WO2008056375A2 - Formulations pharmaceutiques comprenant du valsartan - Google Patents

Formulations pharmaceutiques comprenant du valsartan Download PDF

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Publication number
WO2008056375A2
WO2008056375A2 PCT/IN2007/000516 IN2007000516W WO2008056375A2 WO 2008056375 A2 WO2008056375 A2 WO 2008056375A2 IN 2007000516 W IN2007000516 W IN 2007000516W WO 2008056375 A2 WO2008056375 A2 WO 2008056375A2
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
valsartan
wet granulation
prepared
active agent
Prior art date
Application number
PCT/IN2007/000516
Other languages
English (en)
Other versions
WO2008056375A3 (fr
Inventor
Anirudha Kute
Nikhil Prabhakar Malewar
Makarand Krishnakumar Avachat
Original Assignee
Lupin 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 Lupin Limited filed Critical Lupin Limited
Publication of WO2008056375A2 publication Critical patent/WO2008056375A2/fr
Publication of WO2008056375A3 publication Critical patent/WO2008056375A3/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
    • A61K31/41—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Definitions

  • the invention relates to a solid pharmaceutical composition comprising valsartan and optionally hydrochlorothiazide and a process for its preparation.
  • Valsartan is an angiotensin II antagonist and is known to be effective in the treatment of congestive heart failure and reducing blood pressure irrespective of age, sex or race and is also well tolerated. It has also been approved to treat people after heart attacks.
  • Hydrochlorothiazide is a thiazide diuretic and was first disclosed in the U.S. patent 3,163,645.
  • U.S. patent No: 5,399,578 describes the preparation of valsartan and its pharmaceutically acceptable salt. It also describes a pharmaceutical composition of valsartan and a process for its preparation. Valsartan, lactose and Potato starch are mixed and granulated with an ethanolic solution of gelatin. After drying, the rest of potato starch, talc, magnesium stearate and highly disperse colloidal silica are admixed to the granulate and compressed into tablets. Tablets can be film-coated.
  • valsartan, lactose and maize starch are mixed and granulated with a dispersion of maize starch in warmed water. After drying, the rest of maize starch, talc and calcium stearate are admixed to the granulate and compressed in cores. Cores are coated with a dispersion of hydroxypropylmethylcellulose and shellac in dichloromethane.
  • EP 0914119 and EP 1410797 describe a solid oral dosage form of valsartan and optionally hydrochlorthiazide (HCTZ) prepared by compression method having more than 35% by weight based on total weight of the compressed solid oral dosage form, of the active ingredient. The process is carried out in the absence of water.
  • PCT application WO 2005/041941 relates to a pharmaceutical composition containing valsartan, optionally a combination of valsartan with hydrochlorothiazide, obtainable by direct tabletting.
  • PCT application WO 00/38676 further describes solid oral dosage forms comprising valsartan (20 to 65%), macrocrystalline cellulose (31 to 65%) and crospovidone (2 to 13%). Further, a solid oral dosage form comprising valsartan and microcrystalline cellulose in a weight ratio from 2.5: 1 to 0.3:1 is claimed. The method for preparing such compositions is again dry granulation.
  • WO 01/97805 claims a composition of valsartan or a pharmaceutically acceptable salt or hydrate thereof and a disintegrant in a weight ratio of between 5.1:1 and 0.5:1.
  • the suggested method for preparing such compositions is again dry granulation.
  • An object of the invention is to provide a pharmaceutical composition comprising Angiotensin II Antagonist, wherein the pharmaceutical composition is prepared by wet granulation.
  • Another object of the invention is to provide a pharmaceutical composition comprising Angiotensin II Antagonist and one or more diuretics, wherein the pharmaceutical composition is prepared by wet granulation.
  • Another object of the invention is to provide a pharmaceutical composition comprising valsartan, wherein the pharmaceutical composition is prepared by wet granulation.
  • Another object of the invention is to provide a pharmaceutical composition comprising valsartan and one or more diuretics, wherein the pharmaceutical composition is prepared by wet granulation.
  • Another object of the invention is to provide a pharmaceutical composition comprising valsartan and hydrochlorothiazide, wherein the pharmaceutical composition is prepared by wet granulation.
  • Another object of the invention is to provide a pharmaceutical composition comprising valsartan prepared by wet granulation, wherein the pharmaceutical composition is bioequivalent to Diovan®.
  • Another object of the invention is to provide a pharmaceutical composition comprising valsartan and hydrochlorothiazide prepared by wet granulation, wherein the pharmaceutical composition is bioequivalent to DiovanHCT®.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising a) an active agent comprising an effective amount of Angiotensin II Antagonist and b) pharmaceutically acceptable additives, wherein the active agent is present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising
  • an active agent comprising an effective amount of Angiotensin II Antagonist and one or more diuretics, and b) pharmaceutically acceptable additives, wherein the active agents are present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising a) an active agent comprising an effective amount of valsartan; and b) pharmaceutically acceptable additives, wherein the active agent is present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising
  • an active agent comprising an effective amount of valsartan and one or more diuretics; and b) pharmaceutically acceptable additives, wherein the active agents are present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising
  • an active agent comprising an effective amount of valsartan, Hydrochlorothiazide, and b) pharmaceutically acceptable additives, wherein the active agents are present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising valsartan, pregelatinized starch, microcrystalline cellulose, crospovidone, croscarmelloses sodium, colloidal silicon dioxide and magnesium stearate.
  • Another object of the invention is to provide a pharmaceutical composition prepared by wet granulation comprising valsartan, hydrochlorothiazide, pregelatinized starch, microcrystalline cellulose, crospovidone, croscarmelloses sodium, colloidal silicon dioxide and magnesium stearate.
  • the present invention relates to a pharmaceutical composition
  • a pharmaceutical composition comprising Angiotensin II Antagonist, wherein the pharmaceutical composition is prepared by wet granulation.
  • a further active ingredient can also be present in the composition, preferably a diuretic agent.
  • the present invention relates to a pharmaceutical composition
  • a pharmaceutical composition comprising Angiotensin II Antagonist, wherein the pharmaceutical composition is prepared by wet granulation.
  • a further active ingredient can also be present in the composition, preferably a diuretic agent.
  • a pharmaceutical composition comprises valsartan, wherein the pharmaceutical composition is prepared by wet granulation.
  • a pharmaceutical composition comprises valsartan and hydrochlorothiazide, wherein the pharmaceutical composition is prepared by wet granulation.
  • a pharmaceutical composition prepared by wet granulation comprises a) an active agent comprising an effective amount of Angiotensin II Antagonist; and b) pharmaceutically acceptable additives, wherein the active agent is present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • a pharmaceutical composition prepared by wet granulation comprises a) an active agent comprising an effective amount of Angiotensin II Antagonist and diuretics; and
  • a pharmaceutical composition prepared by wet granulation LO comprises a) an active agent comprising an effective amount of valsartan; and b) pharmaceutically acceptable additives, wherein the active agent is present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • a pharmaceutical composition prepared by wet granulation comprises a) an active agent comprising an effective amount of valsartan and diuretics; and b) pharmaceutically acceptable additives,
  • the active agents are present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • a pharmaceutical composition prepared by wet granulation comprises 5 a) an active agent comprising an effective amount of valsartan and hydrochlorothiazide, and b) pharmaceutically acceptable additives, wherein the active agents are present in an amount less than 35% by weight based on the total weight of the pharmaceutical composition.
  • a pharmaceutical composition is provided wherein the Angiotensin II Antagonist and one or more diuretic (such as Hydrochlorothiazide) are formulated together in a single tablet.
  • the tablet of the invention is in the form of a bilayered tablet, which includes a first layer and a second layer.
  • “Pharmaceutical composition” includes granules, pellets, tablets., pills, capsules and the like prepared by conventional methods well known to a person skilled in the art.
  • the dosage form is preferably suitable for oral application and is preferably formulated in unit dosage form.
  • Angiotensin II Antagonist includes Valsartan, Losartan, Irbesartan, Olmeasartan Telmisartan, Eprosartan and Candesartan as pharmaceutically acceptable salts, derivatives, polymorphs, enantiomers, isomers, esters, acids, crystalline form, amorphous form hydrated or solvated form, anhydrous form or mixtures thereof.
  • Diuretics as used in the present invention include thiazide diuretics such as hydrochlorothiazide.
  • the pharmaceutical composition of the invention further comprises pharmaceutically acceptable additives, which include but are not limited to disintegrants, binders, lubricants, glidants, fillers or diluents and solvents.
  • pharmaceutically acceptable additives include but are not limited to disintegrants, binders, lubricants, glidants, fillers or diluents and solvents.
  • Disintegrants include but are not limited to, starches like maize starch, dried starch; modified starches viz. pregelatinized starch and sodium starch glycolate; gums such as alginic acid, sodium alginate, guar gum; croscarmellose sodium, cellulose products such as macrocrystalline cellulose and its salts, microfine . cellulose, low substituted hydroxypropylcellulose and mixtures thereof; ion exchange resins like polacrilin potassium; most preferably crosslinked polyvinylpyrrolidone, crospovidone, crosslinked CMC and Ac- Di-SoI; bentonite.
  • Binders include, but are not limited to, carbohydrates like starches such as potato starch, wheat starch, corn starch; liquid glucose, dextrin; celluloses such as hydroxypropyl celluloses and modified celluloses like hydroxyethyl cellulose, hydroxypropylmethyl cellulose, ethyl cellulose, sodium carboxy methyl cellulose; macrocrystalline cellulose such as products known under the registered trade marks Avicel, Filtrak, Heweten or Pharmacel; natural gums like acacia, alginic acid, guar gum; povidone, syrup, polyethylene oxide, gelatine, amino acid derivatives and mixtures thereof.
  • Lubricants may be selected from, but are not limited to, those conventionally known in the art such as Mg, Al or Ca or Zn stearate, polyethylene glycol, glyceryl behenate, mineral oil, sodium stearyl fumarate, stearic acid, hydrogenated vegetable oil and talc.
  • Glidants include, but are not limited to, silicon dioxide; magnesium trisilicate, powdered cellulose, starch, talc and tribasic calcium phosphate.
  • Fillers or diluents which include, but are not limited to any modified or unmodified carbohydrates or their salts, esters; confectioner's sugar, compressible sugar, dextrates, dextrin, dextrose, fructose, lactitol, mannitol, sucrose, starch, lactose, xylitol, sorbitol, talc, celluloses or modified celluloses, microcrystalline cellulose, inorganic fillers such as group I and II metal salts like carbonates, silicates, borates, sulphates, phosphates and mixtures thereof.
  • Solvents include aqueous or non-aqueous solvents.
  • additives can be selected and used by the skilled artisan having regard to the particular desired properties of the solid oral dosage form.
  • the amount of each type of additive employed, e.g. glidant, binder, disintegrant, filler or diluent and lubricant may vary within ranges conventional in, the art.
  • the pharmaceutical composition of the invention wherein the dosage form can be formed by various methods known in the art such as by dry granulation, wet granulation, direct compression, extrusion spheronization, layering and the like.
  • the preferred method of formulating the pharmaceutical composition is wet granulation by aqueous or non-aqueous method.
  • a wet granulation process is characterized in that the binder is pre-mixed with the active ingredient, and then the solvent is mixed with this pre- mix.
  • a wet granulation process is characterized in that the binder is dissolved or suspended in the solvent, and this solution or suspension is mixed with the active ingredient.
  • composition of the invention is further coated, wherein coating or the coating layer comprises one or more excipients selected from the group comprising coating agents, plasticizers,' antitacking agents, surfactants, coloring agents and opacifiers.
  • Coating agents are one or more selected from the group comprising, but are not limited to, polysaccharides such as maltodextrin; alkyl celluloses such as methyl or ethyl cellulose, hydroxyalkylcelluloses (e.g. hydroxypropylcellulose or hydroxypropylmethylcelluloses); polyvinylpyrrolidone, polyvinyl alcohol, copolymers of vinylpyrrolidone and vinyl acetate (e.g.
  • aqueous or non-aqueous systems may be applied from aqueous or non-aqueous systems or combinations of aqueous and non — aqueous systems as appropriate.
  • the solvent used in the non-aqueous coating comprises isopropyl alcohol, acetone, methanol and mixtures thereof. Purified water is used in the aqueous coating.
  • Plasticizers are selected from the group comprising, but are not limited to, dibutyl phthalate, triethyl citrate, polyethylene glycol, polyethylene derivative such as polysorbate and mixtures thereof.
  • Antitacking agents are one or more selected from the group comprising, but are not limited to, talc, stearic acid its salts and derivatives, and colloidal silicon dioxide.
  • Surfactants are one or more selected from the group comprising, but are not limited to, polysorbates and sodium lauryl sulphate.
  • Coloring agents may be selected from, but are not limited to, those conventionally known in the art such as titanium dioxide, iron oxide red, black iron oxide, yellow iron oxide etc.
  • Coating can be done using numerous known methods employed in the art, e.g. spray coating in a fluidized bed, or by any known methods using apparatus available in conventional pans 5 or perforated pans.
  • step 3 material in to a suitable blender and mix.
  • step 3 material in to a suitable blender and mix.
  • step 4 Granulate the mixture of step 4 with purified water. 6. Dry the wet granules in a suitable dryer at temperature of 45-50°C, till a desired LOD is obtained.
  • step 8 Load the dried granules of Valsartan and material of step 8 in a suitable blender and mix.
  • step 3 material Load the step 3 material in to a suitable blender and mix. 5. Granulate the mixture of step 4 with purified water.
  • step 3 material in to a suitable blender and mix.
  • step 8 Load the dried ' granules of Valsartan and material of step 8 in a suitable blender and mix.
  • a randomized, open label, balanced, two-treatment, two-period, two-sequence, single -dose, crossover bioequivalence study was carried out in 8 healthy human volunteers receiving single dose of Valsartan and Hydrochlorothiazide in fasted state using immediate release tablets comprising 320mg of Valsartan and 25mg of Hydrochlorothiazide prepared according to example 1, as test and DIOVAN HCT ® having Valsartan 320mg and Hydrochlorothiazide 25mg, by Novartis, as reference. Study was monitored in terms of the pharmacokinetic parameters C max and AUC.
  • AUCs are plots of plasma concentrations of valsartan along the ordinate (Y-axis) against time on the abscissa (X-axis).
  • the values for AUC represent a number of values taken from all the subjects in a population and are, therefore, mean values averaged over the entire population.
  • C max the observed maximum in a plot of plasma level concentration of valsartan (Y-axis) versus time (X-axis) is likewise an average value.
  • T/R ratio The ratios of the log transformed mean values for C max and AUC for the test and reference product (T/R ratio) is a measure of the bioequivalence between the test and reference product. Values between 80 and 125 % for the 90% confidence intervals of these ratios indicate bioequivalence as recommended by the US FDA. Bioequivalence data for the Valsartan Hydrochlorothiazide tablets against the commercially available tablets "DIOVAN HCT ® " is shown below in Table 1.
  • AUC (o-t) Area under the plasma concentration time curve from time 0 to t
  • AUC ( O-00 ) Area under the plasma concentration time curve from time 0 to ⁇

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une composition pharmaceutique comprenant un antagoniste de l'angiotensine II, ladite composition pharmaceutique étant préparée par granulation en voie humide ; une composition pharmaceutique comprenant un antagoniste de l'angiotensine II et un ou plusieurs diurétiques, ladite composition pharmaceutique étant préparée par granulation en voie humide ; une composition pharmaceutique préparée par granulation en voie humide comprenant un agent actif comprenant une quantité efficace d'un antagoniste de l'angiotensine II et des additifs acceptables du point de vue pharmaceutique, l'agent actif étant présent en quantité inférieure à 35 % en poids sur la base du poids total de la composition pharmaceutique.
PCT/IN2007/000516 2006-11-09 2007-11-02 Formulations pharmaceutiques comprenant du valsartan WO2008056375A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1200/KOL/2006 2006-11-09
IN1200KO2006 2006-11-09

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Publication Number Publication Date
WO2008056375A2 true WO2008056375A2 (fr) 2008-05-15
WO2008056375A3 WO2008056375A3 (fr) 2008-07-10

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008120242A1 (fr) * 2007-03-29 2008-10-09 Alembic Limited Formulations de comprimés de valsartan
WO2009022169A1 (fr) * 2007-08-10 2009-02-19 Generics [Uk] Limited Composition de valsartan solide
WO2011102702A2 (fr) 2010-02-16 2011-08-25 Krka, D. D., Novo Mesto Procédé pour la préparation de formes posologiques solides orales comprenant du valsartan
CN102247376A (zh) * 2011-08-15 2011-11-23 北京赛科药业有限责任公司 复方缬沙坦氢氯噻嗪固体制剂及其制备方法
WO2013098576A1 (fr) 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Composition pharmaceutique de valsartan à libération immédiate
WO2013098578A1 (fr) 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Composition pharmaceutique d'hydrochlorothiazide de valsartan à libération immédiate
KR101446603B1 (ko) * 2011-11-22 2014-10-07 주식회사 인트로팜텍 텔미사르탄을 포함하는 단층정 복합 제제
KR101509489B1 (ko) * 2008-11-10 2015-04-08 (주)아모레퍼시픽 발사르탄을 함유하는 고형 경구제형의 제조 방법

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6465502B1 (en) * 1998-12-23 2002-10-15 Novartis Ag Additional therapeutic use
WO2005082329A2 (fr) * 2004-02-19 2005-09-09 Ranbaxy Laboratories Limited Procede de preparation de formes posologiques solides de valsartan et d'hydrochlorthiazide
WO2005089720A1 (fr) * 2004-03-10 2005-09-29 Ranbaxy Laboratories Limited Comprimes a base de valsartan et procede de preparation associe
EP1674080A1 (fr) * 2004-12-24 2006-06-28 KRKA, D.D., Novo Mesto Composition pharmaceutique comprenant du valsartan

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6465502B1 (en) * 1998-12-23 2002-10-15 Novartis Ag Additional therapeutic use
WO2005082329A2 (fr) * 2004-02-19 2005-09-09 Ranbaxy Laboratories Limited Procede de preparation de formes posologiques solides de valsartan et d'hydrochlorthiazide
WO2005089720A1 (fr) * 2004-03-10 2005-09-29 Ranbaxy Laboratories Limited Comprimes a base de valsartan et procede de preparation associe
EP1674080A1 (fr) * 2004-12-24 2006-06-28 KRKA, D.D., Novo Mesto Composition pharmaceutique comprenant du valsartan

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008120242A1 (fr) * 2007-03-29 2008-10-09 Alembic Limited Formulations de comprimés de valsartan
WO2009022169A1 (fr) * 2007-08-10 2009-02-19 Generics [Uk] Limited Composition de valsartan solide
AU2008288296B2 (en) * 2007-08-10 2014-01-16 Generics [Uk] Limited Solid valsartan composition
KR101509489B1 (ko) * 2008-11-10 2015-04-08 (주)아모레퍼시픽 발사르탄을 함유하는 고형 경구제형의 제조 방법
WO2011102702A2 (fr) 2010-02-16 2011-08-25 Krka, D. D., Novo Mesto Procédé pour la préparation de formes posologiques solides orales comprenant du valsartan
CN102247376A (zh) * 2011-08-15 2011-11-23 北京赛科药业有限责任公司 复方缬沙坦氢氯噻嗪固体制剂及其制备方法
KR101446603B1 (ko) * 2011-11-22 2014-10-07 주식회사 인트로팜텍 텔미사르탄을 포함하는 단층정 복합 제제
WO2013098576A1 (fr) 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Composition pharmaceutique de valsartan à libération immédiate
WO2013098578A1 (fr) 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Composition pharmaceutique d'hydrochlorothiazide de valsartan à libération immédiate

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