JP4393192B2 - リバビリンシロップ処方物 - Google Patents
リバビリンシロップ処方物 Download PDFInfo
- Publication number
- JP4393192B2 JP4393192B2 JP2003539656A JP2003539656A JP4393192B2 JP 4393192 B2 JP4393192 B2 JP 4393192B2 JP 2003539656 A JP2003539656 A JP 2003539656A JP 2003539656 A JP2003539656 A JP 2003539656A JP 4393192 B2 JP4393192 B2 JP 4393192B2
- Authority
- JP
- Japan
- Prior art keywords
- liquid formulation
- present
- ribavirin
- pharmaceutically acceptable
- concentration
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
Links
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
- A61K9/08—Solutions
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
-
- 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
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/26—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Virology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Description
本発明は、リバビリン、緩衝化系、少なくとも1つの薬学的に受容可能な甘味剤、および少なくとも1つの薬学的に受容可能な増粘剤を含む液体処方物を提供し、ここで、この液体処方物のpHは、約4.8〜約5.3の範囲にある。
本明細書中で用いられる場合、用語濃度は、他に示されない限り、シロップ1リットルあたりのグラムでの成分の量を意味する。
Claims (12)
- 液体処方物であって、該液体処方物は、リバビリン、4.8〜5.3のpHを提供する緩衝化系であって、該緩衝化系の成分が、クエン酸ナトリウム二水和物およびクエン酸無水物を含む、緩衝化系、少なくとも1つの薬学的に受容可能な甘味剤、および少なくとも1つの薬学的に受容可能な増粘剤を含み、ここで、該液体処方物は、12ヶ月まで25℃/60%相対湿度で貯蔵安定性である、液体処方物。
- 処方物が、薬学的に受容可能なシロップ処方物である、請求項1に記載の液体処方物。
- 前記クエン酸ナトリウム二水和物が5g/Lの濃度にて存在し、前記クエン酸無水物が2g/Lの濃度にて存在する、請求項1または2に記載の液体処方物。
- 前記リバビリンが、20g/L〜65g/Lの濃度にて存在する、請求項1〜3のいずれか1項に記載の液体処方物。
- 前記リバビリンが、40g/Lの濃度にて存在する、請求項1〜4のいずれか1項に記載の液体処方物。
- 少なくとも2つの薬学的に受容可能な甘味剤が存在する、請求項1〜5のいずれか1項に記載の液体処方物。
- 前記存在する少なくとも2つの薬学的に受容可能な甘味剤が、顆粒化スクロースおよびソルビトール溶液である、請求項1〜6のいずれか1項に記載の液体処方物。
- 前記顆粒化されたスクロースが300g/Lの濃度にて存在し、前記ソルビトール溶液が100g/L〜150g/Lの濃度にて存在する、請求項1〜7のいずれか1項に記載の液体処方物。
- 少なくとも1つのさらなる薬学的に受容可能な甘味剤をさらに含む、請求項1〜8のいずれか1項に記載の液体処方物。
- 前記少なくとも1つの薬学的に受容可能な増粘剤がプロピレングリコールUSPであり、該プロピレングリコールUSPが100g/Lの濃度にて存在する、請求項1〜9のいずれか1項に記載の液体処方物。
- 前記さらなる薬学的に受容可能な甘味剤が、グリセロール無水物である、請求項9に記載の液体処方物。
- 請求項1〜11のいずれか1項に記載の液体処方物であって、該液体処方物は、以下の成分:
(a)40.0g/Lの濃度のリバビリン;
(b)5.27g/Lのクエン酸ナトリウム二水和物;
(c)2.15g/Lのクエン酸無水物;
(d)1.0g/Lの安息香酸ナトリウム;
(e)150.0g/Lのグリセロール無水物;
(f)300.0g/Lの顆粒化スクロース;
(g)142.0g/Lのソルビトール溶液;
(h)100.0g/Lのプロピレングリコール;
(i)1.0g/Lの芳香剤;ならびに
(j)純水
からなる、液体処方物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US33475101P | 2001-10-31 | 2001-10-31 | |
PCT/US2002/034898 WO2003037312A2 (en) | 2001-10-31 | 2002-10-31 | Ribavirin syrup formulations |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2005507931A JP2005507931A (ja) | 2005-03-24 |
JP4393192B2 true JP4393192B2 (ja) | 2010-01-06 |
Family
ID=23308655
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003539656A Expired - Fee Related JP4393192B2 (ja) | 2001-10-31 | 2002-10-31 | リバビリンシロップ処方物 |
Country Status (27)
Country | Link |
---|---|
US (1) | US6790837B2 (ja) |
EP (1) | EP1480653B1 (ja) |
JP (1) | JP4393192B2 (ja) |
KR (1) | KR100929320B1 (ja) |
CN (1) | CN1319535C (ja) |
AR (1) | AR037131A1 (ja) |
AT (1) | ATE439847T1 (ja) |
AU (1) | AU2002350081B2 (ja) |
BR (1) | BR0213536A (ja) |
CA (1) | CA2464151C (ja) |
CO (1) | CO5570681A2 (ja) |
CY (1) | CY1110524T1 (ja) |
DE (1) | DE60233438D1 (ja) |
DK (1) | DK1480653T3 (ja) |
ES (1) | ES2330419T3 (ja) |
HK (1) | HK1066719A1 (ja) |
HU (1) | HU229259B1 (ja) |
MX (1) | MXPA04004068A (ja) |
NO (1) | NO334361B1 (ja) |
NZ (1) | NZ531967A (ja) |
PE (1) | PE20030545A1 (ja) |
PL (1) | PL205342B1 (ja) |
PT (1) | PT1480653E (ja) |
SI (1) | SI1480653T1 (ja) |
TW (1) | TWI259082B (ja) |
WO (1) | WO2003037312A2 (ja) |
ZA (1) | ZA200402975B (ja) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2540052C (en) * | 2003-10-08 | 2012-04-10 | Mallinckrodt Inc. | Methylphenidate solution and associated methods of administration and production |
US20060110479A1 (en) * | 2004-11-24 | 2006-05-25 | Mitra Shankar K | Natural composition for curing hepatitis-B, methods for making the same and pharmaceutical formulations thereof |
RU2493826C2 (ru) * | 2007-07-12 | 2013-09-27 | Новартис Аг | Пероральные фармацевтические растворы, содержащие телбивудин |
SE1450131A1 (sv) | 2011-10-21 | 2014-05-07 | Abbvie Inc | DAA-kombinationsbehandling (t.ex. med ABT-072 eller ABT-333)för användning vid behandling av HCV |
CN104383541A (zh) | 2011-10-21 | 2015-03-04 | 艾伯维公司 | 用于治疗hcv的包含至少两种直接抗病毒剂和利巴韦林但无干扰素的方法 |
US8466159B2 (en) | 2011-10-21 | 2013-06-18 | Abbvie Inc. | Methods for treating HCV |
US8492386B2 (en) | 2011-10-21 | 2013-07-23 | Abbvie Inc. | Methods for treating HCV |
US9682093B2 (en) | 2012-03-30 | 2017-06-20 | Charles R. Drew University Of Medicine And Science | Compositions and methods for treating or preventing metabolic syndrome disorders |
US20140271923A1 (en) | 2013-03-14 | 2014-09-18 | Christopher Brian Reid | Compositions & formulations for preventing and treating chronic diseases that cluster in patients such as cardiovascular disease, diabetes, obesity, polycystic ovary syndrome, hyperlipidemia and hypertension, as well as for preventing and treating other diseases and conditions |
WO2017189978A1 (en) | 2016-04-28 | 2017-11-02 | Emory University | Alkyne containing nucleotide and nucleoside therapeutic compositions and uses related thereto |
US20190336443A1 (en) * | 2018-05-03 | 2019-11-07 | Navinta Iii Inc | Ready-To-Use Liquid Parenteral Formulations Of Ribavirin |
CN109568257A (zh) * | 2018-12-24 | 2019-04-05 | 江西润泽药业有限公司 | 一种利巴韦林注射液及其制备方法 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4211771A (en) * | 1971-06-01 | 1980-07-08 | Robins Ronald K | Treatment of human viral diseases with 1-B-D-ribofuranosyl-1,2,4-triazole-3-carboxamide |
JPS58198416A (ja) * | 1982-05-15 | 1983-11-18 | Ota Seiyaku Kk | セフアレキシンドライシロツプ剤の製造法 |
JPS63177797A (ja) * | 1987-01-19 | 1988-07-21 | Ajinomoto Co Inc | リボ−ス−1−リン酸及びリバビリンの製造法 |
US4880784A (en) | 1987-12-21 | 1989-11-14 | Brigham Young University | Antiviral methods utilizing ribofuranosylthiazolo[4,5-d]pyrimdine derivatives |
WO1995029677A1 (en) * | 1994-04-28 | 1995-11-09 | Bionumerik Pharmaceuticals, Inc. | Lactone stable formulation of camptothecin or 7-ethyl camptothecin |
US5767097A (en) * | 1996-01-23 | 1998-06-16 | Icn Pharmaceuticals, Inc. | Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes |
US6423695B1 (en) * | 1998-01-13 | 2002-07-23 | Ribapharm, Inc. | Cytokine related treatments of disease |
US6132758A (en) * | 1998-06-01 | 2000-10-17 | Schering Corporation | Stabilized antihistamine syrup |
-
2002
- 2002-10-29 PE PE2002001063A patent/PE20030545A1/es not_active Application Discontinuation
- 2002-10-29 AR ARP020104108A patent/AR037131A1/es active IP Right Grant
- 2002-10-30 TW TW091132150A patent/TWI259082B/zh not_active IP Right Cessation
- 2002-10-31 ES ES02786612T patent/ES2330419T3/es not_active Expired - Lifetime
- 2002-10-31 WO PCT/US2002/034898 patent/WO2003037312A2/en active IP Right Grant
- 2002-10-31 PT PT02786612T patent/PT1480653E/pt unknown
- 2002-10-31 AU AU2002350081A patent/AU2002350081B2/en not_active Ceased
- 2002-10-31 BR BR0213536-1A patent/BR0213536A/pt not_active IP Right Cessation
- 2002-10-31 DK DK02786612T patent/DK1480653T3/da active
- 2002-10-31 MX MXPA04004068A patent/MXPA04004068A/es active IP Right Grant
- 2002-10-31 CN CNB028217233A patent/CN1319535C/zh not_active Expired - Fee Related
- 2002-10-31 JP JP2003539656A patent/JP4393192B2/ja not_active Expired - Fee Related
- 2002-10-31 US US10/285,119 patent/US6790837B2/en not_active Expired - Lifetime
- 2002-10-31 AT AT02786612T patent/ATE439847T1/de active
- 2002-10-31 KR KR1020047005865A patent/KR100929320B1/ko not_active IP Right Cessation
- 2002-10-31 CA CA2464151A patent/CA2464151C/en not_active Expired - Fee Related
- 2002-10-31 SI SI200230853T patent/SI1480653T1/sl unknown
- 2002-10-31 PL PL372224A patent/PL205342B1/pl not_active IP Right Cessation
- 2002-10-31 DE DE60233438T patent/DE60233438D1/de not_active Expired - Lifetime
- 2002-10-31 EP EP02786612A patent/EP1480653B1/en not_active Expired - Lifetime
- 2002-10-31 NZ NZ531967A patent/NZ531967A/en not_active IP Right Cessation
- 2002-10-31 HU HU0600300A patent/HU229259B1/hu unknown
-
2004
- 2004-04-19 ZA ZA2004/02975A patent/ZA200402975B/en unknown
- 2004-04-27 CO CO04038162A patent/CO5570681A2/es active IP Right Grant
- 2004-05-28 NO NO20042228A patent/NO334361B1/no not_active IP Right Cessation
- 2004-12-04 HK HK04109613.4A patent/HK1066719A1/xx not_active IP Right Cessation
-
2009
- 2009-10-29 CY CY20091101125T patent/CY1110524T1/el unknown
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