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STABLE TIGECYCLINE COMPOSITION

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  • Publication Date:
    March 3, 2016
  • Additional Information
    • Document Number:
      20160058865
    • Appl. No:
      14/779889
    • Application Filed:
      March 25, 2014
    • Abstract:
      The present invention relates to a stable pharmaceutical composition of Tigecycline and process for the preparation of the same. The composition comprises Tigecycline and maltose wherein the pH of the bulk solution or solution after reconstitution is in between 3-6.
    • Claim:
      1. A stable pharmaceutical composition comprising Tigecycline and maltose.
    • Claim:
      2. The stable pharmaceutical composition according to claim 1, wherein the composition is prepared from bulk solution comprising a) Tigecycline b) maltose; wherein pH of the bulk solution is in between 3-6.
    • Claim:
      3. The stable pharmaceutical composition according to claim 1, wherein the composition is prepared from bulk solution comprising a) Tigecycline from 1.5-50 mg/mL, b) maltose from 30-100 mg/mL; wherein pH of the bulk solution is in between 3-6.
    • Claim:
      4. The stable pharmaceutical composition according to claim 1, wherein the composition comprising a) Tigecycline from 15-50 mg/mL, b) maltose from 30-100 mg/mL; wherein pH of the reconstituted solution is in between 3-6.
    • Claim:
      5. A process for preparation of a stable pharmaceutical composition according to claim 1 comprising the steps of: 1. Taking WFI in manufacturing tank, sparging inert gas until desired dissolved oxygen level is attained. 2. Adding Maltose and Tigecycline to the solution of step 1 in any order and adjusting pH of the solution in between 3-6. 3. Optionally filtering the bulk solution through suitable filter. 4. Filling the required solution into vials, loading the vials into lyophilizer. 5. Running suitable lyophilization cycle to get the stable pharmaceutical composition comprising Tigecycline and maltose.
    • Claim:
      6. The process for preparation of a stable pharmaceutical composition according to claim 5, wherein Hydrochloric acid is added prior to the addition Tigecycline.
    • Claim:
      7. The stable pharmaceutical composition prepared by process according to claim 6.
    • Claim:
      8. A stable pharmaceutical composition comprising a) Tigecycline b) maltose; wherein pH of the bulk/reconstituted solution is in between 4-5.
    • Claim:
      9. Use of maltose as stabilizing agent for the preparation of stable pharmaceutical composition comprising Tigecycline.
    • Current International Class:
      61; 61
    • Accession Number:
      edspap.20160058865