Details for Patent: 8,975,442

Title:	Process for the preparation of and crystalline forms of optical enantiomers of modafinil
Abstract:	The invention relates to a polymorphic form of (-)-modafinil that produces a powder X-ray diffraction spectrum comprising intensity peaks corresponding to interplanar spacings of about 14.14, 10.66, 7.80 and 4.02 .ANG., and a process for the preparation thereof.
Inventor(s):	Leproust; Pierre (Creteil, FR), Neckebrock; Olivier (Pontault Combault, FR)
Assignee:	Teva Sante (La Defense Cedex (Paris), FR)
Filing Date:	Aug 28, 2013
Application Number:	14/012,363
Claims:	1. A dextrorotatory enantiomer of modafinil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising intensity peaks corresponding to interplanar spacings at about 5.23, 5.03, 4.22, and 4.10 (.ANG.). 2. The dextrorotatory enantiomer of modafinil according to claim 1, wherein the powder X-ray diffraction spectrum further comprises intensity peaks corresponding to interplanar spacings at about 9.63, 4.74, 4.66 and 3.77 (.ANG.). 3. A polymorphic form of the dextrorotatory enantiomer of modafinil that produces a powder X-ray diffraction spectrum comprising reflections at about 16.95, 17.64, 21.06 and 21.67 degrees 2.theta.. 4. The polymorphic form according to claim 3, wherein the powder X-ray diffraction spectrum further comprises reflections at about 9.17, 18.69, 19.03 and 23.61 degrees 2.theta.. 5. A composition consisting essentially of a polymorphic form of the dextrorotatory enantiomer of modafinil that produces a powder X-ray diffraction spectrum comprising intensity peaks corresponding to interplanar spacings of about 5.23, 5.03, 4.22 and 4.10 (.ANG.). 6. The composition according to claim 5, wherein the powder X-ray diffraction spectrum further comprises intensity peaks corresponding to interplanar spacings of about 9.63, 4.74, 4.66 and 3.77 (.ANG.). 7. A composition consisting essentially of a polymorphic form of the dextrorotatory enantiomer of modafinil that produces a powder X-ray diffraction spectrum comprising reflections at about 16.95, 17.64, 21.06 and 21.67 degrees 2.theta.. 8. The composition according to claim 7, wherein the powder X-ray diffraction spectrum further comprises reflections at about 9.17, 18.69, 19.03 and 23.61 degrees 2.theta.. 9. A Form V polymorph of the dextrorotatory enantiomer of modafinil. 10. A composition comprising the Form V polymorph of claim 9. 11. A composition comprising the Form V polymorph of claim 9, wherein said composition is substantially free of other polymorphic forms of the dextrorotatory enantiomer of modafinil. 12. A composition consisting essentially of the Form V polymorph of claim 9. 13. A pharmaceutical composition comprising one or more pharmaceutically acceptable excipients and the Form V polymorph of claim 9. 14. A pharmaceutical composition comprising one or more pharmaceutically acceptable excipients and an active ingredient consisting essentially of the Form V polymorph of claim 9. 15. A process for preparing the Form V polymorph of claim 9, comprising the steps of: (a) providing a solution of the dextrorotatory enantiomer of modafinil dissolved in a hot solvent; (b) cooling the solution from step (a) to produce crystals; (c) isolate the crystals of said Form V polymorph that are formed in step (b); wherein the solvent of step (a) is selected from 2-pentanone and tetrahydrofuran.