IP Library › Granted Patent US 12,370,352
Granted Patent B2
US 12,370,352 · App. 17/387,929 · Granted Jul 29, 2025

Nasal and ophthalmic delivery of aqueous corticosteroid solutions

Inventors: James D. Pipkin (Lawrence, KS); Rupert O. Zimmerer, Jr. (Lawrence, KS); John M. Siebert (Olathe, KS)
Assignee: CyDex Pharmaceuticals, Inc.
A61M31/00A61K9/0043A61K9/0048A61K9/08A61K31/335A61K31/506A61K31/55A61K31/56A61K31/57A61K31/58A61K31/724A61K45/06A61K47/40
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Quick Facts
Patent No.
US 12,370,352
App. No.
17/387,929
Granted
Jul 29, 2025
Kind
B2
Abstract

The present invention is directed to methods of treating nasal and/or ophthalmic diseases, symptoms, or disorders that are therapeutically responsive to corticosteroid therapy by delivering aqueous solution formulations comprising a corticosteroid to nasal and ophthalmic tissues. The invention is also directed to methods, systems, devices, and compositions for delivering aqueous solution formulations comprising a corticosteroid and an antihistamine to nasal and ophthalmic tissues.

Claims (21)

1. A method for treating an allergic symptom or disorder in a subject in need thereof, comprising: nasally administering by a pump sprayer to the subject a solution comprising a therapeutically effective amount of budesonide, SAE-CD, an antihistamine, and a pharmaceutically acceptable aqueous liquid carrier, wherein the molar ratio of SAE-CD to budesonide is about 47:1, wherein the budesonide is present in an amount of about 30 μg per unit dose, and wherein the antihistamine is present in an amount of about 137 μg per unit dose;

wherein the therapeutically effective amount is administered in one unit dose per nostril;

wherein the antihistamine is azelastine or a pharmaceutically acceptable salt thereof;

wherein the SAE-CD is sulfobutylether β-cyclodextrin; and

wherein the method provides more rapid relief from the allergy symptom or disorder compared to a budesonide suspension at the same unit dose.

2. The method of claim 1 , wherein the allergic symptom or disorder includes a non-nasal symptom selected from the group consisting of: itchy or gritty eyes, tearing or watery eyes, red or burning eyes, itchy ears or palate, and combinations thereof.

3. The method of claim 1 , wherein the allergic symptom or disorder further comprises symptoms selected from the group consisting of runny nose, itchy nose, nasal congestion, sneezing and combinations thereof.

4. The method of claim 1 , wherein the solution is administered to the subject 1-2 times per day.

5. A method for treating an ocular symptom or disorder in a subject in need thereof, comprising: nasally administering by a pump sprayer to the subject a solution comprising a therapeutically effective amount of budesonide, SAE-CD, an antihistamine and a pharmaceutically acceptable aqueous liquid carrier, wherein the molar ratio of SAE-CD to budesonide is about 47:1, wherein the budesonide is present in an amount of about 30 μg per unit dose, and wherein the antihistamine is present in an amount of about 137 μg per unit dose;

wherein the therapeutically effective amount is administered in one unit dose per nostril;

wherein the antihistamine is azelastine or a pharmaceutically acceptable salt thereof;

wherein the SAE-CD is sulfobutylether β-cyclodextrin;

wherein the method provides more rapid relief from the ocular symptom or disorder compared to a budesonide suspension at the same unit dose.

6. The method of claim 5 , wherein the ocular symptom or disorder includes a non-nasal symptom selected from the group consisting of itchy or gritty eyes, tearing or watery eyes, red or burning eyes, itchy ears or palate, and combinations thereof.

7. The method of claim 5 , wherein the solution is administered to the subject 1-2 times per day.

8. A method for treating ocular inflammation in a subject in need thereof, comprising: ophthalmically administering to the subject a solution comprising a therapeutically effective amount of budesonide, SAE-CD, an antihistamine and a pharmaceutically acceptable aqueous liquid carrier, wherein the molar ratio of SAE-CD to budesonide is about 47:1, wherein the budesonide is present in an amount of about 30 μg per unit dose, and wherein the antihistamine is present in an amount of about 137 μg per unit dose;

wherein the therapeutically effective amount is administered in one unit dose per nostril;

wherein the budesonide solution provides more rapid reduction in ocular inflammation compared with a budesonide suspension at the same unit dose;

wherein the SAE-CD is sulfobutylether β-cyclodextrin;

wherein the antihistamine is azelastine or a pharmaceutically acceptable salt thereof.

9. The method of claim 8 , wherein the solution is administered to the subject 1-2 times per day.

Assignments (2)
SECURITY INTEREST Recorded Oct 18, 2023
From: CYDEX PHARMACEUTICALS, INC.; LIGAND PHARMACEUTICALS INCORPORATED; METABASIS THERAPEUTICS, INC.; PFENEX INC.
To: CITIBANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 065271/0025 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 3, 2022
From: PIPKIN, JAMES D.; SIEBERT, JOHN M.; ZIMMERER, RUPERT O.
To: CYDEX PHARMACEUTICALS, INC.
Reel/Frame 061288/0408 →
Continuity (5)
Continuation 12479576 · Jun 5, 2009
Continuation In Part PCTUS2008068872 · Jun 30, 2008
Continuation In Part PCTUS2007072387 · Jun 28, 2007
Continuation In Part PCTUS2007072442 · Jun 29, 2007
Related Publication 20220339414A1 · Oct 27, 2022
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