IP Library Granted Patent US 10,098,856
Granted Patent B2
US 10,098,856 · App. 15/171,231 · Granted Oct 16, 2018

Alternating sympathomimetic therapy for the treatment of respiratory ailments

Inventors: Suresh Dixit (Fort Worth, TX); Juan Carlos Menendez (North Richland Hills, TX); Ralph Brown (Southlake, TX)
Assignee: Sovereign Pharmaceuticals, LLC
A61K31/137A61K9/0053A61K9/209A61K9/2013A61K9/2027A61K9/2054A61K31/085A61K31/09A61K31/138A61K31/216A61K31/4402A61K31/485A61K31/5415A61K45/06
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Quick Facts
Patent No.
US 10,098,856
App. No.
15/171,231
Granted
Oct 16, 2018
Kind
B2
Abstract

A combination of dosage units for alleviating respiratory ailments and a method of alleviating respiratory ailments which uses this combination of dosage units. The dosage units comprise one or more first dosage units comprising pseudoephedrine and/or a pharmaceutically acceptable salt thereof and one or more second dosage units comprising phenylephrine and/or a pharmaceutically acceptable salt thereof.

Claims (18)

1. A method of reducing side effects associated with the administration of pseudoephedrine in the alleviation of congestion, wherein the method comprises providing one or more first oral dosage units comprising pseudoephedrine and/or a pharmaceutically acceptable salt thereof and one or more second oral dosage units which are different from the one or more first dosage units and comprise phenylephrine and/or a pharmaceutically acceptable salt thereof for alternating ingestion of the first and second dosage units by a subject in need of alleviation of congestion.

2. The method of claim 1 , wherein at least one of the first and second dosage units at least one of (i) comprises an antihistamine, (ii) is free of an expectorant and (iii) is free of a cough suppressant.

3. The method of claim 2 , wherein at least one of the first and second dosage units comprises an antihistamine.

4. The method of claim 1 , wherein the first and second dosage units each independently further comprise at least one additional active ingredient selected from antihistamines, cough suppressants, expectorants, analgesics, anti-inflammatory agents.

5. The method of claim 1 , wherein the one or more second dosage units are free of pseudoephedrine and pharmaceutically acceptable salts thereof.

6. The method of claim 5 , wherein the one or more first dosage units are free of phenylephrine and pharmaceutically acceptable salts thereof.

7. The method of claim 1 , wherein the one or more first dosage units are provided for alleviating congestion during a period which substantially coincides with a period during which the subject intends to be awake and the one or more second dosage units are provided for alleviating congestion during a period which substantially coincides with a period during which the subject intends to be asleep.

8. The method of claim 1 , wherein the one or more first dosage units and the one or more second dosage units are provided in the form of a packaged combination of the first and second dosage units.

9. The method of claim 1 , wherein the first dosage unit comprises from about 90 mg to about 150 mg of pseudoephedrine hydrochloride or an equivalent amount of at least one of pseudoephedrine and any other pharmaceutically acceptable salt thereof.

10. The method of claim 1 , wherein the second dosage unit comprises from about 20 mg to about 40 mg of phenylephrine hydrochloride or an equivalent amount of at least one of phenylephrine and any other pharmaceutically acceptable salt thereof.

11. The method of claim 1 , wherein the first and second dosage units are independently provided in the form of tablets or capsules.

12. The method of claim 11 , wherein the first and second dosage units are provided as tablets.

13. The method of claim 1 , wherein at least the one or more second dosage units comprise a controlled release formulation.

14. The method of claim 1 , wherein at least one of the first and second dosage units is provided as a multilayered tablet.

15. The method of claim 14 , wherein the first and second dosage units both are provided as bilayered tablets.

16. The method of claim 14 , wherein the first dosage unit comprises a multilayered tablet comprising at least a first layer which is an immediate release layer and a second layer which is a controlled release layer.

17. The method of claim 16 , wherein the first layer of the first dosage unit comprises an antihistamine.

18. The method of claim 14 , wherein the second dosage unit comprises a multilayered tablet comprising at least a first layer which is an immediate release layer and a second layer which is a controlled release layer.

Assignments (3)
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST Recorded Jan 3, 2020
From: MIDCAP BUSINESS CREDIT, LLC
To: SOVEREIGN PHARMACEUTICALS, LLC
Reel/Frame 051463/0377 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 2, 2020
From: SOVEREIGN PHARMACEUTICALS, LLC
To: CAPELLON PHARMACEUTICALS, LLC
Reel/Frame 051400/0616 →
SECURITY INTEREST Recorded Jan 3, 2019
From: SOVEREIGN PHARMACEUTICALS, LLC
To: MIDCAP BUSINESS CREDIT LLC
Reel/Frame 047890/0729 →
Continuity (3)
Continuation 14148947 · Jan 7, 2014
Continuation 11672075 · Feb 7, 2007
Related Publication 20160271078A1 · Sep 22, 2016