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Drug combination pharmaceutical compositions and methods for using them

  • US 20080033027A1
  • Filed: 07/28/2006
  • Published: 02/07/2008
  • Est. Priority Date: 03/21/2005
  • Status: Abandoned Application
First Claim
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1. A therapeutic combination of drugs for an individual in need thereof comprising(a) at least one member of a first drug group and at least one member of a second drug group;

  • wherein a member of the first drug group comprises a beta adrenergic receptor antagonist (a beta blocker) comprising a propranolol, a 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, or equivalent; and

    a member of the second drug group comprises a non-steroidal anti-inflammatory drug (a NSAID) comprising an etodolac, (+) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid, or equivalent;

    (b) the therapeutic combination of (a), wherein the non-steroidal anti-inflammatory drug (a NSAID) comprises etodolac;

    (c) the therapeutic combination of (b), wherein the etodolac is LODINE™

    ;

    (d) the therapeutic combination of any of (a) to (c), wherein the beta adrenergic receptor antagonist (a beta blocker) comprises propranolol;

    (e) the therapeutic combination of (d), wherein the propranolol is INDERAL™

    ;

    (f) the therapeutic combination of (a), wherein the beta adrenergic receptor antagonist (a beta blocker) comprises propranolol and the non-steroidal anti-inflammatory drug (a NSAID) comprises etodolac;

    (g) the therapeutic combination of (a) or (f), wherein the at least one member of the first drug group and the at least one member of the second drug group are formulated as separate compositions;

    (h) the therapeutic combination of (a) or (f), wherein the at least one member of the first drug group and the at least one member of the second drug group are formulated in the same composition;

    (i) the therapeutic combination of any of (a) to (h), wherein a first or second group drug is packaged individually in a single package or packette;

    an intravenous (IV) package, container or packette;

    a plurality of packages or packettes;

    a blister packet;

    a lidded blister or blister card or packets;

    (j) the therapeutic combination of any of (a) to (h), wherein a first and a second group drug are packaged together in a single package or packette;

    an intravenous (IV) package, container or packette;

    a plurality of packages or packettes;

    a blister packet;

    a lidded blister or blister card or packets;

    or a shrink wrap;

    (k) the therapeutic combination of any of (a) to (h), wherein each of the first and second group drugs are packaged together in a single package or packette;

    an intravenous (IV) package, container or packette;

    a plurality of packages or packettes;

    a blister packet;

    a lidded blister or blister card or packets;

    or a shrink wrap, and with both drugs released upon opening of the single package or packette;

    intravenous (IV) package, container or packette;

    plurality of packages or packettes;

    blister packet;

    lidded blister or blister card or packets;

    or shrink wrap;

    (l) the therapeutic combination of any of (a) to (h), wherein each of the first and second group drugs are packaged together in a single package or packette;

    an intravenous (IV) package, container or packette;

    a plurality of packages or packettes;

    a blister packet;

    a lidded blister or blister card or packets;

    or a shrink wrap, and with both drugs are formulated as a tablet, a pill, a lozenge, a capsule, a caplet, a patch, a spray, an inhalant, a gel, a geltab, a nanosuspension, a nanoparticle, a microgel and/or a pellet, and the tablet, pill, lozenge, capsule, gel, geltab, nanosuspension, nanoparticle, microgel and/or a pellet are released upon opening of the single package or packette;

    intravenous (IV) package, container or packette;

    plurality of packages or packettes;

    blister packet;

    lidded blister or blister card or packets;

    or shrink wrap;

    (m) the therapeutic combination of any of (a) to (l), wherein the therapeutic combination is formulated or manufactured as a feed, a food, a pellet, a lozenge, a liquid, a liquid suitable for intravenous (IV) administration, an elixir, an aerosol, an inhalant, a spray, a powder, a tablet, a pill, a capsule, a gel, a geltab, a nanosuspension, a nanoparticle, a microgel or a suppository;

    (n) the therapeutic combination of any of (a) to (l), wherein the single package or a plurality of packages is a blister pack or plurality of blister packettes, or lidded blister or blister card or packets, or a shrink wrap;

    (o) the therapeutic combination of any of (a) to (n), wherein the dosage of etodolac ranges from about 200 mg to 400 mg a day, or, about 10, 15, 20, 25, 30, 35, 40, 45, 50, 75, 80, 85, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900 or 1000 mg or more;

    (p) the therapeutic combination of any of (a) to (n), wherein the dosage of propranolol ranges from 10 to 320 mg per day based on heart rate and blood pressure of the individual, or, about 10, 15, 20, 25, 30, 35, 40, 45, 50, 75, 80, 85, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900 or 1000 mg or more;

    (q) the therapeutic combination of any of (a) to (p), wherein the drugs are packaged in dosages that match a chrono-dosing regimen to match an optimal dose for the time of day;

    (r) the therapeutic combination of (q), wherein the drugs are packaged in dosages that match a chrono-dosing regimen comprising;

    (i) in the AM, 20 mg propranolol, 200 mg etodolac;

    in the afternoon, 10 mg propranolol, 200 mg etodolac;

    in the PM, 10 mg propranolol, 400 mg etodolac;

    (ii) in the AM 40 mg propranolol, 200 mg etodolac;

    in the afternoon 20 mg propranolol, 200 mg etodolac;

    in the evening, 20 mg propranolol, 400 mg etodolac;

    (iii) in the AM 80 mg propranolol, 200 mg etodolac;

    in the afternoon 40 mg propranolol, 200 mg etodolac, in the evening 40 mg, etodolac;

    or(iv) a dose escalation comprising a regimen of (i) to (ii) to (iii);

    (s) the therapeutic combination of (q), wherein the drugs are packaged in dosages that match a chrono-dosing regimen comprising;

    Start;

    AM, 20 mg propranolol, 200 mg etodolac;

    afternoon, 10 mg propranolol, 200 mg etodolac;

    PM 5 mg propranolol, 400 mg etodolac;

    Dose Escalation 1;

    AM 40 mg propranolol, 200 mg etodolac;

    afternoon 20 mg propranolol, 200 mg etodolac;

    evening, 10 mg propranolol, 400 mg etodolac;

    Dose escalation 2;

    AM 80 mg propranolol, 200 mg etodolac;

    afternoon 40 mg propranolol, 200 mg etodolac, evening 20 mg, etodolac;

    (t) the therapeutic combination of any of (a) to (s), wherein the drugs are formulated for administration once a day, b.i.d. or t.i.d, or weekly, or biweekly, or monthly;

    (u) the therapeutic combination of any of (a) to (t), dosaged as set forth in any one of exemplary ingredient combinations 1 to 90;

    (v) the therapeutic combination of any of (a) to (u), formulated for administration intravenously, topically, orally, by inhalation, by infusion, by injection, by inhalation, intraperitoneally, intramuscularly, subcutaneously, intra-aurally, for intra-articular administration, for intra-mammary administration, for topical administration or for absorption through epithelial or mucocutaneous linings;

    (w) the therapeutic combination of any of (a) to (v), further comprising instructions for use in the treatment of cachexia or anorexia;

    (x) the therapeutic combination of (w), wherein the cachexia is defined as at least two of the symptoms selected from the group consisting of;

         1) a hyper-inflammatory state,

         2) altered hormone levels and cytokine levels;

         3) increased heart rate variability;

         4) weight loss, and

         5) increased heart rate, wherein optionally the increased heart rate is having a sustained elevated heart rate of at least about 6 bpm;

    (y) the therapeutic combination of (w), wherein the cachexia is defined by an individual having at least a sustained elevated heart rate of at least about 6 bpm and weight loss;

    (z) the therapeutic combination of any of (a) to (y), further comprising a nutritional supplement;

    or(aa) any combination of (a) to (z).

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