BR0207880A - Formulação farmacêutica, processo para preparação da mesma e uso de formulação sólida - Google Patents
Formulação farmacêutica, processo para preparação da mesma e uso de formulação sólidaInfo
- Publication number
- BR0207880A BR0207880A BR0207880-5A BR0207880A BR0207880A BR 0207880 A BR0207880 A BR 0207880A BR 0207880 A BR0207880 A BR 0207880A BR 0207880 A BR0207880 A BR 0207880A
- Authority
- BR
- Brazil
- Prior art keywords
- atorvastatin
- calcium
- formulation
- preparation
- amorphous
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 239000007787 solid Substances 0.000 title abstract 2
- 238000000034 method Methods 0.000 title 1
- XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 abstract 3
- XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 abstract 3
- 229960005370 atorvastatin Drugs 0.000 abstract 3
- 239000000126 substance Substances 0.000 abstract 3
- BWFCZHDTTAYGNN-CNZCJKERSA-N calcium;(3r,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid Chemical compound [Ca].C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 BWFCZHDTTAYGNN-CNZCJKERSA-N 0.000 abstract 2
- 230000001225 therapeutic effect Effects 0.000 abstract 2
- OJRHUICOVVSGSY-RXMQYKEDSA-N (2s)-2-chloro-3-methylbutan-1-ol Chemical compound CC(C)[C@H](Cl)CO OJRHUICOVVSGSY-RXMQYKEDSA-N 0.000 abstract 1
- 102000004286 Hydroxymethylglutaryl CoA Reductases Human genes 0.000 abstract 1
- 108090000895 Hydroxymethylglutaryl CoA Reductases Proteins 0.000 abstract 1
- 125000002490 anilino group Chemical group [H]N(*)C1=C([H])C([H])=C([H])C([H])=C1[H] 0.000 abstract 1
- 239000003529 anticholesteremic agent Substances 0.000 abstract 1
- 229960001770 atorvastatin calcium Drugs 0.000 abstract 1
- 159000000007 calcium salts Chemical class 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 125000002915 carbonyl group Chemical group [*:2]C([*:1])=O 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
- 239000003826 tablet Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
Abstract
"FORMULAçãO FARMACêUTICA, PROCESSO PARA PREPARAçãO DA MESMA E USO DE FORMULAçãO SóLIDA". Atorvastatina cálcica, a substância conhecida pelo nome químico sal semi cálcio de [(R-(R*,R*)]-2-(4-fluorfenil)-<225>,<sym>dihidróxi-5- (1-metil-etil) -3-fenil-4- [(fenilamino) carbonil] 1H-pirrolo-1-ácido heptanóico, é conhecida como inibidora de HMG-CoA redutase e é usada como um agente antihipercolesterolêmico. A atorvastatina nas composições farmacêuticas disponíveis no mercado é normalmente preparada como seu sal de cálcio, uma vez que ele permite que a atorvastatina seja convenientemente formulada nas formulações farmacêuticas, por exemplo, comprimidos, cápsulas, pós e similares para administração oral. A atorvastatina cálcica pode existir em uma forma amorfa ou em uma de pelo menos quatro formas cristalinas conhecidas (Forma I, Forma II, Forma III e Forma IV). A atorvastatina cálcica é a substância que é muito ligeiramente solúvel em água, com pKa 4, 5, e concluiu-se que as formas cristalinas são menos solúveis do que a forma amorfa, o que pode causar problemas na biodisponibilidade de atorvastatina no corpo. A presente invenção resolve o problema de proporcionar equivalência terapêutica de formulação terapêutica de atorvastatina independentemente da forma (cristalina, amorfa ou mistura de ambas) da atorvastatina cálcica usada para sua preparação.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SI200100069A SI20848A (sl) | 2001-03-14 | 2001-03-14 | Farmacevtska formulacija, ki vsebuje atorvastatin kalcij |
PCT/IB2002/000736 WO2002072073A2 (en) | 2001-03-14 | 2002-03-13 | Pharmaceutical formulation comprising atorvastatin calcium |
Publications (1)
Publication Number | Publication Date |
---|---|
BR0207880A true BR0207880A (pt) | 2004-03-02 |
Family
ID=20432850
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR0207880-5A BR0207880A (pt) | 2001-03-14 | 2002-03-13 | Formulação farmacêutica, processo para preparação da mesma e uso de formulação sólida |
Country Status (25)
Country | Link |
---|---|
US (1) | US7030151B2 (pt) |
EP (2) | EP2263655B1 (pt) |
JP (1) | JP4295988B2 (pt) |
KR (1) | KR100905730B1 (pt) |
CN (1) | CN1630510B (pt) |
AT (1) | ATE500818T1 (pt) |
BG (1) | BG66339B1 (pt) |
BR (1) | BR0207880A (pt) |
CA (1) | CA2440331C (pt) |
CZ (1) | CZ306128B6 (pt) |
DE (1) | DE60239425D1 (pt) |
ES (2) | ES2361609T3 (pt) |
HR (1) | HRP20030726B1 (pt) |
HU (1) | HU230213B1 (pt) |
IL (2) | IL157534A0 (pt) |
ME (1) | ME00517B (pt) |
MX (1) | MXPA03008340A (pt) |
PL (2) | PL211803B1 (pt) |
RS (2) | RS55021B1 (pt) |
RU (1) | RU2293555C2 (pt) |
SI (2) | SI20848A (pt) |
SK (1) | SK287925B6 (pt) |
UA (1) | UA78201C2 (pt) |
WO (1) | WO2002072073A2 (pt) |
ZA (1) | ZA200306575B (pt) |
Families Citing this family (55)
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USRE44578E1 (en) | 2000-04-10 | 2013-11-05 | Teva Pharmaceutical Industries, Ltd. | Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids |
WO2001076566A1 (en) | 2000-04-10 | 2001-10-18 | Teva Pharmaceutical Industries Ltd. | Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids |
IL156055A0 (en) * | 2000-11-30 | 2003-12-23 | Teva Pharma | Novel crystal forms of atorvastatin hemi calcium and processes for their preparation as well as novel processes for preparing other forms |
EP1345896B1 (en) | 2000-12-27 | 2009-01-07 | Teva Pharmaceutical Industries Limited | Crystalline forms of atorvastatin |
MXPA03010266A (es) | 2001-06-29 | 2004-03-10 | Warner Lambert Co | Formas cristalinas de la sal de calcio del acido [r-(r*, r*)]-2 -(4-fluorofenil)-¦, d-dihidroxi-5 -(1-metiletil)-3 -fenil-4- [(fenilamino) carbonil ]-1h- pirrol-1-heptanoico (2:1) (atorvastatin). |
BR0307720A (pt) * | 2002-02-14 | 2005-01-25 | Ranbaxi Lab Ltd | Formulações de atorvastatina estabilizadas com adições de metal alcalino, método para produzir uma formulação farmacêutica e estabilizar dita formulação |
AU2003298514A1 (en) * | 2002-05-17 | 2004-05-04 | Eisai Co., Ltd. | Methods and compositions using cholinesterase inhibitors |
US20070053976A1 (en) * | 2002-05-17 | 2007-03-08 | Eisai R & D Management Co., Ltd. | Novel combination of drugs as antidepressant |
CA2385529A1 (en) * | 2002-05-21 | 2003-11-21 | Bernard Charles Sherman | Stable dosage forms comprising atorvastatin calcium |
SI21302A (sl) * | 2002-10-11 | 2004-04-30 | LEK farmacevtska dru�ba d.d. | Stabiliziran farmacevtski izdelek z amorfno aktivno učinkovino |
SI21402A (sl) | 2003-02-12 | 2004-08-31 | LEK farmacevtska dru�ba d.d. | Obloženi delci in farmacevtske oblike |
US7790197B2 (en) | 2003-06-09 | 2010-09-07 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
CA2465565A1 (en) * | 2003-06-12 | 2004-12-12 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
CA2465693A1 (en) | 2003-06-12 | 2004-12-12 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
US20050271717A1 (en) * | 2003-06-12 | 2005-12-08 | Alfred Berchielli | Pharmaceutical compositions of atorvastatin |
TR200301614A2 (tr) * | 2003-09-26 | 2005-10-21 | Bi̇ofarma İlaç Sanayi̇ Ve Ti̇caret A.Ş. | Atorvastatin kalsiyum tablet formülasyonunun hazırlanması için yeni yöntem |
BRPI0510713A (pt) | 2004-05-05 | 2007-11-20 | Pfizer Prod Inc | formas de sal de ácido [r-(r*,r*)]-2-(4-fluorofenil)-beta, delta-diidróxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)ca rbonil]-1h-pirrol-1- heptanóico |
CA2672554C (en) | 2004-07-20 | 2012-01-03 | Warner-Lambert Company Llc | Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl).beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1) |
MX2007004722A (es) * | 2004-10-28 | 2007-06-15 | Warner Lambert Co | Procedimiento para formar atorvastatina amorfa. |
US20090208539A1 (en) | 2004-11-22 | 2009-08-20 | Adel Penhasi | Stable atorvastatin formulations |
JP2008521878A (ja) * | 2004-12-02 | 2008-06-26 | ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー | 非晶質アトルバスタチンの医薬組成物及びその製造のための方法 |
ES2263370B1 (es) * | 2005-02-16 | 2007-12-01 | Ercros Industrial, S.A. | Atorvastatina calcica amorfa estabilizada y procedimiento para su obtencion. |
WO2006123358A2 (en) * | 2005-02-22 | 2006-11-23 | Sun Pharmaceutical Industries Limited | Stabilized atorvastatin-containing formulation |
JP5002904B2 (ja) * | 2005-04-04 | 2012-08-15 | ブラザー工業株式会社 | 無線タグ通信装置、その通信方法、及びその通信プログラム |
CA2547216A1 (en) * | 2005-09-21 | 2007-03-21 | Renuka D. Reddy | Process for annealing amorphous atorvastatin |
ATE466840T1 (de) | 2005-11-21 | 2010-05-15 | Warner Lambert Co | Neue formen von är-(r*,r*)ü-2-(4-fluorphenyl)-b,d-dihydroxy-5-( -methylethyl)-3-phenyl-4- ä(phenylamino)carbonylü-1h-pyrrol-1-heptansäure magnesium |
EP1923057A1 (en) * | 2005-11-21 | 2008-05-21 | Teva Pharmaceutical Industries Ltd | Atorvastatin pharmaceutical formulation |
KR20080079646A (ko) * | 2005-11-21 | 2008-09-01 | 테바 파마슈티컬 인더스트리즈 리미티드 | 아토르바스타틴 제제 |
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US7772273B2 (en) * | 2006-02-10 | 2010-08-10 | Lifecycle Pharma A/S | Stabilized atorvastatin |
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MY159533A (en) * | 2009-01-02 | 2017-01-13 | Univ Putra Malaysia | Porous bioceramic composition for bone repair |
JO3635B1 (ar) * | 2009-05-18 | 2020-08-27 | Millennium Pharm Inc | مركبات صيدلانية صلبة وطرق لانتاجها |
KR101248804B1 (ko) * | 2010-05-14 | 2013-03-29 | 한미사이언스 주식회사 | HMG-CoA 환원효소 억제제 및 이베살탄을 포함하는 이층정 약제학적 복합제제 |
KR20120011249A (ko) | 2010-07-28 | 2012-02-07 | 주식회사 경보제약 | 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법 |
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CN102755322B (zh) * | 2012-07-24 | 2013-12-11 | 兆科药业(广州)有限公司 | 一种乐卡地平和阿托伐他汀复方制剂 |
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KR102643099B1 (ko) | 2020-01-31 | 2024-03-05 | 주식회사 일원바이오 | 양춘사 및 백출 복합 추출물을 유효성분으로 함유하는 고지혈증 또는 동맥경화의 예방, 개선 또는 치료용 조성물 |
KR20210098059A (ko) | 2020-01-31 | 2021-08-10 | 주식회사 일원바이오 | 양춘사 추출물을 유효성분으로 함유하는 고지혈증 또는 동맥경화의 예방, 개선 또는 치료용 조성물 |
CN115916181A (zh) * | 2020-05-22 | 2023-04-04 | 度勒科特公司 | 非酒精性脂肪性肝炎(nash)的治疗 |
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FI94339C (fi) * | 1989-07-21 | 1995-08-25 | Warner Lambert Co | Menetelmä farmaseuttisesti käyttökelpoisen /R-(R*,R*)/-2-(4-fluorifenyyli)- , -dihydroksi-5-(1-metyylietyyli)-3-fenyyli-4-/(fenyyliamino)karbonyyli/-1H-pyrroli-1-heptaanihapon ja sen farmaseuttisesti hyväksyttävien suolojen valmistamiseksi |
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HRP960313B1 (en) * | 1995-07-17 | 2002-08-31 | Warner Lambert Co | Form iii crystalline (r- (r*, r*)-2- (4-fluorophenyl) -beta-delta-hydroxy-5-(1-methylethyl) -3-phenyl-4- ((phenylamino) carbonyl -1h-pyrrole-1-heptanoic acid calcium salt (2:1) |
HU223599B1 (hu) * | 1995-07-17 | 2004-10-28 | Warner-Lambert Company | I,II és IV kristályformájú [R-(R*,R*)]-2(4-fluor-fenil)-béta,delta-dihidroxi-5-(1-metil-etil)-3-fenil-4-[(fenil-amino)-karbonil]-1H-pirrol-1-heptánkarbonsav-hemikalciumsó-hidrát (atorvasztatin-hidrát) és a vegyületeket tartalmazó gyógyászati készítmények |
US5874029A (en) | 1996-10-09 | 1999-02-23 | The University Of Kansas | Methods for particle micronization and nanonization by recrystallization from organic solutions sprayed into a compressed antisolvent |
SI20109A (sl) * | 1998-12-16 | 2000-06-30 | LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. | Stabilna farmacevtska formulacija |
US6372246B1 (en) | 1998-12-16 | 2002-04-16 | Ortho-Mcneil Pharmaceutical, Inc. | Polyethylene glycol coating for electrostatic dry deposition of pharmaceuticals |
US6696086B1 (en) * | 1999-09-10 | 2004-02-24 | Lek Pharmaceuticals D.D. | Solid pharmaceutical formulation containing lovastatin and simvastatin, respectively, and its preparation |
SI20425A (sl) | 1999-12-10 | 2001-06-30 | LEK tovarna farmacevtskih in kemi�nih izdelkov d.d. | Priprava amorfnega atorvastatina |
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US6806290B2 (en) * | 2000-06-09 | 2004-10-19 | Lek Pharmaceuticals D.D. | Stabilized pharmaceutically effective composition and pharmaceutical formulation comprising the same |
ES2215050T3 (es) * | 2000-06-09 | 2004-10-01 | Lek Pharmaceutical And Chemical Co. D.D. | Composicion estabilizada farmaceuticamente eficaz y formulacion farmaceutica que la comprende. |
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