Claims
- 1. A method for processing Form 1 ranitidine hydrochloride crystals from a post nucleation solution of ranitidine hydrochloride wherein the improvement comprises preparing the post nucleation solution, from a pre-nucleation solution containing ranitidine hydrochloride and consisting essentially of a solvent of at least one C1-C6 alkanol having a water content of less than about 0.7% and having a temperature from about 0° C. to about 70° C., by allowing the nucleation to commence therefrom, and then adding a digestion solvent to the post nucleation solution.
- 2. The method according to claim 1 wherein the C1-C6 alkanol is isopropanol.
- 3. The method according to claim 1 wherein the C1-C6 alkanol is ethanol.
- 4. The method according to claim 1 wherein the solution of ranitidine hydrochloride in the solvent is prepared by dissolving ranitidine base in the solvent containing from about 0.8 to about 1.2 molar equivalents of hydrogen chloride and wherein the method is carried out at temperatures from about 0° C. to about 70° C.
- 5. The method according to claim 4 wherein the C1-C6 alkanol is isopropanol.
- 6. The method according to claim 5 wherein the digestion solvent is water.
- 7. The method of claim 4 further comprising collecting Form 1 ranitidine hydrochloride and wherein the method is carried out at temperatures from about 0° C. to about 60° C.
- 8. The method according to claim 7, wherein the ranitidine base is dissolved in the C1-C6 alkanol solvent at a temperature of about 60° C.
- 9. The method according to claim 1 wherein the solution of ranitidine hydrochloride in the solvent is prepared by dissolving ranitidine hydrochloride in the C1-C6 alkanol solvent and wherein the method is carried out at temperatures from about 0° C. to about 70° C.
- 10. The method according to claim 9, wherein the ranitidine hydrochloride dissolved in the C1-C6 alkanol solvent is Form 2 ranitidine hydrochloride.
- 11. The method according to claim 9, wherein the ranitidine hydrochloride is dissolved in the C1-C6 alkanol solvent at a temperature of from about 0° C. to about 40° C.
- 12. The method according to claim 4 wherein the solution of ranitidine hydrochloride in the solvent is prepared by dissolving ranitidine base in isopropanol containing 1.08 molar equivalents of hydrogen chloride and where the method is carried out at a temperature of about 60° C.
- 13. The method according to claim 4 wherein the solution of ranitidine hydrochloride in the solvent is prepared by dissolving ranitidine base in isopropanol containing 1.00 molar equivalents of hydrogen chloride and where the method is carried out at a temperature of about 40° C.
- 14. The method according to claim 4 wherein the solution of ranitidine hydrochloride in the solvent is prepared by dissolving ranitidine base in isopopanol containing 1.00 molar equivalents of hydrogen chloride and wherein the method is carried out a temperature of about 14° C.
- 15. The method according to claim 9 wherein the solution of ranitidine hydrochloride in the solvent is prepared by dissolving ranitidine hydrochloride in ethanol having a water content of less than 0.27% and where the method is carried out and maintained at a temperature of about 36° C.
- 16. The method according to claim 1 wherein the nucleation of Form 1 ranitidine hydrochloride crystals is initiated using Form 1 ranitidine hydrochloride seed crystals.
Parent Case Info
[0001] This application is a continuation of U.S. application Ser. No. 10/159,846, filed May 30, 2002, which is a continuation of Ser. No. 09/668,203, filed Sep. 22, 2000, which is a continuation of Ser. No. 09/360,871, filed Jul. 23, 1999, which is a continuation of Ser. No. 09/070,446, filed Apr. 30, 1998, now abandoned, which is a continuation of Ser. No. 08/822,168, filed Mar. 21, 1997, now abandoned, which claims the benefit of U.S. Provisional Application No. 60/042,579, filed Mar. 25, 2996.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60042579 |
Feb 1997 |
US |
Continuations (5)
|
Number |
Date |
Country |
Parent |
10159846 |
May 2002 |
US |
Child |
10894169 |
Jul 2004 |
US |
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 |