JP2013231029A - 既製のゲムシタビン注入溶液 - Google Patents
既製のゲムシタビン注入溶液 Download PDFInfo
- Publication number
- JP2013231029A JP2013231029A JP2013094336A JP2013094336A JP2013231029A JP 2013231029 A JP2013231029 A JP 2013231029A JP 2013094336 A JP2013094336 A JP 2013094336A JP 2013094336 A JP2013094336 A JP 2013094336A JP 2013231029 A JP2013231029 A JP 2013231029A
- Authority
- JP
- Japan
- Prior art keywords
- solution
- gemcitabine
- large volume
- infusion
- dosage form
- 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.)
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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
- A61K31/70—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
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- 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
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
- B65D85/30—Containers, packaging elements or packages, specially adapted for particular articles or materials for articles particularly sensitive to damage by shock or pressure
- B65D85/42—Containers, packaging elements or packages, specially adapted for particular articles or materials for articles particularly sensitive to damage by shock or pressure for ampoules; for lamp bulbs; for electronic valves or tubes
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
【解決手段】大容量注入容器に充填された、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液を含んでなり、該溶液はすぐに注入できる準備がされた(ready-to-be-infused)溶液である、ゲムシタビンの大容量注入剤形。
【選択図】図1
Description
次に示される実施例は何の限定をされることなく本発明の範囲のものを説明する。
本発明に関するすぐに注入できる溶液は以下のように調製される。
実施例1、2および実施例3のすぐに注入する準備のできている溶液は実施例1の前記手順にしたがって調製され、注入溶液は濾過により滅菌される(最終段階での滅菌は行わない)。濾過された溶液はガラスバイアルや無菌PVCバックのいずれかに充填された。充填された容器は2−8℃および20−25℃で保存された。前記溶液は安定性、すなわち、結晶や粒子の存在、が評価された。物理的安定性の結果は下記表6に示される。
Claims (10)
- 大容量注入容器に充填された、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液を含んでなり、該溶液はすぐに注入できる溶液である、ゲムシタビンの大容量注入投与剤形。
- 前記注入容器がポリ塩化ビニルではないポリマーの単一コンパートメント容器である、請求項1に記載の大容量注入投与剤形。
- 前記水性媒体が共溶媒でない、請求項1に記載の大容量注入投与剤形。
- 前記溶液が1mlあたり5mgから1mlあたり20mgのゲムシタビン濃度を有する、請求項1に記載の大容量注入投与剤形。
- 二次的な包装システムで覆われた大容量ポリマー注入容器に充填された、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液を含んでなる大容量注入剤形を含んでなり、該溶液はすぐに注入できる溶液である、キット。
- ゲムシタビンまたはその薬学的に許容可能な塩が、10mg/mlの濃度で存在し、かつ、100ml〜300mlの容量で充填される、請求項7に記載のキット。
- 前記注入容器が、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液160mlを含み、かつ、容器当たり1600mgのゲムシタビン塩酸塩の1投与量を提供する、請求項8に記載の大容量注入投与剤形を含んでなるキット。
- 前記注入容器が、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液170mlを含み、かつ、容器当たり1700mgのゲムシタビン塩酸塩の1投与量を提供する、請求項8に記載の大容量注入投与剤形を含んでなるキット。
- 前記注入容器が、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液180mlを含み、かつ、容器当たり1800mgのゲムシタビン塩酸塩の1投与量を提供する、請求項8に記載の大容量注入投与剤形を含んでなるキット。
- 前記注入容器が、水性媒体中のゲムシタビンまたはその薬学的に許容可能な塩の安定した大容量溶液190mlを含み、かつ、容器当たり1900mgのゲムシタビン塩酸塩の1投与量を提供する、請求項8に記載の大容量注入投与剤形を含んでなるキット。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IN1334MU2012 | 2012-04-27 | ||
IN1334/MUM/2012 | 2012-04-27 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2013231029A true JP2013231029A (ja) | 2013-11-14 |
JP6159567B2 JP6159567B2 (ja) | 2017-07-05 |
Family
ID=48325397
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013094336A Active JP6159567B2 (ja) | 2012-04-27 | 2013-04-26 | 既製のゲムシタビン注入溶液 |
Country Status (16)
Country | Link |
---|---|
US (1) | US9241948B2 (ja) |
EP (1) | EP2656848B2 (ja) |
JP (1) | JP6159567B2 (ja) |
KR (1) | KR101716215B1 (ja) |
CN (3) | CN109077995A (ja) |
AU (1) | AU2013261012B2 (ja) |
BR (1) | BR112014026334B1 (ja) |
CA (1) | CA2871061C (ja) |
ES (1) | ES2537294T5 (ja) |
MX (1) | MX357935B (ja) |
PL (1) | PL2656848T5 (ja) |
PT (1) | PT2656848E (ja) |
RU (1) | RU2621144C2 (ja) |
SI (1) | SI2656848T2 (ja) |
WO (1) | WO2013171763A1 (ja) |
ZA (1) | ZA201408502B (ja) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015000869A (ja) * | 2013-06-18 | 2015-01-05 | サムヤン バイオファーマシューティカルズ コーポレイション | 有機溶媒無含有ゲムシタビン水溶液組成物 |
JP2015205924A (ja) * | 2015-07-30 | 2015-11-19 | サムヤン バイオファーマシューティカルズ コーポレイション | 有機溶媒無含有ゲムシタビン水溶液組成物 |
JP2016093480A (ja) * | 2014-09-03 | 2016-05-26 | サン、ファーマスーティカル、インダストリーズ、リミテッドSun Pharmaceutical Industries Ltd. | 灌流投与剤形 |
Families Citing this family (5)
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US9064577B2 (en) | 2012-12-06 | 2015-06-23 | Micron Technology, Inc. | Apparatuses and methods to control body potential in memory operations |
US10114999B1 (en) | 2016-12-02 | 2018-10-30 | Koupon Media, Inc. | Using dynamic occlusion to protect against capturing barcodes for fraudulent use on mobile devices |
AU2019355057A1 (en) * | 2018-10-04 | 2021-05-27 | Daniel E. Levy | Method for preparing and delivering bisantrene formulations |
WO2021028842A1 (en) * | 2019-08-13 | 2021-02-18 | Hetero Healthcare Limited | A stable ready-to-use injectable composition of gemcitabine or its salt and methods for producing same |
KR20240084203A (ko) * | 2022-12-06 | 2024-06-13 | 주식회사 삼양홀딩스 | 안정성이 향상된 상온 보관용 젬시타빈 수용액제 및 그 제조 방법 |
Citations (6)
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JP2003526471A (ja) * | 2000-03-16 | 2003-09-09 | バクスター・インターナショナル・インコーポレイテッド | 新しい非pvc材料のコンテナおよび剥離可能なシールコンテナ |
US20060089329A1 (en) * | 2004-10-22 | 2006-04-27 | Edgar Schridde | Ready-to-use gemcitabine solution concentrates |
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2013
- 2013-04-26 JP JP2013094336A patent/JP6159567B2/ja active Active
- 2013-04-26 CN CN201811109917.XA patent/CN109077995A/zh active Pending
- 2013-04-26 WO PCT/IN2013/000281 patent/WO2013171763A1/en active Application Filing
- 2013-04-26 US US13/871,438 patent/US9241948B2/en active Active
- 2013-04-26 RU RU2014147388A patent/RU2621144C2/ru active
- 2013-04-26 MX MX2014013101A patent/MX357935B/es active IP Right Grant
- 2013-04-26 CN CN202110882352.4A patent/CN113577019A/zh active Pending
- 2013-04-26 CA CA2871061A patent/CA2871061C/en active Active
- 2013-04-26 AU AU2013261012A patent/AU2013261012B2/en active Active
- 2013-04-26 CN CN201380022179.4A patent/CN104254319A/zh active Pending
- 2013-04-26 KR KR1020147029928A patent/KR101716215B1/ko active IP Right Grant
- 2013-04-26 BR BR112014026334-5A patent/BR112014026334B1/pt active IP Right Grant
- 2013-04-29 SI SI201330029T patent/SI2656848T2/sl unknown
- 2013-04-29 PT PT131658627T patent/PT2656848E/pt unknown
- 2013-04-29 ES ES13165862.7T patent/ES2537294T5/es active Active
- 2013-04-29 PL PL13165862T patent/PL2656848T5/pl unknown
- 2013-04-29 EP EP13165862.7A patent/EP2656848B2/en active Active
-
2014
- 2014-11-19 ZA ZA2014/08502A patent/ZA201408502B/en unknown
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JP2003526471A (ja) * | 2000-03-16 | 2003-09-09 | バクスター・インターナショナル・インコーポレイテッド | 新しい非pvc材料のコンテナおよび剥離可能なシールコンテナ |
US20060089329A1 (en) * | 2004-10-22 | 2006-04-27 | Edgar Schridde | Ready-to-use gemcitabine solution concentrates |
US20060154891A1 (en) * | 2004-12-23 | 2006-07-13 | Edgar Schridde | Ready-to-use gemcitabine solutions and gemcitabin concentrates |
CN101428035A (zh) * | 2007-12-11 | 2009-05-13 | 常州安孚立德药业技术有限公司 | 一种盐酸吉西他滨或吉西他滨组合物 |
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2015000869A (ja) * | 2013-06-18 | 2015-01-05 | サムヤン バイオファーマシューティカルズ コーポレイション | 有機溶媒無含有ゲムシタビン水溶液組成物 |
JP2016093480A (ja) * | 2014-09-03 | 2016-05-26 | サン、ファーマスーティカル、インダストリーズ、リミテッドSun Pharmaceutical Industries Ltd. | 灌流投与剤形 |
JP2021038223A (ja) * | 2014-09-03 | 2021-03-11 | サン ファーマシューティカル インダストリーズ リミテッドSun Pharmaceutical Industries Ltd. | 灌流投与剤形 |
JP7029510B2 (ja) | 2014-09-03 | 2022-03-03 | サン ファーマシューティカル インダストリーズ リミテッド | 灌流投与剤形 |
JP2022062078A (ja) * | 2014-09-03 | 2022-04-19 | サン ファーマシューティカル インダストリーズ リミテッド | 灌流投与剤形 |
JP7466579B2 (ja) | 2014-09-03 | 2024-04-12 | サン ファーマシューティカル インダストリーズ リミテッド | 灌流投与剤形 |
JP2015205924A (ja) * | 2015-07-30 | 2015-11-19 | サムヤン バイオファーマシューティカルズ コーポレイション | 有機溶媒無含有ゲムシタビン水溶液組成物 |
Also Published As
Publication number | Publication date |
---|---|
WO2013171763A1 (en) | 2013-11-21 |
MX2014013101A (es) | 2015-01-26 |
AU2013261012B2 (en) | 2017-02-02 |
US20130288994A1 (en) | 2013-10-31 |
AU2013261012A1 (en) | 2014-11-13 |
MX357935B (es) | 2018-07-31 |
KR101716215B1 (ko) | 2017-03-27 |
KR20150014438A (ko) | 2015-02-06 |
BR112014026334B1 (pt) | 2022-04-12 |
BR112014026334A8 (pt) | 2021-06-15 |
EP2656848B2 (en) | 2018-09-19 |
ES2537294T3 (es) | 2015-06-05 |
CA2871061C (en) | 2017-06-20 |
PL2656848T3 (pl) | 2015-10-30 |
SI2656848T1 (sl) | 2015-07-31 |
ES2537294T5 (es) | 2018-12-10 |
SI2656848T2 (sl) | 2019-04-30 |
EP2656848A1 (en) | 2013-10-30 |
ZA201408502B (en) | 2015-11-25 |
JP6159567B2 (ja) | 2017-07-05 |
BR112014026334A2 (pt) | 2017-06-27 |
US9241948B2 (en) | 2016-01-26 |
PL2656848T5 (pl) | 2019-02-28 |
EP2656848B1 (en) | 2015-04-08 |
CA2871061A1 (en) | 2013-11-21 |
PT2656848E (pt) | 2015-07-01 |
RU2014147388A (ru) | 2016-06-20 |
CN104254319A (zh) | 2014-12-31 |
RU2621144C2 (ru) | 2017-05-31 |
CN113577019A (zh) | 2021-11-02 |
CN109077995A (zh) | 2018-12-25 |
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