Nastech Pharmaceutical Company, Inc.

Harish K Pimplaskar

Anthony P Sileno

Charanjit R Behl

Vincent D Romeo

Jorge C deMeireles

Wei J Xia

Intranasal dosage units for promoting sleep in a mammal are disclosed. The dosage units are in the form of an aqueous buffered solution having a pH greater than 7.0, a sleep-promoting amount of Doxylamine, and an effective amount of an anionic surfactant. The anionic surfactant amount is an amount effective to provide a peak plasma concentration of Doxylamine to be reached within 30 minutes of administering the dosage unit to the nasal mucosa of a mammal. The dosage units are particularly suitable for administration to humans.

Intranasal formulations for promoting sleep and method of using the same

A method is disclosed for increasing the solubility of clemastine through the use of organic acid or its salts as a solubilizing agent. Particularly useful as solubilizing agents are salts of carboxylic acids, such as fumarate, maleate and citrate. Pharmaceutical compositions containing clemastine, and organic acids or its salts as solubilizing agents, are also disclosed.

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Lindenhurst, NY, United States of America

Harish K Pimplaskar