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Safety of psuedoephedrine drug products

  • US 8,883,863 B1
  • Filed: 12/21/2012
  • Issued: 11/11/2014
  • Est. Priority Date: 04/03/2008
  • Status: Active Grant
First Claim
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1. A pharmaceutical drug product comprising at least one drug substance selected from the group consisting of:

  • amorphous sibutramine pamoate characterized by at least one method selected from;

    a PXRD diffractogram of FIG. 1;

    a DSC thermogram of FIG. 5; and

    an FTIR spectrum of FIG. 3;

    polymorphic sibutramine pamoate characterized by at least one method selected from;

    a PXRD diffractogram of FIG. 2;

    a DSC thermogram of FIG. 6; and

    an FTIR spectrum of FIG. 4;

    amorphous nortriptyline pamoate characterized by at least one method selected from;

    a DSC thermogram of FIG. 9; and

    an FTIR spectrum of FIG. 11;

    polymorphic nortriptyline pamoate characterized by at least one method selected from;

    a DSC thermogram of FIG. 10; and

    an FTIR spectrum of FIG. 12;

    amorphous clomipramine pamoate characterized by at least one method selected from;

    a PXRD diffractogram of FIG. 16;

    a DSC thermogram of FIG. 20; and

    an FTIR spectrum of FIG. 18;

    polymorphic clomipramine pamoate characterized by at least one method selected from;

    a PXRD diffractogram of FIG. 17;

    a DSC thermogram of FIG. 21; and

    an FTIR of FIG. 19;

    amorphous promethazine pamoate characterized by at least one method selected from;

    a PXRD diffractogram of FIG. 26;

    a DSC thermogram of FIG. 32;

    an FTIR spectrum of FIG. 29;

    a PXRD diffractogram of FIG. 27;

    a DSC thermogram of FIG. 33; and

    an FTIR spectrum of FIG. 30;

    andpolymorphic promethazine pamoate characterized by at least one method selected from;

    a PXRD diffractogram of FIG. 28;

    a DSC thermogram of FIG. 34; and

    an FTIR spectrum of FIG. 31.

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