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Last Updated: December 12, 2025

Claims for Patent: 9,694,008

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Summary for Patent: 9,694,008

Title:	Fast-dissolving oral film preparation comprising aripiprazole
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.
Inventor(s):	Yong Soo Kim, Jun Ho SHIN
Assignee:	CMG Pharmaceutical Co Ltd
Application Number:	US14/419,231
Patent 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 4.95 to 5.18; the aripiprazole or the pharmaceutically acceptable salt thereof and the organic acid have a weight ratio in the range of 2:1 to 66:1; the organic acid is citric acid; and the orally fast dissolving film formulation has a pH in the range of 6.2 to 6.4 when dissolved in an oral cavity. 2. The orally fast dissolving film formulation according to claim 1, wherein the citric acid is present in an amount of 0.2 to 1.0% by weight, based on the total weight of the orally fast dissolving film formulation. 3. The orally fast dissolving film formulation according to claim 1, further comprising a sweetening agent comprising sucralose and acesulfame potassium. 4. The orally fast dissolving film formulation according to claim 1, further comprising a film base polymer essentially comprising hydroxypropyl methylcellulose and optionally polyvinyl alcohol.

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