In vitro drug release testing of special dosage forms. (2019)

• Record Type: Book
• Further Information: Note: Edited by Nikoletta Fotaki, Sandra Klein.
• Editors: Fotaki, Nikoletta, 1973-; Klein, Sandra, 1970-
• Contents: List of Contributors xvii Series Preface xix Preface xxi Part I Oral Dosage Forms 1 1 Lipid‐Based Oral Formulations 3; Murat Kilic, Aikaterini Avzoti, Jennifer Dressman, and Christos Reppas 1.1 Introduction 3 1.2 Levels of Release Testing for Lipid‐Based Dosage Forms 7 1.2.1 Dilution 7 1.2.2 Dispersion and Drug Release 9 1.2.3 Digestion 13 1.2.4 Assessing Direct Uptake from the Vehicle 16 1.3 Case Examples 16 1.3.1 Compendial or Fed State Biorelevant Media to Evaluate Fenofibrate Lipid‐based Formulations? 17 1.3.2 Paddle or Biodis Method for Testing a Lipid‐based Formulation? 17 1.3.3 Does Nifedipine Precipitate after Administration as a Soft Gelatin Capsule? 19 1.3.4 Screening of Indomethacin Lipid‐Based Formulations 19 1.3.5 Effect of Supersaturation on In Vivo Performance 22 1.4 Conclusions and Future Directions 22 References 23 2 Chewable Oral Drug Products 27; Johannes Kramer, Jayachandar Gajendran, Alexis Guillot, and Abdulwahab Barakat 2.1 Introduction 27 2.1.1 Dosage Forms for Which Drug Release Occurs in the Oral Cavity 27 2.1.2 Chewable Dosage Forms Classification 28 2.2 The Oral Cavity 30 2.2.1 Anatomy of the Oral Cavity 30 2.2.2 Physiological Conditions from the Perspective of In Vivo Performance 30 2.2.3 Mechanical Forces 31 2.2.4 Need for Masticatory Action 31 2.2.5 Saliva Composition 32 2.2.6 Oral Absorption vs. Subsequent Absorption in the GI Tract 32 2.3 Drug Substances Used in Chewable Dosage Forms 33 2.4 Technology 33 2.4.1 Chewable Tablets 34 2.4.2 Medicated Gums 34 2.4.2.1 Conventional Method (Extrusion) 34 2.4.2.2 Direct Compression Method 34 2.4.3 Soft Gel Capsules as Chewable Dosage Forms 35 2.5 Pharmacopoeial Requirements 35 2.5.1 Chewable Tablets and Capsules 35 2.5.1.1 US FDA and USP Requirements for In Vitro Performance Testing of Chewable Tablets 35 2.5.1.2 Rationale for Use of the Reciprocating Cylinder Apparatus (USP Apparatus 3) 36 2.5.1.3 Current Status of Drug Release/Dissolution Testing Apparatus for Chewable Drug Products 36 2.5.2 Medicated Gums 36 2.5.2.1 Rationale for In Vitro Performance Testing of Medicated Gums 41 2.5.3 Apparatus for In Vitro Drug Release Testing of Medicated Gums 41 2.5.3.1 Non‐Compendial Setup: A USP Apparatus 2‐based Method with Modified Gums 41 2.5.4 Compendial Apparatus 44 2.5.4.1 Ph.Eur. Chewing Apparatus A (Chapter 2.9.25) 44 2.5.4.2 Ph.Eur. Chewing Apparatus B (Chapter 2.9.25) 44 2.5.5 In Vitro–In Vivo Correlation (IVIVC ) 45 2.6 Summary and Conclusion 49 References 50 Part II Non-oral Dosage Forms 55 3 Injectables 57; Susan D’Souza 3.1 Introduction 57 3.2 Significance of In Vitro Release Testing 60 3.3 Considerations in Method Development 61 3.3.1 Sink Conditions 63 3.3.2 Burst Release 63 3.3.3 Stability of Drug 64 3.3.4 Completeness of In Vitro Release 64 3.3.5 Robustness of Technique 65 3.3.6 Accelerated Release 65 3.3.7 In Vitro – In Vivo Correlations (IVIVCs ) 66 3.4 In Vitro Release Methods 66 3.4.1 Sample and Separate 67 3.4.1.1 Volume of Release Media 67 3.4.1.2 Agitation Conditions 67 3.4.1.3 Sampling Techniques 67 3.4.1.4 Sampling Volume 68 3.4.2 Continuous Flow 68 3.4.2.1 CF Setups 69 3.4.2.2 Pumps and Flow Rates 70 3.4.2.3 Sampling Techniques 70 3.5 Dialysis Method 71 3.5.1 Dialysis Setup 72 3.5.2 Volume of Release Media 73 3.5.3 Sampling Technique and Volume 73 3.6 Accelerated In Vitro Release 74 3.7 In Vitro – In Vivo Correlations (IVIVC s) 76 References 78 4 Drug‐Eluting Stents 87; Anne Seidlitz 4.1 Drug‐Eluting Stents: Combination Products at the Interface of Medical Devices and Medicinal Products 87 4.2 DES Characteristics 88 4.3 In Vivo Stent Position and the Resulting Challenges for In Vitro Release Testing of Coronary Stents 90 4.4 Guidelines, Prerequisites, and General Recommendations on DES Testing 92 4.5 Currently Used Test Methods 93 4.5.1 Media 93 4.5.2 Apparatus 96 4.6 Toward More Biorelevant Testing Conditions and New Challenges for DES Testing 101 4.7 Non‐Vascular Stents 107 4.8 Drug‐Coated Balloons: An Alternative to DESs for a Wide Range of Indications? 108 4.9 Concluding Remarks 109 References 110 5 In Vitro Dissolution for Inhalation Products 119; Annalisa Mercuri and Nikoletta Fotaki 5.1 Introduction 119 5.2 The Environment of the Human Lungs 120 5.2.1 The Anatomy of Bronchi and Alveoli 121 5.2.2 Airway Surface Liquid (ASL) 121 5.2.2.1 The Composition of Humans Lung Fluids in the Disease State 123 5.2.2.2 Surface Tension 125 5.2.2.3 Mucus Production and Mucociliary Clearance 125 5.3 Regulatory Perspectives and Current Practices for Testing Inhaled Products 125 5.3.1 Compendial Methods for Testing Inhaled Products 126 5.3.1.1 Andersen Cascade Impactor (ACI) 127 5.3.1.2 Glass Twin Impinger 127 5.3.1.3 Marple‐Miller Impactor (MMI) 129 5.3.1.4 Multi‐Stage Liquid Impinger (MSLI) 129 5.3.1.5 Next Generation Impactor (NGI) 130 5.3.1.6 Analysis of the In Vitro Deposition Data of Inhaled Particles 130 5.3.1.7 In Vitro –In Vivo Deposition Correlations 131 5.3.2 Dissolution Methods for Inhaled Products 132 5.3.2.1 Two‐Stage Impinger 133 5.3.2.2 Horizontal Diffusion Cell 133 5.3.2.3 Static Dissolution Cell 133 5.3.2.4 Shaking Incubator 133 5.3.2.5 Paddle Dissolution Apparatus (USP II Apparatus) 135 5.3.2.6 Dialysis Membranes 136 5.3.2.7 Flow‐through Cell (USP IV Apparatus) 137 5.3.2.8 Transwell™ Method 137 5.3.2.9 Franz Cell Method 137 5.3.3 Dissolution Methods with Integrated Deposition and Cell Permeation Models 138 5.4 Simulated Lung Fluids 139 5.5 Pulmonary Biopharmaceutical Classification System 143 5.6 Conclusions 143 References 144 6 Topicals and Transdermals 155; Kailas Thakker 6.1 Introduction 155 6.2 In Vitro Release Studies for Topical Dosage Forms 156 6.2.1 Drug Release from Semisolid Dosage Forms – Theory and Calculations 157 6.2.2 Compendial Apparatus 158 6.2.2.1 Vertical Diffusion Cell 158 6.2.2.2 Immersion Cell 160 6.2.2.3 USP Apparatus 4 163 6.2.3 Method Development: Points to Consider 163 6.2.3.1 Selection of the Receiving Medium 165 6.2.3.2 Selection of the Membrane 166 6.2.3.3 Apparatus Qualification 166 6.2.3.4 Test Procedure 166 6.2.4 Custom‐Designed Cells 167 6.3 In Vitro Release Studies for Transdermal Systems 167 6.3.1 Compendial Apparatus 168 6.3.1.1 The Paddle over Disc Apparatus 168 6.3.1.2 The Reciprocating Holder Apparatus 168 6.4 Conclusions 171 References 171 7 Vaginal and Intrauterine Delivery Systems 177; Sandra Klein and Katharina Tie
• Edition: 1st
• Publisher Details: Hoboken, New Jersey : John Wiley & Sons, Inc
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615.6; Solid dosage forms; Oral medication; Drugs -- Dosage forms
• Languages: English
• ISBNs: 9781118675830
• Related ISBNs: 9781118675779
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
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