IP Library › Granted Patent US 12,370,189
Granted Patent B2
US 12,370,189 · App. 17/486,225 · Granted Jul 29, 2025

Pharmaceutical formulation

Inventors: Raghu Cavatur (Parsippany, NJ); Kevin Chen (Parsippany, NJ); Matthew James Kaser (Parsippany, NJ); Hongchun Qiu (Basking Ridge, NJ)
Assignee: RB HEALTH (US) LLC
A61K31/485A61K9/2054A61K9/209A61K31/09A61K31/137A61K31/192A61K45/06A61K47/02A61K47/12A61K47/20A61K47/26A61K47/32A61K47/36A61K47/38
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Quick Facts
Patent No.
US 12,370,189
App. No.
17/486,225
Granted
Jul 29, 2025
Kind
B2
Abstract

The present invention is directed to a pharmaceutical composition comprising a pharmaceutically effective amount of guaifenesin, naproxen and at least one further active which is selected to be an antitussive, a decongestant or an antihistamine.

Claims (22)

1. A pharmaceutical composition comprising:

(a) about 600 mg of guaifenesin;

(b) about 30 mg of dextromethorphan or a pharmaceutically acceptable salt thereof;

(c) about 110 mg of naproxen or a pharmaceutically acceptable salt thereof;

(d) at least 25 mg of hypromellose; and

(e) at least 12.25 mg of hydroxyethyl cellulose;

wherein the pharmaceutical composition provides a therapeutic effect in respect of each of guaifenesin, naproxen, and dextromethorphan for 12 hours,

wherein the pharmaceutical composition is a bilayer tablet comprising an immediate release layer containing about 110 mg of the naproxen and at least 95 mg of the guaifenesin and at least 7.5 mg of the dextromethorphan, wherein the immediate release layer contains none of the hypromellose, and wherein the immediate release layer contains none of the hydroxyethyl cellulose.

2. The pharmaceutical composition of claim 1 , further comprising sodium lauryl sulfate and sodium bicarbonate.

3. The pharmaceutical composition of claim 2 , wherein the sodium bicarbonate is in an amount of about 60 mg.

4. The pharmaceutical composition of claim 3 , wherein the immediate release layer contains all of the sodium lauryl sulfate and about 60 mg of the sodium bicarbonate.

5. A pharmaceutical composition comprising:

(a) about 600 mg of guaifenesin;

(b) about 30 mg of dextromethorphan or a pharmaceutically acceptable salt thereof;

(c) about 110 mg of naproxen or a pharmaceutically acceptable salt thereof;

(d) sodium lauryl sulfate; and

(e) about 60 mg of sodium bicarbonate;

wherein the pharmaceutical composition provides a therapeutic effect in respect of each of guaifenesin, naproxen, and dextromethorphan for 12 hours,

wherein the pharmaceutical composition is a bilayer tablet comprising an immediate release layer containing about 110 mg of the naproxen and at least 95 mg of the guaifenesin and at least 7.5 mg of the dextromethorphan, wherein the immediate release layer contains all of the sodium lauryl sulfate and about 60 mg of the sodium bicarbonate.

6. The pharmaceutical composition of claim 5 , further comprising 1-8% hypromellose by weight of the total composition and 1-3% hydroxyethyl cellulose by weight of the total composition.

7. The pharmaceutical composition of claim 6 , wherein the hypromellose is in an amount of at least 25 mg and the hydroxyethyl cellulose is in an amount of at least 12.25 mg.

8. The pharmaceutical composition of claim 7 , wherein the immediate release layer contains none of the hypromellose, and wherein the immediate release layer contains none of the hydroxyethyl cellulose.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 30, 2025
From: CAVATUR, RAGHU; CHEN, KEVIN; KASER, MATTHEW JAMES; QIU, HONGCHUN
To: RECKITT BENCKISER LLC
Reel/Frame 071564/0151 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 30, 2025
From: RECKITT BENCKISER LLC
To: RB HEALTH (US) LLC
Reel/Frame 071565/0371 →
Priority Claims (1)
GB 1506755 · Apr 21, 2015 · national
Continuity (3)
Continuation 15520752
Provisional Application 62066532 · Oct 21, 2014
Related Publication 20220079937A1 · Mar 17, 2022
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