JP5267643B2 - ピタバスタチンカルシウム塩の保存方法 - Google Patents
ピタバスタチンカルシウム塩の保存方法 Download PDFInfo
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- JP5267643B2 JP5267643B2 JP2011260984A JP2011260984A JP5267643B2 JP 5267643 B2 JP5267643 B2 JP 5267643B2 JP 2011260984 A JP2011260984 A JP 2011260984A JP 2011260984 A JP2011260984 A JP 2011260984A JP 5267643 B2 JP5267643 B2 JP 5267643B2
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- Prior art keywords
- pitavastatin calcium
- maintained
- amount
- calcium salt
- water
- 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/12—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with substituted hydrocarbon radicals attached to ring carbon atoms
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/12—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with substituted hydrocarbon radicals attached to ring carbon atoms
- C07D215/14—Radicals substituted by oxygen atoms
-
- 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
- A61K31/47—Quinolines; Isoquinolines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Plural Heterocyclic Compounds (AREA)
- Quinoline Compounds (AREA)
Description
本発明が解決しようとする課題は、特別な貯蔵条件でなくとも、ピタバスタチンカルシウムの結晶性原薬を安定的に保存する方法を提供することにある。
3.含有水分が7重量%以上、15重量%以下の量に維持することを特徴とする上記1に記載の保存方法。
4.含有水分が9重量%以上、15重量%以下の量に維持することを特徴とする上記1に記載の保存方法。
────────────────────────────────
回折角(2θ) d-面間隔 相対強度
(°) (>25%)
────────────────────────────────
4.96 17.7999 35.9
6.72 13.1423 55.1
9.08 9.7314 33.3
10.40 8.4991 34.8
10.88 8.1248 27.3
13.20 6.7020 27.8
13.60 6.5053 48.8
13.96 6.3387 60.0
18.32 4.8386 56.7
20.68 4.2915 100.0
21.52 4.1259 57.4
23.64 3.7604 41.3
24.12 3.6866 45.0
27.00 3.2996 28.5
30.16 2.9607 30.6
────────────────────────────────
粉末X線回折測定装置:MXLabo(マックサイエンス製)
線源:Cu、波長:1.54056A、ゴニオメータ:縦型ゴニオメータ
モノクロメータ:使用、補助装置:なし、管電圧:50.0Kv、管電流:30.0mA
測定方法:
測定前に、シリコン(標準物質)を用いてX−線管アラインメントを検査する。
試料約100mgをガラス試料板にのせ平坦にした後、以下の条件にて測定する。
データ範囲:3.0400〜40.0000deg、データ点数:925
スキャン軸:2θ/θ、θ軸角度:設定なし
サンプリング間隔:0.0400deg、スキャン速度:4.800deg/min
カルシウム化合物としては塩化カルシウム、酢酸カルシウムなどが好ましく、使用量は式(2)の化合物に対して0.3倍モル〜3倍モル、好ましくは0.5〜2倍モルの範囲である。
晶析温度は特に限定されないが、−10〜70℃の範囲であり、好ましくは−5〜40℃の範囲であり、更に好ましくは0〜20℃の範囲である。
晶析時間は特に限定されないが、30分〜15時間程度行えば十分である。
結晶を析出させる際の方法としては、静置で行う方法、攪拌下で行う方法等が挙げられるが、攪拌下で行うのが好ましい。
また、必要に応じて結晶形態Aの種晶を使用してもよい。
水分値は、最終的に5〜15%(W/W)の範囲になるよう調整されるが、好ましくは7〜15%(W/W)、より好ましくは7〜13%(W/W)、最も好ましくは9〜13%(W/W)の範囲である。
得られたピタバスタチンカルシウムは粉砕された後、医薬品用の原薬として使用される。
本発明に係る化合物を含有する上記の医薬的又は獣医薬的組成物は、全組成物の重量に対して、本発明に係る化合物を約0.001〜30%、好ましくは、約0.01〜10%を含有する。
本発明に係る化合物に又は該化合物を含有する組成物に加えて、他の医薬的に又は獣医薬的に活性な化合物を含ませることができる。
即ち、経口投与用の錠剤、カプセル剤、顆粒剤、丸剤は、賦形剤、例えば白糖、乳糖、ブドウ糖、でんぷん、マンニット;結合剤、例えばヒドロキシプロピルセルロース、シロップ、アラビアゴム、ゼラチン、ソルビット、トラガント、メチルセルロース、ポリビニルピロリドン;崩壊剤、例えばでんぷん、カルボキシメチルセルロース又はそのカルシウム塩、微結晶セルロース、ポリエチレングリコール;滑沢剤、例えばタルク、ステアリン酸マグネシウム又はカルシウム、シリカ;潤滑剤、例えばラウリル酸ナトリウム、グリセロール等を使用して調製される。
坐剤は、例えばカカオ脂、ポリエチレングリコール、ラノリン、脂肪酸トリグリセライド、ココナット油、ポリソルベート等を使用して調製される。
尚、実施例に使用した化合物(5)は、WO95/23125号公報に記載の方法に従って製造した。
粉末X線回折を測定して、この結晶が結晶形態Aであることを確認した。
Claims (5)
- 含有水分が5重量%以上、15重量%以下の量に維持することを特徴とする請求項1に記載の保存方法。
- 含有水分が7重量%以上、15重量%以下の量に維持することを特徴とする請求項1に記載の保存方法。
- 含有水分が9重量%以上、15重量%以下の量に維持することを特徴とする請求項1に記載の保存方法。
- 気密条件下に保存することを特徴とする請求項1〜4の何れか1項に記載の保存方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2011260984A JP5267643B2 (ja) | 2003-12-26 | 2011-11-29 | ピタバスタチンカルシウム塩の保存方法 |
Applications Claiming Priority (3)
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---|---|---|---|
JP2003431788 | 2003-12-26 | ||
JP2003431788 | 2003-12-26 | ||
JP2011260984A JP5267643B2 (ja) | 2003-12-26 | 2011-11-29 | ピタバスタチンカルシウム塩の保存方法 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006520594A Division JP5186108B2 (ja) | 2003-12-26 | 2004-12-17 | ピタバスタチンカルシウム塩の結晶 |
Related Child Applications (1)
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JP2013079889A Division JP2013136640A (ja) | 2003-12-26 | 2013-04-05 | ピタバスタチンカルシウム塩の結晶を含む医薬的又は獣医薬的組成物 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2012072175A JP2012072175A (ja) | 2012-04-12 |
JP2012072175A5 JP2012072175A5 (ja) | 2012-11-15 |
JP5267643B2 true JP5267643B2 (ja) | 2013-08-21 |
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Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
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JP2006520594A Active JP5186108B2 (ja) | 2003-12-26 | 2004-12-17 | ピタバスタチンカルシウム塩の結晶 |
JP2011260984A Active JP5267643B2 (ja) | 2003-12-26 | 2011-11-29 | ピタバスタチンカルシウム塩の保存方法 |
JP2013079889A Withdrawn JP2013136640A (ja) | 2003-12-26 | 2013-04-05 | ピタバスタチンカルシウム塩の結晶を含む医薬的又は獣医薬的組成物 |
JP2014157888A Withdrawn JP2014205719A (ja) | 2003-12-26 | 2014-08-01 | キノリン化合物の結晶形及びその製造方法 |
JP2015224264A Withdrawn JP2016029102A (ja) | 2003-12-26 | 2015-11-16 | キノリン化合物の結晶形及びその製造方法 |
JP2016227123A Withdrawn JP2017061536A (ja) | 2003-12-26 | 2016-11-22 | キノリン化合物の結晶形及びその製造方法 |
JP2018002103A Withdrawn JP2018052988A (ja) | 2003-12-26 | 2018-01-10 | キノリン化合物の結晶形及びその製造方法 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006520594A Active JP5186108B2 (ja) | 2003-12-26 | 2004-12-17 | ピタバスタチンカルシウム塩の結晶 |
Family Applications After (5)
Application Number | Title | Priority Date | Filing Date |
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JP2013079889A Withdrawn JP2013136640A (ja) | 2003-12-26 | 2013-04-05 | ピタバスタチンカルシウム塩の結晶を含む医薬的又は獣医薬的組成物 |
JP2014157888A Withdrawn JP2014205719A (ja) | 2003-12-26 | 2014-08-01 | キノリン化合物の結晶形及びその製造方法 |
JP2015224264A Withdrawn JP2016029102A (ja) | 2003-12-26 | 2015-11-16 | キノリン化合物の結晶形及びその製造方法 |
JP2016227123A Withdrawn JP2017061536A (ja) | 2003-12-26 | 2016-11-22 | キノリン化合物の結晶形及びその製造方法 |
JP2018002103A Withdrawn JP2018052988A (ja) | 2003-12-26 | 2018-01-10 | キノリン化合物の結晶形及びその製造方法 |
Country Status (22)
Country | Link |
---|---|
US (18) | US20070112024A1 (ja) |
EP (1) | EP1697326B1 (ja) |
JP (7) | JP5186108B2 (ja) |
KR (11) | KR20170010111A (ja) |
CN (2) | CN102321019B (ja) |
AT (1) | ATE518835T1 (ja) |
AU (2) | AU2004309241A1 (ja) |
CA (1) | CA2551050C (ja) |
CY (1) | CY1112464T1 (ja) |
DK (1) | DK1697326T3 (ja) |
ES (1) | ES2367172T3 (ja) |
HK (1) | HK1095328A1 (ja) |
IL (1) | IL176470A (ja) |
MX (1) | MX338019B (ja) |
NZ (1) | NZ548041A (ja) |
PL (1) | PL1697326T3 (ja) |
PT (1) | PT1697326E (ja) |
RU (1) | RU2370489C2 (ja) |
SI (1) | SI1697326T1 (ja) |
TW (1) | TWI328006B (ja) |
WO (1) | WO2005063711A1 (ja) |
ZA (1) | ZA200605658B (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2014205719A (ja) * | 2003-12-26 | 2014-10-30 | 日産化学工業株式会社 | キノリン化合物の結晶形及びその製造方法 |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
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PL376557A1 (pl) | 2003-02-12 | 2006-01-09 | Ciba Specialty Chemicals Holding Inc. | Postacie krystaliczne pitawastatyny wapnia |
US7801272B2 (en) * | 2007-09-28 | 2010-09-21 | Rigaku Corporation | X-ray diffraction apparatus and X-ray diffraction method |
JP2013516459A (ja) | 2010-01-20 | 2013-05-13 | カディラ・ヘルスケア・リミテッド | ピタバスタチン及び医薬として許容可能なそれらの塩の製造方法 |
KR101158517B1 (ko) | 2010-04-29 | 2012-06-21 | 동방에프티엘(주) | 고 순도 피타바스타틴 칼슘염 결정형 a의 제조방법 |
US9034901B2 (en) | 2010-08-25 | 2015-05-19 | Cadila Healthcare Limited | Pitavastatin calcium and process for its preparation |
EP3178812A1 (en) | 2010-11-12 | 2017-06-14 | Hetero Research Foundation | Novel polymorphs of pitavastatin calcium |
RU2452939C1 (ru) * | 2011-01-18 | 2012-06-10 | Закрытое акционерное общество "Научные приборы" | Рентгенодифракционный способ идентификации партий фармацевтической продукции |
ITMI20111475A1 (it) * | 2011-08-02 | 2013-02-03 | Dipharma Francis Srl | Forme cristalline di pitavastatina sale di calcio |
SI2751081T1 (sl) | 2011-09-12 | 2017-05-31 | Farma Grs, D.O.O. | Polimorfna oblika kalcijevega pitavastatinata |
WO2013098773A1 (en) * | 2011-12-28 | 2013-07-04 | Dr. Reddy's Laboratories Limited | Crystalline forms of pitavastatin calcium |
EP3124017A1 (en) | 2012-08-08 | 2017-02-01 | Kowa Company, Ltd. | Pharmaceutical composition comprising pitavastatine |
WO2014051077A1 (ja) * | 2012-09-27 | 2014-04-03 | 日産化学工業株式会社 | 高純度の含窒素複素環化合物の製造方法 |
JP2014034574A (ja) * | 2013-01-25 | 2014-02-24 | Kowa Company Ltd | 医薬 |
EP2970128B1 (en) * | 2013-03-15 | 2019-12-04 | Asieris Pharmaceutical Technologies Co., Ltd. | Base addition salts of nitroxoline and uses thereof |
CN105213319A (zh) * | 2015-09-17 | 2016-01-06 | 青岛华之草医药科技有限公司 | 一种降血脂药物匹伐他汀钙组合物干混悬剂 |
JP2016222714A (ja) * | 2016-09-20 | 2016-12-28 | 興和株式会社 | 医薬 |
TW202200547A (zh) * | 2020-03-13 | 2022-01-01 | 印度商卡地拉保健有限公司 | 喹啉酮化合物的新穎鹽類 |
WO2022195525A1 (en) * | 2021-03-19 | 2022-09-22 | Zydus Lifesciences Limited | A quinolone compound in solid forms and processes for the preparation thereof |
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JP2877366B2 (ja) | 1988-08-25 | 1999-03-31 | 協和醗酵工業株式会社 | 結晶状l−アスコルビン酸−2−リン酸ナトリウム塩の製造法 |
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CA2482937A1 (en) * | 2002-04-17 | 2003-10-23 | Yamanouchi Pharmaceutical Co., Ltd. | A novel crystal of anhydride of a quinoxalinedione derivative |
PL376557A1 (pl) * | 2003-02-12 | 2006-01-09 | Ciba Specialty Chemicals Holding Inc. | Postacie krystaliczne pitawastatyny wapnia |
TWI328006B (en) * | 2003-12-26 | 2010-08-01 | Nissan Chemical Ind Ltd | Crystal form of quinoline compound and process for its production |
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2004
- 2004-11-29 TW TW093136780A patent/TWI328006B/zh not_active IP Right Cessation
- 2004-12-17 KR KR1020177001565A patent/KR20170010111A/ko not_active Application Discontinuation
- 2004-12-17 NZ NZ548041A patent/NZ548041A/en unknown
- 2004-12-17 KR KR1020197019411A patent/KR20190083674A/ko not_active Application Discontinuation
- 2004-12-17 KR KR1020067011877A patent/KR20070001910A/ko not_active Application Discontinuation
- 2004-12-17 KR KR1020187010082A patent/KR20180040732A/ko not_active Application Discontinuation
- 2004-12-17 KR KR1020117002847A patent/KR20110017936A/ko not_active Application Discontinuation
- 2004-12-17 CN CN201110198613.7A patent/CN102321019B/zh active Active
- 2004-12-17 KR KR1020177023135A patent/KR20170098976A/ko not_active Application Discontinuation
- 2004-12-17 PL PL04807807T patent/PL1697326T3/pl unknown
- 2004-12-17 AU AU2004309241A patent/AU2004309241A1/en not_active Abandoned
- 2004-12-17 CA CA2551050A patent/CA2551050C/en active Active
- 2004-12-17 ZA ZA200605658A patent/ZA200605658B/en unknown
- 2004-12-17 KR KR1020137001739A patent/KR20130014643A/ko not_active Application Discontinuation
- 2004-12-17 EP EP04807807A patent/EP1697326B1/en active Active
- 2004-12-17 AT AT04807807T patent/ATE518835T1/de active
- 2004-12-17 PT PT04807807T patent/PT1697326E/pt unknown
- 2004-12-17 RU RU2006127044/04A patent/RU2370489C2/ru not_active Application Discontinuation
- 2004-12-17 KR KR1020207032499A patent/KR20200130510A/ko not_active Application Discontinuation
- 2004-12-17 WO PCT/JP2004/019451 patent/WO2005063711A1/en active Application Filing
- 2004-12-17 MX MX2011007418A patent/MX338019B/es unknown
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JP2014205719A (ja) * | 2003-12-26 | 2014-10-30 | 日産化学工業株式会社 | キノリン化合物の結晶形及びその製造方法 |
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