Oral Pharmaceutical Formulation Handbook
from C.H.I.P.S.

Formulation and Analytical Development for Low-Dose Oral Drug Products
edited by Jack Zheng

Formulation and Analytical Development for Low-Dose Oral Drug Products provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book.

Formulation and Analytical Development for Low-Dose Oral Drug Products describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression.


1. An Overview

  • Drug Discovery and Development Process
  • Challenges and Strategies in Development of Low-Dose Drug Products
2. Challenges and Strategies in Formulation Development of Oral Solid Low-Dose Drug Products

  • Current Regulatory Environment and Its Impact on New Drug Product Development
  • Challenges in Developing Low-Dose Formulations
  • Manufacturing Platforms for Low-Dose Drug Products
  • Use of Experimental Design in Formulation and Process Development
  • Containments
3. Particle Size of Drug Substance and Product Content Uniformity - Theoretical Considerations

  • Concept of Ideal Mixing
  • Ideal Mixing Model Comparison with the Yalkowsky and Bolton Approach
  • Experimental Support of Model Assumptions
  • Analytical and Practical Considerations
4. Development of Low-Dose Formulations Using Fluidized Bed Granulation

  • Granulation Fundamentals
  • Theory of Fluidization.
  • Formulation Development
  • Process Development
5. Development of Low-Dose Solid Oral Formulations Using Wet Granulation

  • Granulation Mechanisms
  • General Considerations on Wet Granulation
  • Advantages and Disadvantages of Wet Granulation
  • Use of Wet Granulation for Low-Dose Formulations
  • Process-induced Form Changes in Wet Granulation
6. Challenges in Development and Scale-Up of Low Dose Drug Products by Dry Granulation: A Case Study

  • Dry Granulation Process - Pros and Cons
  • Overview of Dry Granulation Processes and Equipment Design
  • Challenges for Low-Dose Product Development and Their Assessment Methods
  • Case Study: Formulation Challenges for Low-Dose Products
  • Process Challenges during Dry Granulation Optimization for Low-Dose Products
7. Development of Low-Dose Solid Oral Tablets Using Direct Compression

  • Advantages of Direct Compression
  • Challenges in Low-Dose Tablet Development Using Direct Compression
  • Formulation Development for Low-Dose Drug Products Using Direct Compression
  • Manufacturing Process Development for Low-Dose Drug Products
  • Scale-Up for Blending Operation
  • Formulation Examples for Direct Compression
8. Reduction of Particle Size of Drug Substance for Low-Dose Drug Products

  • Reduction of Particle Size of Drug Substance by Milling Technologies
  • Reduction of Particle Size of Drug Substance Using Crystallization Technologies
  • Scale Up Considerations
  • Emerging Technologies and Future Directions
9. Function, Quality and Regulations of Pharmaceutical Excipients for Oral Solid Dosage Forms

  • Classification of Pharmaceutical Excipients in Solid Dosage Forms
  • Physicochemical Attributes of Pharmaceutical Excipients 395
  • Regulatory Status and Excipient Quality
10. Analytical Method Development: Challenges and Solutions for Low-Dose Oral Dosage Forms

  • Case Study 1: Drug Adsorption to Surfaces
  • Case Study 2: Challenges due to Non-Drug Related Impurities
  • Case Study 3: HPLC Purity Method Development Challenges for a Fixed Combination Product Containing a Low-Dose Active Ingredient and a High Dose Active Ingredient
  • Case Study 4: Small Volume Dissolution Testing
11. In Vitro Dissolution Testing and Method Development

  • Overview of Dissolution Testing
  • Dissolution Method Development
  • Dissolution Method Development for Low-dose Oral Drug Products
12. Analysis of Physical Transformation of API During Manufacture and Storage

  • Discussion of Solid-State Forms
  • Monitoring Processing Steps
  • Measuring Transitions and Solid-Form Transformations in the Low-Dose Tablet
  • Common Methods Used for Examination of Solid Forms
13. Physical Characterization Tests for API Used in Low-Dose Formulations

  • General Issues in the Physical Characterization of Micronized Powders Used in Low-Dose Formulations
  • Particle Size Analysis
  • Specific Surface Area Analysis
14. An Excipient Library Approach to Analytical Development for Low-Dose, Solid Oral Dosage Form Drug Products

  • Importance of Excipient Absorbance Background to Low-Dose Impurity Analysis
  • Factors Affecting Excipient Absorbance Background
  • Use of Excipient Library
15. Cleaning Verification for Highly Potent Compounds

  • Cleaning Validation versus Cleaning Verification
  • Acceptance Limit Calculations
  • Analytical Method Validation
  • General Analytical Techniques
  • Analytical Techniques for Low-Dose Compounds
16. Containment Challenges and Strategies for Potent Compounds in the Pharmaceutical Industry

  • Safe Exposure Control Levels - Bands, Limits and Handling Guidance
  • The Hierarchy of Workplace Controls
  • Case Studies
17. Sample Handling and Containment in Analytical Testing Laboratories

  • Sample Handling Considerations
  • Handling Potent Compounds in Standard Analytical Laboratories
  • Handling Potent Compounds in a Containment Laboratory
  • Additional Considerations for Handling Potent Materials
18. Regulatory Considerations in the Development of Low-Dose Solid Oral Drug Products

  • Three-Pronged Approach to Low-Dose Formulations
  • Pharmaceutical Development Report
  • Facility Controls for Highly Potent Drugs


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Formulation and Analytical Development for Low-Dose Oral Drug Products
edited by Jack Zheng
2009 461 pages $109.00 + shipping
Texas residents please add 6.75 % sales tax

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