Claims for Patent: 5,453,425

Summary 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.