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.

What is claimed is: 
     
         1 . A medicinal composition comprising a propellant and at least one medicinally active compound, said propellant comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of HFO-1234yf and/or transHFO-1234ze which is a medicinally acceptable carrier for said medicinally active compound. 
     
     
         2 . (canceled) 
     
     
         3 . The medicinal composition of  claim 1  in the form of a medicinal preparation for propellant driven application wherein said at least one medicinally active compound is in the form of a suspension or a solution with said propellant. 
     
     
         4 . The medicinal composition of  claim 3  wherein at least one other active substance is in the form of particles suspended or in solution in the liquid phase. 
     
     
         5 . The medicinal composition according to  claim 3  wherein said medicinally active compound comprises a combination of two or more medicinally active substances solubilized in said propellant. 
     
     
         6 . The medicinal composition according to  claim 1  wherein said medically active compound is selected from the group consisting of corticosteroids, anti-inflammatories, anti-allergics, long-acting beta agonists, short-acting beta agonists, anticholinergics, proteins and peptides, anti-infectives, pain management, vaccines, hormones, gene therapy vectors, oligonucleotides, immunoglobulins and anti-IgE monoclonal antibodies. 
     
     
         7 . The medicinal composition according to  claim 1  wherein said medically active compound comprises one or more medically active ingredients selected from the group consisting of Salbutamol (albuterol), chiral albuterol, budesonide, epinephrine, formoterol, salmeterol xinafoate, beclomethasone dipropionate, budesonide, cromoglycinic acid, fenoterol, flunisolide, fluticasone propionate, mometasone furoate, insulin, nedocromil, orciprenaline, oxitropium bromide, repreterol, disodium cromoglycate, pirbuterol, isoprenaline, adrenaline, rimiterol, terbutalin, tiotropium, ipratropium bromide, epinephrine, omalizumab, the esters, salts, solvates or combinations thereof. 
     
     
         8 . The medicinal composition of  claim 1  further comprising at least one surfactant selected from the group consisting of C5-C20 fatty alcohols, C5-C20 fatty acids, C5-C20 fatty acid esters, lecithin, glycerides, propyleneglycol esters, polyoxyethanes, polysorbates, sorbitan esters and carbohydrates, or combinations thereof. 
     
     
         9 . The medicinal composition of  claim 1  further comprising a cosolvent. 
     
     
         10 . The medicinal composition of  claim 11  wherein said cosolvent has a greater polarity than sad propellant. 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . The medicinal composition according to  claim 1  wherein the propellant comprises at least about 50% by weight of HFO-1234. 
     
     
         14 . The medicinal composition according to  claim 1  wherein the propellant consists essentially of HFO-1234. 
     
     
         15 . The medicinal composition according to  claim 1  wherein said propellant comprises HFO-1234 and one or more other propellants selected from the group consisting of other hydrofluoralkenes, hydrofluoroalkanes, fluorocarbons, perfluorocarbons, fluorocarbon/hydrocarbon diblocks, hydrocarbons, alcohols, ethers and combinations of two or more thereof. 
     
     
         16 . (canceled) 
     
     
         17 . The medicinal composition of  claim 1  wherein said propellant has a Global Warming Potential (GWP) of not greater than about 100. 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . An inhaler for medicinal composition comprising a canister containing a medicament formulation, a chamber capable of fluid communication with said canister, and a patient port for introducing said medicinal composition from said chamber to the oral or nasal cavity of the intended user, said medicinal composition comprising propellant and at least one medicinally active compound, said propellant comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of HFO-1234yf and/or transHFO-1234ze. 
     
     
         21 . The inhaler of  claim 20  wherein said canister is an aerosol canister. 
     
     
         22 . The inhaler of  claim 20  wherein said medicinal composition is a pressurized medicinal composition. 
     
     
         23 . The inhaler of  claim 20  wherein said canister comprises a metered dose dispensing valve with a valve stem movable between non-dispensing and dispensing positions. 
     
     
         24 . (canceled) 
     
     
         25 . A method of treating a mammal comprising administering to the mammal a medicinal formulation comprising at least one propellant and at least one medicinally active compound, said propellant comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of HFO-1234yf and/or transHFO-1234ze. 
     
     
         26 . (canceled) 
     
     
         27 . The method of  claim 25  wherein said mammal has a condition capable of treatment by inhalation and said step of administering comprises administering by inhalation and wherein said medicinal composition is an aerosol formulation suitable for aerosol administration. 
     
     
         28 . The method according to  claim 27  wherein the condition capable of treatment by inhalation is a respiratory ailment. 
     
     
         29 .- 31 . (canceled) 
     
     
         32 . A method of making an aerosol formulation suitable for delivery to the lung of a mammal by inhalation comprising the steps of:
 (a) providing at least one propellant, said propellant comprising a medicinally acceptable carrier and comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of HFO-1234yf and/or transHFO-1234ze;   (b) providing at least one medicinally active compound; and   c) introducing said medicinally active compound to said propellant such that it is carried in said propellant.