Mast cell stabilizers treatment for systemic disorders

• US 9,707,206 B2
• Filed: 08/09/2016
• Issued: 07/18/2017
• Est. Priority Date: 02/10/2014
• Status: Active Grant

• Current Assignee: Respivant Sciences GmbH
• Original Assignee: Patara Pharma, LLC
• Inventors: Gerhart, William, Keller, Manfred, Tutuncu, Ahmet, Soni, Pravin
• Primary Examiner(s): RAO, SAVITHA M
• Application Number:
  US15/232,731
• Publication Number:
  US 20160346245A1
• Time in Patent Office: 343 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: H05K 999/99 dummy group
• 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. Some embodiments relate to dosage forms. Dosage forms can include an aqueous pharmaceutical composition containing (i) from about 2% to about 6% by weight of cromolyn sodium, and (ii) an osmolarity adjusting agent consisting of (A) between about 0.1% to about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) optionally salts of EDTA; and an inhalation device that forms an aerosol of said pharmaceutical composition, said aerosol exhibiting a respirable fraction of said pharmaceutical composition (<5 μm) as measured by USP <1601> of at least about 60%, are provided.

Claims

1. A dosage form comprising:

(a) an aqueous pharmaceutical composition comprising (i) from about 2% to about 6% by weight of cromolyn sodium, and (ii) an osmolarity adjusting agent consisting of (A) between about 0.1% to about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) optionally salts of EDTA; and

(b) an inhalation device that forms an aerosol of said pharmaceutical composition, said aerosol exhibiting a respirable fraction of said pharmaceutical composition (<

5 μ

m) as measured by USP <

1601>

of at least about 60%.

2. The dosage form of claim 1, wherein the salts of EDTA comprise sodium EDTA.

3. The dosage form of claim 1 or 2, wherein the pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.

4. The dosage form of claim 1 or 2, wherein the pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.

5. The dosage form of claim 1 or 2, wherein the aerosol has a respirable fraction (≦

3.3 μ

m) as measured by USP <

1601>

of at least about 30%.

6. The dosage form of claim 1 or 2, wherein the aerosol has a respirable fraction (≦

3.3 μ

m) as measured by USP <

1601>

of at least about 30% and a respirable fraction (≦

5 μ

m) as measured by USP <

1601>

of at least about 75%.

7. The dosage form of claim 1 or 2, wherein the sodium chloride is at a concentration of between 0.1% to 0.2% by weight, inclusive of the endpoints.