Sample Preparation of Pharmaceutical Dosage Forms

1. Front Matter

   Pages i-xiv

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2. Introduction

   1. Front Matter

      Pages 1-1

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   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

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   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

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   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

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   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

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.

• Challenges
• Dosage
• Extraction
• Form
• Nickerson
• Pharmaceutical
• Preparation
• Sample
• Strategies
• Strategy

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

  Beverly Nickerson

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.

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