In vitro lipolysis test

The lipolysis test is recommended during lipid-based formulation (LBF) development to evaluate whether the prototype formulations should be able to solubilize and maintain the drug in solution during the ‘in vivo’ digestion process. It is also a good tool to discriminate between formulations and select the best formulation for further development.

In vitro lipolysis testing: part of the LBF development

A systematic approach is recommended to develop lipid-based formulations:

  • Assessing the solubility of the drug in various excipients
  • Evaluate miscibility and dispersion of selected excipients for  ternary diagramming
  • In vitro lipolysis testing

For more information:

A Systematic Approach to Lipid-Based Formulation Development for a Poorly Soluble API, Fenofibrate
Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph.

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In vitro lipolysis test

Objectives

  • Assess the drug solubility in conditions that mimic the fasted intestinal tract.
  • Determine the extent of digestion by measuring the amount of fatty acids released in the lipolysis medium.

  • Determine the solubility of the drug during a simulated digestion process.

Step 1: dispersion

a. Disperse the drug target dose in 36 mL of lipolysis medium at 37°C.
b. Stir during 10 minutes to ensure gelatin capsule dissolution, excipients hydration and dispersion of the LBF in the media.

Step 2: digestion

c. Add 4 mL of pancreatin solution to start the digestion.
d. Aliquot at regular intervals to assess drug solubilization from the LBF during digestion.
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