Injectable dispersed systems: formulation, processing, and performance
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Boca Raton, Fla.
Taylor & Francis
2005
|
| Series: | Drugs and the pharmaceutical sciences
149 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XXI, 652 S. Ill., graph. Darst. |
| ISBN: | 0849336996 |
Staff View
MARC
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| 245 | 1 | 0 | |a Injectable dispersed systems |b formulation, processing, and performance |c ed. by Diane J. Burgess |
| 264 | 1 | |a Boca Raton, Fla. |b Taylor & Francis |c 2005 | |
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Record in the Search Index
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| adam_text | Contents
Preface . . . . v
Acknowledgments .... xvii
Contributors .... xix
SECTION I: Basic Principles
1. Physical Stability of Dispersed Systems 1
Diane J. Burgess
1. Introduction and Theory .... 1
2. Colloid and Interfacial Chemistry .... 2
3. Thermodynamics of Dispersed Systems .... 10
References .... 34
2. Biopharmaceutical Principles of Injectable
Dispersed Systems 39
C. Oussoren, H. Talsma, J. Zuidema, and F. Kadir
1. Introduction .... 39
2. Drug Absorption from Conventional
Formulations .... 42
3. Drug Absorption from Drug Carrier
Systems .... 49
ix
x Contents
4. Factors Influencing Drug Absorption .... 55
5. Carrier Kinetics and Targeting .... 60
6. Tissue Protective Effect of Dispersed
Systems .... 63
7. Summary .... 65
References .... 66
3. Characterization and Analysis of Dispersed
Systems 77
Jim Jiao and Diane J. Burgess
1. Introduction . . . .77
2. Particle Size Measurement.... 79
3. Zeta Potential .... 97
4. Rheology .... 107
5. Conclusions .... 116
References .... 116
4. In Vitro/In Vivo Release from Injectable
Dispersed Systems 125
Brian C. Clark, Paul A. Dickinson, and Ian T. Pyrah
1. In Vitro Release .... 125
2. Data Manipulation .... 139
3. In Vivo Release .... 142
4. Bioanalysis .... 149
5. Injectability .... 150
6. Conclusions .... 151
References .... 153
5. In Vitro/In Vivo Correlation for Modified Release
Injectable Drug Delivery Systems 159
David Young, Colm Farrell, and Theresa Shepard
1. Introduction .... 159
2. A General Approach to Developing a
Level A IVTVC 161
3. Issues Related to Developing an rVTVC
for Modified Release Parental Drug Delivery
Systems .... 166
4. Conclusion .... 174
References .... 175
Contents xi
SECTION II: Dosage Forms
6. Coarse Suspensions: Design and
Manufacturing 177
Steven L. Nail and Mary P. Stickelmeyer
1. Introduction .... 177
2. Preparation and Characterization
of the Drug .... 180
3. Biopharmaceutical Considerations .... 184
4. Physical Stability of Coarse Suspensions .... 191
5. Formulation of Parenteral Suspensions .... 197
6. Manufacture of Parenteral Coarse
Suspensions .... 203
7. Evaluation of Product Quality .... 208
8. Conclusion .... 209
References .... 210
7. Emulsions: Design and Manufacturing 213
N. Chidambaram and Diane J. Burgess
1. Introduction .... 213
2. Manufacturing and Process Conditions .... 232
3. Lyophilization of Emulsions .... 239
4. Conclusions .... 240
References .... 241
8. Liposomes: Design and Manufacturing 249
Siddhesh D. Patil and Diane J. Burgess
1. Introduction .... 249
2. Liposomes: Definitions and Classes .... 250
3. Versatility of Drugs Delivered Using
Liposomes .... 251
4. Advantages of Liposomal Delivery
Systems .... 256
5. Liposome Composition: Choice
of Lipids 260
6. Manufacture of Liposomes .... 265
7. Liposome Drug Encapsulation
Techniques .... 271
8. Liposome Characterization and
Compendial Requirements .... 275
xii
Contents
9. Conclusions .... 283
References .... 284
9. Microspheres: Design and Manufacturing 30*
Diane J. Burgess and Anthony J. Hickey
1. Introduction .... 306
2. Microsphere Dispersions: Methods and
Characterization .... 312
3. Tissue Targeting .... 325
4. Targeting Diseases .... 326
5. Commercial Prospects .... 326
6. Conclusions .... 338
References .... 339
SECTION III: Case Studies
10. Case Study: Development and Scale Up of
NanoCrystal® Particles .. P
Robert W. Lee d55
1. Introduction .... 355
2. Pharmaceutics .... 358
3. Formulation Development 360
4. Pharmacokinetics/Pharmacodynamics ... 363
5. Manufacturing Process ... 366
6. Scale Up .... 366
7. Summary .... 369
Reference .... 370
Perfluorocarbon Emulsion
Robert T. Lyons 371
1 Introduction .... 371
2 Formulation Development... 374
d Process Optimization 379
4. Process Scale Up 337
5. Conclusions .... 390
References .... 391
Contents xiii
12. Case Study: A Lipid Emulsion—
Sterilization 393
Thomas Berger
1. Outline 393
2. Introduction .... 394
3. R D Area 395
4. Production Environment.... 405
5. Regulatory Submission .... 409
References .... 412
13. Case Study: Formulation of an Intravenous
Fat Emulsion 415
Bernie Mikrut
1. Introduction .... 415
2. Formulation .... 416
3. Processing .... 419
4. Filling/Packaging .... 422
5. Stability Evaluation .... 422
References .... 424
14. Case Study: DOXIL, the Development of Pegylated
Liposomal Doxorubicin 427
Frank J. Martin
1. Introduction .... 427
2. Background .... 428
3. Define Problem .... 429
4. Solutions to Problem: DOXIL (Pegylated
Liposomal Doxorubicin) .... 435
5. Conclusions and Perspectives .... 469
References .... 472
15. Case Study: AmBisome—A Developmental Case
Study of a Liposomal Formulation of the Antifungal
Agent Amphotericin B 481
Jill P. Adler Moore and Richard T. Proffitt
1. Definition of the Problem .... 481
2. Overview of Amphotericin B/Lipid
Formulations .... 484
3. Development of Ambisome Formulation .... 485
xiv Contents
4. Summary .... 514
References .... 515
16. Case Study: Optimization of a Liposomal
Formulation with Respect to Tissue
Damage 527
Gayle A. Brazeau
1. Introduction .... 527
2. Liposomal Formulations and Intramuscular
Injections .... 530
3. Intramuscular Loxapine Formulation .... 530
4. Study Objectives 531
5. In Vitro Liposomal Myotoxicity Studies .... 532
6. Loxapine Liposomal Formulations and In Vitro
Myotoxicity Studies .... 534
7. In Vivo Myotoxicity of a Loxapine Liposomal
Formulation .... 537
8. Concluding Remarks .... 540
References .... 541
17. Case Study: In Vitro/In Vivo Release from
Injectable Microspheres 543
Brian C. Clark, Paul A. Dickinson, and Ian T. Pyrah
1. Introduction .... 543
2. In Vitro Studies 544
3. In Vivo Study .... 560
4. Conclusions .... 570
Reference .... 570
18. Case Study: Biodegradable Microspheres for the
Sustained Release of Proteins 571
Mark A. Tracy
1. Introduction .... 571
2. Guideline #1: Minimize Molecular Mobility to
Maximize Stability .... 572
3. Guideline #2: Understand the Role of Particle
Structure and Morphology in Product
Function and Stability .... 576
4. Conclusions .... 579
References .... 579
Contents xv
SECTION IV: Quality Assurance and Regulation
19. Injectable Dispersed Systems: Quality and
Regulatory Considerations 583
James P. Simpson and Michael J. Akers
1. Introduction and Scope .... 583
2. Regulatory Requirements .... 584
3. Quality During the Product Development
Phase 591
4. Raw Materials .... 598
5. Scale Up and Unit Processing .... 602
6. Finished Product Considerations .... 602
7. Summary .... 616
References .... 616
Appendix 1. ICH Guidelines .... 617
20. Regulatory Considerations for Controlled Release
Parenteral Drug Products: Liposomes and
Microspheres 621
Mei Ling Chen
1. Introduction .... 621
2. Liposomes .... 622
3. Microspheres .... 631
References .... 640
Index 645
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| spelling | Injectable dispersed systems formulation, processing, and performance ed. by Diane J. Burgess Boca Raton, Fla. Taylor & Francis 2005 XXI, 652 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 149 Parenteral solutions Dispersion Dispersion (DE-588)4012484-8 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Dispersion (DE-588)4012484-8 s Pharmazeutische Technologie (DE-588)4045699-7 s b DE-604 Burgess, Diane J. Sonstige oth Drugs and the pharmaceutical sciences 149 (DE-604)BV000002008 149 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013356907&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Injectable dispersed systems formulation, processing, and performance Drugs and the pharmaceutical sciences Parenteral solutions Dispersion Dispersion (DE-588)4012484-8 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| subject_GND | (DE-588)4012484-8 (DE-588)4045699-7 (DE-588)4143413-4 |
| title | Injectable dispersed systems formulation, processing, and performance |
| title_auth | Injectable dispersed systems formulation, processing, and performance |
| title_exact_search | Injectable dispersed systems formulation, processing, and performance |
| title_full | Injectable dispersed systems formulation, processing, and performance ed. by Diane J. Burgess |
| title_fullStr | Injectable dispersed systems formulation, processing, and performance ed. by Diane J. Burgess |
| title_full_unstemmed | Injectable dispersed systems formulation, processing, and performance ed. by Diane J. Burgess |
| title_short | Injectable dispersed systems |
| title_sort | injectable dispersed systems formulation processing and performance |
| title_sub | formulation, processing, and performance |
| topic | Parenteral solutions Dispersion Dispersion (DE-588)4012484-8 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| topic_facet | Parenteral solutions Dispersion Pharmazeutische Technologie Aufsatzsammlung |
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