Claims for Patent: 9,308,199

Summary for Patent: 9,308,199

Title:	Medicament formulations
Abstract:	Medicinal compositions, and devices, methods and systems which use the compositions, comprising a propellant and at least one medicinally active compound. The propellant comprises at least one fluoroolefin having at least two but less than seven carbon atoms.
Inventor(s):	Knopeck; Gary (Lakeview, NY), Diringer; Jeremy (Morristown, NJ), Herena; Louis (Scarsdale, NY), Singh; Rajiv R. (Getzville, NY)
Assignee:	HONEYWELL INTERNATIONAL INC. (Morris Plains, NJ)
Application Number:	11/375,826
Patent Claims:	1. A medicinal composition comprising: (a) a medicinally acceptable a propellant; and (b) at least one medicinally active compound, said propellant having a toxicity level that is not substantially harmful to the intended recipient of said medicinal compound and comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of transHFO-1234ze and wherein said at least one medicinally active compound is in the form of a suspension, dispersion, emulsion or a solution with said propellant. 2. The medicinal composition according to claim 1 wherein said HFO-1234 consists of transHFO-1234ze. 3. The medicinal composition according to claim 1 wherein the propellant consists essentially of transHFO-1234ze. 4. The medicinal composition according to claim 1 wherein said propellant further comprises 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. 5. The medicinal composition according to claim 4 wherein said other propellants are selected from the group consisting of pentafluoroethane (HFC-125); 1,1,2,2-tetrafluoroethane (HFC-134); 1,1,1,2-tetrafluoroethane (HFC-134a); 1,1,1,2,3,3,3-heptafluoropropane (HFC-227ea); and combinations thereof. 6. The medicinal composition of claim 1 wherein said propellant has a Global Warming Potential (GWP) of not greater than about 1000. 7. The medicinal composition of claim 1 wherein said propellant has a Global Warming Potential (GWP) of not greater than about 100. 8. The medicinal composition of claim 1 wherein said propellant has an Ozone Depleting Potential (ODP) of not greater than about 0.05. 9. 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. 10. The medicinal composition of claim 9 wherein at least one other active substance is in the form of particles suspended or in solution in the liquid phase. 11. The medicinal composition according to claim 9 wherein said medicinally active compound comprises a combination of two or more medicinally active substances solubilized in said propellant. 12. 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. 13. 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. 14. 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. 15. The medicinal composition of claim 1 further comprising a cosolvent. 16. The medicinal composition of claim 15 wherein said cosolvent has a greater polarity than said propellant. 17. The medicinal composition of claim 16 wherein said cosolvent comprises one or more alcohols. 18. The medicinal composition of claim 17 wherein said alcohol is selected from the group consisting of ethanol, isopropanol, propylene glycol, glycerol, and combinations thereof. 19. 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: (a) medicinally acceptable propellant; and (b) at least one medicinally active compound, said propellant having a toxicity level that is not substantially harmful to the intended recipient of said medicinal compound and comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of transHFO-1234ze. 20. The inhaler of claim 19 wherein said canister is an aerosol canister. 21. The inhaler of claim 19 wherein said medicinal composition is a pressurized medicinal composition. 22. The inhaler of claim 19 wherein said canister comprises a metered dose dispensing valve with a valve stem movable between non-dispensing and dispensing positions. 23. A canister of the type capable of containing the vapor pressure of a propellant contained therein and further containing a medicinal composition suitable for administration to a mammal, said medicinal composition comprising (a) medicinally acceptable propellant and (b) at least one medicinally active compound, said propellant having a toxicity level that is not substantially harmful to the intended recipient of said medicinal compound and comprising at least 50% by weight of HFO-1234, wherein said HFO-1234 consists essentially of transHFO-1234ze. 24. The canister of claim 23 wherein said canister contains an amount of said medicinal composition sufficient to provide a plurality of therapeutically effective doses of said at least one medicinally active compound. 25. The canister of claim 24 wherein said canister contains a medicinal composition for delivering at least one medicinally effective dose of said at least one medicinally active compound to a mammalian body by administration selected from the group consisting of topical, pulmonary, intrapleural, rectal, vaginal, mucosal and combinations of two or more of these.

Details for Patent 9,308,199

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	06/20/2003		2024-04-29
Genentech, Inc.	XOLAIR	omalizumab	Injection	103976	09/28/2018		2024-04-29