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.
Contents
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
Index
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