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PHARMACEUTICAL FORMULATION OF NITROOXYDERIVATIVES OF NSAIDS

  • US 20090203759A1
  • Filed: 06/29/2006
  • Published: 08/13/2009
  • Est. Priority Date: 07/26/2005
  • Status: Active Grant
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1. A pharmaceutical formulation comprising:

  • a) one or more NO-releasing NSAID(s) of formula (I);

    b) one or more surfactants wherein the ratio surfactant;

    NO-releasing NSAID is from 0.1;

    1 to 10;

    1;

    c) carbonyl scavenger compound selected from free acid forms, salts, carboxylic acid esters derivatives of a compound of formula (II)
    H2N—

    (CH2)m—

    (C6H4)—

    COOH wherein m=0-10 wherein the amount of the compound of formula (II) is from about 0.01% to about 5% by weight of the total weight of the composition;

    wherein in formula (I) M is selected from the group consisting of X is a spacer, i.e. a compound forming a bridge between the nitrogen oxide donating group and the NSAID, and is selected from i) straight or branched C1-C20 alkylene, preferably C1-C10, being optionally substituted with one or more of the substituents selected from the group consisting of;

    halogen atoms, hydroxy, —

    ONO2 or T, wherein T is —

    OC(O)(C1-C10 alkyl)-ONO2 or —

    O(C1-C10 alkyl)-ONO2;

    ii) C5-C7 cycloalkylene group optionally substituted with linear or branched C1-C10 alkyl group, preferably CH3;

    iii) wherein n is an integer from 0 to 20, preferably n is an integer from 0 to 5; and

    n1 is an integer from 1 to 20, preferably n1 is an integer from 1 to 5;

    with the proviso that the —

    ONO2 group of formula (I) is bound to —

    (CH2)n1; and

    iv) wherein X2 is —

    O—

    or —

    S—

    ;

    n3 is an integer from 1 to 6, preferably from 1 to 4, and R2 is H or CH3.

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