Mast cell stabilizers treatment for systemic disorders

• US 10,398,673 B2
• Filed: 02/12/2019
• Issued: 09/03/2019
• Est. Priority Date: 02/10/2014
• Status: Expired due to Fees

• Current Assignee: Respivant Sciences GmbH
• Original Assignee: Respivant Services GmbH
• Inventors: Gerhart, William, Keller, Manfred, Tutuncu, Ahmet, Soni, Pravin
• Primary Examiner(s): Rao, Savitha M
• Application Number:
  US16/273,987
• Publication Number:
  US 20190175546A1
• Time in Patent Office: 203 Days
• CPC Class Codes: A61K 31/277 having a ring, e.g. verapamil
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/4741 condensed with ring systems having oxygen as a ring hetero atom, e.g. tubocuraran derivatives, noscapine, bicuculline
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61K 9/12 Aerosols; Foams A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/041 using heaters
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Methods for the treatment of systemic disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided.

Claims

1. A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition, wherein administration of the pharmaceutical composition to the patient using the inhalation device produces in the patient an AUC_(0-∞

) of cromolyn between from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient.

2. The method of claim 1, wherein the device is a nebulizer or a dry powder inhaler.

3. The method of claim 2, wherein the device is a nebulizer.

4. The method of claim 3, wherein the nebulizer is a high-efficiency nebulizer.

5. The method of claim 3, wherein the nebulizer is a jet nebulizer.

6. The method of claim 2, wherein the device is a dry-powder inhaler.

7. The method of claim 1, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 60%.

8. The method of claim 1, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 75%.

9. The method of claim 1, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 30%.

10. The method of claim 4, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

of at least about 30%.

11. The method of claim 1, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 60% and a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 30%.

12. The method of claim 1, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 75% and a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 30%.

13. The method of claim 11, wherein the device is a nebulizer or a dry powder inhaler.

14. The method of claim 13, wherein the device is a nebulizer.

15. The method of claim 14, wherein the nebulizer is a high-efficiency nebulizer.

16. The method of claim 14, wherein the nebulizer is a jet nebulizer.

17. The method of claim 13, wherein the device is a dry-powder inhaler.

18. A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition, wherein administration of the pharmaceutical composition to the patient using the inhalation device produces in the patient a Cmax of cromolyn between from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.

19. The method of claim 18, wherein the device is a nebulizer or a dry powder inhaler.

20. The method of claim 19, wherein the device is a nebulizer.

21. The method of claim 20, wherein the nebulizer is a high-efficiency nebulizer.

22. The method of claim 20, wherein the nebulizer is a jet nebulizer.

23. The method of claim 19, wherein the device is a dry-powder inhaler.

24. The method of claim 18, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 60%.

25. The method of claim 18, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (<

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 75%.

26. The method of claim 18, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 30%.

27. The method of claim 21, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

of at least about 30%.

28. The method of claim 18, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 60% and a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

or USP <

601>

of at least about 30%.

29. The method of claim 21, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

of at least about 60% and a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

of at least about 30%.

30. The method of claim 21, wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤

5 μ

m) as measured by USP <

1601>

of at least about 75% and a respirable fraction (≤

3.3 μ

m) as measured by USP <

1601>

of at least about 30%.