Inhalation delivery of therapeutic peptides and proteins:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
1997
|
| Schriftenreihe: | Lung biology in health and disease
107 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXII, 913 S. Ill., graph. Darst. |
| ISBN: | 0824797809 |
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Datensatz im Suchindex
| _version_ | 1804126353956536320 |
|---|---|
| adam_text | CONTENTS
Introduction Claude Lenfant in
Foreword Peter R. Byron v
Foreword David Ganderton ix
Foreword Stephen P. Newman v;
Preface xiii
Acknowledgments xviii
Contributors xix
Part One THE HUMAN RESPIRATORY TRACT:
BIOPHYSICAL ISSUES IN PEPTIDE DRUG
DELIVERY 1
Pratnod K. Gupta
1. Physiological and Biomechanical Factors Relevant to Inhaled
Drug Delivery 3
Chang S. Kim and Ixiwrence ./. Folinsbee
I. Introduction 3
II. Respiratory Tract Structure and Function 4
xxiii
xxiv Contents
III. Ventilation and Perfusion 7
IV. Measurement of Airflow Obstruction 11
V. Mucociliary Transport and Alveolar Clearance 14
VI. Conclusions 21
References 22
2. Biophysics of Inhaled Drug Particles 27
Ananth Annapragada, Paul Swanson, and Fernando Muzzio
I. Introduction 27
II. Geometric Characteristics of the Pulmonary System 28
III. Particle Characteristics Relevant to Pulmonary Drug
Delivery 31
IV. Mathematical Modeling of the Pulmonary Route 53
References 56
3. Chemical and Physical Properties of Peptide and Protein
Drugs 59
William R. Porter
I. Common Features of Peptide and Protein Drugs 59
II. Physical Properties of Peptide and Protein Drugs 75
III. Chemical Stability of Peptide and Protein Drugs 79
IV. Characterization of Peptide and Protein Drugs 82
References 87
4. Absorption and Bioavailability of Inhaled Peptides and
Proteins 89
Yihong Qiu, Pramod K. Gupta, and Akwete Lex Adjei
I. Introduction 89
II. Absorption of Peptides and Proteins 90
III. Methods for Assessing Peptide Absorption from the Lung 105
IV. Pharmacokinetic Evaluation of Lung Drug Uptake 113
V. Impact of Absorption Kinetics 123
VI. Conclusions 125
References 125
Contents xxv
Part Two THE HUMAN RESPIRATORY TRACT:
PHARMACEUTICAL ISSUES IN PEPTIDE DRUG
DELIVERY 133
Akwete Lex Adjei
5. Intranasal Delivery of Peptides and Proteins 135
Lisbeth Ilium and Anthony Neil Fisher
I. Introduction 135
II. Use of the Nasal Cavity for Drug Administration 136
III. Structure and Function of the Human Nasal Cavity 138
IV. Barriers to Absorption from the Nasal Cavity 150
V. Methods of Overcoming the Barriers to Absorption 160
VI. Concluding Remarks 170
References 170
6. Therapeutic Inhalation Aerosols 185
Pramod K. Gupta and Akwete Lex Adjei
I. Introduction 185
II. Rational Therapy with Inhalation Aerosols 187
III. Airway Deposition of Inhaled Particles 199
IV. Aerosolization of Pharmaceutical Particles 201
V. Other Factors Affecting Performance of Inhalation
Aerosols 223
VI. Conclusions 228
References 229
7. Generation and Characterization of Aerosols for Drug
Delivery to the Lungs 235
Cecily B. Lalor and Anthony J. Hickey
I. Introduction 235
II. Description of Inhalation Devices 239
III. Particle Size Characterization 248
IV. Dose Delivery 258
V. Stability 261
VI. Selection of Packaging Materials 264
VII. Conclusions 265
References 266
xxvi Contents
Part Three LOCALIZED DELIVERY OF PEPTIDES AND
PROTEINS TO THE LUNG: CASE STUDIES 277
Akwete Lex Adjei
8. Cyclosporine 281
Gilbert J. Burckart, Robert Keenan, Bartley P. Griffith,
and Aldo T. lacono
I. Introduction 281
II. Cyclosporine 282
III. Aerosolized Cyclosporine 287
IV. Formulations of Cyclosporine for Aerosolization 296
V. Conclusions 297
References 297
9. Inhalation Interferon 301
Nico van Zandwijk
I. Introduction 301
II. Interferons 302
III. Biological Properties 302
IV. Antitumor Effects of IFNs 305
V. Other Indications for IFNs 305
VI. Toxicity of IFNs 306
VII. Acute Effects 306
VIII. Chronic Effects 306
IX. IFN Antibodies 307
X. Inhalational IFN: Preclinical and Clinical Data 307
XL Conclusion 310
References 311
10. Alpha 1 Antitrypsin 315
Richard C. Hubbard
I. Introduction 315
II. Protease Antiprotease Balance in the Lower Respiratory
Tract 315
III. In Vitro Evaluation of Alpha 1 Antitrypsin 317
IV. Conceptual Basis of A1AT Augmentation Therapy 318
V. Aerosol Augmentation Therapy 320
VI. Administration of A1AT to Patients with A1AT Deficiency 323
VII. Aerosolized A1 AT in Cystic Fibrosis 327
Contents xxvii
VIII. Conclusions 328
References 329
11. Aerosol Delivery of Alphat Proteinase Inhabitor: A Paradigm
for Delivery of Therapeutic Proteins to the Lung 331
Robert M. Smith
I. Introduction 331
II. Background 332
III. Rationale for Administration of A,PI as an Aerosol 334
IV. Formulation of a Strategy for Aerosol Delivery of A,PI 336
V. Pharmacokinetics of A,PI Delivered as an Aerosol 338
VI. AjPI Levels in Lung Interstitium After Aerosol
Administration 348
VII. Summary 350
References 351
12. Deoxyribonuclease Inhalation 355
Igor Gonda
I. Introduction 355 M
II. History of Inhalation Treatment with Deoxyribonuclease 355 ¦
III. Recombinant Human Deoxyribonuclease (rhDNase) 357 ^
IV. Rationale for Formulation and Aerosol Delivery of
Aqueous Solution of rhDNase for Inhalation 358
V. Characteristics of the Aerosol Delivery Systems 359
VI. Compatibility Issues 360
VII. Conclusion: Safety, Efficacy, and Equivalence in Clinical
Trials 360
References 362
Part Four SYSTEMIC DELIVERY OF PEPTIDES AND
PROTEINS BY INHALATION: CASE STUDIES 367
Akwete Lex Adjei and Pramod K. Gupta
13. Insulin Inhalation: Its Potential as a Nonparenteral Method of
Administration 371
Stephen J. Farr and Glyn Taylor
I. Introduction 371
II. Insulin and the Treatment of Diabetes Mellitus 371
xxviii Contents
III. The Case for Considering Nonparenteral Routes of Insulin
Administration 372
IV. Noninvasive Routes of Insulin Administration 375
V. Pulmonary Delivery of Insulin 375
VI. Future Perspectives 382
References 384
14. LH RH Analogs 389
Akwete Lex Adjei and Mou ying Fu Lu
I. Introduction 389
II. Pharmacology of LH RH 391
III. Preclinical Studies 393
IV. Clinical Studies 402
V. Functional Performance of Devices 404
VI. Formulation Stability and Prime Retention 406
VII. Conclusions 409
References 409
15. Feasibility Studies with Recombinant Human Granulocyte
Colony Stimulating Factor 413
Ralph W. Niven
I. Introduction 413
II. Background 414
III. Formulation 419
IV. Administration Techniques 436
V. Pharmacokinetics 439
VI. Safety 444
VII. Conclusions 446
References 446
16. Inhalation Therapy for Growth Hormone Deficiency 453
Doris A. Wall and Philip L. Smith
I. Introduction 453
II. In Vivo Absorption Following Pulmonary Administration 454
III. In Vitro Nebulization 458
IV. In Vitro Transport 459
V. Conclusions 464
References 466
Contents xxix
Part Five GENE DELIVERY AND TRANSFER VIA THE
LUNG 471
Akwete Lex Adjei
17. General Issues in Gene Delivery via the Lung 475
Marsha M. Thompson and Jeanine P. Wiener Kmnish
I. Introduction 475
II. Strategies for Gene Delivery to the Lung 476
III. Expression Specificity 480
IV. Experimental Models Used to Simulate Lung Disease 483
V. Vectors Used for Gene Transfer in the Lung 484
VI. Summary 486
References 487
18. Inhalation Delivery and Formulation Issues in Gene Therapy
in the Respiratory Tract 493
Thomas W. Patapoff and Igor Gonda
I. Introduction 493
II. Physical Methods of Regional Targeting of Delivery in the
Respiratory Tract 494
III. Biological Versus Nonbiological Vectors 499
IV. General Gene Transfer Issues 502
V. Reporter Genes 503
VI. Animal Models for Gene Transfer Therapy 505
VII. Strategies for Clinical Treatment of CFTR Defect in Cystic
Fibrosis 506
VIII. Approaches to Other Diseases of Respiratory Tract 507
References 508
19. Gene Therapy for Lung Disease: Molecular and Clinical
Therapeutic Issues 515
Larry G. Johnson and Richard C. Boucher
I. Introduction 515
II. Gene Therapy for Cystic Fibrosis 516
III. Gene Therapy for Alpha, Antitrypsin Deficiency 533
IV. Gene Therapy for Respiratory Neoplasms 537
V. Gene Therapy for Other Lung Diseases 542
VI. Conclusions 542
References 543
xxx Contents
20. The Cell Biology of Gene Therapy for Cystic Fibrosis 555
Kenneth Crook and David J. Porteous
I. Introduction 555
II. A Delivery Vehicle for the Gene 557
III. Delivery to the Lung 561
IV. Targeting to Specific Cell Subsets 566
V. Entry of the Delivery Complex into Cells 570
VI. DNA Survival Within the Cell 573
VII. From the Cytoplasm to the Nucleus 575
VIII. Expression of the Transferred DNA 576
IX. Results from Clinical Trials of CFTR Gene Delivery 579
X. Conclusions 581
References 582
Part Six ALTERNATE TECHNOLOGIES IN PULMONARY
DELIVERY 587
Akwete Lex Adjei and Pramod K. Gupta
21. Non Ozone Depleting Propellants 591
Pramod K. Gupta and Akwete Lex Adjei
I. Introduction 591
II. Product Development Issues 592
III. Chlorofluorocarbons 596
IV. Alternative Propellants 601
V. MDI Formulations of Peptide and Protein Drugs in
Alternate Propellants 617
VI. Conclusions 620
References 621
22. Dry Powder Inhalation Aerosols 625
Akwete Lex Adjei and Pramod K. Gupta
I. Introduction 625
II. Dry Powder Inhalation Systems 628
III. Breathing Maneuvers, Lung Dynamics, and Effect of
Disease 640
IV. Micromeritics and Surface Energetics 642
V. Powder Inhalation of Peptides and Proteins: Feasibility
Studies 654
VI. Device Systems 656
Contents xxxi
VII. Conclusions 659
References 662
23. Modulated Release Aerosol 667
Pramod K. Gupta and Akwete Lex Adjei
I. Introduction 667
II. Methods to Develop Modulated Release Aerosols 668
III. Liposomes 670
IV. Polymeric Microspheres 679
V. Other Formulation Approachs for Modulated Release
Aerosols 682
VI. Challenges in the Development of Modulated Release
Aerosols 688
VII. Conclusions 693
References 694
24. Novel Aerosol Peptide Drug Delivery Systems 703
Reid Rubsamen
I. Introduction 703
II. System Requirements 704
III. Example Systems 710
IV. Summary 727
V. Conclusion 728
References 728
Part Seven GUIDELINES FOR DEVELOPMENT OF
AEROSOLIZED PEPTIDES 733
Akwete Lex Adjei
25. Developmental Pharmaceutics of Inhaled Peptides and
Proteins 735
Akwete Lex Adjei and Pramod K. Gupta
I. Introduction 735
II. Product Development 737
III. In Vivo Studies 754
IV. Human Studies 757
V. Stability Studies 762
VI. Conclusions 767
References 767
xxxii Contents
26. Clinical Development of Inhaled Peptides and Proteins 771
Akwete Lex Adjei
I. Introduction 771
II. Structural Issues and Bulk Drug Stability 773
III. Formulation Development and Drug Dosimetry 777
IV. Inhalation Toxicology and Immunogenicity 795
V. Pharmacokinetics and Pharmacodynamics 797
VI. Conclusions 803
References 804
Part Eight KEY WORLDWIDE PATENTS IN PULMONARY
DRUG DELIVERY 815
Pramod K. Gupta
27. Key Worldwide Patents in Pulmonary Drug Delivery 817
Pramod K. Gupta and Akwete Lex Adjei
Author Index 861
Subject Index 903
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| series2 | Lung biology in health and disease |
| spelling | Inhalation delivery of therapeutic peptides and proteins ed. by Akwete Lex Adjei ... New York [u.a.] Dekker 1997 XXII, 913 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Lung biology in health and disease 107 Aërosolen gtt Geneesmiddelen gtt Geneesmiddelentransport gtt Administration, Inhalation Aerosol therapy Aerosols Drug Delivery Systems Peptide drugs Dosage forms Peptides therapeutic use Protein drugs Dosage forms Proteins therapeutic use Wirkstofffreisetzung (DE-588)4190018-2 gnd rswk-swf Proteine (DE-588)4076388-2 gnd rswk-swf Inhalationsmittel (DE-588)4263866-5 gnd rswk-swf Peptide (DE-588)4045125-2 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Peptide (DE-588)4045125-2 s Inhalationsmittel (DE-588)4263866-5 s Wirkstofffreisetzung (DE-588)4190018-2 s DE-604 Proteine (DE-588)4076388-2 s Adjei, Akwete Lex Sonstige oth Lung biology in health and disease 107 (DE-604)BV000008326 107 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007973590&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Inhalation delivery of therapeutic peptides and proteins Lung biology in health and disease Aërosolen gtt Geneesmiddelen gtt Geneesmiddelentransport gtt Administration, Inhalation Aerosol therapy Aerosols Drug Delivery Systems Peptide drugs Dosage forms Peptides therapeutic use Protein drugs Dosage forms Proteins therapeutic use Wirkstofffreisetzung (DE-588)4190018-2 gnd Proteine (DE-588)4076388-2 gnd Inhalationsmittel (DE-588)4263866-5 gnd Peptide (DE-588)4045125-2 gnd |
| subject_GND | (DE-588)4190018-2 (DE-588)4076388-2 (DE-588)4263866-5 (DE-588)4045125-2 (DE-588)4143413-4 |
| title | Inhalation delivery of therapeutic peptides and proteins |
| title_auth | Inhalation delivery of therapeutic peptides and proteins |
| title_exact_search | Inhalation delivery of therapeutic peptides and proteins |
| title_full | Inhalation delivery of therapeutic peptides and proteins ed. by Akwete Lex Adjei ... |
| title_fullStr | Inhalation delivery of therapeutic peptides and proteins ed. by Akwete Lex Adjei ... |
| title_full_unstemmed | Inhalation delivery of therapeutic peptides and proteins ed. by Akwete Lex Adjei ... |
| title_short | Inhalation delivery of therapeutic peptides and proteins |
| title_sort | inhalation delivery of therapeutic peptides and proteins |
| topic | Aërosolen gtt Geneesmiddelen gtt Geneesmiddelentransport gtt Administration, Inhalation Aerosol therapy Aerosols Drug Delivery Systems Peptide drugs Dosage forms Peptides therapeutic use Protein drugs Dosage forms Proteins therapeutic use Wirkstofffreisetzung (DE-588)4190018-2 gnd Proteine (DE-588)4076388-2 gnd Inhalationsmittel (DE-588)4263866-5 gnd Peptide (DE-588)4045125-2 gnd |
| topic_facet | Aërosolen Geneesmiddelen Geneesmiddelentransport Administration, Inhalation Aerosol therapy Aerosols Drug Delivery Systems Peptide drugs Dosage forms Peptides therapeutic use Protein drugs Dosage forms Proteins therapeutic use Wirkstofffreisetzung Proteine Inhalationsmittel Peptide Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007973590&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000008326 |
| work_keys_str_mv | AT adjeiakwetelex inhalationdeliveryoftherapeuticpeptidesandproteins |