Dosage Form Design Parameters

Dosage Form Design Parameters

Volume II

1st Edition - July 25, 2018

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  • Editor: Rakesh Tekade
  • Hardcover ISBN: 9780128144213
  • eBook ISBN: 9780128144220

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Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

Key Features

  • Examines the history and recent developments in drug dosage forms for pharmaceutical sciences
  • Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism
  • Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design


Researchers and postgraduate students in the field of Pharmaceutics. Appropriate for those in the pharmaceutical industry, scientists from chemical engineering, and those in drug discovery and development

Table of Contents

  • 1. Levels of solid state properties: Role of different levels during pharmaceutical development
    2. Polymorphism and its Implications in Pharmaceutical Product Development
    3. Basics of crystallization process applied in drug research
    4. Role of amorphous state in drug delivery
    5. Particulate level properties and its implications on product performance and processing
    6. Bulk level properties and its role in formulation development and processing
    7. Concepts of hypothesis testing and types of errors
    8. Experimental design and analysis of variance
    9. Basic concept and application of Sampling procedures
    10. Statistical techniques in Pharmaceutical Product Development
    11. Drug-excipient interaction and incompatibilities
    12. Documentation protocols in product development department including clinical records
    13. Correlation between in-vitro and in-vivo screens: Special emphasis on high throughput screening, high throughput pharmacokinetic analysis
    14. Sterilization of pharmaceuticals: Technology, Equipment and Validation
    15. Package development of pharmaceutical products: Aspects of packaging materials used for Pharmaceutical Products
    16. Package types for different dosage forms
    17. Food and drug laws effecting pharmaceutical product design, development and commercial manufacturing
    18. Guiding Principles for Human and Animal Research during pharmaceutical product development
    19. Applications of Computer in Pharmaceutical Product Development
    20. Patents and other intellectual property rights in drug delivery
    21. Computer Aided Prediction of Pharmacokinetic (ADMET) Properties
    22. Ethics and Legal Protection of Uses of Computer Applications in Pharmaceutical Research
    22. Ethics and Legal Protection of Uses of Computer Applications in Pharmaceutical Research

Product details

  • No. of pages: 810
  • Language: English
  • Copyright: © Academic Press 2018
  • Published: July 25, 2018
  • Imprint: Academic Press
  • Hardcover ISBN: 9780128144213
  • eBook ISBN: 9780128144220

About the Series Volume Editor

Rakesh Tekade

Dr Rakesh K Tekade, Assistant Professor of the Department of Pharmaceutics, investigates the design, development and characterization of targeted nanotechnology based formulations for the site specific delivery of therapeutic drugs, siRNA, microRNA, plasmids, proteins and peptide for the treatment of cancer. His current research encompasses development of novel polymeric nanomaterial for effective cytosolic delivery of anticancer bioactives. Dr Tekade’s research is focused on designing a new generation of nanoparticles, which could identify the cancer cells and selectively deliver anticancer drugs and genes to inhibit the growth of cancer while sparing healthy tissues. His research work involves the applications of polymer chemistry, nanotechnology, molecular biology, pharmacokinetics/pharmacodynamics and imaging techniques. Dr Tekade has over 70 publications, 01 patent, 7 book chapters, and 3 editorial articles. He has delivered several invited research talks and presented research finding in more than 30 scientific conferences.

Affiliations and Expertise

Assistant Professor, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research Ahmedabad, Gujarat, India

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