CN101511343A - 使用多元醇来获得利福昔明的稳定的多晶型形式 - Google Patents
使用多元醇来获得利福昔明的稳定的多晶型形式 Download PDFInfo
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- CN101511343A CN101511343A CNA2007800330052A CN200780033005A CN101511343A CN 101511343 A CN101511343 A CN 101511343A CN A2007800330052 A CNA2007800330052 A CN A2007800330052A CN 200780033005 A CN200780033005 A CN 200780033005A CN 101511343 A CN101511343 A CN 101511343A
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- rifaximin
- polyhydric alcohol
- beta
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- moisture content
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D498/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms
- C07D498/22—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms in which the condensed system contains four or more hetero rings
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
- C07D491/22—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains four or more hetero rings
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
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- A—HUMAN NECESSITIES
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- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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- A—HUMAN NECESSITIES
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- 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
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- A—HUMAN NECESSITIES
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D499/00—Heterocyclic compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula:, e.g. penicillins, penems; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D499/21—Heterocyclic compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula:, e.g. penicillins, penems; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring with a nitrogen atom directly attached in position 6 and a carbon atom having three bonds to hetero atoms with at the most one bond to halogen, e.g. an ester or nitrile radical, directly attached in position 2
- C07D499/44—Compounds with an amino radical acylated by carboxylic acids, attached in position 6
- C07D499/48—Compounds with an amino radical acylated by carboxylic acids, attached in position 6 with a carbon chain, substituted by hetero atoms or by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, attached to the carboxamido radical
- C07D499/58—Compounds with an amino radical acylated by carboxylic acids, attached in position 6 with a carbon chain, substituted by hetero atoms or by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, attached to the carboxamido radical substituted in alpha-position to the carboxamido radical
- C07D499/64—Compounds with an amino radical acylated by carboxylic acids, attached in position 6 with a carbon chain, substituted by hetero atoms or by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, attached to the carboxamido radical substituted in alpha-position to the carboxamido radical by nitrogen atoms
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- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
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- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
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- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Communicable Diseases (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Abstract
Description
工艺参数 | 预温阶段 | 包衣溶液的应用 | 干燥 |
入口处气流(m3/小时) | 400±100 | 550±100 | 350±50 |
入口处气温(℃) | 60±2 | 60±10 | 80±2 |
产物温度(℃) | 32 | 25-27 | 60±2 |
喷射压力(巴)(起始阶段) | 1-1.5±0.1 | ||
喷射速度(g/分钟) | 150-200 |
包衣组分 | 量(mg) |
HPMC | 14.07 |
二氧化钛 | 4.10 |
Na-EDTA | 0.05 |
丙二醇 | 1.37 |
氧化铁红 E 172 | 0.41 |
Claims (15)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT001692A ITMI20061692A1 (it) | 2006-09-05 | 2006-09-05 | Uso di polioli per ottenere forme polimorfe stabili di rifaximina |
ITMI2006A001692 | 2006-09-05 | ||
PCT/IB2007/002199 WO2008029208A1 (en) | 2006-09-05 | 2007-07-31 | Use of polyols to obtain stable polymorphous forms of rifaximin |
Publications (2)
Publication Number | Publication Date |
---|---|
CN101511343A true CN101511343A (zh) | 2009-08-19 |
CN101511343B CN101511343B (zh) | 2013-06-19 |
Family
ID=38714944
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN2007800330052A Active CN101511343B (zh) | 2006-09-05 | 2007-07-31 | 使用多元醇来获得利福昔明的稳定的多晶型形式 |
Country Status (34)
Country | Link |
---|---|
US (4) | US8217054B2 (zh) |
EP (2) | EP2059232B1 (zh) |
JP (1) | JP5399903B2 (zh) |
KR (2) | KR101279477B1 (zh) |
CN (1) | CN101511343B (zh) |
AR (1) | AR062383A1 (zh) |
AU (1) | AU2007293266B2 (zh) |
BR (1) | BRPI0715853B8 (zh) |
CA (1) | CA2645724C (zh) |
CY (1) | CY1119132T1 (zh) |
DK (1) | DK2059232T3 (zh) |
EA (1) | EA015002B1 (zh) |
ES (1) | ES2626236T3 (zh) |
HR (2) | HRP20090198A9 (zh) |
HU (1) | HUE034300T2 (zh) |
IL (1) | IL196800A (zh) |
IT (1) | ITMI20061692A1 (zh) |
JO (1) | JO3640B1 (zh) |
LT (1) | LT2059232T (zh) |
MA (1) | MA30726B1 (zh) |
ME (1) | ME00600B (zh) |
MX (1) | MX2009002445A (zh) |
MY (1) | MY178450A (zh) |
NO (1) | NO345200B1 (zh) |
NZ (1) | NZ574625A (zh) |
PL (1) | PL2059232T3 (zh) |
PT (1) | PT2059232T (zh) |
RS (1) | RS56024B1 (zh) |
SI (1) | SI2059232T1 (zh) |
TN (1) | TN2009000030A1 (zh) |
TW (1) | TWI335822B (zh) |
UA (1) | UA97108C2 (zh) |
WO (1) | WO2008029208A1 (zh) |
ZA (1) | ZA200900833B (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103118666A (zh) * | 2010-09-22 | 2013-05-22 | 意大利阿尔法韦士曼制药公司 | 含有利福昔明的药物制剂、制备其的方法和治疗肠疾病的方法 |
CN103827122A (zh) * | 2011-02-11 | 2014-05-28 | 萨利克斯药品有限公司 | 利福昔明的形式及其用途 |
CN110403833A (zh) * | 2014-03-31 | 2019-11-05 | 强生消费者公司 | 用于增强碱性有益剂的局部施用的组合物及方法 |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK1698630T3 (da) | 2005-03-03 | 2014-12-08 | Alfa Wassermann Spa | Nye polymorfe former af rifaximin, fremgangsmåde for deres fremstilling og anvendelse deraf i de medicinske præparater |
ITBO20050123A1 (it) | 2005-03-07 | 2005-06-06 | Alfa Wassermann Spa | Formulazioni farmaceutiche gastroresistenti contenenti rifaximina |
ITMI20061692A1 (it) | 2006-09-05 | 2008-03-06 | Alfa Wassermann Spa | Uso di polioli per ottenere forme polimorfe stabili di rifaximina |
US7709634B2 (en) | 2007-09-20 | 2010-05-04 | Apotex Pharmachem Inc. | Amorphous form of rifaximin and processes for its preparation |
IT1398550B1 (it) | 2010-03-05 | 2013-03-01 | Alfa Wassermann Spa | Formulazioni comprendenti rifaximina utili per ottenere un effetto prolungato nel tempo |
JP6092629B2 (ja) * | 2010-03-10 | 2017-03-08 | ルピン・リミテッドLupin Limited | リファキシミン使用準備済懸濁液 |
ITBO20110461A1 (it) | 2011-07-29 | 2013-01-30 | Alfa Wassermann Spa | Composizioni farmaceutiche comprendenti rifaximina, processi per la loro preparazione e loro uso nel trattamento di infezioni vaginali. |
US9359374B2 (en) | 2012-06-13 | 2016-06-07 | Apotex Pharmachem Inc. | Polymorphic forms of rifaximin |
ITBO20120368A1 (it) | 2012-07-06 | 2014-01-07 | Alfa Wassermann Spa | Composizioni comprendenti rifaximina e amminoacidi, cristalli di rifaximina derivanti da tali composizioni e loro uso. |
US9849090B2 (en) | 2012-12-12 | 2017-12-26 | Sun Pharmaceutical Industries Limited | Pharmaceutical compositions of rifaximin |
EP2971062A2 (en) | 2013-03-15 | 2016-01-20 | ALFA WASSERMANN S.p.A. | Method for diagnosing vaginal infections |
US20160038468A1 (en) | 2013-03-15 | 2016-02-11 | Alfa Wassermann S.P.A. | Rifaximin for use in the treating of vaginal infections |
JP6433980B2 (ja) * | 2013-04-12 | 2018-12-05 | アルファシグマ ソシエタ ペル アチオニ | Nsaid投与並びに関連する組成物、方法及びシステム |
ES2621557T3 (es) | 2014-03-31 | 2017-07-04 | Euticals S.P.A. | Mezcla polimórfica de rifaximina y su uso para la preparación de formulaciones sólidas |
ES2742106T3 (es) * | 2014-05-12 | 2020-02-13 | Alfasigma Spa | Nueva forma de cristal solvatado de rifaximina, producción, composiciones y usos de la misma |
CA3013161C (en) * | 2017-04-26 | 2020-03-24 | Sandoz Ag | Oral dosage form comprising rifaximin in form beta |
KR101997341B1 (ko) * | 2017-09-05 | 2019-10-01 | 고려대학교 세종산학협력단 | 박막 트랜지스터 및 그 제조 방법 |
FR3123563A1 (fr) * | 2021-06-03 | 2022-12-09 | Algotherapeutix | Utilisation de l’amitriptyline et/ou l’un de ses sels pharmaceutiquement acceptable comme agent conservateur |
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IT1154655B (it) | 1980-05-22 | 1987-01-21 | Alfa Farmaceutici Spa | Derivati imidazo-rifamicinici metodi per la loro preparazione e loro uso come sostanza ad azione antibatterica |
US4462928A (en) * | 1983-03-31 | 1984-07-31 | Texaco Inc. | Partial oxidation of heavy refinery fractions |
GB8333815D0 (en) | 1983-12-20 | 1984-02-01 | Procter & Gamble | Fabric softeners |
IT1199374B (it) | 1984-05-15 | 1988-12-30 | Alfa Farmaceutici Spa | Processo per la preparazione di pirido-imidazo-rifamicine |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103118666A (zh) * | 2010-09-22 | 2013-05-22 | 意大利阿尔法韦士曼制药公司 | 含有利福昔明的药物制剂、制备其的方法和治疗肠疾病的方法 |
CN103827122A (zh) * | 2011-02-11 | 2014-05-28 | 萨利克斯药品有限公司 | 利福昔明的形式及其用途 |
CN103827122B (zh) * | 2011-02-11 | 2016-08-31 | 萨利克斯药品有限公司 | 利福昔明的形式及其用途 |
CN110403833A (zh) * | 2014-03-31 | 2019-11-05 | 强生消费者公司 | 用于增强碱性有益剂的局部施用的组合物及方法 |
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