JP2006008684A - ジクロフェナクナトリウムとβ−シクロデキストリンとを有する注入可能薬学組成物 - Google Patents
ジクロフェナクナトリウムとβ−シクロデキストリンとを有する注入可能薬学組成物 Download PDFInfo
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- JP2006008684A JP2006008684A JP2005174529A JP2005174529A JP2006008684A JP 2006008684 A JP2006008684 A JP 2006008684A JP 2005174529 A JP2005174529 A JP 2005174529A JP 2005174529 A JP2005174529 A JP 2005174529A JP 2006008684 A JP2006008684 A JP 2006008684A
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- pharmaceutical composition
- cyclodextrin
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- diclofenac sodium
- polysorbate
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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
- A61K9/08—Solutions
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- 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
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- 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
- 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
- A61K47/38—Cellulose; 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
- A61K47/30—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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
【解決手段】 皮下及び/又は筋肉内投与に適した、ジクロフェナクナトリウムと、β−シクロデキストリンと、ポリソルベートとを有する注入可能薬学的組成物。
【選択図】 図1
Description
0.05w/v%のTween(登録商標)20を有するジクロフェナクナトリウム及びヒドロキシプロピルβ−シクロデキストリン複合体の調製。
溶液A:1003mgのTween(登録商標)20を、20mLの脱イオン水に溶解する。
0.005w/v%のTween(登録商標)20を有するジクロフェナクナトリウム及びヒドロキシプロピルβ−シクロデキストリン複合体の調製。
溶液A:100.3mgのTween(登録商標)20を、20mLの脱イオン水に溶解する。
0.18w/v%のTween(登録商標)20を有するジクロフェナクナトリウム及びヒドロキシプロピルβ−シクロデキストリン複合体の調製。
ヒトへの皮下注入による薬物動態
上述の例1の通り調製した72.91mg/mLのジクロフェナクナトリウム溶液を、単位当たり75mgのジクロフェナクナトリウムを有するバイアル中で無菌条件下で滅菌濾過法により滅菌した。
上述の例1に従って調製した72.91mg/mLのジクロフェナクナトリウム溶液を、単位当たり75mgのジクロフェナクナトリウムを有するバイアル中で無菌条件下で滅菌濾過法により滅菌した。
Claims (7)
- 25mg/mL水以上の濃度のジクロフェナクナトリウムと、β−シクロデキストリンとを有する水溶液の形態の注入可能薬学的組成物であって、
当該組成物は、前記水溶液の全量に対して0.01重量%乃至0.06重量%の量のポリソルベートを少なくともさらに有することを特徴とする薬学的組成物。 - 前記ポリソルベートは、ポリソルベート20(ポリエチレンソルビタンモノラウレート)であることを特徴とする請求項1に記載の薬学的組成物。
- 前記ポリソルベートは、前記水溶液の全量に対して0.05重量%を含有することを特徴とする請求項1又は2に記載の薬学的組成物。
- ジクロフェナクナトリウムとβ−シクロデキストリンとのモル比が、1:1乃至1:1.3であることを特徴とする請求項1乃至3のいずれか一項に記載の薬学的組成物。
- 前記β−シクロデキストリンは、ヒドロキシプロピル−β−シクロデキストリンであることを特徴とする請求項1乃至4のいずれか一項に記載の薬学的組成物。
- 前記ジクロフェナクナトリウムの濃度は、75mg/mLであることを特徴とする請求項1乃至5のいずれか一項に記載の薬学的組成物。
- 75mgのジクロフェナクナトリウムを有する単回投与の形態の請求項1乃至6のいずれか一項に記載の薬学的組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI2004A001245 | 2004-06-22 | ||
IT001245A ITMI20041245A1 (it) | 2004-06-22 | 2004-06-22 | Composizioni farmaceutiche iniettabnili comprendenti diclofenac sodico e b-ciclodestrina |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2006008684A true JP2006008684A (ja) | 2006-01-12 |
JP5113323B2 JP5113323B2 (ja) | 2013-01-09 |
Family
ID=35033310
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2005174529A Active JP5113323B2 (ja) | 2004-06-22 | 2005-06-15 | ジクロフェナクナトリウムとβ−シクロデキストリンとを有する注入可能薬学組成物 |
Country Status (13)
Country | Link |
---|---|
US (1) | US7423028B2 (ja) |
EP (1) | EP1609481B1 (ja) |
JP (1) | JP5113323B2 (ja) |
KR (1) | KR101202649B1 (ja) |
CN (1) | CN100569230C (ja) |
AT (1) | ATE373489T1 (ja) |
CA (1) | CA2510813C (ja) |
DE (1) | DE602005002495T2 (ja) |
DK (1) | DK1609481T3 (ja) |
ES (1) | ES2293482T3 (ja) |
IT (1) | ITMI20041245A1 (ja) |
PL (1) | PL1609481T3 (ja) |
PT (1) | PT1609481E (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2019504056A (ja) * | 2015-12-30 | 2019-02-14 | ジェネンテック, インコーポレイテッド | 低減されたポリソルベート分解を有する製剤 |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NZ554779A (en) | 2005-02-01 | 2011-02-25 | Troikaa Pharmaceuticals Ltd | Injectable preparations of diclofenac ((2,6-dichloranilino)phenylacetic acid) and its pharmaceutically acceptable salts |
AU2007230718B2 (en) * | 2006-03-28 | 2012-05-10 | Javelin Pharmaceuticals, Inc. | Formulations of low dose non-steroidal anti-inflammatory drugs and beta-cyclodextrin |
CA2647348A1 (en) | 2006-03-28 | 2007-10-04 | Javelin Pharmaceuticals, Inc. | Formulations of low dose diclofenac and beta-cyclodextrin |
ITMI20121205A1 (it) | 2012-07-11 | 2014-01-12 | Glycores 2000 Srl | Composizione con attivita' antinfiammatoria ed analgesica da somministrare per uso esterno mediante vaporizzazione |
US20140275261A1 (en) | 2013-03-15 | 2014-09-18 | Dr. Reddy's Laboratories, Inc. | Diclofenac parenteral compositions |
CN103432132B (zh) * | 2013-08-31 | 2015-01-21 | 西南大学 | 甲磺酸普立地诺双氯芬酸钠注射液及其制备方法 |
CN107126418B (zh) * | 2016-02-25 | 2020-05-29 | 江苏思邈医药科技有限公司 | 供注射用双氯芬酸钠药物组合物及其制备方法 |
EP3216443A1 (en) | 2016-03-10 | 2017-09-13 | Athenion AG | Beverage preparation capsule for delivery of a solubilisate |
IT201600075246A1 (it) | 2016-07-19 | 2018-01-19 | Jointherapeutics S R L | Composizioni comprendenti una matrice polisaccaridica per il rilascio controllato di principi attivi. |
US11110073B2 (en) | 2017-03-24 | 2021-09-07 | Cadila Healthcare Limited | Storage stable aqueous injectable solution comprising diclofenac |
EP3388054A1 (en) | 2017-04-12 | 2018-10-17 | Athenion AG | Dispensing cap containing a solubilisate of a pharmaceutically active agent or dietary supplement |
US20220280463A1 (en) | 2019-09-09 | 2022-09-08 | Ftf Pharma Private Limited | Pharmaceutical formulations comprising diclofenac |
US11707443B2 (en) | 2019-09-26 | 2023-07-25 | Rk Pharma Inc. | Storage stable aqueous parenteral solutions comprising diclofenac |
Citations (5)
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JPH07252144A (ja) * | 1993-12-02 | 1995-10-03 | South African Druggist Ltd | 薬学組成物 |
WO1996003121A1 (en) * | 1994-07-28 | 1996-02-08 | Southern Research Institute | Antiphlogistic, analgesic, antipyretic injection preparation |
JP2001516351A (ja) * | 1997-03-12 | 2001-09-25 | アボツト・ラボラトリーズ | シクロスポリンの投与のための親水性二成分系 |
US20020016359A1 (en) * | 2000-06-29 | 2002-02-07 | Hellberg Mark R. | Compositions and methods of treating neurodegenerative diseases |
JP2003534366A (ja) * | 2000-05-25 | 2003-11-18 | アルカームズ コントロールド セラピューティクス インコーポレイテッド | 改善された注射性を有する注射可能な懸濁物の調製 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6365180B1 (en) * | 1998-01-20 | 2002-04-02 | Glenn A. Meyer | Oral liquid compositions |
US7008934B2 (en) * | 2001-06-28 | 2006-03-07 | Baxter International Inc. | Composition and method for reducing adverse interactions between phenothiazine derivatives and plasma using cyclodextrins |
-
2004
- 2004-06-22 IT IT001245A patent/ITMI20041245A1/it unknown
-
2005
- 2005-06-15 JP JP2005174529A patent/JP5113323B2/ja active Active
- 2005-06-17 CN CNB2005100768303A patent/CN100569230C/zh active Active
- 2005-06-20 KR KR1020050053096A patent/KR101202649B1/ko active IP Right Grant
- 2005-06-21 US US11/158,517 patent/US7423028B2/en active Active
- 2005-06-21 DK DK05105474T patent/DK1609481T3/da active
- 2005-06-21 PL PL05105474T patent/PL1609481T3/pl unknown
- 2005-06-21 PT PT05105474T patent/PT1609481E/pt unknown
- 2005-06-21 DE DE602005002495T patent/DE602005002495T2/de active Active
- 2005-06-21 CA CA2510813A patent/CA2510813C/en active Active
- 2005-06-21 EP EP05105474A patent/EP1609481B1/en active Active
- 2005-06-21 AT AT05105474T patent/ATE373489T1/de active
- 2005-06-21 ES ES05105474T patent/ES2293482T3/es active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH07252144A (ja) * | 1993-12-02 | 1995-10-03 | South African Druggist Ltd | 薬学組成物 |
WO1996003121A1 (en) * | 1994-07-28 | 1996-02-08 | Southern Research Institute | Antiphlogistic, analgesic, antipyretic injection preparation |
JP2001516351A (ja) * | 1997-03-12 | 2001-09-25 | アボツト・ラボラトリーズ | シクロスポリンの投与のための親水性二成分系 |
JP2003534366A (ja) * | 2000-05-25 | 2003-11-18 | アルカームズ コントロールド セラピューティクス インコーポレイテッド | 改善された注射性を有する注射可能な懸濁物の調製 |
US20020016359A1 (en) * | 2000-06-29 | 2002-02-07 | Hellberg Mark R. | Compositions and methods of treating neurodegenerative diseases |
Non-Patent Citations (1)
Title |
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JPN6012015213; 新・薬剤学総論 第3版, 19870410, pp.329-331, 株式会社 南江堂 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2019504056A (ja) * | 2015-12-30 | 2019-02-14 | ジェネンテック, インコーポレイテッド | 低減されたポリソルベート分解を有する製剤 |
US10933141B2 (en) | 2015-12-30 | 2021-03-02 | Genentech, Inc. | Formulations with reduced degradation of polysorbate |
JP7008023B2 (ja) | 2015-12-30 | 2022-01-25 | ジェネンテック, インコーポレイテッド | 低減されたポリソルベート分解を有する製剤 |
JP2022036977A (ja) * | 2015-12-30 | 2022-03-08 | ジェネンテック, インコーポレイテッド | 低減されたポリソルベート分解を有する製剤 |
Also Published As
Publication number | Publication date |
---|---|
EP1609481B1 (en) | 2007-09-19 |
CN100569230C (zh) | 2009-12-16 |
EP1609481A1 (en) | 2005-12-28 |
US7423028B2 (en) | 2008-09-09 |
PL1609481T3 (pl) | 2008-02-29 |
JP5113323B2 (ja) | 2013-01-09 |
DK1609481T3 (da) | 2008-01-07 |
PT1609481E (pt) | 2007-12-31 |
ES2293482T3 (es) | 2008-03-16 |
CA2510813A1 (en) | 2005-12-22 |
KR20060049413A (ko) | 2006-05-18 |
ATE373489T1 (de) | 2007-10-15 |
ITMI20041245A1 (it) | 2004-09-22 |
US20050282776A1 (en) | 2005-12-22 |
CN1711996A (zh) | 2005-12-28 |
DE602005002495D1 (de) | 2007-10-31 |
DE602005002495T2 (de) | 2008-06-12 |
CA2510813C (en) | 2013-02-12 |
KR101202649B1 (ko) | 2012-11-19 |
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