JP2011506330A5 - - Google Patents
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- JP2011506330A5 JP2011506330A5 JP2010537037A JP2010537037A JP2011506330A5 JP 2011506330 A5 JP2011506330 A5 JP 2011506330A5 JP 2010537037 A JP2010537037 A JP 2010537037A JP 2010537037 A JP2010537037 A JP 2010537037A JP 2011506330 A5 JP2011506330 A5 JP 2011506330A5
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- 238000000034 method Methods 0.000 claims description 13
- 239000000203 mixture Substances 0.000 claims description 7
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- UFSKUSARDNFIRC-UHFFFAOYSA-N lumacaftor Chemical compound N1=C(C=2C=C(C=CC=2)C(O)=O)C(C)=CC=C1NC(=O)C1(C=2C=C3OC(F)(F)OC3=CC=2)CC1 UFSKUSARDNFIRC-UHFFFAOYSA-N 0.000 claims description 4
- 239000002245 particle Substances 0.000 claims description 4
- 241000124008 Mammalia Species 0.000 claims description 3
- -1 2,2-difluorobenzo [d] [1,3] dioxol-5-yl Chemical group 0.000 claims description 2
- KYARBIJYVGJZLB-UHFFFAOYSA-N 7-amino-4-hydroxy-2-naphthalenesulfonic acid Chemical compound OC1=CC(S(O)(=O)=O)=CC2=CC(N)=CC=C21 KYARBIJYVGJZLB-UHFFFAOYSA-N 0.000 claims description 2
- 201000003883 Cystic fibrosis Diseases 0.000 claims description 2
- 239000013078 crystal Substances 0.000 claims description 2
- AIMMVWOEOZMVMS-UHFFFAOYSA-N cyclopropanecarboxamide Chemical compound NC(=O)C1CC1 AIMMVWOEOZMVMS-UHFFFAOYSA-N 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 239000003937 drug carrier Substances 0.000 claims description 2
- 150000003840 hydrochlorides Chemical class 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 239000008194 pharmaceutical composition Substances 0.000 claims description 2
- 238000000634 powder X-ray diffraction Methods 0.000 claims description 2
- 229940124597 therapeutic agent Drugs 0.000 claims description 2
Description
本明細書に記載のプロセスを使用して、形態Ｉを含む本発明の組成物を調製することができる。プロセスに使用される成分の量及び特徴は、本明細書に記載するとおりである。
本発明は、例えば以下の項目を提供する。
（項目１）
形態Ｉとして特徴づけられる３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸。
（項目２）
前記形態Ｉが、ＣｕＫアルファ照射によって得られたＸ線粉末回折における１５．２から１５．６度、１６．１から１６．５度、及び１４．３から１４．７度の１個以上のピークによって特徴づけられる、項目１に記載の形態Ｉ。
（項目３）
前記形態Ｉが１５．４、１６．３及び１４．５度の１個以上のピークによって特徴づけられる、項目２に記載の形態Ｉ。
（項目４）
前記形態Ｉが１４．６から１５．０度のピークによって更に特徴づけられる、項目２に記載の形態Ｉ。
（項目５）
前記形態Ｉが１４．８度のピークによって更に特徴づけられる、項目４に記載の形態Ｉ。
（項目６）
前記形態Ｉが１７．６から１８．０度のピークによって更に特徴づけられる、項目４に記載の形態Ｉ。
（項目７）
前記形態Ｉが１７．８度のピークによって更に特徴づけられる、項目６に記載の形態Ｉ。
（項目８）
前記形態Ｉが１６．４から１６．８度のピークによって更に特徴づけられる、項目６に記載の形態Ｉ。
（項目９）
前記形態Ｉが１６．４から１６．８度のピークによって更に特徴づけられる、項目８に記載の形態Ｉ。
（項目１０）
前記形態Ｉが１６．６度のピークによって更に特徴づけられる、項目９に記載の形態Ｉ。
（項目１１）
前記形態Ｉが７．６から８．０度のピークによって更に特徴づけられる、項目９に記載の形態Ｉ。
（項目１２）
前記形態Ｉが７．８度のピークによって更に特徴づけられる、項目１１に記載の形態Ｉ。
（項目１３）
前記形態Ｉが２５．８から２６．２度のピークによって更に特徴づけられる、項目１１に記載の形態Ｉ。
（項目１４）
前記形態Ｉが２６．０度のピークによって更に特徴づけられる、項目１３に記載の形態Ｉ。
（項目１５）
前記形態Ｉが２１．４から２１．８度のピークによって更に特徴づけられる、項目１３に記載の形態Ｉ。
（項目１６）
前記形態Ｉが２１．６度のピークによって更に特徴づけられる、項目１５に記載の形態Ｉ。
（項目１７）
前記形態Ｉが２３．１から２３．５度のピークによって更に特徴づけられる、項目１５に記載の形態Ｉ。
（項目１８）
前記形態Ｉが２３．３度のピークによって更に特徴づけられる、項目１７に記載の形態Ｉ。
（項目１９）
前記形態Ｉが、図１の回折パターンと実質的に類似した回折パターンによって特徴づけられる、項目１に記載の形態Ｉ。
（項目２０）
前記形態Ｉが、図２の回折パターンと実質的に類似した回折パターンによって特徴づけられる、項目１に記載の形態Ｉ。
（項目２１）
Ｄ９０の粒径分布が約８２μｍ以下である、項目１に記載の形態Ｉ。
（項目２２）
Ｄ５０の粒径分布が約３０μｍ以下である、項目１に記載の形態Ｉ。
（項目２３）
項目１に記載の形態Ｉと薬学的に許容される担体とを含む、薬学的組成物。
（項目２４）
ほ乳動物における嚢胞性線維症を治療する方法であって、有効量の項目１に記載の形態Ｉを該ほ乳動物に投与することを含む、方法。
（項目２５）
前記方法が、追加の治療薬を投与することを含む、項目２４に記載の方法。
（項目２６）
項目１に記載の形態Ｉ及びその使用説明書を含む、キット。
（項目２７）
３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸のＨＣｌ塩を適切な溶媒に有効時間懸濁又は溶解させることを含む、項目１に記載の形態Ｉを調製するプロセス。
（項目２８）
前記適切な溶媒が水又は５０％メタノール／水混合物である、項目２７に記載のプロセス。
（項目２９）
前記適切な溶媒が水である、項目２７に記載のプロセス。
（項目３０）
前記有効時間が２から２４時間である、項目２７に記載のプロセス。
（項目３１）
前記有効時間が２から６時間である、項目２７に記載のプロセス。
（項目３２）
単斜晶系、Ｐ２ １ ／ｎ空間群、及び以下の単位格子寸法を有する、３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸の結晶形態：
ａ＝４．９６２６（７）Å α＝９０°
ｂ＝１２．２９９４（１８）Å β＝９３．９３８（９）°
ｃ＝３３．０７５（４）Å γ＝９０°。
本発明は、例えば以下の項目を提供する。
（項目１）
形態Ｉとして特徴づけられる３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸。
（項目２）
前記形態Ｉが、ＣｕＫアルファ照射によって得られたＸ線粉末回折における１５．２から１５．６度、１６．１から１６．５度、及び１４．３から１４．７度の１個以上のピークによって特徴づけられる、項目１に記載の形態Ｉ。
（項目３）
前記形態Ｉが１５．４、１６．３及び１４．５度の１個以上のピークによって特徴づけられる、項目２に記載の形態Ｉ。
（項目４）
前記形態Ｉが１４．６から１５．０度のピークによって更に特徴づけられる、項目２に記載の形態Ｉ。
（項目５）
前記形態Ｉが１４．８度のピークによって更に特徴づけられる、項目４に記載の形態Ｉ。
（項目６）
前記形態Ｉが１７．６から１８．０度のピークによって更に特徴づけられる、項目４に記載の形態Ｉ。
（項目７）
前記形態Ｉが１７．８度のピークによって更に特徴づけられる、項目６に記載の形態Ｉ。
（項目８）
前記形態Ｉが１６．４から１６．８度のピークによって更に特徴づけられる、項目６に記載の形態Ｉ。
（項目９）
前記形態Ｉが１６．４から１６．８度のピークによって更に特徴づけられる、項目８に記載の形態Ｉ。
（項目１０）
前記形態Ｉが１６．６度のピークによって更に特徴づけられる、項目９に記載の形態Ｉ。
（項目１１）
前記形態Ｉが７．６から８．０度のピークによって更に特徴づけられる、項目９に記載の形態Ｉ。
（項目１２）
前記形態Ｉが７．８度のピークによって更に特徴づけられる、項目１１に記載の形態Ｉ。
（項目１３）
前記形態Ｉが２５．８から２６．２度のピークによって更に特徴づけられる、項目１１に記載の形態Ｉ。
（項目１４）
前記形態Ｉが２６．０度のピークによって更に特徴づけられる、項目１３に記載の形態Ｉ。
（項目１５）
前記形態Ｉが２１．４から２１．８度のピークによって更に特徴づけられる、項目１３に記載の形態Ｉ。
（項目１６）
前記形態Ｉが２１．６度のピークによって更に特徴づけられる、項目１５に記載の形態Ｉ。
（項目１７）
前記形態Ｉが２３．１から２３．５度のピークによって更に特徴づけられる、項目１５に記載の形態Ｉ。
（項目１８）
前記形態Ｉが２３．３度のピークによって更に特徴づけられる、項目１７に記載の形態Ｉ。
（項目１９）
前記形態Ｉが、図１の回折パターンと実質的に類似した回折パターンによって特徴づけられる、項目１に記載の形態Ｉ。
（項目２０）
前記形態Ｉが、図２の回折パターンと実質的に類似した回折パターンによって特徴づけられる、項目１に記載の形態Ｉ。
（項目２１）
Ｄ９０の粒径分布が約８２μｍ以下である、項目１に記載の形態Ｉ。
（項目２２）
Ｄ５０の粒径分布が約３０μｍ以下である、項目１に記載の形態Ｉ。
（項目２３）
項目１に記載の形態Ｉと薬学的に許容される担体とを含む、薬学的組成物。
（項目２４）
ほ乳動物における嚢胞性線維症を治療する方法であって、有効量の項目１に記載の形態Ｉを該ほ乳動物に投与することを含む、方法。
（項目２５）
前記方法が、追加の治療薬を投与することを含む、項目２４に記載の方法。
（項目２６）
項目１に記載の形態Ｉ及びその使用説明書を含む、キット。
（項目２７）
３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸のＨＣｌ塩を適切な溶媒に有効時間懸濁又は溶解させることを含む、項目１に記載の形態Ｉを調製するプロセス。
（項目２８）
前記適切な溶媒が水又は５０％メタノール／水混合物である、項目２７に記載のプロセス。
（項目２９）
前記適切な溶媒が水である、項目２７に記載のプロセス。
（項目３０）
前記有効時間が２から２４時間である、項目２７に記載のプロセス。
（項目３１）
前記有効時間が２から６時間である、項目２７に記載のプロセス。
（項目３２）
単斜晶系、Ｐ２ １ ／ｎ空間群、及び以下の単位格子寸法を有する、３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸の結晶形態：
ａ＝４．９６２６（７）Å α＝９０°
ｂ＝１２．２９９４（１８）Å β＝９３．９３８（９）°
ｃ＝３３．０７５（４）Å γ＝９０°。
Claims (32)
- 形態Ｉとして特徴づけられる３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸。
- 前記形態Ｉが、ＣｕＫアルファ照射によって得られたＸ線粉末回折における１５．２から１５．６度、１６．１から１６．５度、及び１４．３から１４．７度の１個以上のピークによって特徴づけられる、請求項１に記載の形態Ｉ。
- 前記形態Ｉが１５．４、１６．３及び１４．５度の１個以上のピークによって特徴づけられる、請求項２に記載の形態Ｉ。
- 前記形態Ｉが１４．６から１５．０度のピークによって更に特徴づけられる、請求項２に記載の形態Ｉ。
- 前記形態Ｉが１４．８度のピークによって更に特徴づけられる、請求項４に記載の形態Ｉ。
- 前記形態Ｉが１７．６から１８．０度のピークによって更に特徴づけられる、請求項４に記載の形態Ｉ。
- 前記形態Ｉが１７．８度のピークによって更に特徴づけられる、請求項６に記載の形態Ｉ。
- 前記形態Ｉが１６．４から１６．８度のピークによって更に特徴づけられる、請求項６に記載の形態Ｉ。
- 前記形態Ｉが１６．４から１６．８度のピークによって更に特徴づけられる、請求項８に記載の形態Ｉ。
- 前記形態Ｉが１６．６度のピークによって更に特徴づけられる、請求項９に記載の形態Ｉ。
- 前記形態Ｉが７．６から８．０度のピークによって更に特徴づけられる、請求項９に記載の形態Ｉ。
- 前記形態Ｉが７．８度のピークによって更に特徴づけられる、請求項１１に記載の形態Ｉ。
- 前記形態Ｉが２５．８から２６．２度のピークによって更に特徴づけられる、請求項１１に記載の形態Ｉ。
- 前記形態Ｉが２６．０度のピークによって更に特徴づけられる、請求項１３に記載の形態Ｉ。
- 前記形態Ｉが２１．４から２１．８度のピークによって更に特徴づけられる、請求項１３に記載の形態Ｉ。
- 前記形態Ｉが２１．６度のピークによって更に特徴づけられる、請求項１５に記載の形態Ｉ。
- 前記形態Ｉが２３．１から２３．５度のピークによって更に特徴づけられる、請求項１５に記載の形態Ｉ。
- 前記形態Ｉが２３．３度のピークによって更に特徴づけられる、請求項１７に記載の形態Ｉ。
- 前記形態Ｉが、図１の回折パターンと実質的に類似した回折パターンによって特徴づけられる、請求項１に記載の形態Ｉ。
- 前記形態Ｉが、図２の回折パターンと実質的に類似した回折パターンによって特徴づけられる、請求項１に記載の形態Ｉ。
- Ｄ９０の粒径分布が約８２μｍ以下である、請求項１に記載の形態Ｉ。
- Ｄ５０の粒径分布が約３０μｍ以下である、請求項１に記載の形態Ｉ。
- 請求項１に記載の形態Ｉと薬学的に許容される担体とを含む、薬学的組成物。
- ほ乳動物における嚢胞性線維症を治療するための組成物であって、有効量の請求項１に記載の形態Ｉを含む、組成物。
- 前記組成物が、追加の治療薬と組み合わせて投与されることによって特徴づけられる、請求項２４に記載の組成物。
- 請求項１に記載の形態Ｉ及びその使用説明書を含む、キット。
- ３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸のＨＣｌ塩を適切な溶媒に有効時間懸濁又は溶解させることを含む、請求項１に記載の形態Ｉを調製するプロセス。
- 前記適切な溶媒が水又は５０％メタノール／水混合物である、請求項２７に記載のプロセス。
- 前記適切な溶媒が水である、請求項２７に記載のプロセス。
- 前記有効時間が２から２４時間である、請求項２７に記載のプロセス。
- 前記有効時間が２から６時間である、請求項２７に記載のプロセス。
- 単斜晶系、Ｐ２１／ｎ空間群、及び以下の単位格子寸法を有する、３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸の結晶形態：
ａ＝４．９６２６（７）Å α＝９０°
ｂ＝１２．２９９４（１８）Å β＝９３．９３８（９）°
ｃ＝３３．０７５（４）Å γ＝９０°。
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| PCT/US2008/085456 WO2009073757A1 (en) | 2007-12-07 | 2008-12-04 | Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid |
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| JP2014028062A Division JP2014088447A (ja) | 2007-12-07 | 2014-02-18 | ３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソル−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸の固体状形態 |
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- 2015-08-31 US US14/841,163 patent/US9434717B2/en active Active
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2016
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2017
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- 2017-02-14 CY CY20171100198T patent/CY1118630T1/el unknown
- 2017-03-24 NO NO2017009C patent/NO2017009I2/no unknown
- 2017-06-07 JP JP2017112429A patent/JP2017149778A/ja active Pending
- 2017-11-09 US US15/807,663 patent/US10597384B2/en active Active
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2020
- 2020-02-06 US US16/783,338 patent/US20200377484A1/en active Pending
- 2020-04-24 HR HRP20200664TT patent/HRP20200664T1/hr unknown
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- 2020-08-12 NO NO2020025C patent/NO2020025I1/no unknown
- 2020-08-13 HU HUS2000030C patent/HUS2000030I1/hu unknown
- 2020-08-14 LT LTPA2020525C patent/LTC3170818I2/lt unknown
- 2020-08-18 CY CY2020030C patent/CY2020030I1/el unknown
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