Method for relieving sinus congestion
AssigneeThe Procter & Gamble Company
InventorsRichard John Dansereau, Daren Anness, Guhan Balan, David Ramsey
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Abstract
A method for temporarily relieving sinus congestion and pressure comprising administering to a human a dose of a multi-particle pulsatile oral dosage form with an immediate release form and a plurality of delayed release particles. The immediate release form contains about 10 mg phenylephrine hydrochloride. The delayed release form contains a core with coatings including a phenylephrine coating containing about 10 mg phenylephrine hydrochloride and a pH sensitive coating.
Claims19
A method for temporarily relieving sinus congestion and pressure comprising administering to a human a dose of a multi-particle pulsatile oral dosage form comprising:
- a. an immediate release form comprising from 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 wherein at least about 85% of the cores comprise a diameter from about 500 μm to about 710 μm;
- ii. a phenylephrine coating comprising phenylephrine hydrochloride;
- 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 the pH sensitive coating is from 10 μm to about 80 μm thick;
- wherein the plurality of delayed release particles comprise from about 7 mg to about 15 mg phenylephrine or a pharmaceutically acceptable salt thereof.
A method for temporarily relieving sinus congestion and pressure comprising administering to a human a dose of a multi-particle pulsatile oral dosage form comprising:
- a. an immediate release form comprising from 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 hydrochloride;
- iii. a pH sensitive coating wherein the pH sensitive coating comprises an enteric coating;
- wherein the pH sensitive coating is from 10 μm to about 80 μm thick;
- wherein the plurality of delayed release particles comprise from about 7 mg to about 15 mg phenylephrine hydrochloride;
- wherein the pulsatile dosage form comprises a Cmax2 and an AUC4-8 wherein an upper bound of a 90% confidence interval for a ratio of means for the Cmax2 and the AUC4-8 of the pulsatile dosage form relative to two sequential doses of an immediate release phenylephrine taken four hours apart is at least 85%.
Dependencies are inferred from the claim text.