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Submit a ProposalCo-Crystals in Pharmaceutical Sciences
 | Design to Applications Edited by Inderbir Singh, Subrata Mallick and Ritu Rathi Copyright: 2025 | Expected Pub Date:2025/04/30 ISBN: 9781394302475 | Hardcover | 398 pages |
One Line 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.
Audience
Botanists, biologists, pharmaceutical professionals, drug delivery experts, and materials scientists studying pharmaceutical sciences.
Botanists, biologists, pharmaceutical professionals, drug delivery experts, and materials scientists studying pharmaceutical sciences.
Description
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.
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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.
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Author / Editor Details
Inderbir Singh, PhD, is a professor and the Assistant Dean of Research at Chitkara College of Pharmacy, Chitkara University, India. He has published eight books, 25 book chapters, and 180 papers in peer-reviewed journals. He also has 11 utility patents and 15 design registrations under review and has been granted three patents. His research interests include gastroretentive drug delivery systems, biopolymers, biomaterials, modified polymers in drug delivery, pharmaceutical cocrystals, the SeDeM expert system, and 3D printing technology.
Inderbir Singh, PhD, is a professor and the Assistant Dean of Research at Chitkara College of Pharmacy, Chitkara University, India. He has published eight books, 25 book chapters, and 180 papers in peer-reviewed journals. He also has 11 utility patents and 15 design registrations under review and has been granted three patents. His research interests include gastroretentive drug delivery systems, biopolymers, biomaterials, modified polymers in drug delivery, pharmaceutical cocrystals, the SeDeM expert system, and 3D printing technology.
Subrata Mallick, PhD, is a professor and the Head of the Department of Pharmaceutics in the School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan University, Odisha, India, with 26 years of teaching, research, and industry experience. He has published over 100 papers in international journals, six books, over 130 conference abstract proceedings, and five scientific articles, in addition to serving as an editorial board member for several international journals. His areas of interest include transdermal drug delivery systems, transmucosal drug delivery systems, powder compaction, drug degradation kinetics and stabilization, and drug-drug and drug-excipient interactions.
Ritu Rathi, PhD, is a PhD research scholar at Chitkara College of Pharmacy, Chitkara University, India, with five years of research experience in the field of pharmaceutical sciences. In addition to her active pharmaceutical research, she has published 17 articles and book chapters in various national and international journals, applied for three utility patents, and been granted two design registrations. Her research interests include pharmaceutical cocrystals, solubility enhancement techniques, herbal bioactives, and in-silico modeling techniques.
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Table of Contents
Preface
1. Pharmaceutical Cocrystals: Introduction, History and Applications
Oluwatoyin A. Odeku and Olufunke D. Akin-Ajani
1.1 Introduction
1.2 History
1.3 Applications of Cocrystals in Pharmaceutical Sciences
1.3.1 Enhanced Solubility
1.3.2 Improved Bioavailability
1.3.3 Stability Enhancement
1.3.4 Taste Masking and Palatability
1.3.5 Controlled Release
1.3.6 Increased Tabletability
1.3.7 Combination Therapy
1.4 Challenges in the Development of Cocrystals
1.5 Marketed Products
1.6 Future of Pharmaceutical Cocrystals
1.7 Conclusion
Acknowledgment
References
2. Design and Structural Characteristics of Pharmaceutical Cocrystals
Harpreet Singh, Bhuvnesh Kumar Singh, Anil Kumar, Arvind Kumar, Arun Kumar Mishra, Ritu Rathi and Inderbir Singh
2.1 Introduction
2.1.1 Polymorphism
2.1.2 Salt Cocrystal Continuum
2.2 Design of Pharmaceutical Cocrystals
2.2.1 Molecular Recognition and Supramolecular Interactions
2.2.2 Hansen Solubility Parameters (HSPs)
2.2.3 Coformers Selection and Combinatorial Approaches
2.2.3.1 Theoretical Methods
2.2.3.2 GRAS Coformer Libraries
2.2.3.3 High-Throughput Experimentation
2.2.3.4 Coformer Selection
2.2.4 Combinatorial Approaches
2.3 Structural Characteristics of Pharmaceutical Cocrystals
2.3.1 Crystal Structure Analysis
2.3.2 A Perspective on Cocrystal Hydrogen Bonding
2.3.3 Characterization Techniques
2.4 Challenges and Future Directions in Pharmaceutical Cocrystal
2.5 Conclusion
Acknowledgment
References
3. Advancements in Computational Screening Methods for Pharmaceutical Cocrystals
Maan Singh, Abhishek Mali, Madhukiran Dhondale, Ashish Kumar Agrawal, Amrit Paudel and Dinesh Kumar
3.1 Introduction
3.2 Experimental Screening of Cocrystals
3.3 Computational Method for Screening Cocrystals
3.3.1 Molecular Electrostatic Potential Surfaces (MEPS) Measurement
3.3.2 Hirshfeld Surface Analysis (HSA)
3.3.3 Cambridge Structural Database (CSD)
3.3.4 COSMO-RS Approach
3.3.5 Crystal Structure Prediction (CSP)
3.4 Recent Trends in Cocrystal Screening and Future Approach
3.5 Conclusion
Acknowledgments
References
4. Preparation Techniques of Pharmaceutical Cocrystals
Nikita Thakur, Mansi Prashar, Sukhvir Kaur, Neelima Dhingra, Manish Kumar, Ritu Rathi, Inderbir Singh and Poonam Arora
4.1 Introduction
4.2 Cocrystal Preparation Techniques
4.2.1 Solid-State Approach
4.2.1.1 Neat-Grinding Method
4.2.1.2 Liquid-Assisted Grinding Method
4.2.1.3 Hot-Melt Extrusion Approach
4.2.2 Solution-Based Method
4.2.2.1 Solvent Evaporation Approach
4.2.2.2 Slurry Conversion Approach
4.2.2.3 Cooling Crystallization
4.2.2.4 Antisolvent Method
4.2.3 Miscellaneous Approaches
4.2.3.1 Spray Drying and Supercritical CO2-Assisted Spray Drying
4.2.3.2 Twin-Screw Extruder
4.3 Optimization Parameters for Cocrystal Formation
4.3.1 Choice of Coformer
4.3.2 Kinetics of Cocrystallization
4.3.3 Application of Modeling and Process Analytical Technology
4.4 Future Perspectives and Challenges
Acknowledgments
References
5. A Brief on Analytical and Characterization Techniques for Evaluation of Pharmaceutical Cocrystals
Suraj R. Chaudhari, Shashikant B. Bagade, Sonali V. Chaudhari and Atul A. Shirkhedkar
5.1 Introduction
5.2 Analytical Techniques
5.2.1 X-Ray Powder Diffraction (XRPD)
5.2.2 Single-Crystal X-Ray Diffraction (SCXRD)
5.2.3 Differential Scanning Calorimetry (DSC)
5.2.4 Thermogravimetric Analysis (TGA)
5.2.5 Spectroscopic Methods (Infra-red, Raman, and Nuclear Magnetic Resonance)
5.3 Physicochemical Characterization of Cocrystals
5.3.1 Assessment of Solubility and Dissolution Characteristics
5.3.2 Cocrystal Stability
5.3.3 Discussion on Exploration of Analytical Techniques for Characterization of Cocrystals
5.4 Conclusion
Acknowledgment
References
6. Advancements and Applications of Herbal Cocrystals
Rajat Goyal, Pankaj Popli, Kashish Wilson, Hitesh Chopra, Sonia Dhiman and Sumeet Gupta
6.1 Introduction
6.1.1 Definition and Overview
6.1.2 Fundamentals of Cocrystal Formation
6.1.3 Selection of Coformer
6.1.4 Methods of Cocrystal Synthesis
6.1.4.1 Solid-State Methods
6.1.4.2 Solvent-Based Methods
6.1.4.3 Solvent Evaporation Method
6.1.4.4 Miscellaneous Methods
6.1.5 Characterization Techniques
6.2 Benefits and Applications of Herbal Cocrystals
6.2.1 Enhanced Solubility and Bioavailability
6.2.2 Improved Stability and Shelf Life
6.3 Challenges and Limitations of Herbal Cocrystals, Solubility Issues, and Incompatibilities
6.3.1 Scale-Up and Manufacturing Challenges
6.3.2 Safety Concerns
6.3.3 Quality Control
6.3.4 Regulatory Considerations
6.4 Reported Herbal Cocrystals
6.5 Future Perspectives and Trends
6.5.1 Advances in Cocrystal Technology
6.5.2 Potential for New Herbal Therapeutics
6.6 Conclusion
References
7. Drug-Drug Cocrystals: Advancements and Applications
Ritu Rathi, Sushant Sharma, Siddhartha Gautham Pal, Rohil Panwar, Taruna, Rakesh Pahwa and Inderbir Singh
7.1 Introduction
7.1.1 Preparation Techniques
7.1.2 Characterization of DDCS
7.2 Reported Drug-Drug Cocrystals for Non‑Steroidal Anti-Inflammatory Drugs (NSAIDs)
7.3 Reported Drug-Drug Cocrystals for Anticancer Drugs
7.4 Reported Drug-Drug Cocrystals for Antituberculosis Drugs
7.5 Reported Drug-Drug Cocrystals for Diuretics
7.6 Reported Drug-Drug Cocrystals for Miscellaneous Drugs
7.7 Patent Perspectives
7.8 Marketed Product
7.9 Conclusion
Acknowledgment
References
8. Scaling Up Pharmaceutical Cocrystals: Exploring Commercial Opportunities and Industrial Prospective
Kampanart Huanbutta, Tanikan Sangnim, Ritu Rathi and Inderbir Singh
8.1 Introduction
8.2 Challenges and Considerations in Cocrystal Scale-Up
8.2.1 Process Control and Consistency
8.2.2 Kinetics of Cocrystallization
8.2.3 Selection of Appropriate Scale-Up Method
8.2.4 Regulatory Compliance
8.3 Promising Methods for Cocrystal Scale-Up
8.3.1 Solution-Mediated Cocrystallization
8.3.2 Solid/Slurry Cocrystallization
8.4 Quality-By-Design Approaches (QbD) in Cocrystallization Manufacturing
8.5 Process Analytical Technology in Scale-Up Cocrystallization Process
8.6 Commercial Opportunities for Cocrystals
8.7 Future Directions and Outlook
8.7.1 Machine Learning and AI
8.7.2 Advanced Process Analytical Technology (PAT)
8.7.3 Green Chemistry
8.8 Conclusion
Acknowledgment
References
9. Pharmaceutical Cocrystals for Solubility Enhancement of Drugs
Mouli Das, Sk Habibullah, Tanisha Das and Subrata Mallick
9.1 Introduction
9.2 Why Solubility Enhancement is Important?
9.3 Factors Affecting Solubility
9.3.1 Nature of Solute and Solvent
9.3.2 Particle Size
9.3.3 Temperature
9.3.4 Pressure
9.3.5 Molecular Size
9.3.6 Polymorphism
9.3.7 Polarity
9.3.8 Common-Ion Effect
9.4 Solubility and Bioavailability
9.5 Permeability and Cocrystallization
9.6 Enhancing Solubility through Cocrystallization
9.6.1 Hot-Melt Extrusion Technique of Cocrystallization to Enhance Solubility
9.6.2 Amino Acid in Cocrystal to Enhance Solubility
9.6.3 Polymeric Effect on Cocrystallization
9.6.4 Cocrystals of Herbal Bioactive to Enhance Solubility
9.6.5 Solubility Enhancement of Anticancer Drug via Cocrystallization
9.6.6 Drug-Drug Cocrystallization to Enhance Solubility
9.6.7 Cocrystallization for Food Encapsulation
9.7 Conclusion
Acknowledgment
References
10. Pharmaceutical Cocrystals for Improving Physicochemical Properties of Drugs: Enhancement of Therapeutic Efficacy
Debabrata Ghosh Dastidar, Arpan Datta, Sanchari Bhattacharya and Moumita Chowdhury
10.1 Introduction
10.2 Preparation and Characterization Methods for Cocrystals
10.3 Enhancement of Therapeutic Efficacy with Cocrystals
10.3.1 Improving the Physicochemical Properties of Drugs
10.3.1.1 Melting Point
10.3.1.2 Hygroscopicity
10.3.1.3 Solubility and Dissolution
10.3.1.4 Mechanical Behavior
10.3.1.5 Optical Properties
10.3.2 Enhancing Stability and Shelf Life
10.3.2.1 Changing the Reaction Cavity/Environment
10.3.2.2 Alteration of Solid-State Properties
10.3.2.3 Manipulation of Hydrogen Bonding Pattern
10.3.2.4 Influencing Solid-State Microenvironment
10.3.2.5 Increased Thermal Stability
10.3.3 Improving Bioavailability and Pharmacokinetics
10.3.3.1 The Mechanism for Enhancing the Bioavailability and Improve Pharmacokinetics of Drugs
10.3.4 Combination Therapy
10.3.5 Improving the Targeted Delivery of Drugs
10.4 Regulatory Considerations for Cocrystal Approval
10.5 Conclusion and Future Aspects
Acknowledgment
References
11. Application of Pharmaceutical Cocrystals in Improving Mechanical Properties and Stability
Sushant Sharma, Ritu Rathi, Ayushi Taneja, Poonam Arora and Inderbir Singh
11.1 Introduction
11.2 Pharmaceutical Cocrystals Improve Mechanical Properties
11.3 Pharmaceutical Cocrystals Improving Stability
11.4 Conclusion and Future Prospective
Acknowledgments
References
12. Patents and Regulatory Considerations of Pharmaceutical Cocrystals
Ritu Rathi, Ritamay Sau, Rakesh K. Sindhu, Harpreet Singh and Inderbir Singh
12.1 Introduction
12.1.1 Comparison Between USFDA and EMA on the Aspects of Cocrystal
12.2 Generic Concept of Pharmaceutical Cocrystals
12.3 Data Consideration Using Pharmaceutical Cocrystals for Abridged Application
12.3.1 Module 3: Quality Aspects for Pharmaceutical Cocrystals
12.3.1.1 Quality Aspects During Development of Generic Cocrystal API
12.3.2 Module 4: Non-Clinical Safety Toxicological Studies
12.3.3 Module 5: Clinical Studies
12.4 Patent on Cocrystals
12.5 Conclusion
Acknowledgment
References
Index
Back to Top
Preface
1. Pharmaceutical Cocrystals: Introduction, History and Applications
Oluwatoyin A. Odeku and Olufunke D. Akin-Ajani
1.1 Introduction
1.2 History
1.3 Applications of Cocrystals in Pharmaceutical Sciences
1.3.1 Enhanced Solubility
1.3.2 Improved Bioavailability
1.3.3 Stability Enhancement
1.3.4 Taste Masking and Palatability
1.3.5 Controlled Release
1.3.6 Increased Tabletability
1.3.7 Combination Therapy
1.4 Challenges in the Development of Cocrystals
1.5 Marketed Products
1.6 Future of Pharmaceutical Cocrystals
1.7 Conclusion
Acknowledgment
References
2. Design and Structural Characteristics of Pharmaceutical Cocrystals
Harpreet Singh, Bhuvnesh Kumar Singh, Anil Kumar, Arvind Kumar, Arun Kumar Mishra, Ritu Rathi and Inderbir Singh
2.1 Introduction
2.1.1 Polymorphism
2.1.2 Salt Cocrystal Continuum
2.2 Design of Pharmaceutical Cocrystals
2.2.1 Molecular Recognition and Supramolecular Interactions
2.2.2 Hansen Solubility Parameters (HSPs)
2.2.3 Coformers Selection and Combinatorial Approaches
2.2.3.1 Theoretical Methods
2.2.3.2 GRAS Coformer Libraries
2.2.3.3 High-Throughput Experimentation
2.2.3.4 Coformer Selection
2.2.4 Combinatorial Approaches
2.3 Structural Characteristics of Pharmaceutical Cocrystals
2.3.1 Crystal Structure Analysis
2.3.2 A Perspective on Cocrystal Hydrogen Bonding
2.3.3 Characterization Techniques
2.4 Challenges and Future Directions in Pharmaceutical Cocrystal
2.5 Conclusion
Acknowledgment
References
3. Advancements in Computational Screening Methods for Pharmaceutical Cocrystals
Maan Singh, Abhishek Mali, Madhukiran Dhondale, Ashish Kumar Agrawal, Amrit Paudel and Dinesh Kumar
3.1 Introduction
3.2 Experimental Screening of Cocrystals
3.3 Computational Method for Screening Cocrystals
3.3.1 Molecular Electrostatic Potential Surfaces (MEPS) Measurement
3.3.2 Hirshfeld Surface Analysis (HSA)
3.3.3 Cambridge Structural Database (CSD)
3.3.4 COSMO-RS Approach
3.3.5 Crystal Structure Prediction (CSP)
3.4 Recent Trends in Cocrystal Screening and Future Approach
3.5 Conclusion
Acknowledgments
References
4. Preparation Techniques of Pharmaceutical Cocrystals
Nikita Thakur, Mansi Prashar, Sukhvir Kaur, Neelima Dhingra, Manish Kumar, Ritu Rathi, Inderbir Singh and Poonam Arora
4.1 Introduction
4.2 Cocrystal Preparation Techniques
4.2.1 Solid-State Approach
4.2.1.1 Neat-Grinding Method
4.2.1.2 Liquid-Assisted Grinding Method
4.2.1.3 Hot-Melt Extrusion Approach
4.2.2 Solution-Based Method
4.2.2.1 Solvent Evaporation Approach
4.2.2.2 Slurry Conversion Approach
4.2.2.3 Cooling Crystallization
4.2.2.4 Antisolvent Method
4.2.3 Miscellaneous Approaches
4.2.3.1 Spray Drying and Supercritical CO2-Assisted Spray Drying
4.2.3.2 Twin-Screw Extruder
4.3 Optimization Parameters for Cocrystal Formation
4.3.1 Choice of Coformer
4.3.2 Kinetics of Cocrystallization
4.3.3 Application of Modeling and Process Analytical Technology
4.4 Future Perspectives and Challenges
Acknowledgments
References
5. A Brief on Analytical and Characterization Techniques for Evaluation of Pharmaceutical Cocrystals
Suraj R. Chaudhari, Shashikant B. Bagade, Sonali V. Chaudhari and Atul A. Shirkhedkar
5.1 Introduction
5.2 Analytical Techniques
5.2.1 X-Ray Powder Diffraction (XRPD)
5.2.2 Single-Crystal X-Ray Diffraction (SCXRD)
5.2.3 Differential Scanning Calorimetry (DSC)
5.2.4 Thermogravimetric Analysis (TGA)
5.2.5 Spectroscopic Methods (Infra-red, Raman, and Nuclear Magnetic Resonance)
5.3 Physicochemical Characterization of Cocrystals
5.3.1 Assessment of Solubility and Dissolution Characteristics
5.3.2 Cocrystal Stability
5.3.3 Discussion on Exploration of Analytical Techniques for Characterization of Cocrystals
5.4 Conclusion
Acknowledgment
References
6. Advancements and Applications of Herbal Cocrystals
Rajat Goyal, Pankaj Popli, Kashish Wilson, Hitesh Chopra, Sonia Dhiman and Sumeet Gupta
6.1 Introduction
6.1.1 Definition and Overview
6.1.2 Fundamentals of Cocrystal Formation
6.1.3 Selection of Coformer
6.1.4 Methods of Cocrystal Synthesis
6.1.4.1 Solid-State Methods
6.1.4.2 Solvent-Based Methods
6.1.4.3 Solvent Evaporation Method
6.1.4.4 Miscellaneous Methods
6.1.5 Characterization Techniques
6.2 Benefits and Applications of Herbal Cocrystals
6.2.1 Enhanced Solubility and Bioavailability
6.2.2 Improved Stability and Shelf Life
6.3 Challenges and Limitations of Herbal Cocrystals, Solubility Issues, and Incompatibilities
6.3.1 Scale-Up and Manufacturing Challenges
6.3.2 Safety Concerns
6.3.3 Quality Control
6.3.4 Regulatory Considerations
6.4 Reported Herbal Cocrystals
6.5 Future Perspectives and Trends
6.5.1 Advances in Cocrystal Technology
6.5.2 Potential for New Herbal Therapeutics
6.6 Conclusion
References
7. Drug-Drug Cocrystals: Advancements and Applications
Ritu Rathi, Sushant Sharma, Siddhartha Gautham Pal, Rohil Panwar, Taruna, Rakesh Pahwa and Inderbir Singh
7.1 Introduction
7.1.1 Preparation Techniques
7.1.2 Characterization of DDCS
7.2 Reported Drug-Drug Cocrystals for Non‑Steroidal Anti-Inflammatory Drugs (NSAIDs)
7.3 Reported Drug-Drug Cocrystals for Anticancer Drugs
7.4 Reported Drug-Drug Cocrystals for Antituberculosis Drugs
7.5 Reported Drug-Drug Cocrystals for Diuretics
7.6 Reported Drug-Drug Cocrystals for Miscellaneous Drugs
7.7 Patent Perspectives
7.8 Marketed Product
7.9 Conclusion
Acknowledgment
References
8. Scaling Up Pharmaceutical Cocrystals: Exploring Commercial Opportunities and Industrial Prospective
Kampanart Huanbutta, Tanikan Sangnim, Ritu Rathi and Inderbir Singh
8.1 Introduction
8.2 Challenges and Considerations in Cocrystal Scale-Up
8.2.1 Process Control and Consistency
8.2.2 Kinetics of Cocrystallization
8.2.3 Selection of Appropriate Scale-Up Method
8.2.4 Regulatory Compliance
8.3 Promising Methods for Cocrystal Scale-Up
8.3.1 Solution-Mediated Cocrystallization
8.3.2 Solid/Slurry Cocrystallization
8.4 Quality-By-Design Approaches (QbD) in Cocrystallization Manufacturing
8.5 Process Analytical Technology in Scale-Up Cocrystallization Process
8.6 Commercial Opportunities for Cocrystals
8.7 Future Directions and Outlook
8.7.1 Machine Learning and AI
8.7.2 Advanced Process Analytical Technology (PAT)
8.7.3 Green Chemistry
8.8 Conclusion
Acknowledgment
References
9. Pharmaceutical Cocrystals for Solubility Enhancement of Drugs
Mouli Das, Sk Habibullah, Tanisha Das and Subrata Mallick
9.1 Introduction
9.2 Why Solubility Enhancement is Important?
9.3 Factors Affecting Solubility
9.3.1 Nature of Solute and Solvent
9.3.2 Particle Size
9.3.3 Temperature
9.3.4 Pressure
9.3.5 Molecular Size
9.3.6 Polymorphism
9.3.7 Polarity
9.3.8 Common-Ion Effect
9.4 Solubility and Bioavailability
9.5 Permeability and Cocrystallization
9.6 Enhancing Solubility through Cocrystallization
9.6.1 Hot-Melt Extrusion Technique of Cocrystallization to Enhance Solubility
9.6.2 Amino Acid in Cocrystal to Enhance Solubility
9.6.3 Polymeric Effect on Cocrystallization
9.6.4 Cocrystals of Herbal Bioactive to Enhance Solubility
9.6.5 Solubility Enhancement of Anticancer Drug via Cocrystallization
9.6.6 Drug-Drug Cocrystallization to Enhance Solubility
9.6.7 Cocrystallization for Food Encapsulation
9.7 Conclusion
Acknowledgment
References
10. Pharmaceutical Cocrystals for Improving Physicochemical Properties of Drugs: Enhancement of Therapeutic Efficacy
Debabrata Ghosh Dastidar, Arpan Datta, Sanchari Bhattacharya and Moumita Chowdhury
10.1 Introduction
10.2 Preparation and Characterization Methods for Cocrystals
10.3 Enhancement of Therapeutic Efficacy with Cocrystals
10.3.1 Improving the Physicochemical Properties of Drugs
10.3.1.1 Melting Point
10.3.1.2 Hygroscopicity
10.3.1.3 Solubility and Dissolution
10.3.1.4 Mechanical Behavior
10.3.1.5 Optical Properties
10.3.2 Enhancing Stability and Shelf Life
10.3.2.1 Changing the Reaction Cavity/Environment
10.3.2.2 Alteration of Solid-State Properties
10.3.2.3 Manipulation of Hydrogen Bonding Pattern
10.3.2.4 Influencing Solid-State Microenvironment
10.3.2.5 Increased Thermal Stability
10.3.3 Improving Bioavailability and Pharmacokinetics
10.3.3.1 The Mechanism for Enhancing the Bioavailability and Improve Pharmacokinetics of Drugs
10.3.4 Combination Therapy
10.3.5 Improving the Targeted Delivery of Drugs
10.4 Regulatory Considerations for Cocrystal Approval
10.5 Conclusion and Future Aspects
Acknowledgment
References
11. Application of Pharmaceutical Cocrystals in Improving Mechanical Properties and Stability
Sushant Sharma, Ritu Rathi, Ayushi Taneja, Poonam Arora and Inderbir Singh
11.1 Introduction
11.2 Pharmaceutical Cocrystals Improve Mechanical Properties
11.3 Pharmaceutical Cocrystals Improving Stability
11.4 Conclusion and Future Prospective
Acknowledgments
References
12. Patents and Regulatory Considerations of Pharmaceutical Cocrystals
Ritu Rathi, Ritamay Sau, Rakesh K. Sindhu, Harpreet Singh and Inderbir Singh
12.1 Introduction
12.1.1 Comparison Between USFDA and EMA on the Aspects of Cocrystal
12.2 Generic Concept of Pharmaceutical Cocrystals
12.3 Data Consideration Using Pharmaceutical Cocrystals for Abridged Application
12.3.1 Module 3: Quality Aspects for Pharmaceutical Cocrystals
12.3.1.1 Quality Aspects During Development of Generic Cocrystal API
12.3.2 Module 4: Non-Clinical Safety Toxicological Studies
12.3.3 Module 5: Clinical Studies
12.4 Patent on Cocrystals
12.5 Conclusion
Acknowledgment
References
Index
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