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Lyophilization process and products obtained thereby

  • US 20070116729A1
  • Filed: 11/18/2005
  • Published: 05/24/2007
  • Est. Priority Date: 11/18/2005
  • Status: Active Grant
First Claim
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1. A method of lyophilizing a material comprising:

  • (a) dissolving said material in a solvent for said material to form a solution;

    or making a slurry of the material and adjusting the pH to dissolve the drug to form a solution (b) adding a non-solvent for said material to said solution, which non-solvent is miscible with said solvent to force said material at least partially out of said solution, and wherein said non-solvent is volatilizable under freeze-drying conditions;

    (c) freezing the result of step (b) to yield a frozen result; and

    (d) vacuum drying the frozen result of step (c) to yield a lyophilizate.

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