Verfügbarkeit: Pharmaceutical photostability and stabilization technology

Pharmaceutical photostability and stabilization technology:

Gespeichert in:

Bibliographische Detailangaben
Format:	Buch
Sprache:	English
Veröffentlicht:	New York, NY [u.a.] Informa Healthcare 2007
Schriftenreihe:	Drugs and the pharmaceutical sciences 163
Schlagworte:	Médicaments - Stabilité Photochimie Drug Evaluation, Preclinical > methods Drug Packaging Drug Stability Drug stability Light > adverse effects Pharmaceutical Preparations > radiation effects Photochemistry
Online-Zugang:	Inhaltsverzeichnis Publisher description Inhaltsverzeichnis
Beschreibung:	Includes bibliographical references and index
Beschreibung:	XIV, 445 S. Ill., graph. Darst.
ISBN:	0824759249 9780824759247

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245	1	0	\|a Pharmaceutical photostability and stabilization technology \|c ed. by Joseph T. Piechocki ; Karl Thoma
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adam_text	* * I I * * * LIZ I EDITED BY JOSEPH T. PIECHOCKI PIECHOCKI ASSOCIATES WESTMINSTER, MARYLAND, U.S.A. KARL THOMA LUDWIG - MAXIMILIAN.,- UNIVERSITDT MUNICH, GERMANY INFORMA HEALTHCARE NEW YORK LONDON CONTENTS PREFACE. . . . V CONTRIBUTORS .. XLLL 1. THE HISTORY OF PHARMACEUTICAL PHOTOSTABILITY DEVELOPMENT 1 JOSEPH T. PIECHOCKI INTRODUCTION . . . . 1 SURVEYS .... 26 INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINE DEVELOPMENT . 29 REFERENCES . . . . 33 2. THE INTERNATIONAL CONFERENCE ON HARMONIZATION PHOTOSTABILITY GUIDELINE 47 HANNE HJORTH TONNESEN INTRODUCTION . . . . 47 ICH GUIDELINE . . . . 47 GUIDELINE PROBLEMS . . 48 CONCLUSION . . . . 59 REFERENCES . . . . 59 3. TERMINOLOGY 61 JOSEPH T. PIECHOCKI INTRODUCTION .... 61 GENERAL TERMINOLOGY .... 61 ICH SOURCES . . . . 71 CONCLUSION . . . . 76 REFERENCES . . . . 76 4. BASIC PRINCIPLES OF DRUG PHOTOSTABILITY TESTING 79 JOHN M. ALLEN AND SANDRA K. ALLEN INTRODUCTION . . . . 79 BASIC CONCEPTS . . . . 79 PHOTOREACTIVITY . . . . 80 KINETICS OF DRUG PHOTOREACTIONS . . . . 82 ACTINOMETRY . . . . 82 PHYSICAL COMPOSITION OF SAMPLES . . . . 83 PROTECTION OF PHOTOLABILE DRUGS . . . . 84 INTERNATIONAL COMMITTEE FOR HARMONIZATION GUIDELINE . . . . 84 CONCLUSIONS . . . . 85 REFERENCES . . . . 86 VII VIII CONTENTS 5. SPECTRA 87 JOSEPH T. PIECHOCKI INTRODUCTION .... 87 EMISSION SPECTRA . . . . 87 INCIDENT RADIATION . . . . 89 ABSORPTION SPECTRA . . . . 90 SPECTRAL POWER DISTRIBUTIONS ... 95 SUNUNARY . . . . 96 REFERENCES . . . . 97 6. SOURCES 99 JOSEPH T. PIECHOCKI INTRODUCTION . . . . 99 INTERNATIONAL CONFERENCE ON HARMONIZATION OPTIONS .. 99 INDIVIDUAL INTERNATIONAL CONFERENCE ON HARMONIZATION LAMP CLASSES .... 100 SOURCE SELECTION CRITERIA . . . . 110 LAMP STUDIES . . . . 115 ALTERNATIVE LAMPS . . . . 116 CONCLUSION .... 116 REFERENCES . . . . 117 7. GLASSES, FILTERS, AND CONTAINERS . . . . . . . . . . . . . . . . . . . . . . .. 121 JOSEPH T. PIECHOCKI INTRODUCTION .... 121 GLASSES . . . . 121 FILTERS . . . . 128 CONTAINERS . . . . 132 SUMMARY . . . . 134 REFERENCES . . . . 136 8. CHEMICAL ACTINOMETRY 139 GUNTER GAUGLITZ AND STEPHAN M. HUBIG INTRODUCTION . . . . 139 MEASUREMENT OF LIGHT FLUX (INTENSITY) .... 140 PHOTOKINETIC PRINCIPLES .... 141 SELECTED CHEMICAL ACTINOMETERS . . . . 145 SPECIAL APPLICATIONS . . . . 153 REFERENCES .... 161 9. RADIOMETRY/PHOTOMETRY 165 ROBERT ANGELO ELECTROMAGNETIC SPECTRUM . . . . 165 RADIOMETRIC AND PHOTOMETRIC CONCEPTS AND UNITS .... 165 QUALITY OF MEASUREMENT . . . . 168 PHOTOSTABILITY 174 SUMMARY 176 REFERENCES . . . . 176 CONTENTS IX 10. SAMPLE PRESENTATION FOR PHOTOSTABILITY STUDIES: PROBLEMS AND SOLUTIONS 177 STEVEN W. BAERTSCHI AND SCOTT R. THATCHER INTRODUCTION .... 177 TYPES OF STUDIES . . . . 177 PHOTOLYSIS SOURCES OR CHAMBERS .... 178 CONTAINERS .... 189 DRUG SUBSTANCE . . . . 194 DRUG PROD UCTS . . . . 198 GENERIC DRUGS . . . . 199 CONCLUSION . . . . 199 REFERENCES . . . . 200 11. DETERMINING THE KINETICS AND MECHANISM OF A PHOTOCHEMICAL REACTION 203 DOUGLAS MOORE REACTION KINETICS AND PHOTOSTABILITY . . . . 203 KINETICS OF PHOTOSENSITIZED REACTIONS . . . . 211 APPLICATION OF KINETIC MEASUREMENTS TO REACTION MECHANISM DETERMINATION IN PHOTOSTABILITY . . . . 212 REFERENCES . . . . 220 12. UNEXPECTED PHOTOCHEMISTRY IN PHARMACEUTICAL PRODUCTS: A REVIEW ON THE ROLE OF DILUENTS, EXCIPIENTS, AND PRODUCT COMPONENTS IN PROMOTING PHARMACEUTICAL PHOTOCHEMISTRY 223 ALLEN C. TEMPLETON, WILLIAM E. BOWEN, LEE J. KLEIN, PAUL A. HARMON, YLL LLI, AND ROBERT A. REED INTRODUCTION . . . . 223 DILUENT MEDIATED PHOTOCHEMISTRY . . . . 225 EXCIPIENT MEDIATED PHOTOCHEMISTRY .... 227 PRODUCT COMPONENT MEDIATED PHOTOCHEMISTRY 244 CONCLUSION . . . . 248 REFERENCES . . . . 248 13. CHAMBERS AND MAPPING . . . . . . . . . . . . . . . . . . . . . . . . . . .. 253 JOSEPH T. PIECHOCKI INTRODUCTION . . . . 253 TESTING APPARATUS/CHAMBERS 253 FLUORESCENT LAMP CHAMBERS 256 ENVIRONMENTAL GROWTH CHAMBERS (EGC) ... 259 XENON CHAMBERS . . . . 269 METAL HALIDE LAMPS . . . . 273 MAPPING . . . . 277 CONCLUSION . . . . 290 REFERENCES . . . . 290 14. CURRENT METHODS FOR THE ANALYTICAL INVESTIGATION OF THE PHOTODEGRADATION OF ACTIVE PHARMACEUTICAL INGREDIENTS AND PRODUCTS 293 KARL THOMA AND NORBERT KUBLER INTRODUCTION . . . . 293 PROCEDURE FOR PHOTOSTABILITY EXPOSURE . . . . 293 X ANALYTICAL METHODS FOR PHOTOSTABILITY TESTING .... 297 HPLC SYSTEMS . . . . 302 CONCLUSION . . . . 302 REFERENCES . . . . 303 CONTENTS 15. PHOTOSTABILIZATION BY PACKAGING 305 KARL THOMA AND WOLFGANG AMAN INTRODUCTION ... 305 GLASSES . . . . 305 PLASTICS .... 310 OTHER PACKAGING .. 317 CONCLUSION . . . . 319 REFERENCES .... 319 16. PHOTOSTABILIZATION OF SOLID AND SEMISOLID DOSAGE FORMS 323 KARL THOMA AND HEIKO SPILGIES PHOTOSTABILIZATION AS PART OF THE DRUG FORMULATION . . . . 323 PHOTOSTABILIZATION OF TABLETS .... 329 PHOTOSTABILIZATION OF CAPSULES . . . . 334 PHOTOSTABILIZATION OF DERMAL PREPARATIONS . . . . 336 CONCLUSION .... 341 REFERENCES . . . . 342 17. PHOTOSTABILITY STUDIES OF SOLUTIONS AND METHODS OF PREVENTING PHOTODEGRADATION . . . . . . . . . . . . . . . . . . . . . . . .. 345 AHMED F. ASKER INTRODUCTION . . . . 345 PHOTODEGRADATION EFFECT . . . . 345 ROUTES OF PHOTOCHEMICAL DEGRADATION . . . . 347 PHOTOSTABILITY TESTING .... 349 FACTORS AFFECTING PHOTODEGRADATION IN SOLUTIONS ... 351 PROTECTION TECHNIQUES . . . . 365 CONCLUSION . . . . 372 REFERENCES . . . . 373 18. PHOTOSTABILITY OF COSMETIC SUNSCREENS 379 HANS U. GONZENBACH INTRODUCTION . . . . 379 PHOTOSTABILITY OF SUNSCREENS . . . . 382 UV FILTERS AND THEIR PHOTOCHEMISTRY 383 DETERMINATION OF PHOTOSTABILITY . . . . 388 PHOTOSTABILIZATION . . . . 390 SYNOPSIS . 393 REFERENCES . . . . 395 19. PHOTODEGRADATION AND PHOTOPROTECTION IN CLINICAL PRACTICE 397 IRENE KRAMER INTRODUCTION . . . . 397 PHOTODEGRADATION AND PHOTOPROTECTION DURING ADMINISTRATION . . . . 398 CONTENTS PHOTODEGRADATION OF SELECTED DRUGS AND MANAGEMENT OF PHOTOPROTECTION DURING ADMINISTRATION . . . . 403 TOTAL PARENTERAL NUTRITION SOLUTIONS .... 419 CONCLUSION . . . . 423 REFERENCES . . . . 423 INDEX. . . .. . . . 429 XI
adam_txt	* * I I * * * LIZ I EDITED BY JOSEPH T. PIECHOCKI PIECHOCKI ASSOCIATES WESTMINSTER, MARYLAND, U.S.A. KARL THOMA LUDWIG - MAXIMILIAN.,- UNIVERSITDT MUNICH, GERMANY INFORMA HEALTHCARE NEW YORK LONDON CONTENTS PREFACE. . . . V CONTRIBUTORS . XLLL 1. THE HISTORY OF PHARMACEUTICAL PHOTOSTABILITY DEVELOPMENT 1 JOSEPH T. PIECHOCKI INTRODUCTION . . . . 1 SURVEYS . 26 INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINE DEVELOPMENT . 29 REFERENCES . . . . 33 2. THE INTERNATIONAL CONFERENCE ON HARMONIZATION PHOTOSTABILITY GUIDELINE 47 HANNE HJORTH TONNESEN INTRODUCTION . . . . 47 ICH GUIDELINE . . . . 47 GUIDELINE PROBLEMS . . 48 CONCLUSION . . . . 59 REFERENCES . . . . 59 3. TERMINOLOGY 61 JOSEPH T. PIECHOCKI INTRODUCTION . 61 GENERAL TERMINOLOGY . 61 ICH SOURCES . . . . 71 CONCLUSION . . . . 76 REFERENCES . . . . 76 4. BASIC PRINCIPLES OF DRUG PHOTOSTABILITY TESTING 79 JOHN M. ALLEN AND SANDRA K. ALLEN INTRODUCTION . . . . 79 BASIC CONCEPTS . . . . 79 PHOTOREACTIVITY . . . . 80 KINETICS OF DRUG PHOTOREACTIONS . . . . 82 ACTINOMETRY . . . . 82 PHYSICAL COMPOSITION OF SAMPLES . . . . 83 PROTECTION OF PHOTOLABILE DRUGS . . . . 84 INTERNATIONAL COMMITTEE FOR HARMONIZATION GUIDELINE . . . . 84 CONCLUSIONS . . . . 85 REFERENCES . . . . 86 VII VIII CONTENTS 5. SPECTRA 87 JOSEPH T. PIECHOCKI INTRODUCTION . 87 EMISSION SPECTRA . . . . 87 INCIDENT RADIATION . . . . 89 ABSORPTION SPECTRA . . . . 90 SPECTRAL POWER DISTRIBUTIONS . 95 SUNUNARY . . . . 96 REFERENCES . . . . 97 6. SOURCES 99 JOSEPH T. PIECHOCKI INTRODUCTION . . . . 99 INTERNATIONAL CONFERENCE ON HARMONIZATION OPTIONS . 99 INDIVIDUAL INTERNATIONAL CONFERENCE ON HARMONIZATION LAMP CLASSES . 100 SOURCE SELECTION CRITERIA . . . . 110 LAMP STUDIES . . . . 115 ALTERNATIVE LAMPS . . . . 116 CONCLUSION . 116 REFERENCES . . . . 117 7. GLASSES, FILTERS, AND CONTAINERS . . . . . . . . . . . . . . . . . . . . . . . 121 JOSEPH T. PIECHOCKI INTRODUCTION . 121 GLASSES . . . . 121 FILTERS . . . . 128 CONTAINERS . . . . 132 SUMMARY . . . . 134 REFERENCES . . . . 136 8. CHEMICAL ACTINOMETRY 139 GUNTER GAUGLITZ AND STEPHAN M. HUBIG INTRODUCTION . . . . 139 MEASUREMENT OF LIGHT FLUX (INTENSITY) . 140 PHOTOKINETIC PRINCIPLES . 141 SELECTED CHEMICAL ACTINOMETERS . . . . 145 SPECIAL APPLICATIONS . . . . 153 REFERENCES . 161 9. RADIOMETRY/PHOTOMETRY 165 ROBERT ANGELO ELECTROMAGNETIC SPECTRUM . . . . 165 RADIOMETRIC AND PHOTOMETRIC CONCEPTS AND UNITS . 165 QUALITY OF MEASUREMENT . . . . 168 PHOTOSTABILITY 174 SUMMARY 176 REFERENCES . . . . 176 CONTENTS IX 10. SAMPLE PRESENTATION FOR PHOTOSTABILITY STUDIES: PROBLEMS AND SOLUTIONS 177 STEVEN W. BAERTSCHI AND SCOTT R. THATCHER INTRODUCTION . 177 TYPES OF STUDIES . . . . 177 PHOTOLYSIS SOURCES OR CHAMBERS . 178 CONTAINERS . 189 DRUG SUBSTANCE . . . . 194 DRUG PROD UCTS . . . . 198 GENERIC DRUGS . . . . 199 CONCLUSION . . . . 199 REFERENCES . . . . 200 11. DETERMINING THE KINETICS AND MECHANISM OF A PHOTOCHEMICAL REACTION 203 DOUGLAS MOORE REACTION KINETICS AND PHOTOSTABILITY . . . . 203 KINETICS OF PHOTOSENSITIZED REACTIONS . . . . 211 APPLICATION OF KINETIC MEASUREMENTS TO REACTION MECHANISM DETERMINATION IN PHOTOSTABILITY . . . . 212 REFERENCES . . . . 220 12. UNEXPECTED PHOTOCHEMISTRY IN PHARMACEUTICAL PRODUCTS: A REVIEW ON THE ROLE OF DILUENTS, EXCIPIENTS, AND PRODUCT COMPONENTS IN PROMOTING PHARMACEUTICAL PHOTOCHEMISTRY 223 ALLEN C. TEMPLETON, WILLIAM E. BOWEN, LEE J. KLEIN, PAUL A. HARMON, YLL LLI, AND ROBERT A. REED INTRODUCTION . . . . 223 DILUENT MEDIATED PHOTOCHEMISTRY . . . . 225 EXCIPIENT MEDIATED PHOTOCHEMISTRY . 227 PRODUCT COMPONENT MEDIATED PHOTOCHEMISTRY '" 244 CONCLUSION . . . . 248 REFERENCES . . . . 248 13. CHAMBERS AND MAPPING . . . . . . . . . . . . . . . . . . . . . . . . . . . 253 JOSEPH T. PIECHOCKI INTRODUCTION . . . . 253 TESTING APPARATUS/CHAMBERS 253 FLUORESCENT LAMP CHAMBERS 256 ENVIRONMENTAL GROWTH CHAMBERS (EGC) . 259 XENON CHAMBERS . . . . 269 METAL HALIDE LAMPS . . . . 273 MAPPING . . . . 277 CONCLUSION . . . . 290 REFERENCES . . . . 290 14. CURRENT METHODS FOR THE ANALYTICAL INVESTIGATION OF THE PHOTODEGRADATION OF ACTIVE PHARMACEUTICAL INGREDIENTS AND PRODUCTS 293 KARL THOMA AND NORBERT KUBLER INTRODUCTION . . . . 293 PROCEDURE FOR PHOTOSTABILITY EXPOSURE . . . . 293 X ANALYTICAL METHODS FOR PHOTOSTABILITY TESTING . 297 HPLC SYSTEMS . . . . 302 CONCLUSION . . . . 302 REFERENCES . . . . 303 CONTENTS 15. PHOTOSTABILIZATION BY PACKAGING 305 KARL THOMA AND WOLFGANG AMAN INTRODUCTION . 305 GLASSES . . . . 305 PLASTICS . 310 OTHER PACKAGING . 317 CONCLUSION . . . . 319 REFERENCES . 319 16. PHOTOSTABILIZATION OF SOLID AND SEMISOLID DOSAGE FORMS 323 KARL THOMA AND HEIKO SPILGIES PHOTOSTABILIZATION AS PART OF THE DRUG FORMULATION . . . . 323 PHOTOSTABILIZATION OF TABLETS . 329 PHOTOSTABILIZATION OF CAPSULES . . . . 334 PHOTOSTABILIZATION OF DERMAL PREPARATIONS . . . . 336 CONCLUSION . 341 REFERENCES . . . . 342 17. PHOTOSTABILITY STUDIES OF SOLUTIONS AND METHODS OF PREVENTING PHOTODEGRADATION . . . . . . . . . . . . . . . . . . . . . . . . 345 AHMED F. ASKER INTRODUCTION . . . . 345 PHOTODEGRADATION EFFECT . . . . 345 ROUTES OF PHOTOCHEMICAL DEGRADATION . . . . 347 PHOTOSTABILITY TESTING . 349 FACTORS AFFECTING PHOTODEGRADATION IN SOLUTIONS . 351 PROTECTION TECHNIQUES . . . . 365 CONCLUSION . . . . 372 REFERENCES . . . . 373 18. PHOTOSTABILITY OF COSMETIC SUNSCREENS 379 HANS U. GONZENBACH INTRODUCTION . . . . 379 PHOTOSTABILITY OF SUNSCREENS . . . . 382 UV FILTERS AND THEIR PHOTOCHEMISTRY 383 DETERMINATION OF PHOTOSTABILITY . . . . 388 PHOTOSTABILIZATION . . . . 390 SYNOPSIS . 393 REFERENCES . . . . 395 19. PHOTODEGRADATION AND PHOTOPROTECTION IN CLINICAL PRACTICE 397 IRENE KRAMER INTRODUCTION . . . . 397 PHOTODEGRADATION AND PHOTOPROTECTION DURING ADMINISTRATION . . . . 398 CONTENTS PHOTODEGRADATION OF SELECTED DRUGS AND MANAGEMENT OF PHOTOPROTECTION DURING ADMINISTRATION . . . . 403 TOTAL PARENTERAL NUTRITION SOLUTIONS . 419 CONCLUSION . . . . 423 REFERENCES . . . . 423 INDEX. . . . . . . 429 XI
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series	Drugs and the pharmaceutical sciences
series2	Drugs and the pharmaceutical sciences
spelling	Pharmaceutical photostability and stabilization technology ed. by Joseph T. Piechocki ; Karl Thoma New York, NY [u.a.] Informa Healthcare 2007 XIV, 445 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 163 Includes bibliographical references and index Médicaments - Stabilité Photochimie Drug Evaluation, Preclinical methods Drug Packaging Drug Stability Drug stability Light adverse effects Pharmaceutical Preparations radiation effects Photochemistry Piechocki, Joseph T. Sonstige oth Thoma, Karl 1931-2002 Sonstige (DE-588)121050777 oth Drugs and the pharmaceutical sciences 163 (DE-604)BV000002008 163 http://www.gbv.de/dms/bs/toc/515028444.pdf lizenzfrei Inhaltsverzeichnis http://www.loc.gov/catdir/enhancements/fy0665/2006049564-d.html Publisher description lizenzfrei GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016275849&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis
spellingShingle	Pharmaceutical photostability and stabilization technology Drugs and the pharmaceutical sciences Médicaments - Stabilité Photochimie Drug Evaluation, Preclinical methods Drug Packaging Drug Stability Drug stability Light adverse effects Pharmaceutical Preparations radiation effects Photochemistry
title	Pharmaceutical photostability and stabilization technology
title_auth	Pharmaceutical photostability and stabilization technology
title_exact_search	Pharmaceutical photostability and stabilization technology
title_exact_search_txtP	Pharmaceutical photostability and stabilization technology
title_full	Pharmaceutical photostability and stabilization technology ed. by Joseph T. Piechocki ; Karl Thoma
title_fullStr	Pharmaceutical photostability and stabilization technology ed. by Joseph T. Piechocki ; Karl Thoma
title_full_unstemmed	Pharmaceutical photostability and stabilization technology ed. by Joseph T. Piechocki ; Karl Thoma
title_short	Pharmaceutical photostability and stabilization technology
title_sort	pharmaceutical photostability and stabilization technology
topic	Médicaments - Stabilité Photochimie Drug Evaluation, Preclinical methods Drug Packaging Drug Stability Drug stability Light adverse effects Pharmaceutical Preparations radiation effects Photochemistry
topic_facet	Médicaments - Stabilité Photochimie Drug Evaluation, Preclinical methods Drug Packaging Drug Stability Drug stability Light adverse effects Pharmaceutical Preparations radiation effects Photochemistry
url	http://www.gbv.de/dms/bs/toc/515028444.pdf http://www.loc.gov/catdir/enhancements/fy0665/2006049564-d.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016275849&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
volume_link	(DE-604)BV000002008
work_keys_str_mv	AT piechockijosepht pharmaceuticalphotostabilityandstabilizationtechnology AT thomakarl pharmaceuticalphotostabilityandstabilizationtechnology

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