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Drug product extraction & HPLC method provides large dose range | Velesco Pharma

Analytical Method Challenge 3

Large Potential Dose Range of Low Solubility Compound

 

A small virtual pharma manufacturing client 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 indicating program was undertaken and the client was able to file an IND with an eight-week stability.

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