How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms

From Conception to Post-Approval

1st Edition - October 1, 2016

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  • Author: Bhavishya Mittal
  • eBook ISBN: 9780128047323
  • Paperback ISBN: 9780128047316

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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

  • 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

Product details

  • No. of pages: 190
  • Language: English
  • Copyright: © Academic Press 2016
  • Published: October 1, 2016
  • Imprint: Academic Press
  • eBook ISBN: 9780128047323
  • Paperback ISBN: 9780128047316

About the Author

Bhavishya Mittal

Bhavishya Mittal is an Associate Director in the Oral and Implants Product Development Department at Allergan Pharmaceuticals in Irvine, CA. Prior to Allergan, Bhavi worked at the US Food and Drug Administration (FDA), Takeda Pharmaceuticals and Astellas Pharmaceuticals. 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 16 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 past Vice Chair for the Manufacturing Sciences and Engineering (MSE) section of AAPS. His research interests include formulation design, process engineering, scale-up/tech-transfer, and computational modeling of pharmaceutical unit operations for solid oral dosage manufacturing. In addition to technical topics, Bhavi maintains an active interest in general risk mitigation strategies, efficient outsourcing management, business analytics, strategic decision-making sciences, and financial engineering.

Affiliations and Expertise

Associate Director, Oral and Implants Product Development, Allergan plc, Irvine, CA, USA

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