Otsuka America Pharmaceutical, Inc.

Neurovance, Inc.

Noven Therapeutics, LLC

Yonglai Yang

David Alan Engers

Valeriya N Smolenskaya

Fred J Fleitz

Anthony Alexander McKinney

Franklin Bymaster

Walter Piskorski

Venkat Kusukuntla

Stephan D Parent

Travis Houston

Bruce Charles Friedman

Valeriya Smolenskaya

Anthony Alexander Mckinney

The present invention relates to crystalline forms of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane hydrochloride and compositions comprising the same and methods of making and using the same.

Crystalline compounds

The invention relates to solid dispersions containing paroxetine mesylate. One solid dispersion contains amorphous paroxetine mesylate and a methacrylic acid-methyl methacrylate copolymer, where the weight ratio of paroxetine mesylate to polymer ranges from about 30:70 to about 90:10. Another solid dispersion contains amorphous paroxetine mesylate and a -vinylpyrrolidone/vinylacetate copolymer (PVP-VA), where the weight ratio of paroxetine mesylate to copolymer ranges from about 30:70 to about 50:50. An amorphous solid dispersion of the invention may have a single glass transition temperature. An amorphous solid dispersion is stable for at least 48 hours at 60&#xb0; C. and 75% relative humidity. A further embodiment of the invention relates to pharmaceutical compositions of paroxetine mesylate comprising a solid dispersion of the invention and at least one pharmaceutically acceptable excipient. Methods for the treatment using paroxetine mesylate in the form of a solid dispersion according to the invention are also disclosed.

Solid dispersions of amorphous paroxetine mesylate

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Hockessin, DE, United States of America

Yonglai Yang