STABLE PHARMACEUTICAL AQUEOUS SOLUTIONS OF ANTIPSYCHOTIC DRUGS

摘要

The present invention relates to stable pharmaceutical aqueous solution of antipsychotic drugs suitable for oral administration. More particularly the antipsychotic drug is risperidone or a pharmaceutically acceptable salt of risperidone. The present invention has a pH of the solution about 1. 5 to 1. 9 and contains antimicrobial agents which are effective in said pH interval. The pharmaceutical aqueous solution further contain flavoring agents pH adjusting agents and optionally other excipients like antioxidants, buffering agents, sweeteners and solubility enhancers. The solution of the present invention remains physicochemically stable for at least 30 days at 80 and 40 and 75 o RH with the total impurities being below l o . The density of the solution of the present invention is 1-1. 3 g ml in 20 .