WO2008130630A4 - Polymorphic form of rimonabant hydrochloride and processes for preparation thereof - Google Patents
Polymorphic form of rimonabant hydrochloride and processes for preparation thereof Download PDFInfo
- Publication number
- WO2008130630A4 WO2008130630A4 PCT/US2008/005022 US2008005022W WO2008130630A4 WO 2008130630 A4 WO2008130630 A4 WO 2008130630A4 US 2008005022 W US2008005022 W US 2008005022W WO 2008130630 A4 WO2008130630 A4 WO 2008130630A4
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- rimonabant hydrochloride
- crystalline
- crystalline rimonabant
- hydrochloride
- processes
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D231/00—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings
- C07D231/02—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings
- C07D231/10—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members
- C07D231/14—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Addiction (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Psychiatry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Child & Adolescent Psychology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Provided is a crystalline form of Rimonabant hydrochloride, processes for its preparation and pharmaceutical compositions containing such crystalline form of Rimonabant hydrochloride.
Claims
1. A crystalline Rimonabant hydrochloride, characterized by a powder XRJD pattern with peaks at about 13.4, 13.9, 14.9 and 18.1 ± 0.2 degrees two-theta.
2. The crystalline Rimonabant hydrochloride of claim 1 , further characterized by a powder XRD pattern with peaks at about 16.8, 24.6, 29.6 and 30.5 ± 0.2 degrees two-theta.
3. The crystalline Rimonabant hydrochloride of claims 1 or 2, having a powder XRD pattern substantially as depicted in Figure 1.
4. The crystalline Rimonabant hydrochloride of any one of claims 1 to 3, having a purity of more than 80% of the crystalline Rimonabant hydrochloride in a given sample as measured by XRD.
5. The crystalline Rimonabant hydrochloride of claim 4 having a purity of more than 90% of the crystalline Rimonabant hydrochloride in a given sample as measured by XRD.
6. The crystalline Rimonabant hydrochloride of claim 5 having a purity of more than 99% of the crystalline Rimonabant hydrochloride in a given sample as measured by XRD.
7. A method of preparing crystalline Rimonabant HCl characterized by a powder XRD pattern with peaks at about 13.4, 13.9, 14.9 and 18.1 ± 0.2 degrees two-theta comprising: combining Rimonabant hydrochloride and ethanol thereby forming a heterogeneous mixture to obtain the crystalline Rimonabant hydrochloride.
8. The method of claim 7, wherein the heterogeneous mixture is a slurry or suspension.
9. The method of claims 7 or 8, wherein the ratio of Rimonobant HCl to ethanol is about 5 to about 50.
10. The method of claim 9, wherein the ratio is about 5 to about 15.
11. The method of any one of claims 7 to 10, wherein combining Rimonabant hydrochloride and ethanol is carried out at a temperature of about 00C to about 55°C.
AMENDED SHEET (ARTICLE 19)
12. The method of claim 11 , wherein the temperature is about 20°C to about 450C.
13. The method of claim 12, wherein the temperature is about room temperature.
14. The method of any one of claims 7 to 13, wherein the heterogeneous mixture is maintained for a period of about 36 to about 60 hours.
15. The method of claim 14, wherein the heterogeneous mixture is maintained for about 48 hours.
16. The method of any one of claims 7 to 15, further comprising isolating and drying the crystalline Form. Q
17. A pharmaceutical composition comprising the crystalline Rimonabant hydrochloride form of any one of claims 1-6 and at least one pharmaceutically acceptable excipient.
18. A pharmaceutical composition comprising the crystalline Rimonabant hydrochloride form made by the processes of any one of claims 7-16, and at least one pharmaceutically acceptable excipient.
19. A process for preparing a pharmaceutical formulation comprising combining the crystalline Rimonabant hydrochloride form of any one of claims 1-6 with at least one pharmaceutically acceptable excipient.
20. A process for preparing a pharmaceutical formulation comprising combining the crystalline Rimonabant hydrochloride form made by the processes of any one of claims 7-16, and at least one pharmaceutically acceptable excipient.
21. Use of the crystalline Rimonabant hydrochloride form of any one of claims 1 - 6 for the manufacture of a pharmaceutical composition.
22. Use of the crystalline Rimonabant hydrochloride form made by the processes of any one of claims 7- 1 β, for the manufacture of a pharmaceutical composition.
AMENDED SHEET (ARTICLE 19)
17
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US92383007P | 2007-04-16 | 2007-04-16 | |
| US60/923,830 | 2007-04-16 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| WO2008130630A2 WO2008130630A2 (en) | 2008-10-30 |
| WO2008130630A3 WO2008130630A3 (en) | 2009-02-19 |
| WO2008130630A4 true WO2008130630A4 (en) | 2009-04-16 |
Family
ID=39666000
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2008/005022 Ceased WO2008130630A2 (en) | 2007-04-16 | 2008-04-16 | Polymorphic form of rimonabant hydrochloride and processes for preparation thereof |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2008130630A2 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102206182B (en) * | 2011-04-11 | 2013-03-13 | 中国药科大学 | Method for synthesizing Rimonabant hydrochloride |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0606199A2 (en) * | 2005-01-06 | 2009-11-17 | Cadila Healthcare Ltd | rimonabant hydrochloride, process for the preparation of a rimonabant hydrochloride, pharmaceutical composition, pharmaceutical dosage form, use of a rimonabant hydrochloride and method of treatment |
| US20100204470A1 (en) * | 2006-06-27 | 2010-08-12 | Sandoz Ag | method for salt preparation |
| US20080004313A1 (en) * | 2006-06-28 | 2008-01-03 | Mai De Ltd. | Preparation of crystalline polymorphs of rimonabant hydrochloride |
-
2008
- 2008-04-16 WO PCT/US2008/005022 patent/WO2008130630A2/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2008130630A2 (en) | 2008-10-30 |
| WO2008130630A3 (en) | 2009-02-19 |
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