|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) |
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.