CA2444535A1 - Formoterol/steroid bronchodilating compositions and methods of use thereof - Google Patents

Formoterol/steroid bronchodilating compositions and methods of use thereof Download PDF

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CA2444535A1
CA2444535A1 CA002444535A CA2444535A CA2444535A1 CA 2444535 A1 CA2444535 A1 CA 2444535A1 CA 002444535 A CA002444535 A CA 002444535A CA 2444535 A CA2444535 A CA 2444535A CA 2444535 A1 CA2444535 A1 CA 2444535A1
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pharmaceutical composition
composition
concentration
sodium
buffer
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CA2444535C (en
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Partha S. Banerjee
Imtiaz A. Chaudry
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Mylan Specialty LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof, and a steroidal anti-inflammatory agent. Methods for treatment, prevention, or amelioration of one or more symptons of bronchoconstrictive disorders using the compositions provided herein are also provided.

Claims (74)

1. A pharmaceutical composition, comprising (i) formoterol, or a derivative thereof; and (ii) a steroidal anti-inflammatory agent, or a derivative thereof;
in a pharmacologically suitable fluid, wherein the composition is stable during long term storage and the fluid comprises water.
2. The pharmaceutical composition of claim 1, wherein the composition has an estimated shelf-life of greater than 1 month usage time at 25 °C and greater than or equal to 1 year storage time at 5 °C.
3. The pharmaceutical composition of claim 1 or 2, wherein greater than about 80% of the initial formoterol is present after 1 month usage time at 25 °C and 1 year storage time at 5 °C.
4. The pharmaceutical composition of any of claims 1-3, wherein the pharmacologically suitable fluid comprises a polar solvent.
5. The pharmaceutical composition of claim 4, wherein the polar solvent is a protic solvent.
6. The pharmaceutical composition of any of claims 1-5, further comprising a tonicity adjusting agent.
7. The pharmaceutical composition of claim 6, wherein the tonicity adjusting agent is ammonium carbonate, ammonium chloride, ammonium lactate, ammonium nitrate, ammonium phosphate, ammonium sulfate, ascorbic acid, bismuth sodium tartrate, boric acid, calcium chloride, calcium disodium edetate, calcium gluconate, calcium lactate, citric acid, dextrose, diethanolamine, dimethylsulfoxide, edetate disodium, edetate trisodium monohydrate, fluorescein sodium, fructose, galactose, glycerin, lactic acid, lactose, magnesium chloride, magnesium sulfate, mannitol, polyethylene glycol, potassium acetate, potassium chlorate, potassium chloride, potassium iodide, potassium nitrate, potassium phosphate, potassium sulfate, proplyene glycol, silver nitrate, sodium acetate, sodium bicarbonate, sodium biphosphate, sodium bisulfite, sodium borate, sodium bromide, sodium cacodylate, sodium carbonate, sodium chloride, sodium citrate, sodium iodide, sodium lactate, sodium metabisulfite, sodium nitrate, sodium nitrite, sodium phosphate, sodium propionate, sodium succinate, sodium sulfate, sodium sulfite, sodium tartrate, sodium thiosulfate, sorbitol, sucrose, tartaric acid, triethanolamine, urea, urethan, uridine or zinc sulfate.
8. The pharmaceutical composition of claim 6 or 7, wherein the tonicity adjusting agent is sodium chloride.
9. The pharmaceutical composition of any of claims 1-3, wherein the pharmacologically suitable fluid comprises a buffer.
10. The pharmaceutical composition of any of claims 1-8, further comprising a buffer.
11. The pharmaceutical composition of claim 9 or 10, wherein the buffer is citric acid/phosphate, acetate, barbital, borate, Britton-Robinson, cacodylate, citrate, collidine, formate, maleate, Mcllvaine, phosphate, Prideaux-Ward, succinate, citrate-phosphate-borate (Teorell-Stanhagen), veronal acetate, MES (2-(N-morpholino)ethanesulfonic acid), BIS-TRIS (bis(2-hydroxyethyl)iminotris(hydroxymethyl)methane), ADA (N-(2-acetamido)-2-iminodiacetic acid), ACES (N-(carbamoylmethyl)-2-aminoethanesulfonaic acid), PIPES (piperazine-N,N'-bis(2-ethanesulfonic acid)), MOPSO (3-(N-morpholino)-2-hydroxypropanesulfonic acid), BIS-TRIS PROPANE (1,3-bis(tris(hydroxymethyl)methylamino)propane), BES
(N,N-bis(2-hydroxyethyl)-2-aminoethanesulfonaic acid), MOPS (3-(N-morpholino)propanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), HEPES (N-(2-hydroxyethyl)piperazine-N'-(2-ethanesulfonic acid), DIPSO (3-(N,N-bis(2-hydroxyethyl)amino)-2-hydroxypropanesulfonic acid), MOBS (4-(N-morpholino)butanesulfonic acid), TAPSO (3-(N-tris(hydroxymethyl)methylamino)-2-hydroxy-propanesulfonic acid), tris(hydroxymethylaminomethane, HEPPSO (N-(2-hydroxyethyl)piperazine-N'-(2-hydroxypropanesulfonic acid), POPSO
(piperazine-N,N'-bis(2-hydroxypropanesulfonic acid)), TEA
(triethanolamine), EPPS (N-(2-hydroxyethyl)piperazine-N'-(3-propane-sulfonic acid), TRICINE (N-tris(hydroxymethyl)methylglycine), GLY-GLY
(glycylglycine), BICINE (N,N-bis(2-hydroxyethyl)glycine), HEPBS (N-(2-hydroxyethyl)piperazine-N'-(4-butanesulfonic acid)), TAPS (N-tris(hydroxy-methyl)methyl-3-aminopropanesulfonic acid), or AMPD (2-amino-2-methyl-1,3-propanediol) buffer.
12. The pharmaceutical composition of any of claims 9-11, wherein the buffer comprises citric acid/phosphate buffer, acetate buffer, citrate buffer or phosphate buffer.
13. The pharmaceutical composition of any of claims 9-12, wherein the buffer is citrate buffer.
14. The pharmaceutical composition of any of claims 9-13, wherein the buffer concentration is from about 0.01 mM to about 150 mM.
15. The pharmaceutical composition of any of claims 9-14, wherein the buffer concentration is from about 1 mM to about 50 mM.
16. The pharmaceutical composition of any of claims 9-15, wherein the buffer concentration is from about 1 mM to about 20 mM.
17. The pharmaceutical composition of any of claims 9-16, wherein the buffer concentration is about 20 mM.
18. The pharmaceutical composition of any of claims 9-16, wherein the buffer concentration is about 5 mM.
19. The pharmaceutical composition of any of claims 1-18, wherein the ionic strength of the composition is about 0 to about 0.4.
20. The pharmaceutical composition of any of claims 1-19, wherein the ionic strength of the composition is about 0.05 to about 0.16.
21. The pharmaceutical composition of any of claims 1-20, wherein the pH of the composition is about 2.0 to about 8Ø
22. The pharmaceutical composition of any of claims 1-21, wherein the pH of the composition is about 4.0 to about 6Ø
23. The pharmaceutical composition of any of claims 1-22, wherein the pH of the composition is about 4.5 to about 5.5.
24. The pharmaceutical composition of any of claims 1-23, wherein the pH of the composition is about 5Ø
25. The pharmaceutical composition of any of claims 1-24, wherein the formoterol free base concentration is about 5 µg/mL to about 2 mg/mL.
26. The pharmaceutical composition of any of claims 1-25, wherein the formoterol free base concentration is about 10 µg/mL to about 1 mg/mL.
27. The pharmaceutical composition of any of claims 1-26, wherein the formoterol free base concentration is about 50 µg/mL to about 200 µg/mL.
28. The pharmaceutical composition of any of claims 1-27, wherein the formoterol free base concentration is about 59 µg/mL.
29. The pharmaceutical composition of any of claims 1-27, wherein the formoterol free base concentration is about 1 18 µg/mL.
30. The pharmaceutical composition of any of claims 9-29, wherein the buffer is citrate buffer; the buffer concentration is about 5 mM; the ionic strength of the composition is about 0.05 to about 0.16;
and the pH of the composition is about 5Ø
31. The pharmaceutical composition of any of claims 1-30, wherein the steroidal anti-inflammatory agent is beclomethasone dipropionate (BDP), beclomethasone monopropionate (BMP), flunisolide, triamcinolone acetonide, dexamethasone, tipredane, ciclesonid, rofleponide, mometasone, mometasone furoate, RPR 106541, fluticasone or fluticasone propionate or budesonide, or a derivative thereof.
32. The pharmaceutical composition of any of claims 1-31, wherein the steroidal anti-inflammatory agent is budesonide or fluticasone propionate, or a derivative thereof.
33. The pharmaceutical composition of any of claims 1-32, wherein the steroidal anti-inflammatory agent is budesonide, or a derivative thereof.
34. The pharmaceutical composition of any of claims 31-33, wherein the budesonide concentration is about 5 µg/mL to about 2 mg/mL.
35. The pharmaceutical composition of any of claims 31-34, wherein the budesonide concentration is about 75 µg/mL to about 500 µg/mL.
36. The pharmaceutical composition of any of claims 31-35, wherein the budesonide concentration is about 125 µg/mL or about 250 µg/mL.
37. The pharmaceutical composition of any of claims 1-32, wherein the steroidal anti-inflammatory agent is fluticasone propionate.
38. The pharmaceutical composition of any of claims 31, 32 or 37, wherein the concentration of fluticasone propionate is about 5 µg/mL
to about 2 mg/mL.
39. The pharmaceutical composition of any of claims 31, 32, 37 or 38, wherein the concentration of fluticasone propionate is about 75 µg/mL to about 1000 µg/mL.
40. The pharmaceutical composition of any of claims 31, 32 or 37-39, wherein the concentration of fluticasone propionate is about 125 µg/mL or about 250 µg/mL.
41. The pharmaceutical composition of any of claims 1-40, further comprising one or more of (a) to (j) as follows: (a) a .beta.2-adrenoreceptor agonist; (b) a dopamine (D2) receptor agonist; (c) an IL-5 inhibitor; (d) an antisense modulator of IL-5; (e) a tryptase inhibitor; (f) a tachykinin receptor antagonist; (g) milrinone or milrinone lactate; (h) a leukotriene receptor antagonist; (i) a 5-lypoxygenase inhibitor; or (j) an anti-IgE antibody.
42. The pharmaceutical composition of any of claims 9-29, wherein the buffer is citrate buffer; the buffer concentration is about 20 mM; the ionic strength of the composition is about 0.05 to about 0.16;
and the pH of the composition is about 5Ø
43. The pharmaceutical composition of any of claims 1-42, further comprising an anticholinergic agent.
44. The pharmaceutical composition of claim 43, wherein the anticholinergic agent is ipratropium bromide, oxitropium bromide, atropine methyl nitrate, tiotropium bromide or glycopyrronium bromide.
45. The pharmaceutical composition of claim 43 or 44, wherein the anticholinergic agent is ipratropium bromide.
46. The pharmaceutical composition of claim 45, wherein the ipratropium bromide is present at a concentration of about 5 µg/mL to about 5 mg/mL.
47. The pharmaceutical composition of claim 43 or 44, wherein the anticholinergic agent is tiotropium bromide.
48. The pharmaceutical composition of claim 47, wherein the tiotropium bromide is present at a concentration of about 5 µg/mL to about 5 mg/mL.
49. The pharmaceutical composition of any of claims 1-48 that is a solution.
50. The pharmaceutical composition of any of claims 1-50 that is a suspension.
51. The pharmaceutical composition of any of claims 1-50 that has been nebulized.
52. A nebulized suspension or solution, comprising (i) formoterol or a derivative thereof; and (ii) a steroidal anti-inflammatory agent, or a derivative thereof; in a pharmacologically suitable fluid.
53. A kit, comprising:
(a) an aqueous composition comprising (i) formoterol or a derivative thereof, and (ii) a steroidal anti-inflammatory agent or a derivative thereof, formulated for single dosage administration; and (b) a nebulizer.
54. The kit of claim 53, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 59 µg/mL;
(b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 5 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
55. The kit of claim 53, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 118 µg/mL; (b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 5 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
56. A kit, comprising:
(a) the pharmaceutical composition of any of claims 1-50; and (b) a nebulizer.
57. The kit of claim 53, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 59 µg/mL;
(b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 20 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
58. The kit of claim 53, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 118 µg/mL; (b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 20 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
59. A combination, comprising:
(a) the pharmaceutical composition of any of claims 1-50 formulated for single dosage administration; and (b) a vial.
60. The combination of claim 59, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 59 µg/mL; (b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 5 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
61. The combination of claim 59, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 118 µg/mL; (b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 5 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
62. The combination of claim 59, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 59 µg/mL; (b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 20 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
63. The combination of claim 59, wherein the aqueous composition comprises (a) formoterol free base at a concentration of about 118 µg/mL; (b) aqueous saline comprising sodium chloride; and (c) citrate buffer at a concentration of about 20 mM;
wherein the ionic strength of the composition is about 0.05 to about 0.16; and the pH of the composition is about 5Ø
64. A combination, comprising:
a composition comprising formoterol, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage and the fluid comprises water; and a composition comprising a bronchodilating steroid, or a derivative thereof.
65. The combination of claim 64, further comprising a nebulizer.
66. The combination of claim 65 that is packaged as a kit;
optionally comprising instructions for use of the nebulizer; and optionally comprising instructions for mixing the compositions.
67. A method for the treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders, comprising administering an effective amount of the pharmaceutical composition of any of claims 1-50 to a subject in need of such treatment.
68. The method of claim 67, further comprising administering one or more of (a) to (j) as follows: (a) a .beta.2-adrenoreceptor agonist;
(b) a dopamine (D2) receptor agonist; (c) an IL-5 inhibitor; (d) an antisense modulator of IL-5; (e) a tryptase inhibitor; (f) a tachykinin receptor antagonist; (g) milrinone or milrinone lactate; (h) a leukotriene receptor antagonist; (i) a 5-lypoxygenase inhibitor; or (j) an anti-IgE antibody;
simultaneously with, prior to or subsequent to the formoterol/steroidal anti-inflammatory agent composition.
69. A method for the treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders, comprising:
(i) administering an effective amount of a pharmaceutical composition comprising formoterol, or a derivative thereof, in a pharmacologically suitable fluid, wherein the composition is stable during long term storage and the fluid comprises water; and (ii) simultaneously with, prior to, or subsequent to administering the formoterol composition, administering an effective amount of a pharmaceutical composition comprising a steroidal anti-inflammatory agent in a pharmacologically acceptable carrier.
70. The method of claim 68, wherein the steroidal anti-inflammatory agent is beclomethasone dipropionate (BDP), beclomethasone monopropionate (BMP), flunisolide, triamcinolone acetonide, dexamethasone, tipredane, ciclesonid, rofleponide, mometasone, mometasone furoate, RPR 106541, fluticasone or fluticasone propionate or budesonide, or a derivative thereof.
71. The method of claim 70, wherein the steroidal anti-inflammatory agent is fluticasone propionate or budesonide, or a derivative thereof.
72. The method of claim 70 or 71, wherein the steroidal anti-inflammatory agent is budesonide, or a derivative thereof.
73. The method of claim 70 or 71, wherein the steroidal anti-inflammatory agent is fluticasone propionate, or a derivative thereof.
74. An article of manufacture, comprising packaging material, an aqueous composition comprising the composition of any of claims 1-50 formulated for single dosage administration, which is useful for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction, and a label that indicates that the composition is used for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction.
CA2444535A 2001-04-17 2002-03-01 Formoterol/steroid bronchodilating compositions and methods of use thereof Expired - Lifetime CA2444535C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US28460701P 2001-04-17 2001-04-17
US60/284,607 2001-04-17
US09/887,496 US20030055026A1 (en) 2001-04-17 2001-06-22 Formoterol/steroid bronchodilating compositions and methods of use thereof
US09/887,496 2001-06-22
PCT/US2002/006252 WO2002083113A2 (en) 2001-04-17 2002-03-01 Aerosol compositions containing formoterol and a steroid such as e.g. budesonide or fluticasone for delivery into the lungs via nebulization

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Publication Number Publication Date
CA2444535A1 true CA2444535A1 (en) 2002-10-24
CA2444535C CA2444535C (en) 2010-07-13

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US (6) US20030055026A1 (en)
EP (1) EP1385494B1 (en)
JP (2) JP4580145B2 (en)
AU (1) AU2002250199B2 (en)
CA (1) CA2444535C (en)
ES (1) ES2572973T3 (en)
HK (1) HK1061523A1 (en)
PT (1) PT1385494T (en)
SI (1) SI1385494T1 (en)
WO (1) WO2002083113A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007059620A1 (en) * 2005-11-23 2007-05-31 Feanny Stephen J Method for administering formoterol using a nebulizer

Families Citing this family (74)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6667344B2 (en) 2001-04-17 2003-12-23 Dey, L.P. Bronchodilating compositions and methods
US20030055026A1 (en) * 2001-04-17 2003-03-20 Dey L.P. Formoterol/steroid bronchodilating compositions and methods of use thereof
GB0204829D0 (en) * 2002-03-01 2002-04-17 Glaxo Group Ltd A fluid dispensing device
EP2319585A1 (en) * 2002-08-29 2011-05-11 Cipla Ltd. Pharmaceutical products and compositions comprising salmeterol, fluticasone and ipratropium or tiotropium
AU2003293833B2 (en) * 2002-12-12 2009-10-01 Covis Pharma B.V. Combination medicament
US6861422B2 (en) * 2003-02-26 2005-03-01 Boehringer Ingelheim Pharma Gmbh & Co. Kg Dihydropteridinones, processes for preparing them and their use as pharmaceutical compositions
GB0312148D0 (en) * 2003-05-28 2003-07-02 Aventis Pharma Ltd Stabilized pharmaceutical products
GB0315889D0 (en) 2003-07-08 2003-08-13 Aventis Pharma Ltd Stable pharmaceutical products
ATE372777T1 (en) 2003-07-09 2007-09-15 Us Gov Health & Human Serv USE OF NITRITE SALTS TO TREAT CARDIOVASCULAR DISEASES
TWI359675B (en) 2003-07-10 2012-03-11 Dey L P Bronchodilating β-agonist compositions
US20050026884A1 (en) * 2003-07-31 2005-02-03 Robinson Cynthia B. Combination of dehydroepiandrosterone or dehydroepiandrosterone-sulfate with a beta-agonist bronchodilator for treatment of asthma or chronic obstructive pulmonary disease
US20050059643A1 (en) * 2003-08-05 2005-03-17 Boehringer Ingelheim International Gmbh Medicaments for inhalation comprising a steroid and a betamimetic
DE10347994A1 (en) * 2003-10-15 2005-06-16 Pari GmbH Spezialisten für effektive Inhalation Aqueous aerosol preparation
PE20050941A1 (en) * 2003-12-16 2005-11-08 Nycomed Gmbh AQUEOUS CYCLESOUND SUSPENSIONS FOR MISTING
KR20070007076A (en) * 2003-12-31 2007-01-12 사이덱스 인크 INHALANT FORMULATION CONTAINING SULFOALKYL ETHER gamma;-CYCLODEXTRIN AND CORTICOSTEROID
US20070020196A1 (en) * 2003-12-31 2007-01-25 Pipkin James D Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid prepared from a unit dose suspension
AU2011235943B2 (en) * 2003-12-31 2014-06-26 Cydex Pharmaceuticals, Inc Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid
US20070020299A1 (en) * 2003-12-31 2007-01-25 Pipkin James D Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid
WO2005082413A2 (en) * 2004-02-27 2005-09-09 Altana Pharma Ag Ciclesonide and glycopyrronium combination
JP2007531743A (en) * 2004-04-05 2007-11-08 セプラコア インコーポレーテッド (R, R) -formoterol in combination with other drugs
ITRM20040268A1 (en) * 2004-05-31 2004-08-31 Italchimici S P A PHARMACEUTICAL FORMULATION OF A STABLE FORMOTEROL SOLUTION BY INHALATION AND ON ITS PREPARATION.
DE102004029784A1 (en) * 2004-06-21 2006-01-05 Boehringer Ingelheim Pharma Gmbh & Co. Kg Novel 2-Benzylaminodihydropteridinones, process for their preparation and their use as medicaments
DE102004033670A1 (en) * 2004-07-09 2006-02-02 Boehringer Ingelheim Pharma Gmbh & Co. Kg New pyridodihydropyrazinone, process for its preparation and its use as a medicament
US7759485B2 (en) * 2004-08-14 2010-07-20 Boehringer Ingelheim International Gmbh Process for the manufacture of dihydropteridinones
US20060074088A1 (en) * 2004-08-14 2006-04-06 Boehringer Ingelheim International Gmbh Dihydropteridinones for the treatment of cancer diseases
US20060058311A1 (en) * 2004-08-14 2006-03-16 Boehringer Ingelheim International Gmbh Combinations for the treatment of diseases involving cell proliferation
US20060035903A1 (en) * 2004-08-14 2006-02-16 Boehringer Ingelheim International Gmbh Storage stable perfusion solution for dihydropteridinones
US7728134B2 (en) * 2004-08-14 2010-06-01 Boehringer Ingelheim International Gmbh Hydrates and polymorphs of 4[[(7R)-8-cyclopentyl-7-ethyl-5,6,7,8-tetrahydro-5-methyl-6-oxo-2-pteridinyl]amino]-3-methoxy-N-(1-methyl-4-piperidinyl)-benzamide, process for their manufacture and their use as medicament
EP1632493A1 (en) * 2004-08-25 2006-03-08 Boehringer Ingelheim Pharma GmbH & Co.KG Dihydropteridine derivatives, methods for their preparation and their use as drugs
EP1630163A1 (en) * 2004-08-25 2006-03-01 Boehringer Ingelheim Pharma GmbH & Co.KG Dihydropteridinones, methods for their preparation and their use as drugs
DE102004058337A1 (en) * 2004-12-02 2006-06-14 Boehringer Ingelheim Pharma Gmbh & Co. Kg Process for the preparation of fused piperazin-2-one derivatives
EP1712220A1 (en) * 2005-04-15 2006-10-18 PARI GmbH Spezialisten für effektive Inhalation Pharmaceutical aerosol composition
EP1921919B1 (en) 2005-07-14 2012-04-04 Lithera, Inc. Sustained release enhanced lipolytic formulation for regional adipose tissue treatment
CA2617589A1 (en) * 2005-08-03 2007-02-08 Boehringer Ingelheim International Gmbh Dihydropteridinones in the treatment of respiratory diseases
US20070249572A1 (en) * 2005-12-20 2007-10-25 Verus Pharmaceuticals, Inc. Systems and methods for the delivery of corticosteroids
US20070178050A1 (en) * 2005-12-20 2007-08-02 Verus Pharmaceuticals, Inc. Methods and systems for the delivery of corticosteroids having an increased lung depositon
US20070185066A1 (en) * 2005-12-20 2007-08-09 Verus Pharmaceuticals, Inc. Systems and methods for the delivery of corticosteroids
US20070197486A1 (en) * 2005-12-20 2007-08-23 Verus Pharmaceuticals, Inc. Methods and systems for the delivery of corticosteroids
US20070178049A1 (en) * 2005-12-20 2007-08-02 Verus Pharmaceuticals, Inc. Systems and methods for the delivery of corticosteroids having an enhanced pharmacokinetic profile
EP1971348A2 (en) * 2005-12-20 2008-09-24 Tika Läkemedel AB Systems and methods for the delivery of corticosteroids having an increased lung deposition
US20070197487A1 (en) * 2005-12-20 2007-08-23 Verus Pharmaceuticals, Inc. Systems and methods for the delivery of corticosteroids having an increased lung deposition
US20070160542A1 (en) * 2005-12-20 2007-07-12 Verus Pharmaceuticals, Inc. Methods and systems for the delivery of corticosteroids having an enhanced pharmacokinetic profile
AU2006329042B2 (en) * 2005-12-21 2012-02-02 Meda Pharma Gmbh & Co Kg Combination of anticholinergics, glucocorticoids, beta2-agonists, PDE4 inhibitor and antileukotriene for the treatment of inflammatory diseases
US7439358B2 (en) 2006-02-08 2008-10-21 Boehringer Ingelheim International Gmbh Specific salt, anhydrous and crystalline form of a dihydropteridione derivative
GB0604141D0 (en) * 2006-03-01 2006-04-12 Arrow Int Ltd Nebulizer formulation
US20070274925A1 (en) * 2006-05-26 2007-11-29 Dey, L.P. Nebulizable compositions of quaternary ammonium muscarinic receptor antagonists
GB0612748D0 (en) * 2006-06-27 2006-08-09 Univ College London Hospitals Treatment and/or prevention of inflammatory lung disease
EP1894568A1 (en) * 2006-08-31 2008-03-05 Novartis AG Pharmaceutical compositions for the treatment of inflammatory or obstructive airway diseases
ES2398480T3 (en) * 2006-10-17 2013-03-19 Lithera, Inc. Procedures, compositions, and formulations for the treatment of thyroid eye disease
EP2327403A3 (en) * 2007-02-19 2011-08-31 Cipla Limited Pharmaceutical combinations of at least two bronchodilators
ES2493641T3 (en) * 2007-06-28 2014-09-12 Cydex Pharmaceuticals, Inc. Nasal administration of aqueous corticosteroid solutions
EP3098223A1 (en) * 2007-08-03 2016-11-30 Boehringer Ingelheim International GmbH Crystalline form of a dihydropteridione derivative
US8040246B2 (en) * 2007-12-04 2011-10-18 Avaya Inc. Systems and methods for facilitating a first response mission at an incident scene
US9132084B2 (en) 2009-05-27 2015-09-15 Neothetics, Inc. Methods for administration and formulations for the treatment of regional adipose tissue
WO2010144628A2 (en) * 2009-06-09 2010-12-16 Elevation Pharmaceuticals, Inc. Treatment of chronic obstructive pulmonary disease with nebulized beta 2-agonist or combined nebulized beta 2-agonist and anticholinergic administration
AU2010260513A1 (en) * 2009-06-16 2012-02-02 Wen Tan Use of R-Bambuterol as inhaled medicament and combination therapies for treatment of respiratory disorders
JP5717329B2 (en) 2009-10-09 2015-05-13 キヤノン株式会社 Solid-state imaging device and manufacturing method thereof
SG182485A1 (en) * 2010-01-15 2012-08-30 Lithera Inc Lyophilized cake formulations
US8546566B2 (en) 2010-10-12 2013-10-01 Boehringer Ingelheim International Gmbh Process for manufacturing dihydropteridinones and intermediates thereof
MX2013004137A (en) 2010-10-12 2013-07-29 Cipla Ltd Pharmaceutical composition.
GEP201606551B (en) 2010-11-24 2016-10-10 Novamedica Llc Selective, lipophilic, and long-acting beta agonists monotherapeutic formulations tions and methods for cosmetic treatment of adiposity and contour bulging
US9358233B2 (en) 2010-11-29 2016-06-07 Boehringer Ingelheim International Gmbh Method for treating acute myeloid leukemia
RU2013142268A (en) * 2011-02-17 2015-03-27 Сипла Лимитед PHARMACEUTICAL COMPOSITION
US9370535B2 (en) 2011-05-17 2016-06-21 Boehringer Ingelheim International Gmbh Method for treatment of advanced solid tumors
RS59734B1 (en) 2012-01-23 2020-02-28 Sage Therapeutics Inc Neuroactive steroid formulations comprising a complex of allopregnanolone and sulfobutyl ether beta-cyclodextrin
JP2015512929A (en) 2012-04-11 2015-04-30 シプラ・リミテッド Pharmaceutical composition
WO2015011236A1 (en) 2013-07-26 2015-01-29 Boehringer Ingelheim International Gmbh Treatment of myelodysplastic syndrome
US9867831B2 (en) 2014-10-01 2018-01-16 Boehringer Ingelheim International Gmbh Combination treatment of acute myeloid leukemia and myelodysplastic syndrome
MA45276A (en) * 2015-06-18 2018-04-25 Sage Therapeutics Inc NEUROACTIVE STEROID SOLUTIONS AND THEIR METHODS OF USE
US9925168B2 (en) * 2016-01-22 2018-03-27 Chiesi Farmaceutici S.P.A. Preparation of micronized particles of an antimuscarinic compound by hydrodynamic cavitation
CA3158448A1 (en) 2016-03-08 2017-09-14 Sage Therapeutics, Inc. Neuroactive steroids, compositions, and uses thereof
CN105748447A (en) * 2016-03-08 2016-07-13 上海现代药物制剂工程研究中心有限公司 Budesonide and formoterol spray inhalation suspension and preparation method thereof
WO2022023515A1 (en) 2020-07-31 2022-02-03 Chemo Research , S.L. Combination therapy for inhalation administration
WO2022217029A1 (en) * 2021-04-09 2022-10-13 Arizona Board Of Regents On Behalf Of The University Of Arizona Compositions and methods for delivering pharmaceutical agents

Family Cites Families (138)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2305092A1 (en) 1972-02-05 1973-08-16 Yamanouchi Pharma Co Ltd Alpha-aminomethylbenzyl alcohol derivs. - prepd. by redn. of corresponding protected derivs.
US3994974A (en) * 1972-02-05 1976-11-30 Yamanouchi Pharmaceutical Co., Ltd. α-Aminomethylbenzyl alcohol derivatives
SE378109B (en) * 1972-05-19 1975-08-18 Bofors Ab
US3994976A (en) * 1974-07-08 1976-11-30 The Dow Chemical Company Substituted phenylthioamidines
PH24267A (en) * 1980-02-15 1990-05-29 Glaxo Group Ltd Androstane carbothioates and pharmaceutical compositions containing the same
ZW6584A1 (en) * 1983-04-18 1985-04-17 Glaxo Group Ltd Phenethanolamine derivatives
US5052558A (en) * 1987-12-23 1991-10-01 Entravision, Inc. Packaged pharmaceutical product
US5033252A (en) * 1987-12-23 1991-07-23 Entravision, Inc. Method of packaging and sterilizing a pharmaceutical product
GB8825892D0 (en) 1988-11-04 1988-12-07 Fisons Plc Pharmaceutical composition
US5290815A (en) * 1989-09-07 1994-03-01 Glaxo Group Limited Treatment of inflammation and allergy
US5270305A (en) * 1989-09-08 1993-12-14 Glaxo Group Limited Medicaments
SE8903219D0 (en) * 1989-10-02 1989-10-02 Astra Ab PROCESS FOR THE MANUFACTURE OF BUDESONIDE
DE69130762T2 (en) * 1990-09-18 1999-09-09 Rodime Plc DIGITAL SERVO CONTROL FOR A DISK DRIVE
US5434304A (en) * 1990-09-26 1995-07-18 Aktiebolaget Astra Process for preparing formoterol and related compounds
US5795564A (en) * 1991-04-05 1998-08-18 Sepracor, Inc. Methods and compositions for treating pulmonary disorders using optically pure (R,R)-formoterol
US5874063A (en) * 1991-04-11 1999-02-23 Astra Aktiebolag Pharmaceutical formulation
SE9302777D0 (en) * 1993-08-27 1993-08-27 Astra Ab Process for conditioning substances
ES2079210T3 (en) 1991-12-12 1996-01-01 Glaxo Group Ltd PHARMACEUTICAL FORMULATION OF AEROSOL.
ATE213946T1 (en) 1991-12-18 2002-03-15 COMPOSITION CONTAINING FORMOTEROL AND BUDESONIDE
US5323907A (en) * 1992-06-23 1994-06-28 Multi-Comp, Inc. Child resistant package assembly for dispensing pharmaceutical medications
US5275212A (en) * 1993-02-24 1994-01-04 Minnesota Mining And Manufacturing Company Aerosol filling method
NZ263084A (en) * 1993-03-12 1997-08-22 Arris Pharm Corp Dipeptide derivatives, treatment of immunomediated inflammatory disorders
TW385308B (en) * 1994-03-04 2000-03-21 Merck & Co Inc Prodrugs of morpholine tachykinin receptor antagonists
GB9410222D0 (en) * 1994-05-21 1994-07-06 Glaxo Wellcome Australia Ltd Medicaments
US5602110A (en) * 1994-08-31 1997-02-11 Case Western Reserve University Method and composition for treating cystic fibrosis
US5983956A (en) * 1994-10-03 1999-11-16 Astra Aktiebolag Formulation for inhalation
SE9700134D0 (en) 1997-01-20 1997-01-20 Astra Ab New formulation
US5980949A (en) * 1994-10-03 1999-11-09 Astra Aktiebolag Formulation for inhalation
DE19541689A1 (en) 1994-11-14 1996-05-15 Byk Gulden Lomberg Chem Fab Medicament contg. ciclesonid and beta2-sympathomimetic
GB9425160D0 (en) 1994-12-10 1995-02-08 Glaxo Group Ltd Medicaments
JP4155594B2 (en) 1994-12-22 2008-09-24 アストラゼネカ・アクチエボラーグ Aerosol formulation
GB9426252D0 (en) 1994-12-24 1995-02-22 Glaxo Group Ltd Pharmaceutical composition
SE9501384D0 (en) 1995-04-13 1995-04-13 Astra Ab Process for the preparation of respirable particles
US5683983A (en) * 1995-06-07 1997-11-04 Glaxo Group Limited Peptides and compounds that bind to the IL-5 receptor
US5677280A (en) * 1995-06-07 1997-10-14 Glaxo Group Limited Peptides and compounds that bind to the IL-5 receptor
US5668110A (en) * 1995-06-07 1997-09-16 Affymax Technologies N.V. Peptides and compounds that bind to the IL-5 receptor
US5654276A (en) * 1995-06-07 1997-08-05 Affymax Technologies N.V. Peptides and compounds that bind to the IL-5 receptor
US5874481A (en) * 1995-06-07 1999-02-23 Alliance Pharmaceutical Corp. Fluorochemical solutions for the delivery of lipophilic pharmaceutical agents
US6041777A (en) * 1995-12-01 2000-03-28 Alliance Pharmaceutical Corp. Methods and apparatus for closed-circuit ventilation therapy
US5733526A (en) * 1995-12-14 1998-03-31 Alliance Pharmaceutical Corp. Hydrocarbon oil/fluorochemical preparations and methods of use
GB9612297D0 (en) 1996-06-11 1996-08-14 Minnesota Mining & Mfg Medicinal aerosol formulations
GB9616237D0 (en) 1996-08-01 1996-09-11 Norton Healthcare Ltd Aerosol formulations
SE9603669D0 (en) 1996-10-08 1996-10-08 Astra Ab New combination
US5750549A (en) * 1996-10-15 1998-05-12 Merck & Co., Inc. Cycloalkyl tachykinin receptor antagonists
US5929094A (en) * 1996-10-25 1999-07-27 Merck & Co., Inc. Heteroaryl spiroethercycloalkyl tachykinin receptor antagonists
GB9625843D0 (en) * 1996-12-12 1997-01-29 Merck & Co Inc Phenyl spiroethercycloalkyl tachykinn receptor antagonists
US6040344A (en) * 1996-11-11 2000-03-21 Sepracor Inc. Formoterol process
FR2756739B1 (en) * 1996-12-05 2000-04-28 Astra Ab NEW BUDESONIDE FORMULATION
SE9604486D0 (en) * 1996-12-05 1996-12-05 Astra Ab Novel formulation
SE9700135D0 (en) * 1997-01-20 1997-01-20 Astra Ab New formulation
SE9700133D0 (en) * 1997-01-20 1997-01-20 Astra Ab New formulation
JP2001511160A (en) * 1997-02-05 2001-08-07 ヤゴ リサーチ アクチェンゲゼルシャフト Aerosol formulation for medical use
US6126919A (en) * 1997-02-07 2000-10-03 3M Innovative Properties Company Biocompatible compounds for pharmaceutical drug delivery systems
PL192441B1 (en) 1997-03-20 2006-10-31 Schering Corp Production of powder agglomerates
US6503537B2 (en) * 1997-03-20 2003-01-07 Schering Corporation Preparation of powder agglomerates
WO1998051281A1 (en) * 1997-05-14 1998-11-19 Senju Pharmaceutical Co., Ltd. Aqueous suspension preparations with excellent redispersibility
JP2002510310A (en) 1997-06-27 2002-04-02 アストラ・アクチエボラーグ New combination of anti-asthma drugs
US20010044584A1 (en) * 1997-08-28 2001-11-22 Kensey Kenneth R. In vivo delivery methods and compositions
SE9703407D0 (en) 1997-09-19 1997-09-19 Astra Ab New use
WO1999017754A1 (en) 1997-10-08 1999-04-15 Sepracor Inc. Dosage form for aerosol administration
SE9704186D0 (en) * 1997-11-14 1997-11-14 Astra Ab New composition of matter
SE9704644D0 (en) 1997-12-12 1997-12-12 Astra Ab New use
US6598603B1 (en) * 1997-12-31 2003-07-29 Astra Aktiebolag Method for treating respiratory diseases
EP1075278A1 (en) 1998-01-13 2001-02-14 AstraZeneca UK Limited PHARMACEUTICAL COMPOSITIONS COMPRISING A COMPOUND HAVING DOPAMINE (D 2?) RECEPTOR AGONIST ACTIVITY AND A COMPOUND (B) HAVING $g(b) 2?-ADRENORECEPTOR AGONIST ACTIVITY
CA2320104A1 (en) 1998-02-10 1999-08-19 Cangene Corporation Method for the prevention and treatment of a type i hypersensitivity disorder
GB9806462D0 (en) 1998-03-26 1998-05-27 Glaxo Group Ltd Improved compositions for inhalation
AU759264B2 (en) 1998-05-27 2003-04-10 Euro-Celtique S.A. Preparations for the application of anti-inflammatory, especially antiseptic agents and/or agents promoting the healing of wounds, to the upper respiratory tract and/or the ear
PT1087750E (en) 1998-06-18 2004-02-27 Boehringer Ingelheim Pharma Pharmaceutical formulations for aerosols with two or more active substances
US5965622A (en) * 1998-06-23 1999-10-12 Sepracor Inc. Desformoterol and process for its preparation
US6241969B1 (en) * 1998-06-26 2001-06-05 Elan Corporation Plc Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
EP1100465B1 (en) 1998-07-24 2004-11-24 Jago Research Ag Medicinal aerosol formulations
EP1102579B1 (en) 1998-08-04 2003-03-19 Jago Research Ag Medicinal aerosol formulations
DE19835346A1 (en) 1998-08-05 2000-02-10 Boehringer Ingelheim Pharma Two-part capsule for pharmaceutical preparations for powder inhalers
US6136294C1 (en) 1998-09-22 2002-09-24 Aeropharm Technology Inc Amino acid stabilized medical aerosol formulation
DE19847968A1 (en) * 1998-10-17 2000-04-20 Boehringer Ingelheim Pharma Separate storage of an active material and a solvent comprises a closure cap and a container, with a chamber attached to the unit.
JP3636430B2 (en) * 1998-10-17 2005-04-06 ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト Storable active substance concentrate containing formoterol
DE19847970A1 (en) 1998-10-17 2000-04-20 Boehringer Ingelheim Pharma Stable concentrated liquid formulation of inhalable drug, e.g. formoterol or salbutamol, in solution or suspension medium, used after dilution for treatment of respiratory disorders by inhalation
DE19847969A1 (en) * 1998-10-17 2000-04-20 Boehringer Ingelheim Pharma Stable liquid formulation of formoterol in solution or suspension medium, used after dilution for treatment of asthma by inhalation
US6235725B1 (en) * 1998-10-30 2001-05-22 Baker Norton Pharmaceuticals, Inc. Methods and compositions for the prevention of tolerance to medications
HU226164B1 (en) 1998-11-13 2008-05-28 Jagotec Ag Use of magnesium stearate in dry powder compositions suitable for inhalation and compositions suitable for inhalation
SE9804003D0 (en) 1998-11-23 1998-11-23 Astra Ab A method of producing drug particles
SE9804001D0 (en) 1998-11-23 1998-11-23 Astra Ab New process
US6261539B1 (en) * 1998-12-10 2001-07-17 Akwete Adjei Medicinal aerosol formulation
US6004537A (en) * 1998-12-18 1999-12-21 Baker Norton Pharmaceuticals, Inc. Pharmaceutical solution aerosol formulations containing fluoroalkanes, budesonide and formoterol
GB9902689D0 (en) 1999-02-08 1999-03-31 Novartis Ag Organic compounds
GB9903759D0 (en) * 1999-02-18 1999-04-14 Novartis Ag Organic compounds
GB9904919D0 (en) 1999-03-03 1999-04-28 Novartis Ag Organic compounds
SE9900833D0 (en) 1999-03-09 1999-03-09 Astra Ab Novel combination
SE9900834D0 (en) 1999-03-09 1999-03-09 Astra Ab Novel combination
US6716452B1 (en) 2000-08-22 2004-04-06 New River Pharmaceuticals Inc. Active agent delivery systems and methods for protecting and administering active agents
US6136603A (en) * 1999-03-26 2000-10-24 Isis Pharmaceuticals Inc. Antisense modulation of interleukin-5 signal transduction
US6303145B2 (en) * 1999-05-10 2001-10-16 Sepracor Inc. (S,R) formoterol methods and compositions
US20020081266A1 (en) * 1999-08-20 2002-06-27 Norton Healthcare Ltd. Spray dried powders for pulmonary or nasal administration
US6161535A (en) * 1999-09-27 2000-12-19 Carrier Corporation Method and apparatus for preventing cold spot corrosion in induced-draft gas-fired furnaces
DE19947235A1 (en) 1999-09-30 2001-04-05 Asta Medica Ag New combination of loteprednol and beta¶2¶ adrenoreceptor agonists
US6887870B1 (en) 1999-10-12 2005-05-03 Bristol-Myers Squibb Company Heterocyclic sodium/proton exchange inhibitors and method
SE9903995D0 (en) 1999-11-03 1999-11-03 Astra Ab New combination
GB9928311D0 (en) 1999-11-30 2000-01-26 Novartis Ag Organic compounds
US6596261B1 (en) 2000-01-25 2003-07-22 Aeropharm Technology Incorporated Method of administering a medicinal aerosol formulation
US6369115B1 (en) 2000-03-20 2002-04-09 Dura Pharmaceuticals, Inc. Stabilized powder formulations
US20030026766A1 (en) 2000-04-13 2003-02-06 Mark Sanders Medicaments for treating respiratory disorders comprising formoterol and fluticasone
GB0009584D0 (en) 2000-04-18 2000-06-07 Glaxo Group Ltd Pharmaceutical compositions
GB0009591D0 (en) * 2000-04-18 2000-06-07 Glaxo Group Ltd Medical combinations
US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
GB0012260D0 (en) 2000-05-19 2000-07-12 Astrazeneca Ab Novel composition
GB0012261D0 (en) 2000-05-19 2000-07-12 Astrazeneca Ab Novel process
AU2000250701B2 (en) 2000-05-22 2004-07-01 Chiesi Farmaceutici S.P.A. Stable pharmaceutical solution formulations for pressurised metered dose inhalers
GB0016876D0 (en) 2000-07-11 2000-08-30 Astrazeneca Ab Novel formulation
AU2001247123A1 (en) 2000-07-19 2002-02-05 Aeropharm Technology, Inc. A medicinal aerosol formulation
SE516555C2 (en) 2000-08-04 2002-01-29 Microdrug Ag electrostatic Powder
US20020099013A1 (en) * 2000-11-14 2002-07-25 Thomas Piccariello Active agent delivery systems and methods for protecting and administering active agents
FI20002177A0 (en) 2000-10-02 2000-10-02 Orion Yhtymae Oyj New combination for asthma therapy
JP5021149B2 (en) 2000-10-09 2012-09-05 スリーエム イノベイティブ プロパティズ カンパニー Medical aerosol formulation
BR0107304A (en) * 2000-10-12 2002-08-13 Boehringer Ingelheim Pharma Inhalation powder containing tiotropium
US6884782B2 (en) 2000-11-08 2005-04-26 Amgen Inc. STAT modulators
WO2002043806A2 (en) 2000-12-01 2002-06-06 Rheologics, Inc In vivo delivery methods and compositions
GB0030074D0 (en) 2000-12-08 2001-01-24 Univ London Pharmacy Particulate inhalation carrier
SE0004750D0 (en) 2000-12-19 2000-12-19 Astrazeneca Ab Novel formulation
EP1343550B1 (en) 2000-12-22 2017-11-22 Glaxo Group Limited Metered dose inhaler for salmeterol xinafoate
EP1229034B1 (en) 2001-01-31 2005-04-13 Pfizer Products Inc. Nicotinamide derivatives and their mimetics as inhibitors of PDE4 isozymes
MXPA03006887A (en) 2001-01-31 2003-11-13 Pfizer Prod Inc Nicotinamide biaryl derivatives useful as inhibitors of pde4 isozymes.
EA200300622A1 (en) 2001-01-31 2003-12-25 Пфайзер Продактс Инк. DERIVATIVES OF AMIDES TIAZOLYL-, OXAZOLYL, PYRROLYL-AND IMIDAZOZYL ACID, USEFUL AS AN INHIBITORS OF PDE4 ISOFERMENT
EA200300652A1 (en) 2001-01-31 2003-12-25 Пфайзер Продактс Инк. ESSENTIAL DERIVATIVES USEFUL AS AN INHIBITORS INHIBITORS PDE4
DE10104370A1 (en) 2001-02-01 2002-08-08 Boehringer Ingelheim Pharma Medicinal compositions with fewer side effects
DE10104367A1 (en) 2001-02-01 2002-08-08 Boehringer Ingelheim Pharma Medicinal compositions containing betamimetics with fewer side effects
MXPA03007017A (en) 2001-02-06 2004-09-13 Innovata Biomed Ltd Medicaments.
ITMI20010428A1 (en) 2001-03-02 2002-09-02 Chemo Breath S A INHALATION COMPOSITIONS BASED ON FORMOTEROL
US6667344B2 (en) * 2001-04-17 2003-12-23 Dey, L.P. Bronchodilating compositions and methods
US20030055026A1 (en) * 2001-04-17 2003-03-20 Dey L.P. Formoterol/steroid bronchodilating compositions and methods of use thereof
KR100422250B1 (en) * 2001-08-21 2004-03-11 삼성전자주식회사 Portable Computer
CA2460140C (en) 2001-09-18 2009-09-01 Nycomed Danmark Aps Compositions for treatment of common cold
US6702997B2 (en) * 2001-10-26 2004-03-09 Dey, L.P. Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
JP2003221335A (en) * 2001-10-26 2003-08-05 Dey Lp Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptom of chronic obstructive pulmonary disease
GB0129395D0 (en) 2001-12-07 2002-01-30 Pfizer Ltd Pharmaceutical combination
US20040023935A1 (en) * 2002-08-02 2004-02-05 Dey, L.P. Inhalation compositions, methods of use thereof, and process for preparation of same
US20040110845A1 (en) * 2002-12-06 2004-06-10 Ramana Malladi Stabilized albuterol compositions and method of preparation thereof
US20040109826A1 (en) * 2002-12-06 2004-06-10 Dey, L.P. Stabilized albuterol compositions and method of preparation thereof
TWI359675B (en) * 2003-07-10 2012-03-11 Dey L P Bronchodilating β-agonist compositions

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007059620A1 (en) * 2005-11-23 2007-05-31 Feanny Stephen J Method for administering formoterol using a nebulizer

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US8623851B2 (en) 2014-01-07
US20030055026A1 (en) 2003-03-20
US20110166202A1 (en) 2011-07-07
US20140171398A1 (en) 2014-06-19
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US20100120734A1 (en) 2010-05-13
US20100069342A1 (en) 2010-03-18

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