Analytical Method Challenge 2

Extraction of Difficult Compounds

 

Example 1

Velesco was contracted to develop updated HPLC drug product methods for a combination product with two low dose active pharmaceutical ingredients (APIs) and one preservative. The new formulations contained excipients that posed challenging extraction issues.

 

Velesco solution:

• Typical extraction techniques were not working, so the Velesco scientists looked deeper into the literature on the physical properties of the suspected problem excipient, a surfactant.
• It was noted that above a certain temperature, the surfactant formed super large micelles.  It was thought that the rearrangement of the micelles at that temperature could possibly be exploited to release the drug into diluent during sonication.
• Extraction was successful, giving appropriate accuracy for the analytical methods to be validated for ongoing stability studies.

 

Example 2

Velesco was employed to troubleshoot and solve API extraction inconsistencies observed during stability studies for a Phase 3 drug product.

 

Velesco solution:

• Velesco quickly determined the main cause for the inconsistent assay values observed and implemented straightforward solutions to provide consistent results.
• Velesco was additionally contracted by the client to develop and validate the Phase 3 drug product release and stability-indicating methods, as well as conduct dissolution testing in support of a waiver of in vivo bioavailability and bioequivalence studies.
• The analytical methods were successfully transferred to the drug product manufacturer.

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