How to Develop Robust Solid Oral Dosage Forms - 1st Edition - ISBN: 9780128047316, 9780128047323

How to Develop Robust Solid Oral Dosage Forms

1st Edition

From Conception to Post-Approval

Authors: Bhavishya Mittal
eBook ISBN: 9780128047323
Paperback ISBN: 9780128047316
Imprint: Academic Press
Published Date: 1st October 2016
Page Count: 190
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How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips.

By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.

Key Features

  • Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more
  • Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin
  • Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues


Pharmaceutical scientists in formulation and research and development, academic professors and graduate students in pharmaceutical sciences and pharmacology

Table of Contents

  • Author Biography
  • Foreword
  • Preface
  • Acknowledgments
  • About the Expertise in Pharmaceutical Process Technology Series
  • List of Abbreviations and Acronyms
  • Chapter 1. Rules of Drug Product Development
    • 1.1. Introduction
    • 1.2. The Big Picture
    • 1.3. Rule 1: Biopharmaceutics and Bioavailability
    • 1.4. Rule 2: Manufacturability
    • 1.5. Rule 3: Stability
    • 1.6. Rule 4: Business Acuity
    • 1.7. Bring It Together
    • 1.8. Closing Thoughts—Developing a Problem-Solving Attitude
  • Chapter 2. Pharmacokinetics and Preformulation
    • 2.1. Biopharmaceutics and Pharmacokinetics
    • 2.2. Drug Transport in Solid Oral Dosages
    • 2.3. Properties Impacting Drug Dissolution
    • 2.4. Properties Impacting Permeability
    • 2.5. Properties Impacting Manufacturability
    • 2.6. Closing Statements—Initiating Nonclinical Studies
  • Chapter 3. Formulation Development
    • 3.1. Quality by Design and Rational Development Approach
    • 3.2. Quality Target Product Profile
    • 3.3. Developing the Composition
    • 3.4. Putting It All Together
  • Chapter 4. Pharmaceutical Unit Operations
    • 4.1. Introduction
    • 4.2. Elements of Unit Operations
    • 4.3. Granulation Process
    • 4.4. High-shear Wet Granulation
    • 4.5. Fluid-bed Granulation
    • 4.6. Roller Compaction
    • 4.7. Drying
    • 4.8. Particle Size Reduction
    • 4.9. Blending
    • 4.10. Encapsulation
    • 4.11. Compression
    • 4.12. Coatings
    • 4.13. Conclusions
  • Chapter 5. Process Development
    • 5.1. Rules for Process Development
    • 5.2. Evaluation of Process Parameters
  • Chapter 6. Analytical Considerations
    • 6.1. Introduction
    • 6.2. Integration of Analytical Testing With Process Control
    • 6.3. Integration of Analytical Testing With Product Stability
    • 6.4. Planning for Stability in Robust Product Development
  • Chapter 7. Process Scale-up, Tech-Transfer, and Optimization
    • 7.1. Introduction
    • 7.2. Quality Risk Management and Risk Assessment
    • 7.3. Design of Experiments
    • 7.4. Best Practices for Scale-up
    • 7.5. End Notes
  • Chapter 8. Business Acuity
    • 8.1. Current Pharmaceutical Business Environment
    • 8.2. Operations Management
    • 8.3. Suppliers, Inputs, Processes, Outputs, Customers Mapping
    • 8.4. Impact of Operating Environment
    • 8.5. Knowledge Management
    • 8.6. Incorporation of Simulation Technologies
    • 8.7. Planning for the Future
  • Index


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© Academic Press 2017
Academic Press
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About the Author

Bhavishya Mittal

Bhavishya Mittal is a Staff Fellow at the Office of Pharmaceutical Quality at the US Food and Drug Administration (FDA) in Silver Spring, MD. Previously, Bhavi was employed as a Senior Scientist in the Formulation Sciences department at Takeda Pharmaceuticals International Company based in Cambridge, MA. Bhavi has a PhD in Materials Engineering from the Pennsylvania State University and a BS in Chemical Engineering from Regional Engineering College, Jalandhar (India). Bhavi has 13 years of industrial experience in formulation and process development of various solid oral dosages of small therapeutic molecules (oncology, inflammation, and CNS indications) aimed for NDA and ANDA filings. He is the co-chair of the Formulation and Drug Delivery (FDD) working group at MassBio. He is the author/co-author of 1 patent, 10 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is an active member of various international professional societies such as AAPS and ISPE. His research interests include formulation design, process engineering, scale-up and tech-transfer, and computational modeling of pharmaceutical unit operations for solid oral dosage manufacturing.

Affiliations and Expertise

Staff Fellow, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, MD, USA

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