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Pharmaceutical Photostability and Stabilization Technology-[1]-[pdf]-[T. Piechocki Joseph, Karl Thoma]

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    书籍信息:
    标题: Pharmaceutical Photostability and Stabilization Technology
    语言: English
    格式: pdf
    大小: 46.1M
    页数: 439
    年份: 2006
    作者: T. Piechocki Joseph, Karl Thoma
    版次: 1
    系列: Drugs and the Pharmaceutical Sciences
    出版社: Informa Healthcare

    简介

    Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background in the scientific principles involved in photostability testing. Presenting the advantages and disadvantages of various procedures so the reader can select and utilize the most appropriate technique best-suited to their needs, this source includes references to current literature in the field and offers an opinion on future opportunities and challenges.


    目录
    Pharmaceutical Photostability
    and Stabilization Technology......Page 10
    Table of Contents......Page 15
    DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs......Page 2
    Preface......Page 13
    REFERENCES......Page 14
    Contributors......Page 20
    Bordier......Page 22
    Table of Contents......Page 0
    Coebergh......Page 23
    Arny......Page 26
    Blythe......Page 31
    Lachman et al.......Page 32
    Reisch......Page 34
    Thoma......Page 35
    Kerker......Page 36
    Gauglitz......Page 37
    Tønnesen......Page 38
    Moore......Page 39
    Beaumont......Page 41
    Piechocki......Page 43
    Matsuda......Page 44
    Matsuo......Page 45
    Lachman et al.......Page 47
    Alsante et al.......Page 48
    Japanese......Page 49
    Draft 1......Page 50
    Draft 2......Page 51
    Draft 4......Page 52
    Final Document......Page 53
    REFERENCES......Page 54
    Forced Degradation Studies......Page 67
    Irradiation Sources......Page 68
    Source Selection......Page 69
    Exposure Level......Page 70
    Irradiance Level and Temperature Effects......Page 72
    Sample Cooling......Page 73
    Calibration......Page 74
    Meter Calibration......Page 75
    Presentation of Samples......Page 76
    Interpretation of Data......Page 77
    REFERENCES......Page 79
    Light......Page 81
    Einstein......Page 83
    Equivalency......Page 84
    Inner Filter Effect......Page 85
    Room Light......Page 86
    Lux (lx)......Page 87
    Photochromism......Page 88
    Photometer......Page 89
    Radiometer......Page 90
    D65......Page 91
    Xenon Lamps......Page 92
    Metal-Halide Lamps......Page 93
    Cool White......Page 95
    REFERENCES......Page 96
    BASIC CONCEPTS......Page 99
    Direct Drug Photoreactivity......Page 100
    Indirect Photoreactivity......Page 101
    ACTINOMETRY......Page 102
    Solid Tablets......Page 103
    INTERNATIONAL COMMITTEE FOR HARMONIZATION GUIDELINE......Page 104
    CONCLUSIONS......Page 105
    REFERENCES......Page 106
    EMISSION SPECTRA......Page 107
    Arc Lamps......Page 108
    INCIDENT RADIATION......Page 109
    ABSORPTION SPECTRA......Page 110
    Activation Spectra......Page 111
    Action Spectra......Page 112
    Pseudo-Action Spectrum......Page 114
    SPECTRAL POWER DISTRIBUTIONS......Page 115
    SUMMARY......Page 116
    REFERENCES......Page 117
    INTERNATIONAL CONFERENCE ON HARMONIZATION OPTIONS......Page 119
    Fluorescent Lamps......Page 120
    Ultraviolet Lamps......Page 124
    Visible Lamps......Page 125
    Xenon Lamps......Page 126
    SOURCE SELECTION CRITERIA......Page 130
    LAMP STUDIES......Page 135
    CONCLUSION......Page 136
    REFERENCES......Page 137
    GLASSES......Page 140
    Quartz......Page 143
    Aging......Page 144
    Window (Plate) Glass......Page 145
    Self-Cleaning Glass......Page 146
    FILTERS......Page 147
    Absorption......Page 148
    Dichroic......Page 149
    Plastic......Page 150
    CONTAINERS......Page 151
    SUMMARY......Page 153
    REFERENCES......Page 155
    INTRODUCTION......Page 158
    Chemical Methods......Page 159
    Basic Photokinetic Equations......Page 160
    Amount of Radiation Absorbed......Page 161
    Monitoring of Actinometer Response: Spectrophotometric Analysis......Page 163
    SELECTED CHEMICAL ACTINOMETERS......Page 164
    The Azobenzene Actinometer......Page 165
    The Meso-diphenylhelianthrene Actinometer......Page 167
    The Aberchrome 540 Actinometer......Page 168
    The Potassium Reineckate Actinometer......Page 169
    The Quinine Actinometer......Page 170
    SPECIAL APPLICATIONS......Page 172
    Laser Actinometry with Ferrioxalate......Page 173
    Laser Intensity Measurements with the Azobenzene Actinometer......Page 174
    Laser Intensity Measurements with a Photooxygenation Actinometer......Page 175
    Chemical Actinometry of Polychromatic Light Sources......Page 176
    The Matsuura Method for Approximate Estimates of Solid-State Quantum Yields......Page 178
    The First Actinometric Reaction on a Solid Support......Page 179
    REFERENCES......Page 180
    Radiant Flux (Power) and Luminous Flux (Lumen)......Page 183
    Radiant and Luminous Intensity......Page 184
    Radiance and Luminance......Page 185
    QUALITY OF MEASUREMENT......Page 186
    Spatial Response......Page 187
    Spectral Response......Page 188
    Absolute Calibration......Page 191
    PHOTOSTABILITY......Page 192
    REFERENCES......Page 194
    Forced Degradation......Page 195
    Sources......Page 196
    Chambers......Page 197
    Mapping......Page 200
    Chamber Temperature and Lamp Intensity......Page 204
    Temperature Control......Page 206
    CONTAINERS......Page 207
    Cross-Contamination of Samples......Page 208
    Greenhouse Effect......Page 209
    Shading......Page 211
    DRUG SUBSTANCE......Page 212
    DRUG PRODUCTS......Page 216
    CONCLUSION......Page 217
    REFERENCES......Page 218
    REACTION KINETICS AND PHOTOSTABILITY......Page 220
    Derivation of the Photochemical Rate Equation......Page 223
    Experimental Examples......Page 225
    Deviations from First-Order Kinetics......Page 226
    KINETICS OF PHOTOSENSITIZED REACTIONS......Page 228
    APPLICATION OF KINETIC MEASUREMENTS TO REACTION MECHANISM DETERMINATION IN PHOTOSTABILITY......Page 229
    Initial Mechanism Studies......Page 230
    Singlet Oxygen Detection......Page 231
    Free-Radical Formation......Page 232
    Laser Flash Photolysis......Page 234
    Detection of Free Radicals......Page 235
    Photodehalogenation Reactions......Page 236
    REFERENCES......Page 237
    INTRODUCTION......Page 239
    DILUENT MEDIATED PHOTOCHEMISTRY......Page 241
    EXCIPIENT MEDIATED PHOTOCHEMISTRY......Page 243
    PRODUCT COMPONENT MEDIATED PHOTOCHEMISTRY......Page 260
    REFERENCES......Page 264
    TESTING APPARATUS/CHAMBERS......Page 268
    FLUORESCENT LAMP CHAMBERS......Page 271
    Binder GmbH......Page 272
    Caron......Page 273
    Environmental Specialties (LUWA)......Page 274
    Hotpack (SP Industries)......Page 275
    Nagano Science......Page 276
    Percival Scientific, Inc.......Page 277
    Powers Scientific, Inc.......Page 278
    Q-Lab Corporation......Page 279
    Termaks......Page 280
    Weiss Gallenkamp......Page 281
    Atlas Material Testing Technology LLC......Page 284
    Luzchem Research Inc......Page 286
    Q-Lab......Page 287
    Atlas Material Testing Technology LLC......Page 288
    Dr. Hönle......Page 289
    Rumed® (Rubarth Apparate GmbH)......Page 291
    MAPPING......Page 292
    Brumfield......Page 294
    Clapham and Sanderson......Page 298
    Baertschi......Page 304
    REFERENCES......Page 305
    Selection of a Suitable Photostability Testing Cabinet......Page 308
    Measurement of the Photon Exposure......Page 310
    Selection of a Suitable Photon Dose......Page 311
    Spectrophotometry......Page 312
    High Performance Liquid Chromatography......Page 313
    Liquid Chromatography-Mass Spectrometry......Page 315
    Particle Beam......Page 316
    CONCLUSION......Page 317
    REFERENCES......Page 318
    Brown Glass......Page 319
    Other Colors......Page 322
    Layer Thickness......Page 323
    Immediate Containers for Liquid Dosage Forms......Page 324
    Blisters......Page 325
    Blisters......Page 326
    Colored......Page 327
    Foils......Page 331
    Cartons......Page 332
    REFERENCES......Page 333
    Influence of Concentration......Page 336
    Influence of Sample Geometry......Page 337
    Influence of the Sample Surface and Volume......Page 338
    Influence of the Drug Physical Form......Page 339
    Influence of Humidity......Page 341
    Ultraviolet Absorbers......Page 342
    Food Colorants......Page 344
    Film Coatings......Page 345
    Photoinstability of Dyes......Page 346
    Shell Additives......Page 347
    Microencapsulation......Page 348
    Testing of Dermal Preparations......Page 349
    Formulation Factors......Page 350
    Photostabilization by Spectral Overlay......Page 351
    Photostabilization by Opacification......Page 352
    Photostabilization by Cyclodextrin and Liposome Inclusion......Page 353
    CONCLUSION......Page 354
    REFERENCES......Page 355
    Change of Potency......Page 357
    Photocarcinogenicity......Page 358
    Photosensitized Degradation......Page 359
    PHOTOSTABILITY TESTING......Page 361
    Buffer Species......Page 363
    Ionic Strength (µ)......Page 365
    Additives......Page 367
    Drug Concentration......Page 369
    Source, Intensity, and Wavelength Effects......Page 370
    Temperature......Page 373
    Type of Packaging......Page 374
    Addition of Light Absorbers......Page 377
    Incorporation of Antioxidants......Page 380
    Complex Formation......Page 383
    CONCLUSION......Page 384
    REFERENCES......Page 385
    INTRODUCTION......Page 391
    Photostability and the Sun-Protection Factor......Page 392
    PHOTOSTABILITY OF SUNSCREENS......Page 394
    Reversible Transformations......Page 395
    Nonreversible Transformations......Page 398
    Alpha-Cleavage (Norrish I) of Dibenzoylmethane......Page 399
    Single Ultraviolet Filters......Page 400
    Sunscreen Preparations......Page 401
    The Inner Filter Effect......Page 402
    Triplet–Triplet Energy Transfer......Page 403
    SYNOPSIS......Page 405
    REFERENCES......Page 407
    INTRODUCTION......Page 409
    PHOTODEGRADATION AND PHOTOPROTECTION DURING ADMINISTRATION......Page 410
    Infusions......Page 411
    Length and Diameter of Intraluminal Tubing......Page 412
    Oral......Page 413
    Topicals......Page 414
    Amphotericin B......Page 415
    Doxycycline......Page 416
    Quinolones......Page 417
    Anthracyclines......Page 418
    Cisplatin......Page 419
    Dacarbazine......Page 420
    Fluorouracil......Page 422
    Irinotecan, Topotecan......Page 423
    Methotrexate......Page 424
    Molsidomine......Page 425
    Nimodipine......Page 426
    Sodium Nitroprusside......Page 428
    Catecholamines......Page 429
    Diuretics......Page 430
    TOTAL PARENTERAL NUTRITION SOLUTIONS......Page 431
    Multivitamins......Page 432
    Vitamin K 1 (Phytomenadione)......Page 433
    Ascorbic Acid......Page 434
    REFERENCES......Page 435

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