US 10,376,478 B2
Pulsed release phenylephrine dosage forms
Richard John Dansereau, Cincinnati, OH (US); Daren K. Anness, Loveland, OH (US); David L. Ramsey, Mason, OH (US); and Guhan Balan, Mason, OH (US)
Assigned to The Procter & Gamble Company, Cincinnati, OH (US)
Filed by The Procter & Gamble Company, Cincinnati, OH (US)
Filed on Sep. 12, 2017, as Appl. No. 15/701,669.
Application 15/701,669 is a continuation of application No. 14/857,848, filed on Sep. 18, 2015.
Claims priority of provisional application 60/052,594, filed on Sep. 19, 2014.
Prior Publication US 2018/0000752 A1, Jan. 4, 2018
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01)
CPC A61K 31/137 (2013.01) [A61K 9/1676 (2013.01); A61K 9/5078 (2013.01); A61K 9/5084 (2013.01)] 12 Claims
 
1. An oral dosage form comprising:
a. an immediate release form comprising about 10 mg to about 20 mg phenylephrine or a pharmaceutically acceptable salt thereof; and
b. a plurality of delayed release particles wherein each delayed release particle comprises:
i. a core;
ii. a phenylephrine coating comprising phenylephrine or a pharmaceutically acceptable salt thereof;
iii. a pH sensitive coating comprising an acrylate copolymer selected from the group consisting of methyl-methacrylate esters copolymerized with methacrylic acid, acrylic acid and esters copolymerized with methacrylic acid and esters, ammonio-containing acrylate copolymers, and combinations thereof;
wherein each delayed release particle comprises from about 30 wt. % to about 60 wt. % of the pH sensitive coating, by weight of the delayed release particle;
wherein the plurality of delayed release particles comprise from about 7 mg to about 15 mg phenylephrine or a pharmaceutically acceptable salt thereof.