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Generated: December 13, 2017

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Title:Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Abstract: The present invention relates to a pharmaceutical composition comprising as active ingredient the hydrochloric acid salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethyl-phenyl]amino]-2-pyrimidinyl]amino- ]benzonitrile and to processes for their preparation.
Inventor(s): Guillemont; Jerome Emile Georges (Ande, FR), Stevens; Paul Theodoor Agnes (Turnhout, BE), Copmans; Alex Herman (Lille, BE), Peeters; Jozef (Beerse, BE), Stappers; Alfred Elisabeth (Oud-Turnhout, BE), Vandecruys; Roger Petrus Gerebern (Westerlo, BE), Stoffels; Paul (Hoostraten, BE)
Assignee: Janssen Pharmaceutica NV (Beerse, BE)
Filing Date:Jul 07, 2008
Application Number:12/168,540
Claims:1. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of formula (I-a) ##STR00004## wherein the compound of formula (I-a) is a polymorphic form selected from the group consisting of: Form B characterized by X-ray powder diffraction peaks at two-theta positions 4.5.degree..+-.0.2.degree., 8.8.degree..+-.0.2.degree., and 12.5.degree..+-.0.2.degree., and further characterized by X-ray powder diffraction peaks at two-theta positions 10.3.degree..+-.0.2.degree., 14.7.degree..+-.0.2.degree., 20.6.degree..+-.0.2.degree., 22.2.degree..+-.0.2.degree., and 26.1.degree..+-.0.2.degree.; Form C characterized by X-ray powder diffraction peaks at two-theta positions 11.9.degree..+-.0.2.degree., 14.3.degree..+-.0.2.degree. and 22.3.degree..+-.0.2.degree., and further characterized by X-ray powder diffraction peaks at two-theta positions 12.8.degree..+-.0.2.degree., 18.5.degree..+-.0.2.degree., 21.2.degree..+-.0.2.degree., 24.3.degree..+-.0.2.degree., and 26.0.degree..+-.0.2.degree.; and Form D characterized by X-ray powder diffraction peaks at two-theta positions 6.6.degree..+-.0.2.degree., 11.6.degree..+-.0.2.degree., and 17.1.degree..+-.0.2.degree., and further characterized by X-ray powder diffraction peaks at two-theta positions 15.0.degree..+-.0.2.degree., 19.2.degree..+-.0.2.degree., 20.5.degree..+-.0.2.degree., 21.6.degree..+-.0.2.degree., and 29.8.degree..+-.0.2.degree..

2. A pharmaceutical composition according to claim 1, wherein the composition is a solid composition.

3. A pharmaceutical composition according to claim 1 further comprising a wetting agent.

4. A pharmaceutical composition according to claim 3 wherein the wetting agent is Tween.

5. A pharmaceutical composition according claim 1 wherein the composition is in the form of a tablet.

6. A pharmaceutical composition according to claim 5 which is film-coated.

7. A process for preparing a pharmaceutical composition comprising (1) a pharmaceutically acceptable carrier comprising a binder; a wetting agent; a diluent; a disintegrant; optionally a glidant; and optionally a lubricant; and (2) a compound of formula (I-a) ##STR00005## wherein the compound of formula (I-a) is a polymorphic form selected from the group consisting of: Form B characterized by x-ray powder diffraction peaks at two-theta positions 4.5.degree..+-.0.2.degree., 8.8.degree..+-.0.2.degree., and 12.5.degree..+-.0.2.degree., and further characterized by X-ray powder diffraction peaks at two-theta positions 10.3.degree..+-.0.2.degree., 14.7.degree..+-.0.2.degree., 20.6.degree..+-.0.2.degree., 22.2.degree..+-.0.2.degree., and 26.1.degree..+-.0.2.degree.; Form C characterized by X-ray powder diffraction peaks at two-theta positions 11.9.degree..+-.0.2.degree., 14.3.degree..+-.0.2.degree. and 22.3.degree..+-.0.2.degree., and further characterized by X-ray powder diffraction peaks at two-theta positions 12.8.degree..+-.0.2.degree., 18.5.degree..+-.0.2.degree., 21.2.degree..+-.0.2.degree., 24.3.degree..+-.0.2.degree., and 26.0.degree..+-.0.2.degree.; Form D characterized by X-ray powder diffraction peaks at two-theta positions 6.6.degree..+-.0.2.degree., 11.6.degree..+-.0.2.degree., and 17.1.degree..+-.0.2.degree., and further characterized by X-ray powder diffraction peaks at two-theta positions 15.0.degree..+-.0.2.degree., 19.2.degree..+-.0.2.degree., 20.5.degree..+-.0.2.degree., 21.6.degree..+-.0.2.degree., and 29.8.degree..+-.0.2.degree.; said process comprising the following steps: (i) dry blending the compound of formula I(a) and part of the diluent; (ii) preparing a binder solution by dissolving the binder and the wetting agent in the binder solution; (iii) spraying the binder solution obtained in step (ii) on the mixture obtained in step (i) to form a wet powder; (iv) drying the wet powder obtained in step (iii) followed by sieving and optionally mixing; (v) mixing the remaining part of the diluent, the disintegrant and the optional glidant in the mixture obtained in step (iv); (vi) optionally adding the lubricant to the mixture obtained in step (v); (vii) compressing the mixture obtained in step (vi) into a tablet; and (viii) optionally film-coating the tablet obtained in step (vii).
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