Oromucosal solutions of zolpidem or pharmaceutically acceptable salts thereof
Abstract:
The present invention relates to buccal or sublingual formulations of Zolpidem or pharmaceutically acceptable salt thereof. The formulations minimize the amount of penetration enhancers and yet provide rapid transmucosal penetration of the drug. These formulations not only provide desired a concentration (0.5% to 10% w/v) of the drug in the form of clear solution, but also achieve stable formulations throughout the shelf-life of at least about 2 years. The pH of the stable non-aqueous solutions of the present invention is in the range of range of 5 to 9, preferably 6 to 9 more preferably 7 to 9.
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