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CHARACTERIZATION of ELECTROSPUN DLPLGA NANOFIBERS for a DRUG DELIVERY SYSTEM for INTRACRANIAL TUMORS and Avms

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CHARACTERIZATION of ELECTROSPUN DLPLGA NANOFIBERS for a DRUG DELIVERY SYSTEM for INTRACRANIAL TUMORS and Avms Copyright Warning & Restrictions The copyright law of the United States (Title 17, United States Code) governs the making of photocopies or other reproductions of copyrighted material. Under certain conditions specified in the law, libraries and archives are authorized to furnish a photocopy or other reproduction. One of these specified conditions is that the photocopy or reproduction is not to be “used for any purpose other than private study, scholarship, or research.” If a, user makes a request for, or later uses, a photocopy or reproduction for purposes in excess of “fair use” that user may be liable for copyright infringement, This institution reserves the right to refuse to accept a copying order if, in its judgment, fulfillment of the order would involve violation of copyright law. Please Note: The author retains the copyright while the New Jersey Institute of Technology reserves the right to distribute this thesis or dissertation Printing note: If you do not wish to print this page, then select “Pages from: first page # to: last page #” on the print dialog screen The Van Houten library has removed some of the personal information and all signatures from the approval page and biographical sketches of theses and dissertations in order to protect the identity of NJIT graduates and faculty. ABSTRACT CHARACTERIZATION OF ELECTROSPUN DLPLGA NANOFIBERS FOR A DRUG DELIVERY SYSTEM FOR INTRACRANIAL TUMORS AND AVMs by Kimberly A. Griswold Eecosiig ocesses ay eecic ies o a oyme souio i oe o ouce sas o oyme i e aoscae age ese oyme ies ae maiuae o ei oosiy ig suace aea ieess a uiomiy I oe o ceae e iea ug eiey sysem o iacaia aeioeous maomaios (AMs a umos oy-(acice-oy-gycoie (GA aoies wee eecosu i a eayoua ( soe ee iee coceaio aios o GA 5/15 / a 75/5 wee aaye o oai e ime ase o ug aeaio 13-is (- cooey-1-iosouea (CU was e coissoe wi e GA aoies o om a omogeous souio eecosu a aaye o ug caaceiaio e SEM aaysis sowe a ie iamee is o a ucio o ug esece e GA gas sowe ie aiaio i mass oss i comaig e eecosu ie o e ug comie ie e SC aaysis oie a g aue aou -53°C o o e aw oyme a e eecosu ie is oie oo a e eecosiig ocess oes o aec e cemica aue o e oyme e esece o CU o e oyme (cose /-1w was eemie y e cage i g osee o e SC gas om a aue o -53°C o wo aues o 19°C a 19°C CHARACTERIZATION OF ELECTROSPUN DLPLGA NANOFIBERS FOR A DRUG DELIVERY SYSTEM FOR INTRACRANIAL TUMORS AND AVMs by Kimberly A. Griswold A Thesis Submitted to the Faculty of New Jersey Institute of Technology In Partial Fulfillment of the Requirements for the Degree of Master of Science in Biomedical Engineering Department of Biomedical Engineering January 2004 APPROVAL PAGE CHARACTERIZATION OF ELECTROSPUN DLPLGA NANOFIBERS FOR A DRUG DELIVERY SYSTEM FOR INTRACRANIAL TUMORS AND AVMs Kimberly A. Griswold Micae ae esyAiso ae eseac oesso o iomaeias I Caes esigiaeOmo esis Co-Aiso ae Meica oco a Assisa oesso o euoogica Sugey a aioogy UM Micae uag Commiee Meme ae Associae oesso o Cemica Egieeig I eea Aie Commiee Meme ae Assisa oesso o iomeica Egieeig I BIOGRAPHICAL SKETCH Author: Kimey A Giswo Degree: Mases o Sciece Date: auay Undergraduate and Graduate Education: • Mase o Sciece i iomeica Egieeig Coceaio i oyme Sciece a iomaeias ew esey Isiue o ecoogy ewak • aceo o Sciece i iomeica Egieeig Coceaio i Oics Uiesiy o ocese ocese Y Major: iomeica Egieeig Coceaio i oyme Sciece a iomaeias Dedicated to the memory of my grandfather, Augustus W. Griswold, co-founder of Dynak Incorporated, engineer, innovative thinker, and inventor. Also to my devout and patient family and friends who through enlightenment allowed me to be comfortable in my own skin. Finally, to my Korean family, all inclusive, known and unknown - for the gift of life, new and old, and for anonymity. v ACKNOWLEDGMENT I would first like to recognize the support and guidance of Dr. Michael Jaffe and Dr. Charles J. Prestigiacomo in not only my academic endeavors, but my personal ones as well. Dr. Michael Jaffe served as my research advisor, but was very influential in the academic path chosen and the career choices I have made. Dr. Charles J. Prestigiacomo served as my assistant research advisor and provided constant support, encouragement, and intellectual stimulation to keep me motivated throughout the project. Special Thanks goes to Dr. Michael Huang for providing such an amazing academic experience and guiding me to a particular field of concentration for this thesis research. It is he to whom I owe all my newfound interest and my desire to obtain greater knowledge in polymer science. Appreciation to my fellow graduate students in the Medical Device and Concept Laboratory, particularly Shobana Shanmugasundaram for her assistance and knowledge in the electrospinning process, and fine-tuned SEM and computer technique. Finally, particular acknowledgment to Joseph Pickton for his judgment and knowledge of Polymer Science, his support and strong shoulder to lean on, and his keen wit for humor. vi AE O COES Chptr Page 1 IOUCIO I 11 Oecie I I ackgou Iomaio 2 I1 Iacaia ascua omaios 3 I Cue eame Meos 7 13 amakieics o CU 11 1 ioegaae oymes 13 15 Kieics o ug eease I5 1 GA Caaceisics 24 EECOSIIG ECIQUE 9 3 MAEIAS 33 MEOOOGY 37 1 Eecosiig ocess 37 Caaceiaio o Eecosu ies 3 3 Eecosiig a Caaceiaio o ug a oyme Come 5 ESUS I ISCUSSIO 73 7 COCUSIO 7 AEI A CAACEISICS O ESECIE AIOS O A A GA 7 AEI IOCOMAIIIY O ACIE/GYCOIE CO- OYMES 79 vii TABLE OF CONTENTS (Continued) Chapter Page APPENDIX C MECHANICAL PROPERTIES OF MEDISORB® POLYMERS... 81 APPENDIX D SOLUBILITY CHART OF MEDISORB® POLYMERS 82 APPENDIX E THERMAL ANALYSIS DATA OF MEDISORB® POLYMERS 83 APPENDIX F CHEMICAL PROPERTIES OF BCNU 84 APPENDIX G GMP ANALYSIS OF 75/25 DLPLGA POLYMER 87 APPENDIX H GMP ANALYSIS OF 85/15 DLPLGA POLYMER 88 APPENDIX I NON-GMP ANALYSIS OF 80/20 DLPLGA POLYMER 89 APPENDIX J POLYMER CHARACTERISTICS OF MEDISORB® POLYMERS 90 APPENDIX K ENVIRONMENTALLY SENSITIVE DRUG RELEASE SYSTEMS 91 REFERENCES 92 iii LIST OF TABLES Table Page 31 ouc Iomaio 33 51 ie Oseaios Usig OM 3 5 aoie iamee 60 53 OM ie Oseaios I 5 5/15-15w ecoe iamee 62 55 Measue iamee o /-Iw + CU 62 ix LIST OF FIGURES Figure Page I.1 (a)Normal arteriovenous anatomy, (b) AVM, (c) advanced AVM with down stream aneurysm 4 I.2 I,3-bis (2-chloroethyl)-1-nitrosoureal 1I I.3 Reservoir systems (a) implantable/oral, (b) transdermal 17 1.4 Environmentally responsive systems (a) reservoir, (b) matrix in swelling- controlled release systems 18 1.5 Basic changes in polymer structure for environmentally sensitive systems due to swelling 20 I.6 (a) Bulk erosion drug delivery, (b) surface degradation for drug release .... 22 I.7 Microspheres of 60 lactide:glycolide PLGA 23 1.8 75:25 lactide:glycolide PLGA microparticles by bulk hydrolysis 23 I.9 (a) surface erosion of polyorthoester rods after 9weeks and (b) l6weeks ..... 23 1.I0 Ring opening polymerization of glycolide dimer to polyglycolic acid 24 1.11 Ring opening polymerization of lactide to polylactides 25 I.12 Degradation and metabolization of PLGA 28 2.1 (a) Fluid jet, (b) Splaying, (c) Whipping motion 30 2.2 Electrospinning setup 3I 5.1 Branching morphology observed in glove samples using OM, magnification of 50 46 5.2 (a) 80/20-10wt% 11/19/03 2 gauge 48 5.2 (b) 80/20-6wt% 1I/20/03 22 gauge 49 5.2 (c) 80/20-6wt% II/20/03 22 gauge 49 5.2 (d) 80/20-10wt% 11/25/03 20 gauge 50 IS O IGUES (Cntnd r Page 5 (e /-1w 1I/5/3 gauge 5 5 ( /-1w 1I/5/3 gauge 51 5 (g /-Iw 11/5/3 gauge 51 5 ( /-1w 1I/5/3 gauge 5 5 (i 5/15-w 1/1/3 gauge 5 5 ( 5/15-w 1/1/3 gauge 53 5 (k 5/I5-w 1/I/3 gauge 53 5 (1 5/I5-w 1/1/3 gauge 5 5 (m 5/15-1w 1//3 gauge 5 5 ( 5/15-1w 1//3 gauge 55 5 (o 5/15-1w 1//3 gauge 55 5 ( Goe same-mui 11/15/3 5 5 (q Goe same-mui I1/I5/3 57 5 ( 5/I5-15w 1/I7/3 gauge 57 5 (s 5/I5-15w 1/I7/3 gauge 5 5 ( /-1w + CU I/I/3 gauge 5 5 (u /-1w + CU 1/I/3 gauge 59 5 ( /-Iw + CU 1/1/3 gauge 59 53 (a GA o 1w aoie wi —3w mass oss 3 53 ( GA o 1w aoie wi —3w mass oss 64 5 (a SC o / GA is ea cyce 66 x LIST OF FIGURES (Continued) Figure Page 5 ( SC o / GA is ea cyce 7 5 (c SC o / GA is ea cyce 68 5 ( SC o / GA is ea cyce 7 5 (e SC o / GA is ea cyce 71 5 ( SC o / GA is ea cyce 7 1 Icease isace iamee eceases om 5um o 333m 73 ii CAE IOUCIO . Objtv The objective for this thesis research is to use the electrospinning process in order to create a D, L poly-(lactide-poly-glycolide) (DLPLGA) drug delivery system, using the drug 1,3-bis (2-chloroethyl)-1-nitrosourea (BCNU), to target intracranial vascular malformations and tumors.
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