Skip to main content
SpringerLink
Log in

Sample Preparation of Pharmaceutical Dosage Forms

Challenges and Strategies for Sample Preparation and Extraction

  • Book
  • © 2011

Overview

Editors:
  1. Beverly Nickerson

    1. Pfizer Global Research & Development, Analytical Research & Development Dept., Pfizer Inc., Groton, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • Volume focused entirely on sample preparation and extraction of pharmaceutical dosage forms

  • A valuable resource in developing and troubleshooting sample preparation methods for drug products at all stages in the lifecycle of a drug product

  • Presents multiple examples and case studies to highlight various potential issues and solutions

This is a preview of subscription content, log in via an institution to check access.

Access this book

Log in via an institution
eBook USD 169.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access

Licence this eBook for your library

Institutional subscriptions

Table of contents (15 chapters)

  1. Front Matter

    Pages i-xiv
    Download chapter PDF

  2. Introduction

    1. Front Matter

      Pages 1-1
      Download chapter PDF

    2. Properties That Impact Sample Preparation and Extraction of Pharmaceutical Dosage Forms

      • Beverly Nickerson
      Pages 3-19

    3. Sampling Considerations

      • Dawen Kou, Hua Ma, Edmund J. Bishop, Shangdong Zhan, Hitesh P. Chokshi
      Pages 21-39

  3. Extraction and Sample Preparation Techniques

    1. Front Matter

      Pages 41-41
      Download chapter PDF

    2. Agitation and Particle Size Reduction Techniques

      • Beverly Nickerson, K. Rick Lung
      Pages 43-61

    3. Liquid–Liquid and Solid-Phase Extraction Techniques

      • Beverly Nickerson, Ivelisse Colón
      Pages 63-92

    4. Extraction Techniques Leveraging Elevated Temperature and Pressure

      • Daniel Brannegan, Carlos Lee, Jian Wang, Larry Taylor
      Pages 93-128

  4. Sample Preparation Method Development and Validation for Various Dosage Form Types

    1. Front Matter

      Pages 129-129
      Download chapter PDF

    2. Addressing Drug–Excipient Interactions

      • Carlos Lee
      Pages 131-143

    3. Sample Preparation for Solid Oral Dosage Forms

      • Beverly Nickerson, Garry Scrivens
      Pages 145-178

    4. Sample Preparation for Select Nonsolid Dosage Forms

      • Xin Bu, Sachin Chandran, John Spirig, Qinggang Wang
      Pages 179-210

    5. Postextraction Considerations

      • Ivelisse Colón
      Pages 211-232

    6. Sample Preparation Method Validation

      • Edmund J. Bishop, Dawen Kou, Gerald Manius, Hitesh P. Chokshi
      Pages 233-251

    7. Application of Quality by Design Principles for Sample Preparation

      • Jackson D. Pellett, Beverly Nickerson, Ivelisse Colón
      Pages 253-281

  5. Additional Sample Preparation Topics

    1. Front Matter

      Pages 283-283
      Download chapter PDF

    2. Automation and Sample Preparation

      • Gang Xue, K. Rick Lung
      Pages 285-307

    3. A Systematic Approach for Investigating Aberrant Potency Values

      • Beverly Nickerson, Ivelisse Colón, Eddie Ebrahimi, Garry Scrivens, Lin Zhang
      Pages 309-332

    4. Green Chemistry Considerations for Sample Preparation

      • Paul Ferguson, Mark Harding
      Pages 333-354

    5. No Sample Preparation

      • Yang (Angela) Liu, George L. Reid, Zhongli Zhang
      Pages 355-385
Back to top

Keywords

About this book

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods.  These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. 

This book is divided into four parts:

•          Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. 

•          Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms.

•          Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods.  

•          Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

Editors and Affiliations

  • Pfizer Global Research & Development, Analytical Research & Development Dept., Pfizer Inc., Groton, USA

    Beverly Nickerson

About the editor

Beverly Nickerson, Ph.D., is Associate Research Fellow in Analytical Development in Pfizer Global Research and Development, Pfizer Inc.  Dr. Nickerson is well published in peer-reviewed journals, is author of several book chapters and has presented at various scientific meetings.  She has extensive experience in early stage and late stage drug development.

Bibliographic Information

Publish with us

Policies and ethics

Back to top

Search

Navigation