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WO2005089720A1 - Comprimes a base de valsartan et procede de preparation associe - Google Patents

Comprimes a base de valsartan et procede de preparation associe Download PDF

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Publication number
WO2005089720A1
WO2005089720A1 PCT/IB2005/000578 IB2005000578W WO2005089720A1 WO 2005089720 A1 WO2005089720 A1 WO 2005089720A1 IB 2005000578 W IB2005000578 W IB 2005000578W WO 2005089720 A1 WO2005089720 A1 WO 2005089720A1
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WO
WIPO (PCT)
Prior art keywords
tablet
valsartan
disintegrants
blend
disintegrant
Prior art date
Application number
PCT/IB2005/000578
Other languages
English (en)
Inventor
Romi Barat Singh
Girish K. Karanth
Vishnubhotla Nagaprasad
Original Assignee
Ranbaxy Laboratories Limited
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ranbaxy Laboratories Limited filed Critical Ranbaxy Laboratories Limited
Publication of WO2005089720A1 publication Critical patent/WO2005089720A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Definitions

  • the present invention relates to valsartan tablets for oral administration comprising valsartan, at least two different disintegrants, and optionally hydrochlorthiazide (HCTZ); and processes of preparation thereof.
  • the present invention also relates to methods of treating hypertension administering to a mammal a valsartan tablet disclosed herein.
  • Valsartan is a non-peptide, orally active and specific angiotensin II antagonist acting on the ATi receptor subtype.
  • Valsartan is chemically described as N-(l-oxopentyl)- N- ⁇ [2'-(lH-tetrazol-5-yl)[l,l'-biphenyl]-4-yl]methyl ⁇ -L -valine.
  • valsartan tablets are marketed by Novartis as DIOVAN ® in doses of 40, 80, 160 and 320 mg and it is indicated for the treatment of hypertension.
  • HCTZ is a loop diuretic and is chemically described as 6-chloro-3,4-dihydro-2H- l,2,4-benzothiadiazine-7-sulfonamide- 1,1 -dioxide.
  • valsartan and HCTZ are indicated for treatment of hypertension in patients failing to achieve the desired effect with monotherapy.
  • Fixed-dose combination tablets are marketed by Novartis as DIOVAN HCT ® in doses of 80 mg/12.5 mg; 160 mg/12.5 mg and 160 mg/25 mg of valsartan/HCTZ respectively.
  • Both valsartan and HCTZ are fluffy materials having low density.
  • preparation of solid dosage forms of acceptable size and suitable for oral administration is a challenging task.
  • U.S. Patent Nos. 6,294,197 and 6,485,745, assigned to Novartis disclose the preparation of compressed tablets of valsartan by a dry granulation technique.
  • the process comprises the steps of: blending valsartan, with or without HCTZ, and at least one pharmaceutically acceptable additive to form a mixture; subjecting the mixture to compression to form a coprimate; converting the coprimate into a granulate; and compressing the granulate to form the compressed tablet.
  • the process of compressing valsartan-containing tablets leads to the formation of a high-density product.
  • high-density products are problematic in that they do not disintegrate satisfactorily, which leads to improper dissolution and sub-therapeutic concentration levels. Accordingly, there remains a need for a process to form valsartan tablets that exhibits good disintegration behavior.
  • valsartan tablets which disintegrate rapidly thereby enhancing dissolution properties, as well as processes of preparing such tablets and methods of treating hypertension by administering such tablets to a patient.
  • tablets comprising valsartan, and at least two disintegrants, wherein the at least two disintegrants are present intragranularly, extragranularly or both.
  • the at least two disintegrants can comprise at least one intragranular disintegrant and at least one extragranular disintegrant.
  • the intragranular disintegrant and the extragranular disintegrant can be the same or different.
  • the at least one intragranular disintegrant and the at least one extragranular disintegrant can also be present in a ratio from about 1 :1 to about 1 :0.1.
  • the at least two disintegrants can be independently selected from starch, starch glycolate, crospovidone; cellulose-based disintegrants, or mixtures thereof.
  • the at least two disintegrants can be crospovidone and at least one additional disintegrant, for example, can be one or more cellulose-based disintegrants, which can include hydroxypropylcellulose-low substituted (L-HPC), carboxy methylcellulose calcium, carboxy methylcellulose sodium, croscarmellose sodium or mixtures thereof.
  • the concentration of the at least two disintegrants can be from about 1% w/w to
  • the concentration of crospovidone can be from about 1% w/w to about 60% w/w.
  • the one or more cellulose-based disintegrants can be L-HPC, wherein L-HPC can be present at a concentration from about 1% w/w to about 60% w/w.
  • the tablet can further comprise 6-chloro-3,4-dihydro-2H-l,2,4-benzothiadiazine-7- sulfonamide- 1,1 -dioxide (HCTZ).
  • the tablet can further comprise one or more pharmaceutically acceptable additives, for example, binders, diluents, lubricants/glidants, coloring agents or mixtures thereof.
  • the tablet can be further coated with one or more non-functional coating layers comprising one or more film- forming polymers, for example, ethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, methylcellulose, carboxymethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropyl methyl phthalate, cellulose acetate, cellulose acetate trimelliatate, cellulose acetate phthalate; waxes, methacrylic acid polymers, or mixtures thereof.
  • processes for the preparation of valsartan tablets comprising the steps of blending valsartan and at least two disintegrants to form a blend, and compressing the blend into a tablet.
  • step (a) can comprise: blending HCTZ, valsartan, at least two disintegrants, optionally one or more lubricants/glidants, optionally one or more diluents, and optionally one or more binders to form a blend, blending one or more binders, valsartan, at least two disintegrants, optionally one or more lubricants/glidants, optionally one or more diluents and optionally HCTZ to form a blend, blending one or more lubricants/glidants, valsartan, at least two disintegrants, optionally one or more binders, optionally one or more diluents and optionally HCTZ to form a blend, or blending one or more diluents, valsartan, at least two disintegrants, optionally one or more binders, optionally one or more lubricants/glidants and optionally HCTZ to form a blend, or blending one or more dil
  • the process can further comprise the step of (c) coating the tablet with one or more non-functional layers.
  • processes for the preparation of valsartan tablet comprising the steps of blending valsartan and at least one intragranular disintegrant to form a first blend, granulating the first blend into a granulate, blending the granulate with at least one extragranular disintegrant to form a second blend, and compressing the second blend into a tablet, wherein the at least one intragranular disintegrant and the at least one extragranular disintegrant are the same or different.
  • Embodiments of the processes can include one or more of the following features.
  • step (a) can comprise blending valsartan, at least one intragranular disintegrant, one or more diluents, and one or more binders to form a first blend; or blending valsartan, at least one intragranular disintegrant, and HCTZ to form a first blend.
  • step (c) can comprise blending the granules with at least one intragranular disintegrant and one or more lubricants/glidants to form a second blend.
  • the at least one intragranular disintegrant can be L-HPC and crospovidone and the at least one extragranular disintegrant is crospovidone.
  • the granules can be prepared by a wet granulation or dry granulation.
  • the tablet can also be coated with one or more non-functional coating layers.
  • the one or more non-functional coating layers can be coated on the tablet as a solution/dispersion of one or more coating components in one or more solvents selected from methylene chloride, isopropyl alcohol, acetone, methanol, ethanol, water or mixtures thereof.
  • methods of treating hypertension comprising administering to a mammal in need thereof a valsartan tablet comprising valsartan, and at least two disintegrants, wherein the disintegrants are present intragranularly, extragranularly or both.
  • Embodiments of the methods can include one or more of the following features.
  • one of the at least two disintegrants can be crospovidone.
  • the tablet can further comprise HCTZ.
  • the present invention relates to processes of manufacturing valsartan tablets, which disintegrate rapidly thereby enhancing dissolution properties. Such good disintegrating behavior and dissolution properties can be facilitated, for example, by using particular combinations of disintegrants, e.g., by using at least two disintegrants. Such disintegrants may be present intragranularly or extragranularly or both.
  • the present invention also relates to valsartan tablets having at least one intragranular and one extragranular disintegrant, wherein the combination of intragranular and extragranular disintegrants are different. Such valsartan tablets provide more desirable disintegration and dissolution properties.
  • valsartan tablets comprising valsartan and at least two disintegrants.
  • valsartan tablets comprising valsartan, at least one intragranular and one extragranular disintegrant, wherein the intragranular and extragranular disintegrants may be different.
  • valsartan tablets comprising valsartan, crospovidone and at least one additional disintegrant other than crospovidone.
  • valsartan tablets comprising valsartan, crospovidone and at least one cellulose-based disintegrant.
  • processes for the preparation of valsartan tablets comprising the steps of: a) blending valsartan and at least two disintegrants to form a blend and b) compressing the blend into a tablet.
  • processes for the preparation of valsartan tablets comprising the steps of: a) blending valsartan and at least one intragranular disintegrant to form a blend b) granulating the blend into a granulate, c) blending the granulate with at least one extragranular disintegrant to form a second blend and d) compressing the second blend into a tablet; wherein the intragranular and extragranular disintegrants may be the same or different.
  • methods for the treatment of hypertension in a mammal in need thereof by administering to the mammal a valsartan tablet comprising a therapeutically effective amount of valsartan and at least two disintegrants.
  • methods for the treatment of hypertension in a mammal in need thereof by administering to the mammal a valsartan tablet comprising a therapeutically effective amount of valsartan, at least one intragranular disintegrant and at least one extragranular disintegrant, wherein the at least one intragranular disintegrant and extragranular disintegrants may be different.
  • Valsartan tablets of any of the aspects above may further comprise HCTZ (6- chloro-3 ,4-dihydro-2H- 1 ,2,4-benzothiadiazine-7-sulfonamide- 1 , 1 -dioxide) .
  • Tablets comprising HCTZ may be prepared by incorporating HCTZ in a blend comprising valsartan.
  • valsartan may include free acid forms of valsartan and pharmaceutically acceptable salts thereof. Valsartan may be used in an amount which either reduces or halts the progress of the pathological condition being treated or which otherwise cures the condition partly or completely; and the amount may vary from about 10 to about 350 mg. In addition to valsartan, the tablet may also comprise from about 6 to about 60 mg HCTZ or pharmaceutically acceptable salt thereof.
  • disintegrants includes all physiologically inert disintegrants used in the pharmaceutical art of dispensing.
  • Examples include starch, starch glycolate, crospovidone, and cellulose-derivatives (e.g., hydroxypropylcellulose-low substituted (L-HPC), carboxy methylcellulose calcium, carboxy methylcellulose sodium, croscarmellose sodium, and the like), or mixtures thereof.
  • the concentration of disintegrants may vary from about 1% w/w to about 80% w/w.
  • crospovidone and L-HPC may be used from about 1% w/w to about 60% w/w and about 1% w/w to about 60%) w/w, respectively.
  • their ratio may vary from about 1 : 1 to about 1 :0.1.
  • valsartan tablets of the present invention may further comprise one or more pharmaceutically acceptable additives, which can, for example, provide bulk and aid in processing.
  • pharmaceutically acceptable additive includes all physiologically inert additives used in the pharmaceutical art of dispensing. Examples include binders, diluents, lubricants/glidants, coloring agents, and the like, or mixtures thereof.
  • binders include methyl cellulose, hydroxypropylcellulose, polyvinylpyrrolidone, gelatin, gum Arabic, ethylcellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol, and the like, or mixtures thereof.
  • diluents include calcium carbonate, calcium phosphate-dibasic, calcium phosphate-tribasic, calcium sulfate, microcrystalhne cellulose, silicified microcrystalhne cellulose, cellulose powdered, dextrates, dextrins, dextrose excipients, fructose, kaolin, lactitol, lactose, mannitol, sorbitol, starch, starch pregelatinized, sucrose, sugar compressible, sugar confectioners, and the like, or mixtures thereof.
  • lubricants and glidants examples include silicon dioxide, colloidal silicon dioxide, stearic acid, magnesium stearate, calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acids, microcrystalhne wax, yellow beeswax, white beeswax and the like, or mixtures thereof.
  • the coloring agents may be selected from any FDA approved color agents for oral use.
  • the valsartan tablets may further be coated with one or more non-functional layers comprising film- forming polymers with or without other coating additives, if desired.
  • film forming polymers examples include ethylcellulose, hydroxypropyl ethylcellulose, hydroxypropylcellulose, methylcellulose, carboxymethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropyl methyl phthalate, cellulose acetate, cellulose acetate trimelliatate, cellulose acetate phthalate; waxes such as polyethylene glycol; methacrylic acid polymers, e.g., EUDRAGIT ® RL and RS; and the like or mixtures thereof.
  • commercially available coating compositions comprising film- forming polymers marketed under various trade names, e.g. , OPADRY ® , may also be used as a coating.
  • Valsartan tablets disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan and at least two disintegrants to form a blend and (b) compressing the blend into a tablet.
  • valsartan tablets disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan with one or more diluents, one or more binders, at least two disintegrants, and one or more lubricants/glidants to form a blend, (b) compressing the blend to form a tablet, and (c) optionally coating the tablet with one or more non-functional layers.
  • valsartan and HCTZ tablets disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan and HCTZ with one or more diluents, one or more binders, at least two disintegrants, and one or more lubricants/glidants to form a blend, (b) compressing the blend to form a tablet, and (c) optionally coating the tablet with one or more non- functional layers.
  • valsartan tablet disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan with one or more diluents, one or more binders, and at least one intragranular disintegrants to form a blend, (b) granulating the blend to form granules, (c) blending the granules with at least one extragranular disintegrant, and one or more lubricants/glidants to form a second blend, (d) compressing the second blend to form a tablet, and (e) optionally coating the tablet with one or more non-functional layers.
  • valsartan and HCTZ tablets disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan and HCTZ with one or more diluents, one or more binders, and at least one intragranular disintegrants to form a blend, (b) granulating the blend to form granules, (c) blending the granules with at least one extragranular disintegrant, and one or more lubricants/glidants to form a second blend, (d) compressing the second blend to form a tablet, and (e) optionally coating the tablets with one or more non- functional layers.
  • valsartan tablets disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan with one or more diluents, one or more binders, L-HPC and crospovidone as intragranular disintegrants to form a blend, (b) dry granulating the blend to form granules, (c) blending the granules with crospovidone as extragranular disintegrant, and one or more lubricants/glidants to form a second blend, (d) compressing the second blend to form a tablet, and (e) coating the tablet with one or more non-functional layers.
  • valsartan and HCTZ tablets disclosed herein can be prepared by processes comprising the steps of: (a) blending valsartan and HCTZ with one or more diluents, one or more binders, L-HPC and crospovidone as intragranular disintegrants to form a blend, (b) dry granulating the blend to form granules, (c) blending the granules with crospovidone as extragranular disintegrant, and one or more lubricants/glidants to form a second blend, (d) compressing the second blend to form a tablet, and (e) coating the tablet with one or more non-functional layers.
  • Granules may be prepared either by wet granulation or dry granulation techniques known to the skilled artisan. Dry granulation may be carried out, for example, by using a roller compactor and compacted at a compaction pressure of about 25-75 bar, more preferably from about 35-65 bar, at a roller speed from about 1-10 ⁇ m, more preferably from 2-5 ⁇ m.
  • the screw-feeder rate can be maintained at about 10-60 ⁇ m, more preferably at about 20-50 ⁇ m and the distance between the roller can be adjusted between about 0.1 to 1.0 mm, more preferably between about 0.2 to 0.5 mm.
  • dry granulation may also be carried out, for example, by the process of slugging.
  • wet granulation may be carried out, for example, by inco ⁇ orating binder in the blend comprising valsartan and granulating with aqueous and/or non aqueous granulating fluids.
  • binder may be dissolved/dispersed in granulating fluid.
  • the optional one or more non-functional coating layers may be applied, for example, as one or more solutions or dispersions of one or more film- forming polymers with or without other coating additives.
  • Such optional one or more non-functional coating layers can be applied using any conventional techniques known in the art, e.g., spray coating in a conventional coating pan or fluidized bed processor; dip coating and the like.
  • solvents used as granulating fluids and for preparing a solution dispersion of the coating components include methylene chloride, isopropyl alcohol, acetone, methanol, ethanol, water or mixtures thereof. While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are included within the scope of the present invention. The examples are provided to illustrate particular aspects of the disclosure and do not limit the scope of the present invention as defined by the claims. Examples Table 1. Valsartan tablet compositions
  • Valsartan was sifted through #44 BSS and blended with all other intragranular ingredients except magnesium stearate in a low shear blender for about 20-30 minutes. 2. The blend of step 1 was sifted and mixed with magnesium stearate for 5 minutes. 3. The blend of step 2 was compacted at a compaction pressure of about 25-75 bar in a roller compactor. 4. The compacts obtained from step 3 were milled in an oscillating granulator fitted with a screen of 0.5 mm. 5. The sized granules from step 4 were blended with extragranular ingredients and compressed into suitable-sized tablets. 6.
  • the tablets were then coated with aqueous Opadry ® to a weight build-up of about 3.0 to 4.0%) w/w.
  • the tablets of Examples 1, 2 and 3 were tested for in vitro release of valsartan in USP type II dissolution apparatus at a temperature of 37 ⁇ 0.5 °C, in 900 mL of 0.067M phosphate buffer (pH 6.8). The samples were analyzed for valsartan content using UV spectroscopic method. The in vitro release profile of valsartan tablets are shown in Table 2.

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Abstract

Cette invention concerne des comprimés à base de valsartan destinés à une administration par voie orale. Ces comprimés comprennent au moins deux délitants différents, et éventuellement de l'hydrochlorthiazide (HCTZ). La présente invention concerne également des procédés permettant de préparer ces comprimés. En outre, cette invention concerne des méthodes permettant de traiter l'hypertension, lesquelles méthodes consistent à administrer, à un mammifère, un comprimé à base de valsartan.
PCT/IB2005/000578 2004-03-10 2005-03-07 Comprimes a base de valsartan et procede de preparation associe WO2005089720A1 (fr)

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IN411/DEL/2004 2004-03-10
IN411DE2004 2004-03-10

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1897537A1 (fr) * 2006-09-04 2008-03-12 Novartis AG Composition contenant un antagoniste des récepteurs de l'angiotensine II
WO2008028885A2 (fr) * 2006-09-04 2008-03-13 Novartis Ag Formulation de composés organiques
WO2008056375A2 (fr) * 2006-11-09 2008-05-15 Lupin Limited Formulations pharmaceutiques comprenant du valsartan
US7378531B2 (en) 2003-04-21 2008-05-27 Teva Pharmaceutical Industries Ltd Process for the preparation of valsartan
EP2067470A1 (fr) * 2007-12-03 2009-06-10 Laboratorios Lesvi, S.L. Compositions pharmaceutiques contenant du valsartan et procédé pour sa préparation
CN101829111A (zh) * 2010-05-23 2010-09-15 浙江华海药业股份有限公司 含有缬沙坦的固体制剂及其制备方法
CN106619618A (zh) * 2016-12-28 2017-05-10 华润赛科药业有限责任公司 一种缬沙坦药物组合物及其制备方法
EP4295839A1 (fr) 2022-06-20 2023-12-27 KRKA, d.d., Novo mesto Combinaison de valsartan et d'indapamide

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0747050A1 (fr) * 1995-06-07 1996-12-11 Bristol-Myers Squibb Company Compositions pharmaceutiques d'irbésartan
WO1997049394A2 (fr) * 1996-06-27 1997-12-31 Novartis Ag Formes posologiques solides de valsartan administrees par voie orale
US20020155986A1 (en) * 1998-12-23 2002-10-24 Bullock Gillian Rosemary Additional therapeutic use
WO2004100857A2 (fr) * 2003-05-07 2004-11-25 Akina, Inc. Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0747050A1 (fr) * 1995-06-07 1996-12-11 Bristol-Myers Squibb Company Compositions pharmaceutiques d'irbésartan
WO1997049394A2 (fr) * 1996-06-27 1997-12-31 Novartis Ag Formes posologiques solides de valsartan administrees par voie orale
US20020155986A1 (en) * 1998-12-23 2002-10-24 Bullock Gillian Rosemary Additional therapeutic use
WO2004100857A2 (fr) * 2003-05-07 2004-11-25 Akina, Inc. Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7378531B2 (en) 2003-04-21 2008-05-27 Teva Pharmaceutical Industries Ltd Process for the preparation of valsartan
EP1897537A1 (fr) * 2006-09-04 2008-03-12 Novartis AG Composition contenant un antagoniste des récepteurs de l'angiotensine II
WO2008028885A2 (fr) * 2006-09-04 2008-03-13 Novartis Ag Formulation de composés organiques
WO2008028885A3 (fr) * 2006-09-04 2008-05-02 Novartis Ag Formulation de composés organiques
WO2008056375A2 (fr) * 2006-11-09 2008-05-15 Lupin Limited Formulations pharmaceutiques comprenant du valsartan
WO2008056375A3 (fr) * 2006-11-09 2008-07-10 Lupin Ltd Formulations pharmaceutiques comprenant du valsartan
EP2067470A1 (fr) * 2007-12-03 2009-06-10 Laboratorios Lesvi, S.L. Compositions pharmaceutiques contenant du valsartan et procédé pour sa préparation
CN101829111A (zh) * 2010-05-23 2010-09-15 浙江华海药业股份有限公司 含有缬沙坦的固体制剂及其制备方法
CN101829111B (zh) * 2010-05-23 2014-12-17 浙江华海药业股份有限公司 含有缬沙坦的固体制剂及其制备方法
CN106619618A (zh) * 2016-12-28 2017-05-10 华润赛科药业有限责任公司 一种缬沙坦药物组合物及其制备方法
EP4295839A1 (fr) 2022-06-20 2023-12-27 KRKA, d.d., Novo mesto Combinaison de valsartan et d'indapamide

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