WO2005037787A1 - Crystalline form of fluvastatin sodium - Google Patents
Crystalline form of fluvastatin sodium Download PDFInfo
- Publication number
- WO2005037787A1 WO2005037787A1 PCT/EP2004/052449 EP2004052449W WO2005037787A1 WO 2005037787 A1 WO2005037787 A1 WO 2005037787A1 EP 2004052449 W EP2004052449 W EP 2004052449W WO 2005037787 A1 WO2005037787 A1 WO 2005037787A1
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- WIPO (PCT)
- Prior art keywords
- fluvastatin sodium
- intensity
- crystalline
- characteristic
- strong intensity
- Prior art date
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
- C07D209/04—Indoles; Hydrogenated indoles
- C07D209/10—Indoles; Hydrogenated indoles with substituted hydrocarbon radicals attached to carbon atoms of the hetero ring
- C07D209/18—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
- C07D209/24—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with an alkyl or cycloalkyl radical attached to the ring nitrogen atom
-
- 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
- A61P3/06—Antihyperlipidemics
Definitions
- the present invention is directed to novel crystalline form of Fluvastatin sodium, processes for the preparation and pharmaceutical compositions comprising this crystalline form.
- Fluvastatin sodium is known by its chemical name ( ⁇ )-7-(3-(4-fluorophenyl)-1-(1-methylethyl)- 1 H-indol-2-yl)-3,5-dihydroxy-6-heptenoic acid monosodium salt.
- Fluvastatin sodium is a racemic mixture of the 3R.5S- and 3S,5R-dihydroxy enantiomers and has the following formula:
- Fluvastatin sodium is an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) and is used to lower the blood cholesterol level.
- HMG-CoA 3-hydroxy-3-methylglutaryl coenzyme A
- Fluvastatin sodium salt is disclosed in US-A-4,739,073.
- Fluvastatin sodium is obtained by lyophilization.
- WO-A-97/49681 and its US equivalent US-A-6, 124,340 describe that lyophilization of Fluvastatin sodium yields a mixture of a crystalline form, designated as Form A, and amorphous material, and disclose a new crystalline form, designated as Form B.
- WO-A-03/13512 discloses 4 new crystalline hydrates, designated as Forms C, D, E and F. These crystalline hydrates have water contents which ranges from 3 to 32%. The stability of these new crystalline hydrates very much depend on the relative air humdity of the surrounding atmosphere.
- Form D is the most stable crystalline form in atmospheres with an air humdity ranging from 30 to 50%
- Form F is stable in atmospheres with an air humidity of up to 90%.
- stable crystalline forms which can be used for example in gel or wet formulations.
- Fluvastatin sodium can surprisingly be prepared as a novel crystalline hydrate, which is stable in saturated aqueous environments.
- This novel crystalline hydrate, herein designated as Form G is a liquid crystalline material which, for example, allows gel or wet formulations of Fluvastatin sodium.
- a crystalline poly morph of ( ⁇ )-7-(3-(4-fluorophenyl)-1 -(1 -methylethyl)-1 H-indol-2-yl)-3,5- dihydroxy-6-heptenoic acid monosodium salt which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (A): 29.2 (w), 15.0 H, 10.1 (m), 7.6 (vs), 6.10 (s), 5.09 (m), 4.37 (s), 3.83 (w), 3.07 (m), herein designated as Form G.
- Form G of Fluvastatin sodium can generally be prepared from any crystalline Form or amorphous Fluvastatin sodium, or mixtures thereof, for example, by filtration of an aqueous suspension.
- the suspension may be obtained, for example, by introducing amorphous or any crystalline form of Fluvastatin sodium, e.g. form A, B, C, D, E or F, into water; usually, the amount of water used is insufficient to dissolve significant amounts of the material, e.g. by using the about 2 - 10 fold weight of water, relative to Fluvastatin sodium. It may also be obtained by crystallizing or partially crystallizing Fluvastatin sodium in water, e.g. by cooling of a solution or diluted suspension in water.
- the water content in the present Form G is 30% by weight or more. Small changes in the water content can cause small deviations in the d-values of characteritic peaks in the X-ray powder diffraction patterns.
- compositions comprising an effective amount of crystalline polymorphic Form G, and a pharmaceutically acceptable carrier.
- the polymorphic form G may be used as a single component or as a mixture with other crystalline forms or the amorphous form of Fluvastatin sodium.
- pharmaceutical compositions of Fluvastatin sodium it is preferred that these contain 25- 100% by weight, especially 50-100% by weight, of Form G, based on the total amount of Fluvastatin sodium.
- such an amount of Form G of Fluvastatin sodium is 75-100% by weight, especially 90-100% by weight. Highly preferred is an amount of 95-100% by weight.
- compositions of the invention include powders, granulates, aggregates and other solid compositions comprising crystalline polymorphic form G.
- compositions that are contemplated by the present invention may further include diluents, such as cellulose-derived materials like powdered cellulose, microcrystalline cellulose, microfine cellulose, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxy methyl, cellulose salts and other substituted and unsubstituted celluloses; starch; pregelatinized starch; inorganic diluents like calcium carbonate and calcium diphosphate and other diluents known to the pharmaceutical industry.
- Suitable diluents include waxes, sugars and sugar alcohols like mannitol and sorbitol, acrylate polymers and copolymers, as well as pectin, dextrin and gelatin. Of special importance are aqueous gels or liquid formulations.
- excipients that are within the contemplation of the present invention include binders, such as acacia gum, pregelatinized starch, sodium alginate, glucose and other binders used in wet and dry granulation and direct compression tableting processes.
- binders such as acacia gum, pregelatinized starch, sodium alginate, glucose and other binders used in wet and dry granulation and direct compression tableting processes.
- Excipients that also may be present in the solid compositions further include disintegrants like sodium starch glycolate, crospovidone, low-substituted hydroxypropyl cellulose and others.
- excipients may include tableting lubricants like magnesium and calcium stearate and sodium stearyl fljmarate; flavorings; sweeteners; preservatives; pharmaceutically acceptable dyes and glidants such as silicon dioxide.
- the dosages include dosages suitable for oral, buccal, rectal, parenteral (including subcutaneous, intramuscular, and intravenous), inhalant and ophthalmic administration. Although the most suitable route in any given case will depend on the nature and severity of the condition being treated, the most preferred route of the present invention is oral.
- the dosages may be conveniently presented in unit dosage form and prepared by any of the methods well-known in the art of pharmacy. Dosage forms include solid dosage forms, like tablets, powders, capsules, suppositories, sachets, troches and losenges as well as liquid suspensions and elixirs.
- Capsule dosages will contain the solid composition within a capsule which may be made of gelatin or other conventional encapsulating material.
- Tablets and powders may be coated. Tablets and powders may be coated with an enteric coating.
- the enteric coated powder forms may have coatings comprising phthalic acid cellulose acetate, hydroxypropylmethyl-cellulose phthalate, polyvinyl alcohol phthalate, carboxymethylethylcellulose, a copolymer of styrene and maleic acid, a copolymer of methacrylic acid and methyl methacrylate, and like materials, and if desired, they may be employed with suitable plasticizers and/or extending agents.
- a coated tablet may have a coating on the surface of the tablet or may be a tablet comprising a powder or granules with an enteric-coating.
- Preferred unit dosages of the pharmaceutical compositions of this invention typically contain from 0.5 to 100 mg of the novel Fluvastatin sodium form or mixtures thereof with each other or other forms of Fluvastatin sodium. More usually, the combined weight of the Fluvastatin sodium forms of a unit dosage are from 2.5 mg to 80 mg, for example 5, 10, 20 or 40 mg.
- Figure 1 is a characteristic X-ray powder diffraction pattern for Form G.
Abstract
A novel crystalline form of Fluvastatin sodium hydrate is described, referred to hereinafter as polymorphic Form G. Furthermore, processes for the preparation of this crystalline form and pharmaceutical compositions comprising this crystalline form are reported.
Description
Crystalline Form of Fluvastatin Sodium
The present invention is directed to novel crystalline form of Fluvastatin sodium, processes for the preparation and pharmaceutical compositions comprising this crystalline form.
Fluvastatin sodium is known by its chemical name (±)-7-(3-(4-fluorophenyl)-1-(1-methylethyl)- 1 H-indol-2-yl)-3,5-dihydroxy-6-heptenoic acid monosodium salt. Fluvastatin sodium is a racemic mixture of the 3R.5S- and 3S,5R-dihydroxy enantiomers and has the following formula:
Fluvastatin sodium is an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) and is used to lower the blood cholesterol level.
Fluvastatin sodium salt is disclosed in US-A-4,739,073. In this patent Fluvastatin sodium is obtained by lyophilization. WO-A-97/49681 and its US equivalent US-A-6, 124,340 describe that lyophilization of Fluvastatin sodium yields a mixture of a crystalline form, designated as Form A, and amorphous material, and disclose a new crystalline form, designated as Form B. WO-A-03/13512 discloses 4 new crystalline hydrates, designated as Forms C, D, E and F. These crystalline hydrates have water contents which ranges from 3 to 32%. The stability of these new crystalline hydrates very much depend on the relative air humdity of the surrounding atmosphere. For example, Form D is the most stable crystalline form in atmospheres with an air humdity ranging from 30 to 50%, whereas Form F is stable in atmospheres with an air humidity of up to 90%. However, there is still a need for stable crystalline forms which can be used for example in gel or wet formulations.
It has now been found that Fluvastatin sodium can surprisingly be prepared as a novel crystalline hydrate, which is stable in saturated aqueous environments. This novel crystalline
hydrate, herein designated as Form G, is a liquid crystalline material which, for example, allows gel or wet formulations of Fluvastatin sodium.
Thus the present invention provides the following novel crystalline form of Fluvastatin sodium:
A crystalline poly morph of (±)-7-(3-(4-fluorophenyl)-1 -(1 -methylethyl)-1 H-indol-2-yl)-3,5- dihydroxy-6-heptenoic acid monosodium salt which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (A): 29.2 (w), 15.0 H, 10.1 (m), 7.6 (vs), 6.10 (s), 5.09 (m), 4.37 (s), 3.83 (w), 3.07 (m), herein designated as Form G. The abbreviations in brackets mean: (vs) = very strong intensity; (s) = strong intensity; (m) = medium intensity; (w) = weak intensity; and (vw) = very weak intensity. A characterisitic X-ray powder diffraction pattern for Form G is depicted in Figure 1.
Furthermore, the present invention is directed to processes for the preparation of Form G. Form G of Fluvastatin sodium can generally be prepared from any crystalline Form or amorphous Fluvastatin sodium, or mixtures thereof, for example, by filtration of an aqueous suspension. The suspension may be obtained, for example, by introducing amorphous or any crystalline form of Fluvastatin sodium, e.g. form A, B, C, D, E or F, into water; usually, the amount of water used is insufficient to dissolve significant amounts of the material, e.g. by using the about 2 - 10 fold weight of water, relative to Fluvastatin sodium. It may also be obtained by crystallizing or partially crystallizing Fluvastatin sodium in water, e.g. by cooling of a solution or diluted suspension in water.
As a rule, the water content in the present Form G is 30% by weight or more. Small changes in the water content can cause small deviations in the d-values of characteritic peaks in the X-ray powder diffraction patterns.
Another object of the present invention are pharmaceutical compositions comprising an effective amount of crystalline polymorphic Form G, and a pharmaceutically acceptable carrier. The polymorphic form G may be used as a single component or as a mixture with other crystalline forms or the amorphous form of Fluvastatin sodium.
As to pharmaceutical compositions of Fluvastatin sodium it is preferred that these contain 25- 100% by weight, especially 50-100% by weight, of Form G, based on the total amount of Fluvastatin sodium. Preferably, such an amount of Form G of Fluvastatin sodium is 75-100% by weight, especially 90-100% by weight. Highly preferred is an amount of 95-100% by weight.
The compositions of the invention include powders, granulates, aggregates and other solid compositions comprising crystalline polymorphic form G. In addition, the compositions that are contemplated by the present invention may further include diluents, such as cellulose-derived materials like powdered cellulose, microcrystalline cellulose, microfine cellulose, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxy methyl, cellulose salts and other substituted and unsubstituted celluloses; starch; pregelatinized starch; inorganic diluents like calcium carbonate and calcium diphosphate and other diluents known to the pharmaceutical industry. Yet other suitable diluents include waxes, sugars and sugar alcohols like mannitol and sorbitol, acrylate polymers and copolymers, as well as pectin, dextrin and gelatin. Of special importance are aqueous gels or liquid formulations.
Further excipients that are within the contemplation of the present invention include binders, such as acacia gum, pregelatinized starch, sodium alginate, glucose and other binders used in wet and dry granulation and direct compression tableting processes. Excipients that also may be present in the solid compositions further include disintegrants like sodium starch glycolate, crospovidone, low-substituted hydroxypropyl cellulose and others. In addition, excipients may include tableting lubricants like magnesium and calcium stearate and sodium stearyl fljmarate; flavorings; sweeteners; preservatives; pharmaceutically acceptable dyes and glidants such as silicon dioxide.
The dosages include dosages suitable for oral, buccal, rectal, parenteral (including subcutaneous, intramuscular, and intravenous), inhalant and ophthalmic administration. Although the most suitable route in any given case will depend on the nature and severity of the condition being treated, the most preferred route of the present invention is oral. The dosages may be conveniently presented in unit dosage form and prepared by any of the methods well-known in the art of pharmacy.
Dosage forms include solid dosage forms, like tablets, powders, capsules, suppositories, sachets, troches and losenges as well as liquid suspensions and elixirs. While the description is not intended to be limiting, the invention is also not intended to pertain to true solutions of Fluvastatin sodium whereupon the properties that distinguish the solid forms of Fluvastatin sodium are lost. However, the use of the novel forms to prepare such solutions is considered to be within the contemplation of the invention.
Capsule dosages, of course, will contain the solid composition within a capsule which may be made of gelatin or other conventional encapsulating material. Tablets and powders may be coated. Tablets and powders may be coated with an enteric coating. The enteric coated powder forms may have coatings comprising phthalic acid cellulose acetate, hydroxypropylmethyl-cellulose phthalate, polyvinyl alcohol phthalate, carboxymethylethylcellulose, a copolymer of styrene and maleic acid, a copolymer of methacrylic acid and methyl methacrylate, and like materials, and if desired, they may be employed with suitable plasticizers and/or extending agents. A coated tablet may have a coating on the surface of the tablet or may be a tablet comprising a powder or granules with an enteric-coating.
Preferred unit dosages of the pharmaceutical compositions of this invention typically contain from 0.5 to 100 mg of the novel Fluvastatin sodium form or mixtures thereof with each other or other forms of Fluvastatin sodium. More usually, the combined weight of the Fluvastatin sodium forms of a unit dosage are from 2.5 mg to 80 mg, for example 5, 10, 20 or 40 mg.
The following Examples illustrate the invention in more detail. Temperatures are given in degrees Celsius. All percentages are given by weight if not otherwise indicated.
Example 1 : Preparation of polymorphic Form G
300 mg of Fluvastatin sodium Form A are suspended in 1.0 ml water at ambient temperature. The resulting suspension is stirred for 18 hours. The solid residue is separated by filtration. Without any further drying, the obtained solid paste is investigated by powder X-ray diffaction in a closed sample chamber under an adjusted relative humidity of about 90% or higher. The X-ray powder diffraction pattern is depicted in Figure 1.
Exactly the same result is obtained when example 1 is repeated and the solid residue is filtered after only 15 minutes of stirring.
Also the same results are obtained when example 1 is repeated starting from any other crystalline form of Fluvastatin sodium.
Brief description of the drawing
Figure 1 is a characteristic X-ray powder diffraction pattern for Form G.
Claims
1. A crystalline polymorph of (±)-7-(3-(4-fluorophenyl)-1 -(1 -methylethyl)-1 H-indol-2-yl)-3,5- dihydroxy-6-heptenoic acid monosodium salt which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (A): 7.6 (vs), 6.10 (s), and 4.37 (s), wherein (vs) = very strong intensity and (s) = strong intensity.
2. A crystalline polymorph of (±)-7-(3-(4-fluorophenyl)-1 -(1 -methylethyl)-1 H-indol-2-yl)-3,5- dihydroxy-6-heptenoic acid monosodium salt which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (A): 10.1 (m), 7.6 (vs), 6.10 (s), 5.09(m), 4.37 (s) and 3.07(m), wherein (vs) = very strong intensity, (s) = strong intensity and (m) = medium intensity.
3. A crystalline polymorph of (+)-7-(3-(4-fluorophenyl)-1 -(1 -methylethyl)-1 H-indol-2-yl)-3,5- dihydroxy-6-heptenoic acid monosodium salt which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (A): 29.2 (w), 15.0 (vw), 10.1 (m), 7.6 (vs), 6.10 (s), 5.09(m), 4.37 (s), 3.83 (w) and 3.07(m), wherein (vs) = very strong intensity, (s) = strong intensity, (m) = medium intensity, (w) = weak intensity and (vw) = very weak intensity.
4. A process for the preparation of a crystalline polymorph according to claims 1 to 3, wherein Fluvastatin sodium is filtered off from an aqueous suspension.
5. A process according to claim 4 for in which the aqueous suspension is prepared from any of the known crystalline forms or the amorphous form of Forms of Fluvastatin sodium.
6. A process according to claim 4 or 5 in which an aqueous suspension of Fluvastatin sodium is stirred before filtration.
7. A pharmaceutical composition comprising an effective amount of a crystalline polymorphic form according to any of claims 1 to 3 and a pharmaceutically acceptable carrier.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/576,784 US7432380B2 (en) | 2003-10-16 | 2004-10-06 | Crystalline form of Fluvastatin sodium |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03103841 | 2003-10-16 | ||
| EP03103841.7 | 2003-10-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2005037787A1 true WO2005037787A1 (en) | 2005-04-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2004/052449 WO2005037787A1 (en) | 2003-10-16 | 2004-10-06 | Crystalline form of fluvastatin sodium |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US7432380B2 (en) |
| WO (1) | WO2005037787A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006030304A2 (en) * | 2004-09-17 | 2006-03-23 | Ranbaxy Laboratories Limited | Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof |
| WO2007100894A2 (en) * | 2006-02-27 | 2007-09-07 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium novel forms and preparation therof |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007524619A (en) * | 2003-06-18 | 2007-08-30 | テバ ファーマシューティカル インダストリーズ リミティド | Fluvastatin sodium crystalline form, process for its preparation, composition containing it, and use thereof |
| EP1711493A2 (en) * | 2004-02-06 | 2006-10-18 | CIBA SPECIALTY CHEMICALS HOLDING INC. Patent Departement | Crystalline forms of zolmitriptan |
| EP1844021A1 (en) * | 2005-01-31 | 2007-10-17 | Ciba Specialty Chemicals Holding Inc. | Crystalline forms of rosuvastatin calcium salt |
| WO2006085338A2 (en) * | 2005-02-11 | 2006-08-17 | Jubilant Organosys Limited | Novel polymorphic forms of fluvastatin sodium and process for preparing the same |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997049681A1 (en) * | 1996-06-24 | 1997-12-31 | Astra Aktiebolag (Publ) | Polymorphic compounds |
| WO2002036563A1 (en) * | 2000-10-31 | 2002-05-10 | Ciba Specialty Chemicals Holding Inc. | Crystalline forms of fluvastatin sodium |
| WO2003013512A2 (en) * | 2001-08-03 | 2003-02-20 | Ciba Specialty Chemicals Holding Inc. | Crystalline forms of fluvastatin sodium |
| WO2004096765A2 (en) * | 2003-05-01 | 2004-11-11 | Morepen Laboratories Ltd. | A novel crystalline polymorph of fluvastatin sodium and a process for preparing it |
| WO2004113292A2 (en) * | 2003-06-18 | 2004-12-29 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium crystal forms, processes for preparing them, compositions containing them and methods of using them |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4739073A (en) | 1983-11-04 | 1988-04-19 | Sandoz Pharmaceuticals Corp. | Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof |
| EP1284964A1 (en) | 2000-05-26 | 2003-02-26 | Ciba SC Holding AG | Process for the preparation of indole derivatives and intermediates of the process |
| EP1423365A1 (en) | 2001-08-22 | 2004-06-02 | Ciba Specialty Chemicals Holding Inc. | Process for the preparation of indole derivatives |
| US20060105441A1 (en) | 2003-03-13 | 2006-05-18 | Reinhold Ohrlein | Process for the preparation of indole derivatives by enzymatic acylation |
| US7368468B2 (en) | 2003-06-18 | 2008-05-06 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium crystal forms XIV, LXXIII, LXXIX, LXXX and LXXXVII, processes for preparing them, compositions containing them and methods of using them |
-
2004
- 2004-10-06 US US10/576,784 patent/US7432380B2/en not_active Expired - Fee Related
- 2004-10-06 WO PCT/EP2004/052449 patent/WO2005037787A1/en active Application Filing
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997049681A1 (en) * | 1996-06-24 | 1997-12-31 | Astra Aktiebolag (Publ) | Polymorphic compounds |
| WO2002036563A1 (en) * | 2000-10-31 | 2002-05-10 | Ciba Specialty Chemicals Holding Inc. | Crystalline forms of fluvastatin sodium |
| WO2003013512A2 (en) * | 2001-08-03 | 2003-02-20 | Ciba Specialty Chemicals Holding Inc. | Crystalline forms of fluvastatin sodium |
| WO2004096765A2 (en) * | 2003-05-01 | 2004-11-11 | Morepen Laboratories Ltd. | A novel crystalline polymorph of fluvastatin sodium and a process for preparing it |
| WO2004113292A2 (en) * | 2003-06-18 | 2004-12-29 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium crystal forms, processes for preparing them, compositions containing them and methods of using them |
| WO2004113291A2 (en) * | 2003-06-18 | 2004-12-29 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium crystal forms xiv, lxxiii,lxxix, lxxx and lxxxvii, processes for preparing them, compositions containing them and methods of using them |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006030304A2 (en) * | 2004-09-17 | 2006-03-23 | Ranbaxy Laboratories Limited | Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof |
| WO2006030304A3 (en) * | 2004-09-17 | 2006-12-07 | Ranbaxy Lab Ltd | Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof |
| WO2007100894A2 (en) * | 2006-02-27 | 2007-09-07 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium novel forms and preparation therof |
| WO2007100894A3 (en) * | 2006-02-27 | 2008-01-24 | Teva Pharma | Fluvastatin sodium novel forms and preparation therof |
Also Published As
| Publication number | Publication date |
|---|---|
| US7432380B2 (en) | 2008-10-07 |
| US20060241167A1 (en) | 2006-10-26 |
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