How to Develop Robust Solid Oral Dosage Forms
From Conception to Post-Approval
- 1st Edition - October 13, 2016
- Author: Bhavishya Mittal
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 0 4 7 3 1 - 6
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 0 4 7 3 2 - 3
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 fo… Read more
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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.
- 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
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
- Edition: 1
- Published: October 13, 2016
- Language: English
BM
Bhavishya Mittal
Bhavishya Mittal is the Vice-President of Product Development and Manufacturing at BioDuro-Sundia (Irvine, CA), where he leads the strategy and operations for drug product development of all small molecule client-owned assets within the portfolio. Before BioDuro, Bhavi worked at Kronos Bio, AbbVie, US FDA, Takeda, and Astellas Pharmaceuticals. Bhavi is also an adjunct faculty at the Keck Graduate Institute’s Henry E. Riggs School of Applied Life Sciences (Claremont, CA). He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India). Bhavi has 21+ years of industrial experience in the formulation design, process development, and project management of numerous drug products of small therapeutic molecules (oncology, inflammation, GI, and CNS indications) aimed for NDA, BLA, and ANDA filings. He is the Chair for the Manufacturing Sciences and Engineering (MSE) community of AAPS. He is the author of 3 published books (with 25 combined chapters), 4 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is also very active in organizing conferences and moderating technical sessions on cutting-edge topics related to pharmaceutical manufacturing sciences.
Affiliations and expertise
Vice-President, Product Development and Manufacturing, BioDuro-SundiaRead How to Develop Robust Solid Oral Dosage Forms on ScienceDirect