Expert Solutions in Analytical Method Development and Validation

Expert Solutions to these Challenging Scenarios

Challenge:

 

Velesco was contracted to develop updated HPLC drug product methods for a combination product with 2 low dose APIs and 1 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 methods to be validated for ongoing stability studies.

Challenge:

 

Velesco was employed by Client #1 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 straight forward 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 methods were successfully transferred to the drug product manufacturer.

Challenge:

 

Client #2 needed a drug product release method for a very poorly soluble drug with a wide potential dosing range (300X).


Velesco Solution:

 

  • Velesco created a drug product extraction and HPLC method that encompassed the whole dose range.
  • A successful dissolution method was developed using surfactants.
  • A stability program was undertaken and the client was able to file an IND with 8 week stability.

Challenge:

 

Client #3 is a virtual company developing a multi-component solid dosage form of existing products for a new indication.

 
Velesco Solution:

 

  • Client outsourced analytical development to a small CRO, where analysis of one component proved challenging.
  • Velesco's analytical scientists identified an appropriate method in less than one week and transferred it to the CRO.

News and Events

Velesco CEO Dave Barnes will attend the Global Clinical Supplies Group meeting in April.

 

Dave Barnes Featured in Pharmoutsourcing article!

 

 

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