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Pharmaceutical compositions of adsorbates of amorphous drugs and lipophilic microphase-forming materials

  • US RE47,033 E1
  • Filed: 04/17/2017
  • Issued: 09/11/2018
  • Est. Priority Date: 08/04/2003
  • Status: Active Grant
First Claim
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1. A composition comprising:

  • (a) a spray-dried solid dispersion adsorbate comprising a completely amorphous drug and a concentration enhancing polymer adsorbed onto an inorganic oxide substrate, and wherein said drug in said adsorbate is substantially completely amorphous and(b) a lipophilic microphase-forming material selected from the group consisting of medium-chain glyceryl mono-, di-, and tri-alkylates, sorbitan esters, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), and mixtures thereof;

    said composition having a mass ratio of said lipophilic microphase-forming material to said drug of from 0.1 to 500, and wherein said lipophilic microphase forming material is co-adsorbed with said drug onto said substrate of the spray-dried solid dispersion adsorbate;

    wherein said lipophilic microphase-forming material is water immiscible and said drug has a partition coefficient Kp between a use environment and said lipophilic microphase-forming material of about 10 or more.

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