam in der Pädiatrie: Entwicklung einer oralen und nasalen flüssigen Midazolam- Formulierung für die Pädiatrie“ (Hospital Pharmacy, University Hospital Basel), supervised by Prof. Dr. phil. C. Surber, Prof. Dr. phil. G. Imanidis, C. Pellanda Since 2004 PhD at Hospital Pharmacy, University Hospital Basel supervised by Prof. Dr. phil. C. Surber: “Transmucosal Nasal Drug Delivery – Systemic Bioavailability of Nasally Applied Midazolam” 2004 - 2006 Graduate study in drug discovery and development, organized by the Pharmacenter Basel- Zurich in collaboration with Novartis and Roche 2005 - 2006 WIN-Project 05 (a project of the University of Basel and Novartis) Work Experience 2000 - 2001 Practical training at Apotheke Göldlin Aarau AG (six months) and at the Hospital Pharmacy, Kantonsspital Aarau AG (six months) 2001 - 2007 regular stand-in at Apotheke Göldlin, Aarau AG 2002 stand-in at Pharmacia Nuova, Brissago TI (two weeks) 2004 stand-in at Dorf-Apotheke, Naters VS (one week) 2004 stand-in at Marty Apotheke, Brig VS (two months) 2005 Supervision of the Master’s thesis of Robert Witschi “Entwicklung und in vitro Freisetzung von nasalen Midazolam Formulierungen“ 2006 Planning and realization of a phase I pharmacokinetic trial (Pharmacokinetics of transmucosal nasal delivered midazolam). This project was carried out in collaboration with Dr. med. M. Haschke, Division of Clinical Pharmacology and Toxicology, Universtity Hospital Basel 2006 - 2007 Clinical Research Assistance in a multicenter trial, phase III (Transmucosal nasal delivery of low-dose midazolam – evaluation of two preparations for procedural anxiolysis). This project was carried out in collaboration with PD Dr. med. D. Weishaupt and Dr. med F.T.C. Tschirch, Institute of Diagnostic Radiology, University Hospital Zurich; Dr. med. B. Eckhardt and J. Beranek, Institute of Radiology, Kantonsspital Winterthur; Prof. Dr. med. A. Nidecker, Imamed Radiologie Nordwest, Basel; Prof. Dr. med. J. Hodler and Dr. med. U. Studler, Department of Radiology, Orthopedic University Hospital Balgrist, Zurich; and Dr. sc. nat. J.M. Fröhlich, Akroswiss AG, Zurich Award 2003 1. Preis Junior für die Beste Arbeit, “Nasale Applikation in der Pädiatrie – Eine Alternative?“ annual meeting 2003 of Swiss Society of Public Health Administration and Hospital Pharmacists Katja Suter-Zimmermann Page 187 of 188 University of Basel, 2008
Page 1:
TRANSMUCOSAL NASAL DRUG DELIVERY Sy
Page 5 and 6:
Acknowledgments At the Hospital Pha
Page 7:
Index EXPERIMENTAL SECTION 5 Projec
Page 11 and 12:
Summary Summary Transmucosal nasal
Page 13:
Summary Project III: In this random
Page 17:
THEORETICAL SECTION
Page 20 and 21:
1. Nasal drug delivery 1.2 Transmuc
Page 22 and 23:
1. Nasal drug delivery 1.3 Challeng
Page 25 and 26:
2. Impact of anatomy and physiology
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
3. Midazolam 3 Midazolam 3.1 Physic
Page 33 and 34:
3. Midazolam 3.2.1 Indications and
Page 35 and 36:
3. Midazolam Administration of high
Page 37 and 38:
3. Midazolam gastrointestinal tract
Page 39 and 40:
4. Compounding of nasal midazolam p
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49:
Page 53 and 54:
5. Project I: Development of prepar
Page 55 and 56:
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67:
Page 70 and 71:
6. Project II: Pharmacokinetic of t
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 91 and 92:
7. Project III: Transmucosal nasal
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103:
Page 106 and 107:
8 Overall discussion pharmacokineti
Page 108 and 109:
8 Overall discussion considered as
Page 111:
Appendix
Page 114 and 115:
10 Appendix 10.2 Project I 10.2.1 R
Page 116 and 117:
10 Appendix 10.2.4 Specification: M
Page 118 and 119:
10 Appendix 10.2.6 Specification: C
Page 120 and 121:
10 Appendix Katja Suter-Zimmermann
Page 122 and 123:
10 Appendix 10.2.9 Specification: C
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145: 10 Appendix Katja Suter-Zimmermann
Page 150 and 151: 10 Appendix 10.3.2 Case report form
Page 158 and 159: 10 Appendix Frequency 10.3.5 Intens
Page 160 and 161: 10 Appendix 10.3.7 Serumconcentrati
Page 162 and 163: 10 Appendix Identification midazola
Page 168 and 169: 10 Appendix 10.3.8 Midazolam serum
Page 170 and 171: 10 Appendix 10.3.10 Nasal delivery
Page 174 and 175: 10 Appendix 10.4.3 Flowchart: multi
Page 185 and 186: 11 References 11 References Abrams,
Page 187 and 188: 11 References Erjefalt, J.S., I. Er
Page 189 and 190: 11 References Irie, T. and K. Uekam
Page 191 and 192: 11 References Malinovsky, J.M., C.
Page 193: 11 References Scheepers, M., B. Sch
show all

Transmucosal Nasal Drug Delivery: Systemic Bioavailability of ...

Create successful ePaper yourself

Delete template?

Save as template?