Claims for Patent: 8,207,197

Summary for Patent: 8,207,197

Title:	Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine
Abstract:	The invention relates to new crystalline 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride, the respective manufacture and methods of use, and compositions containing such a compound.
Inventor(s):	Raga; Manuel (Barcelona, ES), Sallares; Juan (Barcelona, ES), Guerrero; Marta (Barcelona, ES), Guglietta; Antonio (Molins de Rei, ES), Arrang; Jean-Michel (Dourdan, FR), Schwartz; Jean-Charles (Paris, FR), Stark; Holger (Bad Homburg, DE), Schunack; Walter (Berlin, DE), Ligneau; Xavier (Saint Gregoire, FR), Lecomte; Jeanne-Marie (Paris, FR), Ganellin; Charon (Thame, GB)
Assignee:	Bioprojet (Paris, FR)
Application Number:	11/815,736
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,207,197
Patent Claims:	1. Crystalline 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride of formula (I) ##STR00002## optionally comprising water up to 6%, and having an X-ray diffractogram that comprises characteristic peaks (2.theta.) at 11.2.degree. , 19.9.degree. ,20.7.degree. and 34.1.degree. .+-.0.2.degree. 2. The crystalline 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride according to claim 1, having an X-ray diffractogram that comprises characteristic peaks (2.theta.) at 11.2.degree. , 15.4.degree. , 16.3.degree. , 16.9.degree. , 17.8.degree. , 19.9.degree. , 20.7.degree. , 21.0.degree. , 21.8.degree. , 22.6.degree. , 24.5.degree. , 24.6.degree. , 25.0.degree. , 25.5.degree. , 26.3.degree. , 28.3.degree. , 30.3.degree. , 34.1.degree. , 35.8.degree. ,40.0.degree. , 46.0.degree. .+-.0.2.degree. . 3. A process for the production of the compound according to claim 1 comprising: a) reacting 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine with a reactant selected from hydrogen chloride or hydrochloric acid in a suitable solvent and isolating the precipitated 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride; and b) crystallizing the precipitated 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride in a suitable solvent. 4. The process of claim 3 wherein the reactant is hydrogen chloride. 5. The process of claim 4 wherein the hydrogen chloride is added as gaseous hydrogen chloride. 6. The process of claim 3, wherein the suitable solvent of step a) is selected from the group consisting of acetone, methanol, ethanol, propanol, water, ethyl acetate, i-propanol, butanol, i-butanol, s-butanol, t-butanol, hexane, toluene, t-butyl-methyl ether, trichloroethane, and mixtures thereof. 7. The process of claim 6 wherein the suitable solvent is ethyl acetate. 8. The process of claim 3 wherein the suitable solvent of step b) is selected from the group consisting of acetone, methanol, ethanol, propanol, water, ethyl acetate, i-propanol, butanol, i-butanol, s-butanol, t-butanol, hexane, toluene, t-butyl-methyl ether, trichloroethane, and mixtures thereof. 9. The process of claim 8 wherein the suitable solvent is a mixture of ethyl acetate and i-propanol. 10. A pharmaceutical composition comprising a therapeutically effective amount of the compound as defined in claim 1, together with pharmaceutically acceptable excipients or carriers.