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US 10,376,478 B2Granted
Pulsed release phenylephrine dosage forms
AssigneeThe Procter & Gamble Company
InventorsRichard John Dansereau, Daren K. Anness, David L. Ramsey, Guhan Balan
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Abstract
A multi-particle dosage form that can deliver phenylephrine in controlled pulsed doses. The dosage form can contain an immediate release form that can contain phenylephrine or a salt thereof and a plurality of delayed release particles with a coating that can contain phenylephrine or salt thereof and a pH sensitive coating.
Claims12
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.
5 more elements
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 delayed release dosage form comprising 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 wherein the pH sensitive coating comprises a polymer that is degradable in a human small intestine at a pH of at least 5.5;
- wherein each delayed release particle comprises from about 40 wt. % to about 50 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.
5 more elements
Dependencies are inferred from the claim text.