DrugPatentWatch Database Preview
« Back to Dashboard
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)|
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.
For more information try a trial or see the plans and pricing
Serving hundreds of leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.