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Formulation and Analytical Development for Low-Dose Oral Drug Products

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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. ... Weiterlesen
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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Jack Zheng, PhD, is Research Advisor and Team Leader in the Pharmaceutical Sciences R&D Division of Eli Lilly and Company and Adjunct Professor at Beijing University. Dr. Zheng is the author of more than thirty articles and several book chapters. He has been invited to present his work at numerous national and international scientific meetings. He was involved in more than ten new drug product development and regulatory filing with the Food and Drug Administration.

Tested-and-proven strategies for developing and manufacturing low-dose oral drug products

Developing and commercializing a low-dose oral drug product presents a number of hurdles that can quickly offset the drug's benefits. Written by a team of leading scientists in drug development, this book collects and synthesizes the knowledge, techniques, and strategies needed for developing low-dose drugs successfully. With this book's practical support, readers can overcome the hurdles at all stages in drug development, from formulation to manufacturing and control to regulatory compliance.

Following an overview of the drug discovery and development process, the book is divided into four parts:

  • Part One examines formulation and process development of low-dose drugs, including theoretical considerations concerning the particle size of the drug substance and content uniformity, micronization of the drug substance, and manufacturing platform technologies.

  • Part Two focuses on challenges in analytical method development, including analytical control strategy, physical characterization of the micronized powder and the solid state of the active pharmaceutical ingredient in dosage forms, and cleaning verification of manufacturing equipment.

  • Part Three investigates containment technologies used in analytical laboratories and manufacturing plants.

  • Part Four deals with important regulatory considerations.

Readers learn how a variety of analytical methodologies are used in low-dose drug development, including dissolution testing, NMR, HPLC, and X-ray diffraction. Moreover, the book explains several possible manufacturing techniques, such as wet granulation, roller compaction, and direct compression alongside containment technologies for highly potent drugs. Case studies throughout the book demonstrate how particular strategies and techniques are applied in practice.

Pharmaceutical scientists as well as students will find overcoming the obstacles in developing low-dose drug products much easier when they have this book on hand to consult at all stages in the drug development and manufacturing process.




1. An Overview (Jack Y. Zheng).

1.1 The Drug Discovery and Development Process.

1.2 Challenges and Strategies in Development of Low-Dose Drug Products.

1.3 Summary.




2. Challenges and Strategies in Formulation Development of Oral Solid Low-Dose Drug Products (Jack Y. Zheng).

2.1 Introduction.

2.2 Current Regulatory Environment and Its Impact on New Drug Product Development.

2.3 Challenges in Developing Low-Dose Formulations.

2.4 Manufacturing Platforms for Low-Dose Drug Products.

2.5 Use of Experimental Design in Formulation and Process Development.

2.6 Containments.

2.7 Summary.



3. Particle Size of Drug Substance and Product Content Uniformity - Theoretical Considerations (Kevin C. Johnson).

3.1 Introduction.

3.2 Concept of Ideal Mixing.

3.3 Ideal Mixing Model Comparison with the Yalkowsky and Bolton Approach.

3.4 Experimental Support of Model Assumptions.

3.5 Analytical and Practical Considerations.


4. Development of Low-Dose Formulations Using Fluidized Bed Granulation (J. Joe Zhou and Ralph Lipp).

4.1 Introduction.

4.2 Granulation Fundamentals.

4.3 Theory of Fluidization.

4.4 Formulation Development.

4.5 Process Development.

4.6 Summay.


5. Development of Low-Dose Solid Oral Formulations Using Wet Granulation (Ahmad Almaya).

5.1 Introduction.

5.2 Granulation Mechanisms.

5.3 General Considerations on Wet Granulation.

5.4 Advantages and Disadvantages of Wet Granulation.

5.5 Use of Wet Granulation for Low-Dose Formulations.

5.6 Process-Induced Form Changes in Wet Granulation.

5.7 Concluding Remarks.


6. Challenges in Development and Scale-Up of Low Dose Drug Products by Dry Granulation: A Case Study (Mary T. Am Ende, Daniel O. Blackwood, Daniel S. Gierer, and Christopher P. Neu).

6.1 Introduction.

6.2 Dry Granulation Process - Pros and Cons.

6.3 Overview of Dry Granulation Processes and Equipment Design.

6.4 Challenges for Low-Dose Product Development and their Assessment Methods.

6.5 Case Study: Formulation Challenges for Low-Dose Products.

6.6 Process Challenges During Dry Granulation Optimization for Low-Dose Products.

6.7 Conclusions.



7. Development of Low-Dose Solid Oral Tablets Using Direct Compression (Jack Y. Zheng and Robert L. Ternik).

7.1 Introduction.

7.2 Advantages of Direct Compression.

7.3 Challenges in Low-Dose Tablet Development Using Direct Compression.

7.4 Formulation Development for Low-Dose Drug Products Using Direct Compression.

7.5 Manufacturing Process Development for Low-Dose Drug Products.

7.6 Scale-Up for Blending Operation.

7.7 Formulation Examples for Direct Compression.

7.8 Conclusions.



8 Reduction of Particle Size of Drug Substance for Low-Dose Drug Products (Christopher L. Burcham, Paul C. Collins, Daniel J. Jarmer, and Kevin D. Seibert).

8.1 Introduction.

8.2 Reduction of Particle Size of Drug Substance by Milling Technologies.

8.3 Reduction of Particle Size of Drug Substance Using Crystallization Technologies.

8.4 Scale-Up Considerations.

8.5 Emerging Technologies and Future Directions.



9. Function, Quality, and Regulations of Pharmaceutical Excipients for Oral Solid Dosage Forms (Jack Y. Zheng).

9.1 Introduction.<...


Titel: Formulation and Analytical Development for Low-Dose Oral Drug Products
EAN: 9780470386354
ISBN: 978-0-470-38635-4
Digitaler Kopierschutz: Adobe-DRM
Format: E-Book (pdf)
Herausgeber: Wiley
Genre: Medizin
Anzahl Seiten: 432
Veröffentlichung: 04.03.2009
Jahr: 2009
Untertitel: Englisch
Dateigrösse: 6.9 MB