Solid dosage form containing a taste masked active agent
AssigneeNovartis AG
InventorsAlexander M Schobel, Shyam S Vangala
Life of this patent
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Abstract
A solid dosage form containing a taste masked active agent is provided. The solid dosage form may be provided as a water soluble film that is disintegrable in the oral cavity to deliver and release the taste masked active agent. The disintegrable film includes at least one water soluble polymer and a taste masked ketoprofen active. Also provided are methods for preparing the solid dosage form and for using the solid dosage to administer an effective dosage of an active agent, such as ketoprofen, into the oral cavity for absorption.
Claims26
A solid dosage form comprising:
- (a) an edible alkaline agent;
- (b) a pharmacologically effective amount of a ketoprofen active;
- and
- (c) a pharmaceutically acceptable carrier, wherein said solid dosage form is a disintegrable thin strip oral film obtained from a mixture having a pH of about 6 to about 9, wherein said edible alkaline agent is a hydroxide selected from the group consisting of sodium hydroxide, calcium hydroxide, magnesium hydroxide, and potassium hydroxide and is present in sufficient amount to mask bitter taste.
A method for preparing a solid dosage form comprising forming a mixture of an edible alkaline agent, a pharmacologically effective amount of a ketoprofen active, and a pharmaceutically acceptable carrier, wherein said edible alkaline agent is a hydroxide selected from the group consisting of sodium hydroxide, calcium hydroxide, magnesium hydroxide, and potassium hydroxide and is present in the mixture in sufficient amount to mask the bitter taste of the ketoprofen active, and wherein the mixture has a pH of about 6 to about 9;
- and forming a solid dosage form from the mixture wherein the solid dosage form is a disintegrable thin strip oral film.
A method of administering an active agent to treat inflammation, pain, osteoarthritis, acute tendinitis, bursitis, or combinations thereof, the method comprising:
- (a) providing a solid dosage form disintegrable thin strip oral film comprising pharmacologically effective amounts of a ketoprofen active, an edible alkaline agent, and a pharmacologically acceptable carrier;
- and
- (b) introducing said solid dosage form into the oral cavity, wherein the edible alkaline agent is a hydroxide selected from the group consisting of sodium hydroxide, calcium hydroxide, magnesium hydroxide, and potassium hydroxide and is present in a sufficient amount to mask the bitter taste of the ketoprofen active, and wherein the thin strip oral film is obtained from a mixture having a pH of about 6 to about 9.
Dependencies are inferred from the claim text.