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Claims for Patent: 5,453,425

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Claims for Patent: 5,453,425

Title: Risperidone oral formulation
Abstract:The present invention is concerned with physicochemically stable aqueous solutions of risperidone for oral administration which do not contain sorbitol.
Inventor(s): Francois; Marc K. J. (Brussel, BE), Dries; Willy M. A. C. (Merksplas, BE)
Assignee: Janssen Pharmaceutica N.V. (Beerse, BE)
Application Number:08/272,462
Patent Claims: 1. An aqueous solution for oral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, a buffer to maintain the pH in the range of 2 to 6, and a preservative, characterized in that said solution is essentially free of sorbitol.

2. A solution according to claim 1 having a pH ranging from 3 to 4.

3. A solution according to claim 2 wherein said pH range is obtained with a tartaric acid /sodium hydroxide buffer.

4. A solution according to claim 1 wherein the amount of risperidone ranges from 0.01% to 1% by weight based on the total volume of the solution.

5. A solution according to claim 1 wherein the preservative is benzoic acid.

6. A solution according to claim 1 containing

(a) 0.1% risperidone;

(b) 0.2% benzoic acid;

(c) 0.75% tartaric acid and sufficient sodium hydroxide 1N to adjust the pH in the range from 2 to 6; and

(d) water q.s. ad 100%.

7. A solution according to claim 1 further comprising one or more sweetening agents and/or flavouring substances.
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