Claims
- 1. A process for preparing Form 1 ranitidine hydrochloride, consisting of: crystallization of ranitidine hydrochloride from at least one C1-C6 alkanol.
- 2. A process according to claim 1 wherein the C1-C6 alkanol is isopropanol.
- 3. A process according to claim 2 wherein seed crystals of pure Form 1 ranitidine hydrochloride are used.
- 4. A process according to claim 1 wherein the C1-C6 alkanol is ethanol.
- 5. A process according to claim 4 wherein seed crystals of pure Form 1 ranitidine hydrochloride are used.
- 6. A process according to claim 1 wherein ranitidine hydrochloride is formed from ranitidine base in at least one C1-C6 alkanol by the addition of hydrogen chloride.
- 7. A process according to claim 6 wherein the C1-C6 alkanol is isopropanol.
- 8. A process according to claim 7 wherein seed crystals of pure Form 1 ranitidine hydrochloride are used.
- 9. A process according to claim 7 further including digestion of the crystals formed upon nucleation.
- 10. A process according to claim 8 wherein the digestion is carried out by the addition of a digestion solvent.
- 11. A process according to claim 10 wherein the digestion solvent is water.
- 12. A process for preparing Form 1 ranitidine hydrochloride, comprising dissolving ranitidine base in a solvent consisting of at least one C1-C6 alkanol containing hydrogen chloride, crystallizing Form 1 ranitidine hydrochloride from the C1-C6 alkanol solvent, and collecting crystalline Form 1 ranitidine hydrochloride.
- 13. The process of claim 12, wherein the ranitidine base is dissolved in the C1-C6 alkanol solvent at a temperature of about 60° C.
- 14. A process for preparing Form 1 ranitidine hydrochloride, comprising dissolving ranitidine hydrochloride in a solvent consisting of at least one C1-C6 alkanol, crystallizing Form 1 ranitidine hydrochloride from the C1-C6 alkanol solvent, and collecting crystalline Form 1 ranitidine hydrochloride.
- 15. The process of claim 14, wherein the ranitidine hydrochloride dissolved in the C1-C6 alkanol solvent is Form 2 ranitidine hydrochloride.
- 16. The process of claim 14, wherein the ranitidine hydrochloride is dissolved in the C1-C6 alkanol solvent at a temperature of about 60° C.
Parent Case Info
[0001] This application is a continuation of U.S. application Ser. No. 08/822,168, filed Mar. 21, 1997, which claims the benefit of U.S. Provisional Application No. 60/042,579, filed Mar. 25, 1996.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60042579 |
Feb 1997 |
US |
Continuations (4)
|
Number |
Date |
Country |
Parent |
09668203 |
Sep 2000 |
US |
Child |
10159846 |
May 2002 |
US |
Parent |
09360871 |
Jul 1999 |
US |
Child |
09668203 |
Sep 2000 |
US |
Parent |
09070446 |
Apr 1998 |
US |
Child |
09360871 |
Jul 1999 |
US |
Parent |
08822168 |
Mar 1997 |
US |
Child |
09070446 |
Apr 1998 |
US |