FAST-DISSOLVING ORAL FILM PREPARATION COMPRISING ARIPIPRAZOLE

• US 20150196558A1
• Filed: 08/07/2013
• Published: 07/16/2015
• Est. Priority Date: 08/08/2012
• Status: Active Grant

• Current Assignee: CMG Pharmaceutical CO.,LTD
• Original Assignee: CMG Pharmaceutical CO.,LTD
• Inventors: Kim, Yong Soo, Shi, Jun Ho
• Granted Patent: US 9,694,008 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Abstract

The present invention relates to an orally fast dissolving film formulation including aripiprazole. The orally fast dissolving film formulation includes aripiprazole or a pharmaceutically acceptable salt thereof and an organic acid. The orally fast dissolving film formulation has a pH in the range of 4.7 to 6.0. The orally fast dissolving film formulation may further include a film base polymer. The orally fast dissolving film formulation has a high dissolution rate, causes no risk of damage to oral tissues, masks a bitter taste of aripiprazole, and gives a good feeling upon taking.

Claims

1. An orally fast dissolving film formulation comprising aripiprazole or a pharmaceutically acceptable salt thereof and an organic acid wherein the film formulation has a pH in the range of 4.7 to 6.0.

2. The orally fast dissolving film formulation according to claim 1, wherein the organic acid is selected from citric acid, acetic acid, maleic acid, lactic acid, tartaric acid, ascorbic acid, adipic acid, succinic acid, fumaric acid, and mixtures thereof.

3. The orally fast dissolving film formulation according to claim 2, wherein the organic acid is citric acid or tartaric acid.

4. The orally fast dissolving film formulation according to claim 3, wherein the citric acid is present in an amount of 0.2 to 1.0 part by weight, based on the total weight of the orally fast dissolving film formulation.

5. The orally fast dissolving film formulation according to claim 1, further comprising a sweetening agent comprising sucralose and acesulfame potassium.

6. The orally fast dissolving film formulation according to claim 1, further comprising a film base polymer essentially comprising hydroxypropyl methylcellulose and optionally polyvinyl alcohol.

7. The orally fast dissolving film formulation according to claim 6, wherein the orally fast dissolving film formulation has a pH in the range of 5.7 to 6.8 when dissolved in the oral cavity.