Dosage Forms, Formulation Developments and Regulations

Recent and Future Trends in Pharmaceutics, Volume 1

1st Edition - December 4, 2023
Editors: Amit Kumar Nayak, Kalyan Kumar Sen
Language: English
Paperback ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 8 1 7 - 6
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 7 2 4 6 - 8

Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original appr… Read more

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Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included.

The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics.

Cover image
Title page
Table of Contents
Copyright
List of contributors
About the editors
Preface
Acknowledgments
Section I: Drugs, dosage forms, and regulations
Chapter 1. New drug discovery and development
Abstract
1.1 Background
1.2 Origins of drugs
1.3 Hit-to-lead discoveries
1.4 Lead optimization
1.5 Clinical trials
1.6 Final considerations
References
Chapter 2. Introduction to different types of dosage forms and commonly used excipients
Abstract
2.1 Introduction
2.2 Define the “drugs”
2.3 What is there in a “dosage form”?
2.4 Solid dosage forms
2.5 Drug formulation additives
2.6 Oral solid dosage forms
2.7 Diluents
2.8 Binders
2.9 Disintegrating agents
2.10 Lubricants
2.11 Glidants
2.12 Coating materials
2.13 Liquid dosage forms
2.14 Solvents
2.15 Cosolvents
2.16 Sequestering agents
2.17 Buffers and buffering agents
2.18 Semisolid dosage forms
2.19 Gaseous dosage forms
2.20 Advancements in drug delivery modules
References
Chapter 3. Pharmacopoeias, national formulary and extra pharmacopoeia
Abstract
3.1 Introduction
3.2 National Pharmacopoeia
3.3 Regional Pharmacopoeia
3.4 International Pharmacopoeia
3.5 Extra Pharmacopoeia (Martindale)
3.6 Conclusion
References
Chapter 4. Regulatory affairs: historical overview, authorities, and role in drug approval
Abstract
4.1 Introduction
4.2 Historical overview of drug regulatory affairs
4.3 India
4.4 Major regulatory authorities in the world
4.5 Regulatory affairs professionals
4.6 Regulatory requirements for drug approval
4.7 Application submission activities in some major countries
4.8 Drug development team
4.9 Nonclinical drug development: pharmacology, drug metabolism, and toxicology
4.10 General consideration for new drug application, investigator’s brochure, new drug application
4.11 Investigator’s brochure
4.12 New Drug Application
4.13 Clinical research protocol
4.14 Protocol agreement
4.15 Bioequivalence studies
4.16 Data presentation of the FDA submission
4.17 Management of clinical study
4.18 Conclusion
References
Chapter 5. Introduction to intellectual property rights and drug patents
Abstract
5.1 Introduction
5.2 Patent—definition and salient features
5.3 Norms for obtaining a patent
5.4 Types of patents
5.5 Duration of a patent and patent expiry
5.6 Contents of a patent application
5.7 Procedures for filing a patent
5.8 Patent expiry and strategies to deal with the issue of patent expiry
5.9 Patent rights and infringement
5.10 Compulsory licensing
5.11 Indian scenario of drug patenting
5.12 Conclusion
Bibliography
Chapter 6. Introduction to pharmaceutical validation
Abstract
6.1 Introduction
6.2 Documents to be prepared during validation of a pharmaceutical manufacturing process
6.3 Scope of validation
6.4 Types of validation
6.5 Qualification
6.6 Change management and deviation management
6.7 Process qualification
6.8 Validation plan
6.9 Validation report
6.10 Review of validation activities
6.11 Batch sizes for validation
6.12 Six sigma process during carrying out validation
6.13 Analytical method validation
6.14 Water system validation
6.15 Validation of heating, ventilation and air-conditioning system
6.16 Cleaning method validation
6.17 Conclusion
References
Section II: Design of dosage forms and drug delivery formulation strategies
Chapter 7. Design of dosage forms: influences of anatomy and administration routes
Abstract
7.1 Introduction: general considerations in the design of dosage forms
7.2 Role of physicochemical parameters of the drug in its absorption and bioavailability
7.3 Routes of administration and implication on bioavailability
References
Chapter 8. Formulation strategies to improve the bioavailability of poorly absorbed drugs
Abstract
8.1 Introduction
References
Chapter 9. Optimization techniques in pharmaceutical formulation and processing
Abstract
9.1 Introduction
9.2 Concept of optimization
9.3 The variables of an optimization process
9.4 Optimization techniques
9.5 Factorial designs and application in pharmaceutical development
9.6 Optimization computers technology in pharmaceutical formulation development
9.7 Conclusions and futures perspectives
References
Chapter 10. Pharmaceutical product development: a “quality by design” (QbD) approach
Abstract
10.1 Quality by design
10.2 Benefits of the quality by design approach
10.3 Concerns about quality by design
10.4 Preparation of quality by design license file
10.5 Examples of quality by design applications
10.6 Conclusion
References
Chapter 11. Pharmaceutical excipients
Abstract
11.1 Introduction
11.2 Pharmaceutical excipients for solid dosage forms
11.3 Pharmaceutical excipients for liquids dosage forms
11.4 Specific excipients for sterile liquid preparations
11.5 Specific excipients for semisolid dosage forms
References
Chapter 12. Pharmaceutical calculations
Abstract
12.1 Introduction
12.2 Scope of pharmaceutical calculations
12.3 Pharmaceutical calculations: basics
12.4 Ratio, proportion, and variation ratio
12.5 Alcohol strength and proof spirit
12.6 Isotonic and buffer solutions
12.7 Buffer and buffer solutions
12.8 Electrolyte solutions: milliequivalents, millimoles, and milliosmoles
12.9 Formulation of child dose from adult dose
12.10 Pharmacokinetic parameters
12.11 Fraction of drug absorbed and dosing interval
12.12 Calculations involving suppositories
12.13 Determination of the swelling index of gum in water
12.14 Determination of moisture content
12.15 Determination of flow property parameters
12.16 Calculations for tablet evaluations
References
Section III: Pharmaceutical preformulation and formulation studies
Chapter 13. Preformulation considerations in pharmaceutical formulation process
Abstract
13.1 Introduction
13.2 Quality by design implementation in preformulation stage
13.3 Biopharmaceutics classification system
13.4 Solubility and related physicochemical parameters
13.5 Properties of solids
13.6 Preformulation of peptides and proteins
13.7 Drug–excipient interactions
References
Chapter 14. Biopharmaceutical Classification System: a strategic tool in pharmaceutical formulation
Abstract
14.1 Introduction
14.2 Conclusion
Acknowledgments
Conflict of Interest
References
Chapter 15. Technology development and transfer in pharmaceutical product development
Abstract
15.1 Introduction
15.2 Terms associated with technology transfer activities
15.3 Technology transfer from R&D to production
15.4 Development phase
15.5 Impurity profile
15.6 Formulation development
15.7 Technology transfer
15.8 Approved regulatory bodies and agencies
15.9 Commercialization practical aspects and problems (case studies)
15.10 Technology transfer agencies in India
15.11 Technology transfer-related legal documents
References
Chapter 16. Recent developments in pharmaceutical liquids
Abstract
16.1 Introduction
16.2 Components of pharmaceutical liquids
16.3 Classification of pharmaceutical liquids according to their phases
16.4 Challenges in the regulation for development of newer pharmaceutical liquids
16.5 Conclusion and future perspectives
References
Chapter 17. Advances in semisolid dosage form
Abstract
17.1 Introduction
17.2 Percutaneous absorption
17.3 Advantages and disadvantages of semisolid dosage forms
17.4 Factors affecting drug penetration
17.5 Formulation
17.6 Types of semisolid dosage forms
17.7 Method of preparation for ointments, gels, creams, pastes, jellies
17.8 Containers and storage
17.9 New/future developments in semisolid dosage forms
17.10 Conclusions
References
Chapter 18. Pharmaceutical sterilization
Abstract
18.1 Introduction
18.2 Thermal resistance of microorganism
18.3 Risk assessments
18.4 Sterility assurance level
18.5 Methods of sterilization
18.6 Sterilization indicators
18.7 Cleanroom concept: industrial perspective
18.8 Test for sterility
18.9 Conclusion
References
Chapter 19. Pharmaceutical sterile formulations
Abstract
19.1 Introduction
19.2 Parenteral products
19.3 Containers and closures selection
19.4 Ophthalmic preparations
19.5 Conclusion
References
Chapter 20. Dermatological formulations
Abstract
20.1 Introduction
20.2 Structure of skin
20.3 Challenges in development and manufacturing of skincare products
20.4 Common problem associated with oral cavity
20.5 Hair structure
20.6 Cleansing and care
20.7 Preparation of dermatological products
20.8 Evaluation of dermatological Products
20.9 Conclusion
References
Chapter 21. Pharmaceutical aerosols
Abstract
21.1 Introduction to aerosols
21.2 Components of an aerosol system
21.3 Types of aerosol system
21.4 Formulation and manufacture of aerosols
21.5 Evaluation of aerosols
21.6 Quality control of aerosols
21.7 The design and development of metered-dose inhalers
References
Chapter 22. Pharmaceutical packaging: recent trends and challenges
Abstract
22.1 Introduction
22.2 Packaging materials
22.3 Selection of packaging materials
22.4 Factors affecting the choice of pharmaceutical packaging
22.5 Types of packaging materials
22.6 Commonly used pharmaceutical packaging
22.7 Legal and official requirements of pharmaceutical packaging
22.8 Stability aspects of pharmaceutical packaging
22.9 Quality control tests
22.10 Future prospects
22.11 Conclusion
References
Index

Amit Kumar Nayak

Dr. Amit Kumar Nayak (MPharm, PhD) is working as a professor, at the Department of Pharmaceutics, School of Pharmaceutical Sciences, Siksha ‘O' Anusandhan (Deemed to be University), Odisha, India. He has earned his PhD from IFTM University, Moradabad, Uttar Pradesh, India. He has over 14 years of research experiences in the field of pharmaceutics, especially in the development and characterization of novel biopolymeric and nanostructured drug delivery systems. Till date, he has authored more than 138 research and review publications in various high-impact peer-reviewed journals and 135 book chapters. He has edited/authored 23 international books to his credit. Dr. Nayak has presented his research work at several conferences. He has received University Foundation Day Research Award, 2019 and 2022 by Biju Patnaik University of Technology, Odisha. Dr. Nayak is a life member of the Association of Pharmaceutical Teachers of India (APTI) and a registered pharmacist.

Affiliations and expertise

Department of Pharmaceutics, School of Pharmaceutical Sciences, Siksha 'O' Anusandhan (Deemed to be University), Bhubaneswar, Odisha, India

Kalyan Kumar Sen

Dr. Kalyan Kumar Sen (MPharm, PhD) has over 38 years of teaching and industrial and research experience in the field of pharmaceutics, especially in the development and characterization of novel drug delivery systems. He has earned his PhD in pharmacy from Jadavpur University, India. Currently, Dr. Sen is working as a principal and professor of Gupta College of Technological Sciences, Asansol, India. Till date, he has authored several publications in various journals of international repute. He has authored several book chapters. He already has edited two books and co-authored one book. He has been the permanent reviewer of many international journals of high repute. Dr. Sen has participated and presented his research work at several conferences in India. Dr. Sen is a life member of the APTI and several professional bodies.

Affiliations and expertise

Department of Pharmaceutics, Principal of Gupta College of Technological Sciences, Asansol, W.B, India

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