Medicament delivery formulations, devices and methods

Abstract

Disclosed are medicinal compositions, and devices, methods and systems which use same, comprising a propellant and at lease one medicinally active compound, said propellant comprising at least one fluoroolefin having at least two but less than seven carbon atoms.

1 .- 16 . (canceled) 
     
     
         17 . A method of making a medicinal aerosol formulation suitable for delivery through the mouth, nose, ears and/or other mucosal membranes comprising the steps of:
 (a) providing transHFO-1234ze;   (b) providing at least one medicinally active compound comprising a formoterol and/or a budesonide, wherein said at least one medicinally active compound is stable in the presence of said transHFO-12343ze; and   (c) producing an aerosol comprising said transHFO-1234ze and said medicinally active compound in an amount that is therapeutically effective.   
     
     
         18 . The method of  claim 17  wherein said at least one medicinally active compound comprises formoterol. 
     
     
         19 . The method of  claim 17  wherein said at least one medicinally active compound comprises budesonide. 
     
     
         20 . The method of  claim 17  wherein said at least one medicinally active compound comprises budesonide and formoterol. 
     
     
         21 . The method of  claim 17  wherein said aerosol comprises at least about 50% by weight of said transHFO-1234ze. 
     
     
         22 . The method of  claim 17  wherein said producing step comprises creating a stable suspension and/or dispersion and/or solution of said at least one medicinally active compound in said transHFO-1234ze and subsequently forming said aerosol. 
     
     
         23 . The method of  claim 22  wherein said at least one medicinally active compound is in fine particulate form. 
     
     
         24 . The method of  claim 22  wherein said medicinally active compound is present in micronized or micro-particulate form. 
     
     
         25 . The method of  claim 22  wherein said step of forming said aerosol comprises providing said suspension and/or dispersion and/or said solution in a pressurized container and delivering said suspension and/or dispersion and/or said solution from said pressurized container. 
     
     
         26 . The method of  claim 25  wherein said transHFO-1234ze provides kinetic energy to at least aid in the delivery of said at least one medicinally active compound from said pressurized container. 
     
     
         27 . The method of  claim 22  wherein said providing step (a) comprises providing a carrier for said medicinally active compound and wherein said carrier consists essentially of transHFO-1234ze. 
     
     
         28 . The method of  claim 22  wherein said providing step (a) comprises providing a carrier for said medicinally active compound and wherein said carrier consists of transHFO-1234ze. 
     
     
         29 . The method of  claim 22  wherein said aerosol comprises from about 0.01% to about 0.5% by weight of said at least one medicinally active compound. 
     
     
         30 . The method of  claim 22  wherein said medicinally active compound is present in a dissolved form in a liquid phase. 
     
     
         31 . The method of  claim 24  wherein said micronized or micro-particulate form comprises a porous morphology and has a mass average aerodynamic diameter (MAAD) of not greater than about 10 microns. 
     
     
         32 . The method of  claim 24  wherein said micronized or micro-particulate form comprises a porous morphology and has a mass average aerodynamic diameter (MAAD) of not greater than about 5 microns. 
     
     
         33 . The method of  claim 24  wherein said micronized or micro-particulate comprise hollow and/or porous perforated microstructures. 
     
     
         34 . The method of  claim 28  wherein said hollow and/or porous perforated microstructures are permeated or filled by said carrier. 
     
     
         35 . A method of making a medicinal aerosol formulation suitable for delivery through the mouth, nose, ears and/or other mucosal membranes using a pressurize metered dose inhaler comprising the steps of:
 (a) providing a carrier comprising at least transHFO-1234ze;   (b) providing at least one medicinally active compound selected from the group consisting of antiallergics, bronchodilators, bronchoconstrictors, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, anticholinergics, mast cell inhibitors, antihistamines, antiinflammatories, antineoplastics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, corticosteroids, short acting beta-agonists, long-acting beta-agonists, genetic material, viral vectors, antisense agents, proteins, peptides, anti-asthma medication and combinations of any two or more of these, wherein said at least one medicinally active compound is stable in the presence of said transHFO-12343ze; and   (c) producing an aerosol comprising said carrier and said medicinally active compound in an amount that is therapeutically effective.   
     
     
         36 . A method of making a medicinal aerosol formulation suitable for delivery through the mouth, nose, ears and/or other mucosal membranes using a pressurize metered dose inhaler comprising the steps of:
 (a) providing a carrier comprising at least transHFO-1234ze;   (b) providing at least one medicinally active compound selected from the group consisting of antiallergics, bronchodilators, bronchoconstrictors, pulmonary lung surfactants, analgesics, antibiotics, leukotriene inhibitors or antagonists, anticholinergics, mast cell inhibitors, antihistamines, antiinflammatories, antineoplastics, anesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, corticosteroids, short acting beta-agonists, long-acting beta-agonists, genetic material, viral vectors, antisense agents, proteins, peptides, anti-asthma medication and combinations of any two or more of these, wherein said at least one medicinally active compound is stable in the presence of said transHFO-12343ze; and   (c) producing an aerosol comprising said carrier and said medicinally active compound in an amount that is therapeutically effective.   
     
     
         37 . The method of claim  1  wherein said medicinally active compound comprises:
 (a) one or more analgesic comprising codeine, dihydromorphine, ergotamine, fentanyl, and morphine; and/or 
 (b) an anginal preparation comprising a mast cell inhibitor comprising cromolyn sodium; and/or 
 (c) an anti-infective comprising one or more of cephalosporins, macrolides, quinolines, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; and/or 
 (d) an antihistamine comprising methapyrilene; and/or 
 (e) an anti-inflammatory comprising one or more of fluticasone propionate, beclomethasone dipropionate, flunisolide, budesonide, mometasone furoate, tripedane, cortisone, prednisone, prednisilone, dexamethasone, betamethasone, or triamcinolone acetonide; and/or 
 (f) a diuretic comprising amiloride; and/or 
 (g) an anti-tussive comprising noscapine; and/or 
 (h) a bronchodilator comprising one or more of ephedrine, epinephrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, salbutamol (albuterol), salmeterol xinafoate and terbutaline; and/or 
 (i) an anti-cholinergic comprising one or more of ipratropium bromide, tiotropium, atropine, or oxitropium; and/or 
 (j) a lung surfactant comprising one or more of Surfaxin, Exosurf and Survanta; and/or 
 (k) a xanthine comprising one or more of aminophylline, theophylline and caffeine; and/or 
 (l) therapeutic proteins and peptides comprising one or more of DNAse, insulin, glucagon, LHRH, nafarelin, goserelin, leuprolide, interferon, rhu IL-1 receptor; and/or 
 (m) a macrophage activation factor comprising one or more of lymphokines and muramyl dipeptides; and/or 
 (n) opioid peptides and neuropeptides comprising one or more of enkaphalins, endorphins, renin inhibitors, cholecystokinins, DNAse, growth hormones and leukotriene inhibitors; and/or 
 (o) a DNA plasmid.