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|Title:||Process for forming Form 2 ranitidine hydrochloride|
|Abstract:||A novel crystal form of ranitidine (N-[2-[[[5-(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl-N'-methyl-2- nitro-1,1-ethenediamine) hydrochloride, designated Form 2, and having favorable filtration and drying characteristics, is characterized by its infra-red spectrum and/or by its x-ray powder diffraction patterns.|
|Inventor(s):||Crookes; Derek L. (Hertford, GB)|
|Assignee:||Glaxo Group Limited (London, GB2)|
|Filing Date:||Mar 18, 1985|
|Claims:||1. A process for the preparation of Form 2 ranitidine hydrochloride characterized by an infra-red spectrum as a mull in mineral oil showing the following main peaks: |
which comprises crystallising ranitidine hydrochloride from a solution thereof in a solvent under conditions which yield Form 2 ranitidine hydrochloride.
2. A process as claimed in claim 1, wherein the Form 2 ranitidine hydrochloride is prepared from ranitidine free base by reaction with hydrochloric acid.
3. A process as claimed in claim 2 carried out in a hydroxylic solvent.
4. A process for the preparation of Form 2 ranitidine hydrochloride characterized by an infra-red spectrum as a mull in mineral oil showing the following main peaks:
which comprises treating a solution of ranitidine in propan-2-ol with hydrochloric acid at a temperature of up to 70.degree. C. and crystallising Form 2 ranitidine hydrochloride by addition of further propan-2-ol.
5. A process for the preparation of Form 2 ranitidine hydrochloride characterized by an infra-red spectrum as a mull in mineral oil showing the following main peaks:
which comprises treating a solution of ranitidine in 2-methylpropan-2-ol, butan-2-ol or ethanol with hydrochloric acid at a temperature of up to 70.degree. C., followed by crystallisation of said Form 2 ranitidine hydrochloride.
6. A process as claimed in claim 4, wherein the starting solution contains up to 7% v/v water.
7. A process as claimed in claim 1, wherein Form 2 ranitidine hydrochloride is prepared by recrystallisation of ranitidine hydrochloride.
8. A process as claimed in claim 7, wherein recrystallisation takes place from a hydroxylic solvent.
9. A process as claimed in claim 7, wherein the solvent is propan-2-ol, methanol or ethanol.
10. A process as claimed in claim 8, wherein a miscible anti-solvent is added to the solution to complete crystallisation.
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