Alpharx completes lyophilization process for Zysolin

Aug 17 2009

AlphaRx Inc. has announced that it has completed the lyophilization process for Zysolin(TM), allowing the company to proceed to clinical batch material manufacturing for human trials. This process has been solely developed by AlphaRx's scientists and the resulting formulations have been successfully tested in animal studies conducted by the U.S. Army under a Material Transfer Agreement.

"This is a technological milestone for AlphaRx and the entire nanomedicine industry," commented Dr. Joseph Schwarz, AlphaRx's Chief Scientist. "It is well known that many FDA approved ingredients used in nanomedicine formulations can not be readily lyophilized, representing the major obstacle to their therapeutic development, a critical step which we have overcome."

Many biotechnology products require lyophilization, a process of freeze-drying sterile solutions to permit a shelf stable dosage form. By removing the water from the material and sealing the material in a vial, it can be easily stored, shipped, and later reconstituted to its original form for administration.