CA2464735A1 - An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease - Google Patents
An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease Download PDFInfo
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Abstract
The present invention relates to a dual bronchodilator inhalation solution, system, kit and method for relieving bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD). In one alternative embodiment, the solution of the present invention is a prepackaged, sterile, premixed, premeasured single unit dose of albuterol and ipratropium bromide for patients suffering from COPD. The present solution may be free of antimicrobial preservatives, such as benzalkonium chloride. In another alternative embodiment, the solution of the present invention comprises about 2.50 mg albuterol and about 0.50 mg ipratropium bromide.
Claims (56)
1. An inhalation solution comprising:
a premixed, premeasured aqueous formulation comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide for inducing bronchodilation or providing relief of bronchospasm in patients suffering from chronic obstructive pulmonary disease, wherein the amount of albuterol in the inhalation solution ranges from about 0.60 mg to about 5.0 mg and the amount of ipratropium bromide ranges from about 0.01 mg to about 1.0 mg; the solution being provided in a single container.
a premixed, premeasured aqueous formulation comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide for inducing bronchodilation or providing relief of bronchospasm in patients suffering from chronic obstructive pulmonary disease, wherein the amount of albuterol in the inhalation solution ranges from about 0.60 mg to about 5.0 mg and the amount of ipratropium bromide ranges from about 0.01 mg to about 1.0 mg; the solution being provided in a single container.
2. The inhalation solution of claim 1, wherein the inhalation solution is sterile.
3. The inhalation solution of claim 1, wherein the inhalation solution is free of benzalkonium chloride.
4. The inhalation solution of claim 1, wherein the pH of the inhalation solution ranges from about 3.0 to about 4Ø
5. The inhalation solution of claim 1, wherein the pH of the inhalation solution is about 4Ø
6. The inhalation solution of claim 1, wherein the albuterol is in the form of an acid addition salt thereof.
7. The inhalation solution of claim 6, wherein the acid addition salt of albuterol is albuterol sulfate.
8. The inhalation solution of claim 1, wherein the albuterol is in the form of a racemic mixture.
9. The inhalation solution of claim 1, wherein the amount of albuterol in the inhalation solution ranges from about 2.00 mg to about 3.00 mg.
10. The inhalation solution of claim 1, wherein the amount of albuterol in the solution is about 2.5 mg.
11. The inhalation solution of claim 1, wherein the inhalation solution is suitable for nebulization in a nebulizer.
12. The inhalation solution of claim 11, wherein said nebulizer is selected from the group consisting of a jet nebulizer, ultrasonic nebulizer and breath actuated nebulizer.
13. An inhalation solution comprising:
a sterile, premixed, premeasured aqueous formulation free of benzalkonium chloride comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide for inducing bronchodilation or providing relief of bronchospasm in patients suffering from chronic obstructive pulmonary disease, wherein the amount of albuterol in the solution is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg, the solution being provided in a single container and wherein the inhalation solution is suitable for nebulization in a nebulizer.
a sterile, premixed, premeasured aqueous formulation free of benzalkonium chloride comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide for inducing bronchodilation or providing relief of bronchospasm in patients suffering from chronic obstructive pulmonary disease, wherein the amount of albuterol in the solution is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg, the solution being provided in a single container and wherein the inhalation solution is suitable for nebulization in a nebulizer.
14. A method of inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the step:
(a) administering to said patient the inhalation solution of claim 1.
(a) administering to said patient the inhalation solution of claim 1.
15. The method of claim 14, wherein the inhalation solution is sterile when administered to the patient.
16. The method of claim 14, wherein the inhalation solution is free of benzalkonium chloride.
17. The inhalation solution of claim 14, wherein the albuterol is in the form of an acid addition salt thereof.
18. The solution of claim 17, wherein the acid addition salt of albuterol is albuterol sulfate.
19. The inhalation solution of claim 14, wherein the albuterol is in the form of a racemic mixture.
20. The inhalation solution of claim 14, wherein the amount of albuterol in the inhalation solution ranges from about 2.0 mg to about 3.0 mg.
21. The inhalation solution of claim 14, wherein the amount of albuterol in the inhalation solution is about 2.5 mg.
22. The method of claim 14, wherein the inhalation solution is administered to the patient by nebulization.
23. A method of inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the step:
(a) administering to the patient the inhalation solution of claim 13 by nebulization.
(a) administering to the patient the inhalation solution of claim 13 by nebulization.
24. A method of inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the steps:
(a) placing the inhalation solution into a chamber of a nebulizer, said nebulizer having a mouthpiece or facemask associated with the chamber of the nebulizer;
(b) positioning the mouthpiece or facemask in close proximity to the patient's mouth or face;
(c) passing the inhalation solution in a mist form from the nebulizer chamber through the mouthpiece or facemask to the patient while the patient breathes into the mouthpiece or facemask; and (d) the patient breathing into the mouthpiece or facemask until at least substantially all the mist is removed from the nebulizer chamber.
(a) placing the inhalation solution into a chamber of a nebulizer, said nebulizer having a mouthpiece or facemask associated with the chamber of the nebulizer;
(b) positioning the mouthpiece or facemask in close proximity to the patient's mouth or face;
(c) passing the inhalation solution in a mist form from the nebulizer chamber through the mouthpiece or facemask to the patient while the patient breathes into the mouthpiece or facemask; and (d) the patient breathing into the mouthpiece or facemask until at least substantially all the mist is removed from the nebulizer chamber.
25. A method of inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the steps of:
(a) providing instructions for administering to the patient the inhalation solution of claims 1.
(a) providing instructions for administering to the patient the inhalation solution of claims 1.
26. A kit for treating bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said kit comprising:
(a) one or more containers; said one or more containers each comprising a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the amount of albuterol in the solution ranges from about 0.60 mg to about 5.00 mg and the amount of ipratropium bromide in the solution ranges from about 0.01 mg to about 1.00 mg; the solution being suitable for nebulization in a nebulizer.
(a) one or more containers; said one or more containers each comprising a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the amount of albuterol in the solution ranges from about 0.60 mg to about 5.00 mg and the amount of ipratropium bromide in the solution ranges from about 0.01 mg to about 1.00 mg; the solution being suitable for nebulization in a nebulizer.
27. The kit according to claim 26, wherein the inhalation solution is sterile.
28. The kit according to claim 26, wherein the inhalation solution is free of benzalkonium chloride.
29. The kit according to claim 26, wherein the amount of albuterol in the inhalation solution ranges from about 2.0 mg to about 3.0 mg albuterol.
30. The kit according to claim 26, wherein the amount of albuterol in the inhalation solution is about 2.50 mg.
31. The kit according to claim 26, further comprising a label which indicates that the inhalation solution can be used to relieve bronchospasm in patients suffering from chronic obstructive pulmonary disease.
32. The kit according to claim 26, further comprising instructions for using the inhalation solution to relieve bronchospasm associated with chronic obstructive pulmonary disease.
33. The kit according to claim 26, wherein the one or more containers are packaged in the same pouch or box.
34. The kit of claim 33, wherein said one or more containers comprise semi-permeable plastic and are packaged in an aluminum foil pouch.
35. A kit for treating bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said kit comprising:
(a) one or more containers; said one or more containers each comprising a sterile, benzalkonium-free, premixed, premeasured aqueous inhalation solution for use in a nebulizer; said inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein said amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg;
(b) a label which indicates that the inhalation solution can be used to relieve bronchospasm in patients suffering from chronic obstructive pulmonary disease;
and (c) instructions for using the solution to relieve said bronchospasm.
(a) one or more containers; said one or more containers each comprising a sterile, benzalkonium-free, premixed, premeasured aqueous inhalation solution for use in a nebulizer; said inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein said amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg;
(b) a label which indicates that the inhalation solution can be used to relieve bronchospasm in patients suffering from chronic obstructive pulmonary disease;
and (c) instructions for using the solution to relieve said bronchospasm.
36. A prepackaged therapeutic system for treating bronchospasm in patients suffering from chronic obstructive pulmonary disease, said prepackaged therapeutic system comprising packaging material, wherein said packaging material comprises:
(e) one or more containers; said one or more containers each comprising a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein said amount of albuterol ranges from 0.60 mg to about 5.0 mg and said amount of ipratropium bromide ranges from about 0.01 mg to about 1,0 mg; the solution being suitable for nebulization in a nebulizer.
(e) one or more containers; said one or more containers each comprising a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein said amount of albuterol ranges from 0.60 mg to about 5.0 mg and said amount of ipratropium bromide ranges from about 0.01 mg to about 1,0 mg; the solution being suitable for nebulization in a nebulizer.
37. The prepackaged therapeutic system of claim 36, wherein said amount of albuterol ranges from about 2.00 mg to about 3.00 mg.
38. The prepackaged therapeutic system of claim 36, wherein said amount of albuterol is about 2.5 mg.
39. The prepackaged therapeutic system of claim 36, wherein the inhalation solution in each of the one or more containers is sterile.
40. The prepackaged therapeutic system of claim 36, wherein the inhalation solution in each of the one or more containers is free of benzalkonium chloride.
41. The prepackaged therapeutic system of claim 36, wherein said packaging material further comprises a label which indicates that the inhalation solution can be used to relieve bronchospasm associated with chronic obstructive pulmonary disease.
42. The prepackaged therapeutic system of claim 36, wherein said packaging material comprises instructions for using the solution to relieve said bronchospasm.
43. A prepackaged therapeutic system for treating bronchospasm in patients suffering from chronic obstructive pulmonary disease, said prepackaged therapeutic system comprising packaging material, wherein said packaging material comprises:
(b) one or more containers; the one more containers each comprising a sterile, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride for nebulization in a nebulizer; the inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg;
(c) a label indicating that the inhalation solution can be used to relieve said bronchospasm; and (d) instructions for using the inhalation solution to relieve said bronchospasm.
(b) one or more containers; the one more containers each comprising a sterile, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride for nebulization in a nebulizer; the inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg;
(c) a label indicating that the inhalation solution can be used to relieve said bronchospasm; and (d) instructions for using the inhalation solution to relieve said bronchospasm.
44. A method of making a premixed, premeasured inhalation solution for treating bronchospasm in patients suffering from chronic obstructive pulmonary disease;
said method comprising the steps:
(a) placing a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide in a vehicle, wherein the concentration of albuterol in the vehicle ranges from about 0.60 mg to about 5.0 mg and the concentration of the ipratropium bromide in the carrier ranges from 0.01 mg to 1.00 mg; and (b) providing the inhalation solution in a single container.
said method comprising the steps:
(a) placing a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide in a vehicle, wherein the concentration of albuterol in the vehicle ranges from about 0.60 mg to about 5.0 mg and the concentration of the ipratropium bromide in the carrier ranges from 0.01 mg to 1.00 mg; and (b) providing the inhalation solution in a single container.
45. The method of claim 44, further comprising the step of adding hydrochloric acid to adjust the pH of the inhalation solution to a level ranging from about 3.0 to about 4Ø
46. The method of claim 44, further comprising the step of adding an osmotic agent to adjust the isotonicity of the inhalation solution; wherein the osmotic adjusting agent is selected from the group consisting of sodium chloride, potassium chloride, zinc chloride, calcium chloride and mixtures thereof.
47. The method according to claim 44, further comprising the step:
(a) sterilizing the inhalation solution by passing it through a filter or by steam sterilization.
(a) sterilizing the inhalation solution by passing it through a filter or by steam sterilization.
48. The process of claim 44, further comprising the step of adding hydrochloric acid to adjust the pH of the inhalation solution to about 3.5.
80. A device for use in relieving bronchospasm in a patient suffering from chronic obstructive pulmonary disease, the device having indicia; the indicia providing instructions for utilizing a premixed, premeasured inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide to treat said bronchospasm; wherein said amount of albuterol ranges from about 2.00 mg to about 3.00 mg albuterol and the amount of ipratropium bromide ranges from 0.20 mg to 0.60 mg; said solution being suitable for nebulization in a nebulizer.
50. A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease;
said method comprising the steps:
a) mixing water, EDTA, hydrochloric acid, an osmotic adjusting agent, albuterol sulfate and ipratropium bromide into a stainless steel tank at a temperature between 18° C and 25° C to form a nebulizer solution;
i) the final concentration of the albuterol and ipratropium bromide in the nebulizer solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt.
ipratropium;
ii) sufficient hydrochloric acid is added to the nebulizer solution so that the pH of said solution is about 3.0 to about 4.0;
iii) sufficient osmotic adjusting agent is added to the nebulizer solution so that the isotonicity of said solution is about 280 to about 320 mOsm/kg; and b) passing the nebulizer solution through at least one sterilizing filter;
c) sterile filling the nebulizer solution into one or more low density polyethylene dispensing containers, each container being filled with about 3 ml of the sterile, premixed, premeasured aqueous nebulizer solution comprising a unit dose of therapeutically effective amount of albuterol and ipratropium bromide, wherein the dosage of albuterol ranges from about 2.00 mg to about 3.00 mg and the dosage of ipratropium bromide ranges from about 0.1 mg to about 1.0 mg;
d) ~sterile sealing each of the one or more dispensing containers containing the nebulizer solution; and wherein the stability of the nebulizer solution in the one or more dispensing containers is such that the shelf life of said solution is more than 12 months;
wherein the nebulizer solution is free of benzalkonium chloride.
51. ~The method of claim 50, wherein the albuterol is in the form of an acid addition salt thereof.
52. ~The method of claim 50, wherein the acid addition salt of albuterol is albuterol sulfate.
53. ~The method of claim 50, wherein the albuterol is in the form of a racemic mixture.
54. ~The method of claim 50, wherein the nebulizer solution is suitable for nebulization in a jet nebulizer, ultrasonic nebulizer and breath actuated nebulizer.
55. ~The method of claim 50, wherein the osmotic adjusting agent is selected from the group consisting of sodium chloride, potassium chloride, zinc chloride, calcium chloride and mixtures thereof.
56. ~The method of claim 50, wherein the osmotic agent is sodium chloride.
57. ~The method of claim 1, wherein the osmotic adjusting agent is selected from the group consisting of mannitol, glycerol, dextrose and mixtures thereof.
58. ~The method of claim 50, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.4 wt. % to about 1.0 wt. % ionic salt.
59. ~The method of claim 50, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.9% of an osmotic adjusting agent.
60. ~The method of claim 50, further comprising the step of (a) packaging the one or more dispensing containers in an aluminum foil pouch.
61. ~The method of claim 50, wherein the sterilizing filter is a 0.2 micron sterilizing cartridge filter.
62. ~The method of claim 50, further comprising the step of passing the nebulizer solution through a second sterilizing filter.
63. ~The method of claim 62, wherein the second sterilizing filter is a 0.2 micron sterilizing cartridge.
64. ~The method of claim 50, wherein the concentration of albuterol is about 0.083 wt. % and the concentration of ipratropium bromide is about 0.017 wt. %.
65. ~The method of claim 50, wherein the osmolality of the nebulizer solution ranges from about 282 mOsm/kg to about 285 mOsm/kg;
66. ~A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease;
said method comprising the steps:
a) adding purified water into a stainless steel tank at a temperature of between 18° C to 25° C; said tank having a bottom drain and a tri-blender for mixing;
b) while mixing, adding EDTA, hydrochloric acid and at least a therapeutically effective amount of albuterol sulfate and ipratropium bromide to the tank until dissolved;
c) adding purified water to adjust the final volume to a desired amount, thus forming the nebulizer solution;
i) the final concentration of the albuterol and ipratropiurn bromide in the nebulizer solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt.
ipratropium;
ii) ~sufficient hydrochloric acid is added to the nebulizer solution so that the pH of said solution to about 3.0 to about 4.0;
iii) ~sufficient osmotic adjusting agent is added to the nebulizer solution so that isotonicity of said solution is about 280 to about 320 mOsm/kg b) passing the nebulizer solution through a sanitary delivery line directly into a form-fill-seal (FFS) machine;
c) passing the nebulizer solution through a first 0.2 micron sterilizing cartridge filter, then passing the nebulizer solution into a reservoir tank; and then passing the nebulizer solution through a second 0.2 micron sterilizing cartridge filter;
d) said second cartridge filter being connected to at least one filling nozzle positioned within a sterile air shower compartment; the nebulizer solution is passed through the filling nozzle into one or more preformed low density polyethylene dispensing containers;
e) filling each of the one or more dispensing containers with about 3 ml of the nebulizer solution such that each container contains a sterile, unit dose of albuterol and ipratropium bromide, said dose ranging from about 2.00 mg to about 3.00 mg albuterol and 0.1 to 1.0 mg ipratropium;
f) sterile sealing each of the one or more dispensing containers containing the nebulizer solution; and g) ~wherein the stability of the nebulizer solution is such that the shelf life of said solution in one or more dispensing containers is more than 12 months; wherein the nebulizer solution is free of benzalkonium chloride.
67. ~The method of claim 66, wherein the albuterol is in the form of an acid addition salt thereof.
68. ~The method of claim 66, wherein the acid addition salt of albuterol is albuterol sulfate.
69. ~The method of claim 66, wherein the albuterol is in the form of a racemic mixture.
70. ~The method of claim 66, wherein the nebulizer solution is suitable for nebulization in a jet nebulizer, ultrasonic nebulizer and breath actuated nebulizer.
71. ~The method of claim 66, wherein the osmotic adjusting agent is selected from the group consisting of sodium chloride, potassium chloride, zinc chloride, calcium chloride and mixtures thereof.
72. ~The method of claim 66, wherein the osmotic adjusting agent is sodium chloride.
73. ~The method of claim 66, wherein the osmotic adjusting agent is selected from the group consisting of mannitol, glycerol, dextrose and mixtures thereof.
74. ~The method of claim 66, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.4 wt. % to about 1.0 wt. % ionic salt.
75. ~The method of claim 66, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.9 wt. % of an osmotic adjusting agent.
76. ~The method of claim 66, wherein the one or more dispensing containers are formed, filled and sealed in one continuous operation.
77. ~The method of claim 66, further comprising the step: (a) packaging the one or more dispensing containers in an aluminum foil pouch.
78. ~The method of claim 66, wherein the conception of albuterol is about 0.083 wt. % and the concentration of ipratropium bromide is about 0.017 wt. %.
79. ~The method of claim 66, wherein the osmolality of the nebulizer solution ranges from about 282 mOsm/kg to about 285 mOsm/kg.
80. ~A prepackaged therapeutic system for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, the prepackaged therapeutic system comprising:
(f) ~one or more dispensing containers; the one or more containers each prefilled with about 3 ml of a sterile, benzlakonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the dosage of albuterol is about 2.5 mg and the dosage of ipratropium bromide is about 0.5 mg; the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer; the inhalation solution in each of the one or more containers has a long shelf life;
(g) ~one or more labels with indicia thereon, the indicia comprising efficacy dosage, administration, contraindication and adverse reaction data pertaining to the inhalation solution in each of the one or more containers;
(h) ~wherein the contraindication data comprises data indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof; and
80. A device for use in relieving bronchospasm in a patient suffering from chronic obstructive pulmonary disease, the device having indicia; the indicia providing instructions for utilizing a premixed, premeasured inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide to treat said bronchospasm; wherein said amount of albuterol ranges from about 2.00 mg to about 3.00 mg albuterol and the amount of ipratropium bromide ranges from 0.20 mg to 0.60 mg; said solution being suitable for nebulization in a nebulizer.
50. A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease;
said method comprising the steps:
a) mixing water, EDTA, hydrochloric acid, an osmotic adjusting agent, albuterol sulfate and ipratropium bromide into a stainless steel tank at a temperature between 18° C and 25° C to form a nebulizer solution;
i) the final concentration of the albuterol and ipratropium bromide in the nebulizer solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt.
ipratropium;
ii) sufficient hydrochloric acid is added to the nebulizer solution so that the pH of said solution is about 3.0 to about 4.0;
iii) sufficient osmotic adjusting agent is added to the nebulizer solution so that the isotonicity of said solution is about 280 to about 320 mOsm/kg; and b) passing the nebulizer solution through at least one sterilizing filter;
c) sterile filling the nebulizer solution into one or more low density polyethylene dispensing containers, each container being filled with about 3 ml of the sterile, premixed, premeasured aqueous nebulizer solution comprising a unit dose of therapeutically effective amount of albuterol and ipratropium bromide, wherein the dosage of albuterol ranges from about 2.00 mg to about 3.00 mg and the dosage of ipratropium bromide ranges from about 0.1 mg to about 1.0 mg;
d) ~sterile sealing each of the one or more dispensing containers containing the nebulizer solution; and wherein the stability of the nebulizer solution in the one or more dispensing containers is such that the shelf life of said solution is more than 12 months;
wherein the nebulizer solution is free of benzalkonium chloride.
51. ~The method of claim 50, wherein the albuterol is in the form of an acid addition salt thereof.
52. ~The method of claim 50, wherein the acid addition salt of albuterol is albuterol sulfate.
53. ~The method of claim 50, wherein the albuterol is in the form of a racemic mixture.
54. ~The method of claim 50, wherein the nebulizer solution is suitable for nebulization in a jet nebulizer, ultrasonic nebulizer and breath actuated nebulizer.
55. ~The method of claim 50, wherein the osmotic adjusting agent is selected from the group consisting of sodium chloride, potassium chloride, zinc chloride, calcium chloride and mixtures thereof.
56. ~The method of claim 50, wherein the osmotic agent is sodium chloride.
57. ~The method of claim 1, wherein the osmotic adjusting agent is selected from the group consisting of mannitol, glycerol, dextrose and mixtures thereof.
58. ~The method of claim 50, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.4 wt. % to about 1.0 wt. % ionic salt.
59. ~The method of claim 50, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.9% of an osmotic adjusting agent.
60. ~The method of claim 50, further comprising the step of (a) packaging the one or more dispensing containers in an aluminum foil pouch.
61. ~The method of claim 50, wherein the sterilizing filter is a 0.2 micron sterilizing cartridge filter.
62. ~The method of claim 50, further comprising the step of passing the nebulizer solution through a second sterilizing filter.
63. ~The method of claim 62, wherein the second sterilizing filter is a 0.2 micron sterilizing cartridge.
64. ~The method of claim 50, wherein the concentration of albuterol is about 0.083 wt. % and the concentration of ipratropium bromide is about 0.017 wt. %.
65. ~The method of claim 50, wherein the osmolality of the nebulizer solution ranges from about 282 mOsm/kg to about 285 mOsm/kg;
66. ~A method of making a prepackaged, stable, premeasured, premixed aqueous nebulizer solution for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease;
said method comprising the steps:
a) adding purified water into a stainless steel tank at a temperature of between 18° C to 25° C; said tank having a bottom drain and a tri-blender for mixing;
b) while mixing, adding EDTA, hydrochloric acid and at least a therapeutically effective amount of albuterol sulfate and ipratropium bromide to the tank until dissolved;
c) adding purified water to adjust the final volume to a desired amount, thus forming the nebulizer solution;
i) the final concentration of the albuterol and ipratropiurn bromide in the nebulizer solution ranges from about 0.06 wt. % to about 0.1 wt. % albuterol and about 0.03 wt. % to about 0.1 wt.
ipratropium;
ii) ~sufficient hydrochloric acid is added to the nebulizer solution so that the pH of said solution to about 3.0 to about 4.0;
iii) ~sufficient osmotic adjusting agent is added to the nebulizer solution so that isotonicity of said solution is about 280 to about 320 mOsm/kg b) passing the nebulizer solution through a sanitary delivery line directly into a form-fill-seal (FFS) machine;
c) passing the nebulizer solution through a first 0.2 micron sterilizing cartridge filter, then passing the nebulizer solution into a reservoir tank; and then passing the nebulizer solution through a second 0.2 micron sterilizing cartridge filter;
d) said second cartridge filter being connected to at least one filling nozzle positioned within a sterile air shower compartment; the nebulizer solution is passed through the filling nozzle into one or more preformed low density polyethylene dispensing containers;
e) filling each of the one or more dispensing containers with about 3 ml of the nebulizer solution such that each container contains a sterile, unit dose of albuterol and ipratropium bromide, said dose ranging from about 2.00 mg to about 3.00 mg albuterol and 0.1 to 1.0 mg ipratropium;
f) sterile sealing each of the one or more dispensing containers containing the nebulizer solution; and g) ~wherein the stability of the nebulizer solution is such that the shelf life of said solution in one or more dispensing containers is more than 12 months; wherein the nebulizer solution is free of benzalkonium chloride.
67. ~The method of claim 66, wherein the albuterol is in the form of an acid addition salt thereof.
68. ~The method of claim 66, wherein the acid addition salt of albuterol is albuterol sulfate.
69. ~The method of claim 66, wherein the albuterol is in the form of a racemic mixture.
70. ~The method of claim 66, wherein the nebulizer solution is suitable for nebulization in a jet nebulizer, ultrasonic nebulizer and breath actuated nebulizer.
71. ~The method of claim 66, wherein the osmotic adjusting agent is selected from the group consisting of sodium chloride, potassium chloride, zinc chloride, calcium chloride and mixtures thereof.
72. ~The method of claim 66, wherein the osmotic adjusting agent is sodium chloride.
73. ~The method of claim 66, wherein the osmotic adjusting agent is selected from the group consisting of mannitol, glycerol, dextrose and mixtures thereof.
74. ~The method of claim 66, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.4 wt. % to about 1.0 wt. % ionic salt.
75. ~The method of claim 66, wherein the nebulizer solution in the one or more dispensing containers comprises about 0.9 wt. % of an osmotic adjusting agent.
76. ~The method of claim 66, wherein the one or more dispensing containers are formed, filled and sealed in one continuous operation.
77. ~The method of claim 66, further comprising the step: (a) packaging the one or more dispensing containers in an aluminum foil pouch.
78. ~The method of claim 66, wherein the conception of albuterol is about 0.083 wt. % and the concentration of ipratropium bromide is about 0.017 wt. %.
79. ~The method of claim 66, wherein the osmolality of the nebulizer solution ranges from about 282 mOsm/kg to about 285 mOsm/kg.
80. ~A prepackaged therapeutic system for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, the prepackaged therapeutic system comprising:
(f) ~one or more dispensing containers; the one or more containers each prefilled with about 3 ml of a sterile, benzlakonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the dosage of albuterol is about 2.5 mg and the dosage of ipratropium bromide is about 0.5 mg; the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer; the inhalation solution in each of the one or more containers has a long shelf life;
(g) ~one or more labels with indicia thereon, the indicia comprising efficacy dosage, administration, contraindication and adverse reaction data pertaining to the inhalation solution in each of the one or more containers;
(h) ~wherein the contraindication data comprises data indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof; and
49 (i) wherein the adverse reaction data comprises data indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers.
81. The prepackaged therapeutic system of claim 50, wherein the albuterol is in the form of an acid addition salt.
82. The prepackaged therapeutic system of claim 51, wherein the acid addition salt of the albuterol is albuterol sulfate.
83. The prepackaged therapeutic system of claim 50, wherein the dosage and administration data comprises data indicating that the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and about 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed.
84. The prepackaged therapeutic system of claim 50, wherein the adverse reaction data comprises data indicating that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administration of the inhalation solution, said hypersensitivity reactions comprising urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis.
85. The prepackaged therapeutic system of claim 50, wherein the adverse reaction data comprises data indicating that allergic-type reactions may occur after administrating the inhalation solution in the one or more containers, including skin rash, prurities, and urticaria.
81. The prepackaged therapeutic system of claim 50, wherein the albuterol is in the form of an acid addition salt.
82. The prepackaged therapeutic system of claim 51, wherein the acid addition salt of the albuterol is albuterol sulfate.
83. The prepackaged therapeutic system of claim 50, wherein the dosage and administration data comprises data indicating that the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and about 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed.
84. The prepackaged therapeutic system of claim 50, wherein the adverse reaction data comprises data indicating that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administration of the inhalation solution, said hypersensitivity reactions comprising urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis.
85. The prepackaged therapeutic system of claim 50, wherein the adverse reaction data comprises data indicating that allergic-type reactions may occur after administrating the inhalation solution in the one or more containers, including skin rash, prurities, and urticaria.
50 86. The prepackaged therapeutic system of claim 50, wherein the adverse reaction data comprises data indicating a list of one or more adverse events that may occur after administrating the inhalation solution, said adverse events including chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
87. A prepackaged therapeutic system for treating bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said prepackaged therapeutic system comprising:
(e) one or more dispensing containers; the one more containers each prefilled with 3 ml of a sterile, stable, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride; the inhalation solution consisting of sodium chloride, water, edetate disodium, an acid to adjust the pH of the inhalation solution to about 4, and a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg; the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer; said inhalation solution having a long shelf life;
(b) one or more labels with indicia thereon; the indicia comprising efficacy, dosage, administration, contraindication and adverse reaction information pertaining to the inhalation solution in each of the one or more containers;
(c) wherein the dosage and administration data comprises data indicating that the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and about 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed;
87. A prepackaged therapeutic system for treating bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said prepackaged therapeutic system comprising:
(e) one or more dispensing containers; the one more containers each prefilled with 3 ml of a sterile, stable, premixed, premeasured aqueous inhalation solution free of benzalkonium chloride; the inhalation solution consisting of sodium chloride, water, edetate disodium, an acid to adjust the pH of the inhalation solution to about 4, and a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg and the amount of ipratropium bromide is about 0.5 mg; the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer; said inhalation solution having a long shelf life;
(b) one or more labels with indicia thereon; the indicia comprising efficacy, dosage, administration, contraindication and adverse reaction information pertaining to the inhalation solution in each of the one or more containers;
(c) wherein the dosage and administration data comprises data indicating that the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and about 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed;
51 (d) wherein the contraindication data comprises data indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof;
(e) wherein the adverse reaction data comprises data indicating that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administrating the inhalation solution, said hypersensitivity reaction including urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis;
(f) wherein the adverse reaction data comprises data indicating that allergic-type reactions may occur after administrating the inhalation solution in the one or more containers; said allergic type reaction, including skin rash, prurities, and urticaria;
(g) wherein the adverse reaction data comprises data indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers; and (h) the adverse reaction data includes a list of one or more adverse events that may occur after administration of the inhalation solution in each of the one or more containers; the adverse events including chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
(e) wherein the adverse reaction data comprises data indicating that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administrating the inhalation solution, said hypersensitivity reaction including urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis;
(f) wherein the adverse reaction data comprises data indicating that allergic-type reactions may occur after administrating the inhalation solution in the one or more containers; said allergic type reaction, including skin rash, prurities, and urticaria;
(g) wherein the adverse reaction data comprises data indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers; and (h) the adverse reaction data includes a list of one or more adverse events that may occur after administration of the inhalation solution in each of the one or more containers; the adverse events including chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
52 88. A method for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the step of:
(a) providing the patient a prepackaged therapeutic system comprising:
one or more dispensing containers; the one or more containers each prefilled with about 3 ml of a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the amount of albuterol is about 2.5 mg and the amount of ipratropium bromide is about 0.5 mg; the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer; the inhalation solution in each of the one or more containers has a long shelf life;
(b) providing the patient or prescriber of the prepackaged therapeutic system dosage, administration, contraindication and adverse reaction data pertaining to the inhalation solution in each of the one or more containers;
(c) wherein the contraindication data comprises data indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof; and (d) wherein the adverse reaction data comprises data indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers.
89. The method of claim 58, wherein the albuterol is in the form of an acid addition salt.
(a) providing the patient a prepackaged therapeutic system comprising:
one or more dispensing containers; the one or more containers each prefilled with about 3 ml of a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution comprising a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the amount of albuterol is about 2.5 mg and the amount of ipratropium bromide is about 0.5 mg; the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer; the inhalation solution in each of the one or more containers has a long shelf life;
(b) providing the patient or prescriber of the prepackaged therapeutic system dosage, administration, contraindication and adverse reaction data pertaining to the inhalation solution in each of the one or more containers;
(c) wherein the contraindication data comprises data indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof; and (d) wherein the adverse reaction data comprises data indicating that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers.
89. The method of claim 58, wherein the albuterol is in the form of an acid addition salt.
53 90. The method of claim 59, wherein the acid addition salt of the albuterol is albuterol sulfate.
91. The method of claim 58, wherein the dosage and administration data informs the patient or prescriber the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed.
92. The method of claim 58, wherein the adverse reaction informs the patient or prescriber that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administration of the inhalation solution, said hypersensitivity reactions including urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis.
93. The method of claim 58, wherein the adverse reaction data informs the patient or prescriber that allergic-type reactions may occur after administrating the inhalation solution in the one or more containers, including skin rash, prurities, and urticaria.
94. The method of claim 58, wherein the adverse reaction data includes a preprinted list of one or more adverse events that may occur after administrating the inhalation solution, said adverse events comprising chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
95. A method for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the step of:
(a) providing a patient the prepackaged therapeutic system comprising:
one or more dispensing containers; the one more containers each prefilled with about 3 ml of a sterile, stable, premixed, premeasured aqueous inhalation solution free of benzalkonium
91. The method of claim 58, wherein the dosage and administration data informs the patient or prescriber the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed.
92. The method of claim 58, wherein the adverse reaction informs the patient or prescriber that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administration of the inhalation solution, said hypersensitivity reactions including urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis.
93. The method of claim 58, wherein the adverse reaction data informs the patient or prescriber that allergic-type reactions may occur after administrating the inhalation solution in the one or more containers, including skin rash, prurities, and urticaria.
94. The method of claim 58, wherein the adverse reaction data includes a preprinted list of one or more adverse events that may occur after administrating the inhalation solution, said adverse events comprising chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
95. A method for inducing bronchodilation or providing relief of bronchospasm in a patient suffering from chronic obstructive pulmonary disease, said method comprising the step of:
(a) providing a patient the prepackaged therapeutic system comprising:
one or more dispensing containers; the one more containers each prefilled with about 3 ml of a sterile, stable, premixed, premeasured aqueous inhalation solution free of benzalkonium
54 chloride; the inhalation solution consisting of water, edetate disodium, sodium chloride, and an acid to adjust the pH of the inhalation solution to about 4, and a unit dose of a therapeutically effective amount of albuterol and ipratropium bromide, wherein the amount of albuterol is about 2.50 mg/3 ml and the amount of ipratropium bromide is about 0.5 mg/3 ml;
the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer;
(b) providing the patient or prescriber the prepackaged therapeutic system efficacy, dosage, administration, contraindication and adverse reaction data pertaining to the inhalation solution in each of the one or more containers;
(c) wherein the dosage and administration data informs the patient or prescriber that the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed;
(d) wherein the contraindication data comprises information indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof;
(e) wherein the adverse reaction data informs the patient or prescriber that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administrating the inhalation solution in the on a or more containers, said hypersensitivity reaction including urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis;
the inhalation solution in each of the one or more containers is suitable for nebulization in a nebulizer;
(b) providing the patient or prescriber the prepackaged therapeutic system efficacy, dosage, administration, contraindication and adverse reaction data pertaining to the inhalation solution in each of the one or more containers;
(c) wherein the dosage and administration data informs the patient or prescriber that the recommended dose of the inhalation solution in each of the one or more containers is about 2.5 mg of albuterol and 0.5 mg impratropium bromide in 3 ml of an aqueous solution administered 4 times per day by nebulization with up to 2 additional recommended doses allowed per day, if needed;
(d) wherein the contraindication data comprises information indicating that the inhalation solution in each of the one or more containers is contraindicated for humans with hypersensitivity to atropine and derivatives thereof;
(e) wherein the adverse reaction data informs the patient or prescriber that immediate hypersensitivity reactions to the inhalation solution in each of the one or more containers may occur after administrating the inhalation solution in the on a or more containers, said hypersensitivity reaction including urticaris, angioedema, rash, pruritis, oropharyngeal, edema, bronchospasm, and anaphylaxis;
55 (f) wherein the adverse reaction data informs the patient or prescriber that possible allergic-type reactions may occur after administering the inhalation solution in the one or more containers, including skin rash, prurities, and urticaria;
(g) wherein the adverse reaction data informs the patient or prescriber that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers; and (h) the adverse reaction data includes a preprinted list of one or more adverse events that may occur after administration of the inhalation solution in each of the one or more containers; the adverse events comprising chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
(g) wherein the adverse reaction data informs the patient or prescriber that precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of chronic obstructive pulmonary disease symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat may occur after administrating the inhalation solution in the one or more containers; and (h) the adverse reaction data includes a preprinted list of one or more adverse events that may occur after administration of the inhalation solution in each of the one or more containers; the adverse events comprising chest pain, diarrhea, dyspepsia, nausea, leg cramps, bronchitis, lung disease, pharyngitis, pneumonia, and urinary tract infection.
56
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| AU32974/02 | 2002-04-05 | ||
| AU32974/02A AU3297402A (en) | 2001-10-26 | 2002-04-05 | An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
| JP2002-158304 | 2002-04-23 | ||
| JP2002158304A JP2003221335A (en) | 2001-10-26 | 2002-04-23 | Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptom of chronic obstructive pulmonary disease |
| PCT/US2002/033353 WO2003037159A2 (en) | 2001-10-26 | 2002-10-18 | An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
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| CN106344544A (en) * | 2016-08-25 | 2017-01-25 | 杭州百诚医药科技股份有限公司 | Aerosol inhalation preparation for treating bronchial asthma |
| CN110898042B (en) * | 2019-12-12 | 2020-10-16 | 深圳大佛药业股份有限公司 | Salbutamol sulfate solution for inhalation and preparation method thereof |
| CN111053761B (en) * | 2020-01-16 | 2022-05-03 | 杭州旦承医药科技有限公司 | Bisphosphonic acid medicine for inhalation, preparation method thereof and application thereof in chronic obstructive pulmonary disease |
| WO2021188809A1 (en) * | 2020-03-19 | 2021-09-23 | Cai Gu Huang | Inhalable formulation of a solution containing levalbuterol tartrate |
| CN113018280A (en) * | 2021-03-01 | 2021-06-25 | 石家庄四药有限公司 | Solution preparation for ipratropium bromide inhalation and preparation method thereof |
| CN115645381B (en) * | 2022-10-20 | 2023-05-30 | 深圳大佛药业股份有限公司 | Levalmol hydrochloride aerosol inhalation solution sustained release agent and preparation method thereof |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SK280911B6 (en) * | 1992-12-09 | 2000-09-12 | Boehringer Ingelheim Pharmaceuticals, Inc. | Pharmaceutical composition |
| DE19653969A1 (en) * | 1996-12-20 | 1998-06-25 | Boehringer Ingelheim Kg | New aqueous pharmaceutical preparation for the production of propellant-free aerosols |
| US6247617B1 (en) * | 1999-12-13 | 2001-06-19 | Richard Allen Clyde | Single use container for dispensing separately housed sterile compositions |
-
2002
- 2002-04-05 AU AU32974/02A patent/AU3297402A/en not_active Abandoned
- 2002-10-18 CA CA2464735A patent/CA2464735C/en not_active Expired - Fee Related
- 2002-10-18 NZ NZ552548A patent/NZ552548A/en not_active IP Right Cessation
- 2002-10-18 CN CNA2006101077523A patent/CN1939279A/en active Pending
- 2002-10-18 WO PCT/US2002/033353 patent/WO2003037159A2/en active Application Filing
- 2002-10-18 CN CNA028262263A patent/CN1607940A/en active Pending
- 2002-10-18 EP EP02789216A patent/EP1446045A4/en not_active Withdrawn
- 2002-10-18 JP JP2003539509A patent/JP2006505486A/en active Pending
- 2002-10-18 MX MXPA04003927A patent/MXPA04003927A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| EP1446045A2 (en) | 2004-08-18 |
| CN1607940A (en) | 2005-04-20 |
| WO2003037159A3 (en) | 2003-10-16 |
| JP2006505486A (en) | 2006-02-16 |
| AU3297402A (en) | 2003-10-30 |
| EP1446045A4 (en) | 2010-07-21 |
| WO2003037159A2 (en) | 2003-05-08 |
| CN1939279A (en) | 2007-04-04 |
| MXPA04003927A (en) | 2005-03-31 |
| CA2464735C (en) | 2011-03-22 |
| NZ552548A (en) | 2009-03-31 |
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