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Therapeutic formulation for reduced drug side effects

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  • Publication Date:
    November 05, 2019
  • Additional Information
    • Patent Number:
      10463,633
    • Appl. No:
      13/093662
    • Application Filed:
      April 25, 2011
    • Abstract:
      The present invention provides drug therapy formulations for reducing the side effects associated with a therapeutic. In some embodiments, the present invention provides a reduction in sleep- and diet-related side effects associated with a therapeutic.
    • Inventors:
      Desai, Subhash (Wilmette, IL, US)
    • Assignees:
      KemPharm, Inc. (Celebration, FL, US)
    • Claim:
      1. A method of treating ADHD in a subject said method comprising administering to the subject having ADHD a once-daily dose of a pharmaceutical composition, wherein the pharmaceutical composition consists of: a. a rapid release component consisting only of dexamphetamine, wherein the dexamphetamine has a mean diameter of up to 50 nm, and a cryoprotectant further wherein the rapid release component is prepared by a process comprising the steps of: i) dispersing dexamphetamine in ethanol to generate a dispersed dexamphetamine; ii) milling said dispersed dexamphetamine; and iii) lyophilizing said dexamphetamine with said cryoprotectant to generate a powdered nanoparticulate dexamphetamine formulation consisting only of said dexamphetamine and said cryoprotectant; and b. a delayed release component consisting only of guanfacine.
    • Claim:
      2. The method of claim 1 , wherein said dexamphetamine has a mean diameter of up to 25 nm.
    • Claim:
      3. The method of claim 1 , wherein the cryoprotectant is povidone.
    • Claim:
      4. The method of claim 1 , wherein the rapid release component and the delayed release component are not encapsulated within nanoparticles.
    • Claim:
      5. A method of treating ADHD in a subject said method comprising administering to the subject having ADHD a once-daily dose of a pharmaceutical composition, wherein the pharmaceutical composition consists of: a. a rapid release component consisting only of dexamphetamine, wherein the dexamphetamine has a mean diameter of up to 50 nm; b. a cryoprotectant; and c. a delayed release component consisting only of guanfacine.
    • Claim:
      6. The method of claim 5 , wherein the dexamphetamine has a mean diameter of up to 25 nm.
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    • Assistant Examiner:
      Simmons, Chris E
    • Primary Examiner:
      Bredefeld, Rachael E
    • Attorney, Agent or Firm:
      McAndrews, Held & Malloy, Ltd.
    • Accession Number:
      edspgr.10463633