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Details for Patent: 4,672,133

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Details for Patent: 4,672,133

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
Application Number:06/712,610
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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