DK200900284A - Krystallinsk base af escitalopram og smeltetabletter indeholdende escitalopram base - Google Patents
Krystallinsk base af escitalopram og smeltetabletter indeholdende escitalopram base Download PDFInfo
- Publication number
- DK200900284A DK200900284A DKPA200900284A DKPA200900284A DK200900284A DK 200900284 A DK200900284 A DK 200900284A DK PA200900284 A DKPA200900284 A DK PA200900284A DK PA200900284 A DKPA200900284 A DK PA200900284A DK 200900284 A DK200900284 A DK 200900284A
- Authority
- DK
- Denmark
- Prior art keywords
- active pharmaceutical
- tablet according
- melting
- water
- soluble filler
- Prior art date
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- WSEQXVZVJXJVFP-FQEVSTJZSA-N escitalopram Chemical compound C1([C@]2(C3=CC=C(C=C3CO2)C#N)CCCN(C)C)=CC=C(F)C=C1 WSEQXVZVJXJVFP-FQEVSTJZSA-N 0.000 title claims 4
- 229960004341 escitalopram Drugs 0.000 title claims 4
- 238000002844 melting Methods 0.000 claims abstract 13
- 230000008018 melting Effects 0.000 claims abstract 13
- 239000008186 active pharmaceutical agent Substances 0.000 claims abstract 8
- 239000000945 filler Substances 0.000 claims abstract 8
- 239000007884 disintegrant Substances 0.000 claims 3
- 239000005426 pharmaceutical component Substances 0.000 claims 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- AUZONCFQVSMFAP-UHFFFAOYSA-N disulfiram Chemical compound CCN(CC)C(=S)SSC(=S)N(CC)CC AUZONCFQVSMFAP-UHFFFAOYSA-N 0.000 claims 2
- 238000002156 mixing Methods 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- HSRJKNPTNIJEKV-UHFFFAOYSA-N Guaifenesin Chemical compound COC1=CC=CC=C1OCC(O)CO HSRJKNPTNIJEKV-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GQYIWUVLTXOXAJ-UHFFFAOYSA-N Lomustine Chemical compound ClCCN(N=O)C(=O)NC1CCCCC1 GQYIWUVLTXOXAJ-UHFFFAOYSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- RGCVKNLCSQQDEP-UHFFFAOYSA-N Perphenazine Chemical compound C1CN(CCO)CCN1CCCN1C2=CC(Cl)=CC=C2SC2=CC=CC=C21 RGCVKNLCSQQDEP-UHFFFAOYSA-N 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- OFZCIYFFPZCNJE-UHFFFAOYSA-N carisoprodol Chemical compound NC(=O)OCC(C)(CCC)COC(=O)NC(C)C OFZCIYFFPZCNJE-UHFFFAOYSA-N 0.000 claims 1
- 229960004587 carisoprodol Drugs 0.000 claims 1
- JCKYGMPEJWAADB-UHFFFAOYSA-N chlorambucil Chemical compound OC(=O)CCCC1=CC=C(N(CCCl)CCCl)C=C1 JCKYGMPEJWAADB-UHFFFAOYSA-N 0.000 claims 1
- 229960004630 chlorambucil Drugs 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 150000002016 disaccharides Chemical class 0.000 claims 1
- 229960002563 disulfiram Drugs 0.000 claims 1
- HAPOVYFOVVWLRS-UHFFFAOYSA-N ethosuximide Chemical compound CCC1(C)CC(=O)NC1=O HAPOVYFOVVWLRS-UHFFFAOYSA-N 0.000 claims 1
- 229960002767 ethosuximide Drugs 0.000 claims 1
- YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 claims 1
- 229960002297 fenofibrate Drugs 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 229960002146 guaifenesin Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229960002247 lomustine Drugs 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 150000002772 monosaccharides Chemical group 0.000 claims 1
- 239000002674 ointment Substances 0.000 claims 1
- 229960000762 perphenazine Drugs 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 150000005846 sugar alcohols Chemical class 0.000 claims 1
- IRYJRGCIQBGHIV-UHFFFAOYSA-N trimethadione Chemical compound CN1C(=O)OC(C)(C)C1=O IRYJRGCIQBGHIV-UHFFFAOYSA-N 0.000 claims 1
- 229960004453 trimethadione Drugs 0.000 claims 1
- 239000000155 melt Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
Classifications
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- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D307/00—Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom
- C07D307/77—Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom ortho- or peri-condensed with carbocyclic rings or ring systems
- C07D307/87—Benzo [c] furans; Hydrogenated benzo [c] furans
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B63/00—Purification; Separation; Stabilisation; Use of additives
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Emergency Medicine (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Furan Compounds (AREA)
- Plural Heterocyclic Compounds (AREA)
Abstract
Den foreliggende opfindelse angår en smeltetablet, der har en hårdhed på mindst 22 N og en oral desintegrationstid på mindre end 120 s, og som indeholder en aktiv farmaceutisk bestanddel adsorberet på et vandopløseligt fyldstof, hvor den aktive farmaceutiske bestanddel har et smeltepunkt i området 40-1 00 °C, såvel som en fremgangsmåde til fremstilling af en sådan smeltetablet.
Claims (11)
1. Smeltetablet, der har en hårdhed på mindst 22 N og en oral desintegrationstid på mindre end 120 s, og som omfatter en aktiv farmaceutisk bestanddel adsorberet på et vandopløseligt fyldstof, ét eller flere desintegrationsmidler og eventuelt yderligere vandopløseligt fyldstof, hvor den aktive farmaceutiske bestanddel har et smeltepunkt i området 40-100 °C.
2. Smeltetablet ifølge krav 1, kendetegnet ved, at den aktive farmaceutiske bestanddel har et smeltepunkt i området 40-90 °C.
3. Smeltetablet ifølge krav 1 eller 2, kendetegnet ved, at den aktive farmaceutiske bestanddel er valgt fra gruppen bestående af escitalopram, ethosuximid, trimethadion, chlorambucil, disulfiram, fenofibrat, guaifenesin, lomustin, carisoprodol og perphenazin.
4. Smeltetablet ifølge krav 3, kendetegnet ved, at den aktive farmaceutiske bestanddel er escitalopram.
5. Smeltetablet ifølge et hvilket som helst af kravene 1-4, kendetegnet ved, at det vandopløselige fyldstof er valgt fra gruppen bestående af monosaccharider, disaccharider, sukkeralkoholer og polysaccharider.
6. Smeltetablet ifølge krav 5, kendetegnet ved, at det vandopløselige fyldstof er valgt fra gruppen bestående af mannitol, sorbitol, glucose, mannose og lactose.
7. Smeltetablet ifølge et hvilket som helst af kravene 1-6, kendetegnet ved, at den har en hårdhed på mindst 22 N.
8. Smeltetablet ifølge et hvilket som helst af kravene 1-7, kendetegnet ved, at den har en oral desintegrationstid på mindre end 60 s.
9. Smeltetablet ifølge et hvilket som helst af kravene 1-8, kendetegnet ved, at desintegrationsmidlerne er valgt fra gruppen bestående af mi kro krysta I li nsk cellulose, natriumstivelsesglycolat, croscarmellose-natrium, crospovidon og povidon.
10. Smeltetablet ifølge et hvilket som helst af kravene 1-9, kendetegnet ved, at den har en slidstyrke på ikke mere end 1 %.
11. Fremgangsmåde til fremstilling af en smeltetablet ifølge et hvilket som helst af kravene 1-10, der omfatter: a) blanding af det vandopløselige fyldstof og den aktive farmaceutiske bestanddel ved en temperatur over, omkring eller lidt under den aktive farmaceutiske bestanddels smeltepunkt, hvorved den aktive farmaceutiske bestanddel adsorberes på det vandopløselige fyldstof; b) efterfulgt af afkøling til en temperatur under 40 °C; c) blanding af blandingen af den aktive farmaceutiske bestanddel og det vandopløselige fyldstof med ét eller flere desintegrationsmidler og eventuelt andre hjælpestoffer og d) presning af blandingen til tabletter med en hårdhed på mindst 22 N.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200900284A DK200900284A (da) | 2005-06-22 | 2009-02-27 | Krystallinsk base af escitalopram og smeltetabletter indeholdende escitalopram base |
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200500912 | 2005-06-22 | ||
| DK200500912 | 2005-06-22 | ||
| DK200800075 | 2008-01-21 | ||
| DK200800075A DK200800075A (da) | 2005-06-22 | 2008-01-21 | Krystallinsk base af escitalopram og orodispergerbare tabletter indeholdende escitaloprambase |
| DK200900284 | 2009-02-27 | ||
| DKPA200900284A DK200900284A (da) | 2005-06-22 | 2009-02-27 | Krystallinsk base af escitalopram og smeltetabletter indeholdende escitalopram base |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK200900284A true DK200900284A (da) | 2009-02-27 |
Family
ID=37546630
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK06742481.2T DK1896439T4 (da) | 2005-06-22 | 2006-06-22 | Krystallinsk base af escitalopram og orodispergerbare tabletter, der omfatter escitaloprambase |
| DK200800075A DK200800075A (da) | 2005-06-22 | 2008-01-21 | Krystallinsk base af escitalopram og orodispergerbare tabletter indeholdende escitaloprambase |
| DKPA200900284A DK200900284A (da) | 2005-06-22 | 2009-02-27 | Krystallinsk base af escitalopram og smeltetabletter indeholdende escitalopram base |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK06742481.2T DK1896439T4 (da) | 2005-06-22 | 2006-06-22 | Krystallinsk base af escitalopram og orodispergerbare tabletter, der omfatter escitaloprambase |
| DK200800075A DK200800075A (da) | 2005-06-22 | 2008-01-21 | Krystallinsk base af escitalopram og orodispergerbare tabletter indeholdende escitaloprambase |
Country Status (39)
| Country | Link |
|---|---|
| EP (3) | EP1896439B2 (da) |
| JP (5) | JP4906852B2 (da) |
| KR (5) | KR20120064140A (da) |
| CN (2) | CN101189220A (da) |
| AR (2) | AR055062A1 (da) |
| AT (3) | AT10983U1 (da) |
| AU (2) | AU2006261452B2 (da) |
| BG (1) | BG66086B1 (da) |
| BR (1) | BRPI0612295A2 (da) |
| CA (2) | CA2612827C (da) |
| CY (1) | CY1112392T1 (da) |
| CZ (3) | CZ301286B6 (da) |
| DE (2) | DE112006001619T5 (da) |
| DK (3) | DK1896439T4 (da) |
| EA (2) | EA201001108A1 (da) |
| EE (1) | EE00773U1 (da) |
| ES (2) | ES2319073B1 (da) |
| FI (2) | FI20080548L (da) |
| GB (2) | GB2442160B (da) |
| HR (1) | HRP20110093T4 (da) |
| HU (1) | HUP0800135A3 (da) |
| IL (1) | IL187454A0 (da) |
| IS (1) | IS8705A (da) |
| LT (1) | LT5550B (da) |
| LV (1) | LV13677B (da) |
| MX (1) | MX2007015328A (da) |
| MY (2) | MY143252A (da) |
| NO (2) | NO20080359L (da) |
| PL (2) | PL1896439T5 (da) |
| PT (1) | PT1896439E (da) |
| RS (1) | RS51575B2 (da) |
| SG (1) | SG169358A1 (da) |
| SI (1) | SI1896439T2 (da) |
| SK (1) | SK500402007A3 (da) |
| TR (2) | TR200708792T1 (da) |
| TW (2) | TWI347942B (da) |
| UA (1) | UA86536C2 (da) |
| WO (1) | WO2006136169A2 (da) |
| ZA (2) | ZA200711066B (da) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0123400D0 (en) | 2001-09-28 | 2001-11-21 | Novartis Ag | Organic compounds |
| WO2008059514A2 (en) * | 2006-07-31 | 2008-05-22 | Cadila Healthcare Limited | Process for preparing escitalopram |
| EP2134325A2 (en) * | 2007-03-01 | 2009-12-23 | Aurobindo Pharma Limited | Stable solid dosage forms of an antidepressant |
| ME02391B (me) | 2010-07-23 | 2016-09-20 | H Lundbeck As | Postupak za prečišćavanje farmaceutski prihvatljivih soli escitaloprama |
| CN103360353A (zh) * | 2013-08-07 | 2013-10-23 | 中国药科大学 | 草酸艾司西酞普兰杂质的制备方法 |
| JP2018016569A (ja) * | 2016-07-26 | 2018-02-01 | 株式会社トクヤマ | （１ｓ）−１−［３−（ジメチルアミノ）プロピル］−１−（４−フルオロフェニル）−１，３−ジヒドロイソベンゾフラン−５−カルボニトリル蓚酸塩の製造方法 |
| WO2018190294A1 (ja) * | 2017-04-10 | 2018-10-18 | 東和薬品株式会社 | エスシタロプラム医薬組成物 |
| CN110711198B (zh) * | 2018-07-12 | 2022-03-15 | 山东大学 | D-甘露糖在制备抗抑郁药物中的应用 |
| KR102331187B1 (ko) | 2019-04-09 | 2021-11-26 | 주식회사 라이트팜텍 | 에스시탈로프람을 함유하는 안정성이 우수한 경구용 액제 조성물 및 그의 제조방법 |
| WO2022153262A1 (en) * | 2021-01-18 | 2022-07-21 | Anton Frenkel | Pharmaceutical dosage form |
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| AU680345B2 (en) * | 1994-01-27 | 1997-07-24 | Board Of Regents Of The University Of Oklahoma, The | Rapidly dissolving oral dosage form |
| US5607697A (en) * | 1995-06-07 | 1997-03-04 | Cima Labs, Incorporated | Taste masking microparticles for oral dosage forms |
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| DE69801764T2 (de) | 1997-07-08 | 2002-07-04 | H. Lundbeck A/S, Kobenhavn-Valby | Verfahren zur herstellung von citalopram |
| WO1998019512A2 (en) | 1997-11-11 | 1998-05-14 | H. Lundbeck A/S | Method for the preparation of citalopram |
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| AU2001294192A1 (en) * | 2000-10-06 | 2002-04-22 | Takeda Chemical Industries Ltd. | Solid preparations |
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