AR102101A2 - Formulación y método de complejo de aripiprazol - Google Patents
Formulación y método de complejo de aripiprazolInfo
- Publication number
- AR102101A2 AR102101A2 ARP150103114A ARP150103114A AR102101A2 AR 102101 A2 AR102101 A2 AR 102101A2 AR P150103114 A ARP150103114 A AR P150103114A AR P150103114 A ARP150103114 A AR P150103114A AR 102101 A2 AR102101 A2 AR 102101A2
- Authority
- AR
- Argentina
- Prior art keywords
- cyclodextrin
- formulation
- aripiprazole
- complex
- sbecd
- Prior art date
Links
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- 238000000034 method Methods 0.000 title abstract 3
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 abstract 5
- 229960004372 aripiprazole Drugs 0.000 abstract 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 abstract 3
- NZAQRZWBQUIBSF-UHFFFAOYSA-N 4-(4-sulfobutoxy)butane-1-sulfonic acid Chemical compound OS(=O)(=O)CCCCOCCCCS(O)(=O)=O NZAQRZWBQUIBSF-UHFFFAOYSA-N 0.000 abstract 2
- 238000010255 intramuscular injection Methods 0.000 abstract 2
- 239000007927 intramuscular injection Substances 0.000 abstract 2
- 230000007794 irritation Effects 0.000 abstract 2
- ODLHGICHYURWBS-FOSILIAISA-N molport-023-220-444 Chemical compound CC(O)COC[C@@H]([C@@H]([C@H]([C@@H]1O)O)O[C@@H]2O[C@H]([C@H](O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O3)[C@@H](O)[C@@H]2O)COCC(O)C)O[C@H]1O[C@@H]1[C@@H](O)[C@H](O)[C@H]3O[C@H]1COCC(C)O ODLHGICHYURWBS-FOSILIAISA-N 0.000 abstract 2
- 229920000858 Cyclodextrin Polymers 0.000 abstract 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 201000000980 schizophrenia Diseases 0.000 abstract 1
- 235000002906 tartaric acid Nutrition 0.000 abstract 1
- 239000011975 tartaric acid 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
- 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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nanotechnology (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- General Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Biotechnology (AREA)
- Medical Informatics (AREA)
- Crystallography & Structural Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Se proporciona una formulación de aripiprazol que incluye un agente antisicótico en la forma de un complejo de inclusión en una b-ciclodextrina, preferiblemente b-ciclodextrina de éter sulfobutilo (SBECD), que en la forma de un inyectable produce generalmente reversible irritación mínima a moderada en el sitio de inyección intramuscular. Se proporciona un método para minimizar o reducir la irritación causada por el aripiprazol en un sitio de inyección intramuscular y un método para tratar esquizofrenia mediante el empleo de la formulación anterior. Reivindicación 1: Un complejo de inclusión de aripiprazol en una b-ciclodextrina. Reivindicación 2: El complejo como se definió en la reivindicación 1 en donde la b-ciclodextrina es b-ciclodextrina de éter sulfobutilo (SBECD) o hidroxipropil-b-ciclodextrina (HPBCD). Reivindicación 18: La formulación como se definió en la reivindicación 11 que comprende aripiprazol en una cantidad para proveer de aproximadamente 1.5 a aproximadamente 8 mg/mL de formulación, SBECD en una cantidad en la escala de 100 a aproximadamente 200 mg/mL; ácido tartárico en una cantidad dentro de la escala de aproximadamente 7 a aproximadamente 9 mg/mL de hidróxido de sodio cs para ajustar el pH dentro de la escala de aproximadamente 4 a aproximadamente 4.6 y agua cs para 1 mL.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US40471302P | 2002-08-20 | 2002-08-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR102101A2 true AR102101A2 (es) | 2017-02-01 |
Family
ID=31946748
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AR20030102990A AR040887A1 (es) | 2002-08-20 | 2003-08-19 | Formulacion y metodo de complejo de aripiprazol |
| ARP150103114A AR102101A2 (es) | 2002-08-20 | 2015-09-28 | Formulación y método de complejo de aripiprazol |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AR20030102990A AR040887A1 (es) | 2002-08-20 | 2003-08-19 | Formulacion y metodo de complejo de aripiprazol |
Country Status (32)
| Country | Link |
|---|---|
| US (8) | US7115587B2 (es) |
| EP (1) | EP1542668B1 (es) |
| JP (1) | JP4729306B2 (es) |
| KR (1) | KR101043866B1 (es) |
| CN (1) | CN100335047C (es) |
| AR (2) | AR040887A1 (es) |
| AT (1) | ATE428423T1 (es) |
| AU (1) | AU2003269965B2 (es) |
| BR (1) | BR0313602A (es) |
| CA (1) | CA2495864C (es) |
| CY (1) | CY1110331T1 (es) |
| DE (1) | DE60327225D1 (es) |
| DK (1) | DK1542668T3 (es) |
| ES (1) | ES2322953T3 (es) |
| GE (1) | GEP20063996B (es) |
| HR (1) | HRP20050149B1 (es) |
| IL (1) | IL166623A (es) |
| IS (1) | IS2878B (es) |
| MX (1) | MXPA05001865A (es) |
| MY (1) | MY140793A (es) |
| NO (1) | NO333458B1 (es) |
| NZ (1) | NZ537995A (es) |
| PE (1) | PE20040895A1 (es) |
| PL (1) | PL212428B1 (es) |
| PT (1) | PT1542668E (es) |
| RS (1) | RS51903B (es) |
| RU (1) | RU2342931C2 (es) |
| SI (1) | SI1542668T1 (es) |
| TW (1) | TWI307626B (es) |
| UA (1) | UA79984C2 (es) |
| WO (1) | WO2004017897A2 (es) |
| ZA (1) | ZA200501064B (es) |
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| US20040170705A1 (en) * | 2001-03-08 | 2004-09-02 | Dusan Miljkovic | Compositions and methods for non-insulin glucose uptake |
| CA2495864C (en) * | 2002-08-20 | 2011-09-27 | Bristol-Myers Squibb Company | Aripiprazole complex formulation and method |
| ES2315721T5 (es) * | 2003-10-23 | 2012-08-24 | Otsuka Pharmaceutical Co., Ltd. | Formulación de aripiprazol inyectable estéril de liberación controlada y procedimiento |
| US7714129B2 (en) | 2003-12-16 | 2010-05-11 | Teva Pharmaceutical Industries Ltd. | Methods of preparing anhydrous aripiprazole form II |
| TW200529850A (en) * | 2003-12-16 | 2005-09-16 | Teva Pharma | Methods of preparing aripiprazole crystalline forms |
| UA89513C2 (uk) * | 2004-12-03 | 2010-02-10 | Элан Фарма Интернешнл Лтд. | Стабільна композиція з наночастинок ралоксифену гідрохлориду |
| WO2006113310A2 (en) * | 2005-04-13 | 2006-10-26 | Elan Pharma International Limited | Nanoparticulate and controlled release compositions comprising prostaglandin derivatives |
| WO2006133046A2 (en) * | 2005-06-03 | 2006-12-14 | Elan Pharma International, Limited | Nanoparticulate imatinib mesylate formulations |
| US20090036406A1 (en) * | 2005-06-13 | 2009-02-05 | Takeda Pharmaceutical Company Limited | Injection |
| US20100204178A1 (en) | 2006-10-02 | 2010-08-12 | James Cloyd | Novel parenteral carbamazepine formulation |
| NZ568700A (en) | 2005-11-28 | 2012-03-30 | Marinus Pharmaceuticals | Solid stabilized particulate formulations comprising ganaxolone |
| GB0618879D0 (en) | 2006-09-26 | 2006-11-01 | Zysis Ltd | Pharmaceutical compositions |
| CN101322709B (zh) * | 2007-06-12 | 2011-03-02 | 成都康弘药业集团股份有限公司 | 一种含有阿立哌唑的药物组合物及其制备方法 |
| LT2170279T (lt) * | 2007-07-31 | 2018-03-12 | Otsuka Pharmaceutical Co., Ltd. | Aripiprazolo suspensijos ir liofilizuotos kompozicijos gamybos būdai |
| US8501740B2 (en) * | 2007-10-09 | 2013-08-06 | Board Of Regents, The University Of Texas System | Methods of treatment of opioid tolerance, physical dependence, pain and addiction with inhibitors of certain growth factor receptors |
| EP2268265A2 (en) * | 2008-03-21 | 2011-01-05 | Elan Pharma International Limited | Compositions for site-specific delivery of imatinib and methods of use |
| US7635773B2 (en) | 2008-04-28 | 2009-12-22 | Cydex Pharmaceuticals, Inc. | Sulfoalkyl ether cyclodextrin compositions |
| US8431576B2 (en) | 2009-06-25 | 2013-04-30 | Alkermes Pharma Ireland Limited | Heterocyclic compounds for the treatment of neurological and psychological disorders |
| JP5732453B2 (ja) | 2009-06-25 | 2015-06-10 | アルカーメス ファーマ アイルランド リミテッド | Ｎｈ酸性化合物のプロドラッグ |
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| KR101125210B1 (ko) * | 2009-09-11 | 2012-03-19 | 주식회사 대웅제약 | 아리피프라졸-벤토나이트-ａｅａ 혼성체, 이를 함유하는 약학 조성물 및 그 제조방법 |
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| JP2022543837A (ja) | 2019-08-05 | 2022-10-14 | マリナス ファーマシューティカルズ， インコーポレイテッド | てんかん重積状態の治療に使用するためのガナキソロン |
| JP2023503928A (ja) | 2019-12-06 | 2023-02-01 | マリナス ファーマシューティカルズ， インコーポレイテッド | 結節性硬化症の治療での使用のためのガナキソロン |
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| US6407079B1 (en) | 1985-07-03 | 2002-06-18 | Janssen Pharmaceutica N.V. | Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation |
| US5002935A (en) | 1987-12-30 | 1991-03-26 | University Of Florida | Improvements in redox systems for brain-targeted drug delivery |
| JP2893175B2 (ja) * | 1988-10-31 | 1999-05-17 | 大塚製薬株式会社 | カルボスチリル誘導体 |
| US5006528A (en) | 1988-10-31 | 1991-04-09 | Otsuka Pharmaceutical Co., Ltd. | Carbostyril derivatives |
| JP2608788B2 (ja) * | 1988-10-31 | 1997-05-14 | 大塚製薬 株式会社 | 精神分裂病治療剤 |
| US5376645A (en) | 1990-01-23 | 1994-12-27 | University Of Kansas | Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof |
| KR0166088B1 (ko) | 1990-01-23 | 1999-01-15 | . | 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도 |
| IT1263831B (it) | 1993-01-29 | 1996-09-04 | Paolo Chiesi | Complessi di inclusione multicomponente ad elevata solubilita' costituiti da un farmaco di tipo basico, un acido ed una ciclodestrina |
| JPH07165616A (ja) * | 1993-12-09 | 1995-06-27 | Hisamitsu Pharmaceut Co Inc | シクロデキストリンの複合組成物及び複合化法 |
| US5646131A (en) | 1994-02-22 | 1997-07-08 | The Arab Company For Drug Industries And Medical Applicances (Acdima) | Method for solubilizing drugs using cyclodextrins and carboxylic acids |
| IT1269578B (it) | 1994-04-22 | 1997-04-08 | Chiesi Farma Spa | Complessi di inclusione multicomponente ad elevata solubilita' costituiti da un farmaco di tipo acido, una ciclodestrina e una base. |
| UA57734C2 (uk) | 1996-05-07 | 2003-07-15 | Пфайзер Інк. | Комплекси включення арилгетероциклічних солей |
| JP4012994B2 (ja) | 1996-05-08 | 2007-11-28 | 大塚製薬株式会社 | 抗不安薬 |
| JPH10194996A (ja) | 1996-12-25 | 1998-07-28 | Janssen Pharmaceut Nv | アシル化シクロデキストリン含有製薬組成物 |
| GB9713149D0 (en) | 1997-06-21 | 1997-08-27 | Pfizer Ltd | Pharmaceutical formulations |
| GB9915231D0 (en) | 1999-06-29 | 1999-09-01 | Pfizer Ltd | Pharmaceutical complex |
| CA2311734C (en) | 2000-04-12 | 2011-03-08 | Bristol-Myers Squibb Company | Flash-melt oral dosage formulation |
| MY129350A (en) * | 2001-04-25 | 2007-03-30 | Bristol Myers Squibb Co | Aripiprazole oral solution |
| AR033485A1 (es) * | 2001-09-25 | 2003-12-26 | Otsuka Pharma Co Ltd | Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma |
| SE0200301D0 (sv) * | 2002-02-01 | 2002-02-01 | Axon Biochemicals Bv | Thio-carbostyril derivative |
| CA2495864C (en) * | 2002-08-20 | 2011-09-27 | Bristol-Myers Squibb Company | Aripiprazole complex formulation and method |
| KR20050071611A (ko) | 2002-10-25 | 2005-07-07 | 화이자 프로덕츠 인코포레이티드 | 현탁액 형태의 아릴헤테로환 활성제의 저장 제형 |
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