Co-Crystals in Pharmaceutical Sciences : Design to Applications

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Co-Crystals in Pharmaceutical Sciences : Design to Applications

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  • 製本 Hardcover:ハードカバー版/ページ数 400 p.
  • 言語 ENG
  • 商品コード 9781394302475
  • DDC分類 615.19

Full Description

The book is essential for anyone in the pharmaceutical field, as it offers invaluable insights into the innovative world of cocrystals, their design principles, experimental techniques, and practical applications that can significantly enhance drug development and address critical industry challenges.

Co-Crystals in Pharmaceutical Sciences: Design to Applications is a comprehensive exploration of pharmaceutical cocrystals that introduces their scope and potential impact on drug development. This volume highlights the structural characteristics influencing cocrystals and delves into design principles and molecular interactions. Focus is placed on the advantages and challenges of integrating in-silico techniques for screening, which accelerates cocrystal discovery. Detailed coverage of experimental techniques, validation, and process optimization provides a solid foundation for readers. The book uniquely explores herbal and drug-drug cocrystals, showcasing synergies between traditional herbal medicine and modern pharmaceuticals. Scaling up cocrystal synthesis and potential commercial opportunities are examined in depth. Chapters on pharmaceutical applications emphasize how cocrystals address solubility, stability, and therapeutic challenges, with real-world examples illustrating their impact. The role of cocrystals in enhancing mechanical properties for more efficient formulations is discussed, and insights into the patent landscape and regulatory considerations round out the book, making it an indispensable resource for researchers and industry professionals alike.

Audience

Botanists, biologists, pharmaceutical professionals, drug delivery experts, and materials scientists studying pharmaceutical sciences.

Contents

Preface xiii

1 Pharmaceutical Cocrystals: Introduction, History and Applications 1
Oluwatoyin A. Odeku and Olufunke D. Akin-Ajani

1.1 Introduction 2

1.2 History 3

1.3 Applications of Cocrystals in Pharmaceutical Sciences 4

1.3.1 Enhanced Solubility 5

1.3.2 Improved Bioavailability 5

1.3.3 Stability Enhancement 6

1.3.4 Taste Masking and Palatability 7

1.3.5 Controlled Release 8

1.3.6 Increased Tabletability 8

1.3.7 Combination Therapy 9

1.4 Challenges in the Development of Cocrystals 12

1.5 Marketed Products 17

1.6 Future of Pharmaceutical Cocrystals 17

1.7 Conclusion 18

Acknowledgment 18

References 19

2 Design and Structural Characteristics of Pharmaceutical Cocrystals 29
Harpreet Singh, Bhuvnesh Kumar Singh, Anil Kumar, Arvind Kumar, Arun Kumar Mishra, Ritu Rathi and Inderbir Singh

2.1 Introduction 30

2.1.1 Polymorphism 33

2.1.2 Salt Cocrystal Continuum 34

2.2 Design of Pharmaceutical Cocrystals 34

2.2.1 Molecular Recognition and Supramolecular Interactions 35

2.2.2 Hansen Solubility Parameters (HSPs) 36

2.2.3 Coformers Selection and Combinatorial Approaches 37

2.2.3.1 Theoretical Methods 37

2.2.3.2 GRAS Coformer Libraries 38

2.2.3.3 High-Throughput Experimentation 38

2.2.3.4 Coformer Selection 38

2.2.4 Combinatorial Approaches 40

2.3 Structural Characteristics of Pharmaceutical Cocrystals 44

2.3.1 Crystal Structure Analysis 44

2.3.2 A Perspective on Cocrystal Hydrogen Bonding 44

2.3.3 Characterization Techniques 45

2.4 Challenges and Future Directions in Pharmaceutical Cocrystal 46

2.5 Conclusion 48

Acknowledgment 48

References 49

3 Advancements in Computational Screening Methods for Pharmaceutical Cocrystals 55
Maan Singh, Abhishek Mali, Madhukiran Dhondale, Ashish Kumar Agrawal, Amrit Paudel and Dinesh Kumar

3.1 Introduction 56

3.2 Experimental Screening of Cocrystals 59

3.3 Computational Method for Screening Cocrystals 62

3.3.1 Molecular Electrostatic Potential Surfaces (MEPS) Measurement 62

3.3.2 Hirshfeld Surface Analysis (HSA) 66

3.3.3 Cambridge Structural Database (CSD) 69

3.3.4 COSMO-RS Approach 72

3.3.5 Crystal Structure Prediction (CSP) 76

3.4 Recent Trends in Cocrystal Screening and Future Approach 78

3.5 Conclusion 81

Acknowledgments 82

References 82

4 Preparation Techniques of Pharmaceutical Cocrystals 93
Nikita Thakur, Mansi Prashar, Sukhvir Kaur, Neelima Dhingra, Manish Kumar, Ritu Rathi, Inderbir Singh and Poonam Arora

4.1 Introduction 94

4.2 Cocrystal Preparation Techniques 95

4.2.1 Solid-State Approach 96

4.2.1.1 Neat-Grinding Method 96

4.2.1.2 Liquid-Assisted Grinding Method 97

4.2.1.3 Hot-Melt Extrusion Approach 98

4.2.2 Solution-Based Method 99

4.2.2.1 Solvent Evaporation Approach 99

4.2.2.2 Slurry Conversion Approach 100

4.2.2.3 Cooling Crystallization 101

4.2.2.4 Antisolvent Method 102

4.2.3 Miscellaneous Approaches 103

4.2.3.1 Spray Drying and Supercritical CO 2 -Assisted Spray Drying 103

4.2.3.2 Twin-Screw Extruder 104

4.3 Optimization Parameters for Cocrystal Formation 108

4.3.1 Choice of Coformer 108

4.3.2 Kinetics of Cocrystallization 109

4.3.3 Application of Modeling and Process Analytical Technology 110

4.4 Future Perspectives and Challenges 112

Acknowledgments 113

References 114

5 A Brief on Analytical and Characterization Techniques for Evaluation of Pharmaceutical Cocrystals 121
Suraj R. Chaudhari, Shashikant B. Bagade, Sonali V. Chaudhari and Atul A. Shirkhedkar

5.1 Introduction 122

5.2 Analytical Techniques 123

5.2.1 X-Ray Powder Diffraction (XRPD) 123

5.2.2 Single-Crystal X-Ray Diffraction (SCXRD) 124

5.2.3 Differential Scanning Calorimetry (DSC) 126

5.2.4 Thermogravimetric Analysis (TGA) 127

5.2.5 Spectroscopic Methods (Infra-red, Raman, and Nuclear Magnetic Resonance) 128

5.3 Physicochemical Characterization of Cocrystals 131

5.3.1 Assessment of Solubility and Dissolution Characteristics 131

5.3.2 Cocrystal Stability 132

5.3.3 Discussion on Exploration of Analytical Techniques for Characterization of Cocrystals 133

5.4 Conclusion 143

Acknowledgment 144

References 144

6 Advancements and Applications of Herbal Cocrystals 153
Rajat Goyal, Pankaj Popli, Kashish Wilson, Hitesh Chopra, Sonia Dhiman and Sumeet Gupta

6.1 Introduction 154

6.1.1 Definition and Overview 154

6.1.2 Fundamentals of Cocrystal Formation 155

6.1.3 Selection of Coformer 157

6.1.4 Methods of Cocrystal Synthesis 158

6.1.4.1 Solid-State Methods 159

6.1.4.2 Solvent-Based Methods 160

6.1.4.3 Solvent Evaporation Method 160

6.1.4.4 Miscellaneous Methods 160

6.1.5 Characterization Techniques 161

6.2 Benefits and Applications of Herbal Cocrystals 163

6.2.1 Enhanced Solubility and Bioavailability 163

6.2.2 Improved Stability and Shelf Life 164

6.3 Challenges and Limitations of Herbal Cocrystals, Solubility Issues, and Incompatibilities 164

6.3.1 Scale-Up and Manufacturing Challenges 164

6.3.2 Safety Concerns 165

6.3.3 Quality Control 165

6.3.4 Regulatory Considerations 166

6.4 Reported Herbal Cocrystals 166

6.5 Future Perspectives and Trends 166

6.5.1 Advances in Cocrystal Technology 166

6.5.2 Potential for New Herbal Therapeutics 177

6.6 Conclusion 178

References 179

7 Drug-Drug Cocrystals: Advancements and Applications 189
Ritu Rathi, Sushant Sharma, Siddhartha Gautham Pal, Rohil Panwar, Taruna, Rakesh Pahwa and Inderbir Singh

7.1 Introduction 190

7.1.1 Preparation Techniques 192

7.1.2 Characterization of DDCS 196

7.2 Reported Drug-Drug Cocrystals for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 199

7.3 Reported Drug-Drug Cocrystals for Anticancer Drugs 202

7.4 Reported Drug-Drug Cocrystals for Antituberculosis Drugs 206

7.5 Reported Drug-Drug Cocrystals for Diuretics 209

7.6 Reported Drug-Drug Cocrystals for Miscellaneous Drugs 212

7.7 Patent Perspectives 214

7.8 Marketed Product 218

7.9 Conclusion 218

Acknowledgment 218

References 219

8 Scaling Up Pharmaceutical Cocrystals: Exploring Commercial Opportunities and Industrial Prospective 231
Kampanart Huanbutta, Tanikan Sangnim, Ritu Rathi and Inderbir Singh

8.1 Introduction 232

8.2 Challenges and Considerations in Cocrystal Scale-Up 233

8.2.1 Process Control and Consistency 233

8.2.2 Kinetics of Cocrystallization 233

8.2.3 Selection of Appropriate Scale-Up Method 234

8.2.4 Regulatory Compliance 235

8.3 Promising Methods for Cocrystal Scale-Up 235

8.3.1 Solution-Mediated Cocrystallization 235

8.3.2 Solid/Slurry Cocrystallization 240

8.4 Quality-By-Design Approaches (QbD) in Cocrystallization Manufacturing 243

8.5 Process Analytical Technology in Scale-Up Cocrystallization Process 244

8.6 Commercial Opportunities for Cocrystals 246

8.7 Future Directions and Outlook 246

8.7.1 Machine Learning and AI 246

8.7.2 Advanced Process Analytical Technology (PAT) 248

8.7.3 Green Chemistry 248

8.8 Conclusion 249

Acknowledgment 250

References 250

9 Pharmaceutical Cocrystals for Solubility Enhancement of Drugs 257
Mouli Das, Sk Habibullah, Tanisha Das and Subrata Mallick

9.1 Introduction 258

9.2 Why Solubility Enhancement is Important? 259

9.3 Factors Affecting Solubility 260

9.3.1 Nature of Solute and Solvent 260

9.3.2 Particle Size 260

9.3.3 Temperature 261

9.3.4 Pressure 261

9.3.5 Molecular Size 262

9.3.6 Polymorphism 262

9.3.7 Polarity 262

9.3.8 Common-Ion Effect 262

9.4 Solubility and Bioavailability 263

9.5 Permeability and Cocrystallization 264

9.6 Enhancing Solubility through Cocrystallization 265

9.6.1 Hot-Melt Extrusion Technique of Cocrystallization to Enhance Solubility 265

9.6.2 Amino Acid in Cocrystal to Enhance Solubility 266

9.6.3 Polymeric Effect on Cocrystallization 266

9.6.4 Cocrystals of Herbal Bioactive to Enhance Solubility 267

9.6.5 Solubility Enhancement of Anticancer Drug via Cocrystallization 272

9.6.6 Drug-Drug Cocrystallization to Enhance Solubility 281

9.6.7 Cocrystallization for Food Encapsulation 281

9.7 Conclusion 282

Acknowledgment 283

References 283

10 Pharmaceutical Cocrystals for Improving Physicochemical Properties of Drugs: Enhancement of

Therapeutic Efficacy 293
Debabrata Ghosh Dastidar, Arpan Datta, Sanchari Bhattacharya and Moumita Chowdhury

10.1 Introduction 294

10.2 Preparation and Characterization Methods for Cocrystals 295

10.3 Enhancement of Therapeutic Efficacy with Cocrystals 297

10.3.1 Improving the Physicochemical Properties of Drugs 302

10.3.1.1 Melting Point 302

10.3.1.2 Hygroscopicity 303

10.3.1.3 Solubility and Dissolution 303

10.3.1.4 Mechanical Behavior 305

10.3.1.5 Optical Properties 306

10.3.2 Enhancing Stability and Shelf Life 307

10.3.2.1 Changing the Reaction Cavity/ Environment 308

10.3.2.2 Alteration of Solid-State Properties 309

10.3.2.3 Manipulation of Hydrogen Bonding Pattern 309

10.3.2.4 Influencing Solid-State Microenvironment 310

10.3.2.5 Increased Thermal Stability 311

10.3.3 Improving Bioavailability and Pharmacokinetics 312

10.3.3.1 The Mechanism for Enhancing the Bioavailability and Improve Pharmacokinetics of Drugs 312

10.3.4 Combination Therapy 316

10.3.5 Improving the Targeted Delivery of Drugs 318

10.4 Regulatory Considerations for Cocrystal Approval 319

10.5 Conclusion and Future Aspects 322

Acknowledgment 323

References 323

11 Application of Pharmaceutical Cocrystals in Improving Mechanical Properties and Stability 329
Sushant Sharma, Ritu Rathi, Ayushi Taneja, Poonam Arora and Inderbir Singh

11.1 Introduction 330

11.2 Pharmaceutical Cocrystals Improve Mechanical Properties 332

11.3 Pharmaceutical Cocrystals Improving Stability 341

11.4 Conclusion and Future Prospective 344

Acknowledgments 350

References 350

12 Patents and Regulatory Considerations of Pharmaceutical Cocrystals 357
Ritu Rathi, Ritamay Sau, Rakesh K. Sindhu, Harpreet Singh and Inderbir Singh

12.1 Introduction 358

12.1.1 Comparison Between USFDA and EMA on the Aspects of Cocrystal 363

12.2 Generic Concept of Pharmaceutical Cocrystals 365

12.3 Data Consideration Using Pharmaceutical Cocrystals for Abridged Application 367

12.3.1 Module 3: Quality Aspects for Pharmaceutical Cocrystals 367

12.3.1.1 Quality Aspects During Development of Generic Cocrystal API 369

12.3.2 Module 4: Non-Clinical Safety Toxicological Studies 369

12.3.3 Module 5: Clinical Studies 370

12.4 Patent on Cocrystals 370

12.5 Conclusion 373

Acknowledgment 374

References 374

Index 379

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