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Delivery Systems for Tuberculosis Prevention and Treatment


Delivery Systems for Tuberculosis Prevention and Treatment


Advances in Pharmaceutical Technology 1. Aufl.

von: Anthony J. Hickey, Amit Misra, P. Bernard Fourie

134,99 €

Verlag: Wiley
Format: EPUB
Veröffentl.: 25.08.2016
ISBN/EAN: 9781118943199
Sprache: englisch
Anzahl Seiten: 456

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Beschreibungen

<p>Provides a review of novel pharmaceutical approaches for Tuberculosis drugs</p> <ul> <li>Presents a novel perspective on tuberculosis prevention and treatment</li> <li>Considers the nature of disease, immunological responses, vaccine and drug delivery, disposition and response</li> <li>Multidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering</li> </ul>
<p>List of Contributors xvi</p> <p>Foreword xviii</p> <p>Series Preface xxi</p> <p>Preface xxiii</p> <p><b>1 Introduction: A Guide to Treatment and Prevention of Tuberculosis Based on Principles of Dosage Form Design and Delivery 1</b><br /><i>A.J. Hickey</i></p> <p>1.1 Background 1</p> <p>1.2 Dosage Form Classification 3</p> <p>1.3 Controlled and Targeted Delivery 5</p> <p>1.4 Physiological and Disease Considerations 6</p> <p>1.5 Therapeutic Considerations 7</p> <p>1.6 Conclusion 8</p> <p>References 8</p> <p><b>Section 1 Pathogen and Host 11</b></p> <p><b>2 Host Pathogen Biology for Airborne Mycobacterium tuberculosis: Cellular and Molecular Events in the Lung 13</b><br /><i>Eusondia Arnett, Nitya Krishnan, Brian D. Robertson and Larry S. Schlesinger</i></p> <p>2.1 Introduction 13</p> <p>2.2 Lung 14</p> <p>2.3 General Aspects of Mucus and Surfactant 17</p> <p>2.4 General M. tuberculosis 18</p> <p>2.5 M. tuberculosis Interaction with the Lung Macrophage 19</p> <p>2.6 M. tuberculosis Interaction with other Respiratory Immune Cells 23</p> <p>2.7 TB Granuloma 29</p> <p>2.8 Conclusion 30</p> <p>References 30</p> <p><b>3 Animal Models of Tuberculosis 48</b><br /><i>David N. McMurray</i></p> <p>3.1 Introduction 48</p> <p>3.2 What is an Animal Model of TB? 49</p> <p>3.3 How are Animal Models of TB Used? 50</p> <p>3.4 TB Animal Models Currently Used for TB Drug and Vaccine Evaluation 51</p> <p>3.5 Summary 58</p> <p>References 59</p> <p><b>Section 2 Immunological Intervention 67</b></p> <p><b>4 Vaccine Preparation: Past, Present, and Future</b> <b>69</b><br /><i>Dominique N. Price, Nitesh K. Kunda, Amber A. McBride and Pavan Muttil</i></p> <p>4.1 Introduction 69</p> <p>4.2 Early Efforts in TB Vaccine Development 71</p> <p>4.3 Current BCG Vaccine Formulation 73</p> <p>4.4 Novel TB Vaccination Strategies 76</p> <p>4.5 Future Perspective 84</p> <p>4.6 Conclusions 85</p> <p>References 85</p> <p><b>5 TB Vaccine Assessment 91</b><br /><i>Andre G. Loxton, Mary K. Hondalus and Samantha L. Sampson</i></p> <p>5.1 Introduction 91</p> <p>5.2 Preclinical Vaccine Assessment 92</p> <p>5.3 Clinical Assessment of Vaccines 97</p> <p>5.4 Laboratory Immunological Analysis and Assessment of Vaccine Trials 102</p> <p>5.5 How well do the Available Preclinical Models Predict Vaccine Success in Humans? 103</p> <p>References 105</p> <p><b>Section 3 Drug Treatment 111</b></p> <p><b>6 Testing Inhaled Drug Therapies for Treating Tuberculosis 113</b><br /><i>Ellen F. Young, Anthony J. Hickey and Miriam Braunstein</i></p> <p>6.1 Introduction 113</p> <p>6.2 The Need for New Drug Treatments for Tuberculosis 114</p> <p>6.3 Inhaled Drug Therapy for Tuberculosis 114</p> <p>6.4 Published Studies of Inhalation Therapy for TB 115</p> <p>6.5 The Guinea Pig Model for Testing Inhaled Therapies for TB 116</p> <p>6.6 Guinea Pig Study Design 117</p> <p>6.7 Purchase and Grouping Animals 118</p> <p>6.8 Infecting Guinea Pigs with Virulent Mycobacterium tuberculosis 118</p> <p>6.9 Dosing Groups of Guinea Pigs with TB Drugs 119</p> <p>6.10 Collecting Data 121</p> <p>6.11 Aerosol Dosing Chambers and Practice 122</p> <p>6.12 Nebulizer Aerosol Delivery Systems for Liquids 123</p> <p>6.13 Dry?-Powder Aerosol Delivery Systems for Solids 125</p> <p>6.14 Summary 127</p> <p>Acknowledgements 127</p> <p>References 127</p> <p><b>7 Preclinical Pharmacokinetics of Antitubercular Drugs 131</b><br /><i>Mariam Ibrahim and Lucila Garcia?-Contreras</i></p> <p>7.1 Introduction 131</p> <p>7.2 Factors Influencing the Pharmacokinetic Behavior of Drugs 132</p> <p>7.3 Pulmonary Delivery of Anti?-TB Drugs 138</p> <p>7.4 Pharmacokinetic Study Design 140</p> <p>7.5 Implications of PK Parameters on Efficacy 144</p> <p>7.6 Case Studies (Drugs Administered by Conventional and Pulmonary Routes) 146</p> <p>References 152</p> <p><b>8 Drug Particle Manufacture – Supercritical Fluid, High?-Pressure Homogenization</b> <b>156</b><br /><i>Kimiko Makino and Hiroshi Terada</i></p> <p>8.1 Introduction 156</p> <p>8.2 Preparation of Nano?- and Micro?-particles 157</p> <p>References 159</p> <p><b>9 Spray Drying Strategies to Stop Tuberculosis 161</b><br /><i>Jennifer Wong, Maurizio Ricci and Hak?-Kim Chan</i></p> <p>9.1 Introduction 161</p> <p>9.2 Overview of Spray Drying 162</p> <p>9.3 Advances in Spray Drying Technology 174</p> <p>9.4 Anti?-Tuberculosis Therapeutics Produced by Spray Drying 179</p> <p>9.5 Conclusion 187</p> <p>9.6 Acknowledgements 187</p> <p>References 187</p> <p><b>10 Formulation Strategies for Antitubercular Drugs by Inhalation 197</b><br /><i>Francesca Buttini and Gaia Colombo</i></p> <p>10.1 Introduction 197</p> <p>10.2 Lung Delivery of TB Drugs 198</p> <p>10.3 Powders for Inhalation and Liquids for Nebulization 200</p> <p>10.4 Antibacterial Powders for Inhalation: Manufacturing of Respirable Microparticles 202</p> <p>10.5 Antibacterial Powders for Inhalation: Devices and Delivery Strategies 208</p> <p>10.6 Conclusions and Perspectives 211</p> <p>References 211</p> <p><b>11 Inhaled Drug Combinations 213</b><br /><i>Sanketkumar Pandya, Anuradha Gupta, Rajeev Ranjan, Madhur Sachan, Atul Kumar Agrawal and Amit Misra</i></p> <p>11.1 Introduction 213</p> <p>11.2 Standard Combinations in Oral and Parenteral Regimens 214</p> <p>11.3 The Rationale for Inhaled Therapies of TB 216</p> <p>11.4 Combinations of Anti?-TB Drugs with Other Agents 222</p> <p>11.5 Formulation of Inhaled Drug Combinations 224</p> <p>11.6 Conclusions 230</p> <p>References 230</p> <p><b>12 Ion Pairing for Controlling Drug Delivery 239</b><br /><i>Stefano Giovagnoli, Aurélie Schoubben and Carlo Rossi</i></p> <p>12.1 Introduction 239</p> <p>12.2 Ion Pairing Definitions and Concepts 240</p> <p>12.3 Ion Pairs, Complexes and Drug Delivery 245</p> <p>12.4 Remarks 252</p> <p>References 254</p> <p><b>13 Understanding the Respiratory Delivery of High Dose Anti?-Tubercular Drugs 258</b><br /><i>Shyamal C. Das and Peter J. Stewart</i></p> <p>13.1 Introduction 258</p> <p>13.2 Tuberculosis 259</p> <p>13.3 Drugs Used to Treat Tuberculosis, Doses, Challenges and Requirements for Therapy in Lungs 260</p> <p>13.4 Approaches for Respiratory Delivery of Drugs 262</p> <p>13.5 Current DPI Formulations and Their Mechanisms of Aerosolization 262</p> <p>13.6 DPI Formulations for Tuberculosis and Requirements 264</p> <p>13.7 Issues to Consider in Respiratory Delivery of Powders for Tuberculosis 264</p> <p>13.8 Relationship between De?-agglomeration and Tensile Strength 266</p> <p>13.9 Strategies to Improve De?-agglomeration 268</p> <p>13.10 DPI Formulations having High Aerosolization 269</p> <p>13.11 Devices for High Dose Delivery 270</p> <p>13.12 Future Considerations 271</p> <p>References 272</p> <p><b>Section 4 Alternative Approaches 275</b></p> <p><b>14 Respirable Bacteriophage Aerosols for the Prevention and Treatment of Tuberculosis 277</b><br /><i>Graham F. Hatfull and Reinhard Vehring</i></p> <p>14.1 Introduction 277</p> <p>14.2 Treatment or Prevention of Tuberculosis Using Phage?-based Agents 282</p> <p>14.3 Selection of Mycobacteriophages 284</p> <p>14.4 Respiratory Drug Delivery of Phages 285</p> <p>14.5 Summary and Outlook 288</p> <p>Acknowledgements 288</p> <p>References 288</p> <p><b>15 RNA Nanoparticles as Potential Vaccines 293</b><br /><i>Robert DeLong</i></p> <p>15.1 Introduction 293</p> <p>15.2 Nanoparticles 293</p> <p>15.3 RNA Nanoparticle Vaccines 294</p> <p>15.4 Progression of Nanomedicines into the Clinic 295</p> <p>15.5 The Stability Problem 295</p> <p>15.6 The Delivery Problem 298</p> <p>15.7 RNA as Targeting Agent or Adjuvant? 298</p> <p>15.8 Challenges for RNA Nanoparticle Vaccine Characterization 300</p> <p>15.9 On the Horizon 301</p> <p>References 301</p> <p><b>16 Local Pulmonary Host?-Directed Therapies for Tuberculosis via Aerosol Delivery 307</b><br /><i>Mercedes Gonzalez?-Juarrero</i></p> <p>16.1 Introduction 307</p> <p>16.2 Lung Immunity to Pulmonary M. tuberculosis Infection 309</p> <p>16.3 Host?-Directed Therapies 313</p> <p>16.4 Limitations of Preclinical Studies to Develop Inhalational Host?-Directed Therapies for Tuberculosis 317</p> <p>16.5 Preclinical Testing of Inhaled Small Interference RNA as Host?-Directed Therapies for Tuberculosis 318</p> <p>Acknowledgements 319</p> <p>References 319</p> <p><b>Section 5 Future Opportunities 325</b></p> <p><b>17 Treatments for Mycobacterial Persistence and Biofilm Growth 327</b><br /><i>David L. Hava and Jean C. Sung</i></p> <p>17.1 Introduction 327</p> <p>17.2 Mycobacterial Persistence and Drug Tolerance 328</p> <p>17.3 Mycobacterial Multicellular Growth 329</p> <p>17.4 Mycobacterial Lipids Involved in Biofilm Formation 330</p> <p>17.5 Therapies to Treat Mycobacterial Biofilms and Persistence 332</p> <p>17.6 Conclusion 339</p> <p>References 339</p> <p><b>18 Directed Intervention and Immunomodulation against Pulmonary Tuberculosis 346</b><br /><i>Dominique N. Price and Pavan Muttil</i></p> <p>18.1 Introduction 346</p> <p>18.2 TB Immunology 347</p> <p>18.3 Animal Models of Immunotherapies and Vaccines for TB 351</p> <p>18.4 The Current TB Vaccine – Bacille Calmette Guérin 353</p> <p>18.5 Other Vaccines Platforms 357</p> <p>18.6 Pulmonary Immunization 361</p> <p>18.7 Immunotherapeutic Agents against TB 364</p> <p>18.8 Conclusion 367</p> <p>References 367</p> <p><b>Section 6 Clinical Perspective 379</b></p> <p><b>19 Clinical and Public Health Perspectives 381</b><br /><i>Ruvandhi R. Nathavitharana and Edward A. Nardell</i></p> <p>19.1 Introduction 381</p> <p>19.2 Background 382</p> <p>19.3 Clinical Considerations 382</p> <p>19.4 Public Health Considerations 385</p> <p>19.5 Inhaled Drugs and Other Alternative Delivery Systems 387</p> <p>19.6 Clinical Trials of Inhaled Injectable Drugs 388</p> <p>19.7 Other Novel Delivery Strategies 393</p> <p>19.8 Pediatric Delivery Systems 393</p> <p>19.9 Conclusion 394</p> <p>References 394</p> <p><b>20 Concluding Remarks: Prospects and Challenges for Advancing New Drug and Vaccine Delivery Systems into Clinical Application 400</b><br /><i>P. Bernard Fourie and Richard Hafner</i></p> <p>20.1 Introduction 400</p> <p>20.2 Progress in the Formulation and Manufacturing of Drugs and Vaccines for Tuberculosis 401</p> <p>20.3 Considerations in the Development of TB Drug and Vaccine Delivery Options 404</p> <p>20.4 Concluding Remarks 410</p> <p>References 411</p> <p>Index 415</p>
<p><b>Anthony J. Hickey</b>, Distinguished Fellow (appointed June 2012), is a Program Director in Inhaled Therapeutics in the Center for Aerosol and Nanomaterials Engineering at the Research Triangle Institute, North Carolina, USA.<br />Dr Hickey has more than 30 years of academic and research experience in pulmonary biology, aerosol physics, powder dynamics, pharmacokinetics and drug disposition, formulation design, and device development. Since joining RTI in 2011, he has conducted research related to pulmonary drug and vaccine delivery for tuberculosis treatment and therapy.<br />Additionally, Dr. Hickey is an adjunct professor of biomedical engineering at the University of North Carolina at Chapel Hill School of Medicine, emeritus professor of molecular pharmaceutics at the University of North Carolina at Chapel Hill Eshelman School of Pharmacy, and founder and president of Cirrus Pharmaceuticals, Inc.</p>

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