Contents
Chapter 1 Introduction to Formulations Development
1.2 How Formulation Experiments are Different
Displaying Formulation Compositions Using Trilinear Coordinates
Pharmaceutical Tablet Formulation
Pharmaceutical Tablet Compactability
1.4 Summary and Looking Forward
Chapter 2 Basics of Experimentation and Response Surface Methodology
2.1 Fundamentals of Good Experimentation
How Many Formulations or Blends Do I Need to Test?
2.2 Diagnosis of the Experimental Environment
2.3 Experimentation Strategy and the Evolution of the Experimental Environment
2.4 Roadmap for Experimenting with Formulations
Part 2: Design and Analysis of Formulation Experiments
Chapter 3 – Experimental Designs for Formulations
3.1 Geometry of the Experimental Region
3.5 Summary and Looking Forward
Chapter 4 – Modeling Formulation Data
4.1 The Model Building Process
4.2 Summary Statistics and Basic Plots
4.3 Basic Formulation Models and Interpretation of Coefficients
4.4 Model Evaluation and Criticism
4.6 Transformation of Variables
4.7 Models with More Than Three Components
4.8 Summary and Looking Forward
Chapter 5 – Screening Formulation Components
5.1 Purpose of Screening Experiments
5.2 Screening Concepts for Formulations
5.4 Graphical Analysis of Simplex-Screening Designs
5.5 After the Screening Design
5.6 Estimation of the Experimental Variation
5.7 Summary and Looking Forward
Part 3: Experimenting With Constrained Systems
Chapter 6 – Experiments with Single and Multiple Component Constraints
6.2 Components with Lower Bounds
6.4 Computation of the Extreme Vertices
6.6 Sustained Release Tablet Development - Three Components
6.7 Four-Component Flare Experiment
Addition of the Constraint Plane Centroids
6.8 Graphical Display of a Four-Component Formulation Space
6.9 Identification of Clusters of Vertices
6.10 Construction of Extreme Vertices Designs for Quadratic Formulation Models
Replication and Assessing Model Lack of Fit
6.11 Designs for Formulation Systems with Multicomponent Constraints
6.12 Sustained Release Tablet Formulation Study
6.13 Summary and Looking Forward
Chapter 7 – Screening Constrained Formulation Systems
7.1 Strategy for Screening Formulations
7.2 A Formulation Screening Case Study
7.3 Blending Model and Design Considerations
7.4 Analysis: Estimation of Component Effects
Calculating Component Effects: Examples
7.6 XVERT Algorithm for Computing Subsets of Extreme Vertices
Eight-Component XVERT Design and Analysis
7.7 Summary and Looking Forward
Plackett-Burman Designs for 12, 16, and 20 Runs
Chapter 8 – Response Surface Modeling With Constrained Systems
8.1 Design and Analysis Strategy for Response Surface Methodology
8.2 Plastic Part Optimization Study
8.3 Quadratic Blending Model Design Considerations
8.4 Example – Plastic Part Formulation
8.5 Example – Glass Formulation Optimization
8.6 Using the XVERT Algorithm to Create Designs for Quadratic Models
8.7 How to Use Computer-Aided Design of Experiments
8.9 Blocking Formulation Experiments
8.10 Summary and Looking Forward
Chapter 9 - Experiments Involving Formulation and Process Variables
9.2 Additive and Interactive Models
9.3 Designs for Formulations with Process Variables
9.4 The Option of Non-Linear Models
9.6 An Illustration Using the Fish Patty Data
9.7 Summary and Looking Forward
Chapter 10 – Additional and Advanced Topics
10.2 More Advanced Model Forms
Common Alternative Model Forms
Application of Alternative Models to the Flare Data
10.4 Handling Multiple Responses
The Derringer and Suich Approach
10.5 Multicollinearity in Formulation Models