Characterizing and Comparing Dissolution Profiles for New Drug Formulations - Mastering JMP

Video was recorded in February 2025 using JMP 18.

Do you need to formulate drug products to match a specific dissolution profile?   Do you need to re-formulate or validate that changes in raw material suppliers do not change a drug's dissolution profile? Do you develop dissolution methods for product release?

In this session, we will:

• Compare a new formulation's dissolution profile to an existing formulation to determine similarity using Graph Builder and Fit Curve (eg., F2 Analysis and Higuchi models).
• Determine how we can modify the formulation to achieve a dissolution profile that is more similar to the existing formulation by deploying  JMP Pro Curve DOE Analysis.

Suggested Prerequisites:

• Some experience fitting curves to non-linear data.
• Familiarity  with DOE.
• Locate Fit Curve and Graph Builder platforms in JMP.  These one-page guides/videos may be helpful:
  • Fitting Nonlinear Curves
  • Graph Builder

After you use the attached journal to try the techniques in the video, consider using the companion Hands-On Activity created by statistician and JMP Educator @Di_Michelson  for further practice:  Comparing Dissolution Curves Hands-On Activities and Solutions.

Resources

• JMP documentation on Statistical Details for Dissolution Curve Analysis
• JMP documentation on Fit Curve Options
•  The Statistical Basis of BCa Bootstrap f2 Dissolution by  R. Chandramouli, JMP Technical Enablement Engineer
• Exploring Model-Dependent and Model-Independent Approaches to Dissolution Modeling
  by R. Chandramouli, JMP Technical Enablement Engineer
• Understanding Regulatory Dissolution Testing by R. Chandramouli, JMP Technical Enablement Engineer

• Similarity Factor f2: A Global Overview by R. Chandramouli, JMP Technical Enablement Engineer