JP2012530682A - (2s)−(−)−n−(6−クロロ−2,3−ジヒドロ−ベンゾ[1,4]ジオキシン−2−イルメチル)−スルファミドの結晶形態 - Google Patents
(2s)−(−)−n−(6−クロロ−2,3−ジヒドロ−ベンゾ[1,4]ジオキシン−2−イルメチル)−スルファミドの結晶形態 Download PDFInfo
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Abstract
Description
頭上撹拌機と添加漏斗と加熱マントルと温度制御ユニットと窒素流出口とを備えた5Lの4つ首反応フラスコに、(2S)−(−)−N−(6−クロロ−2,3−ジヒドロ−ベンゾ[1,4]ジオキシン−2−イルメチル)−スルファミド(300g、1.08モル)と50%のIPA−ヘプタン(1500mL、7.36モル)とを装填した。得られたスラリーを75℃に加熱した。いくつかの固体を観察して混合物中にそのままにした。わずかな減圧下で、加熱濾過フラスコと濾紙を使用して、混合物を加熱濾過した。フラスコを50%のIPA−ヘプタン(およそ200mL)で洗浄した。加熱濾過後、反応混合物の温度は、62℃であった。20分間かけて46℃に冷却したところ、沈殿は観察されなかった。30℃に冷却したところ、沈殿は認められなかった。得られた混合物を40℃に加熱し、次にヘプタン(175mL、1.19モル)を30分間かけて加えた。ヘプタンを添加後、いくつかの固体が大きくなるのが観察された。固体が温度(+4℃)で有意な増分で急速に大きくなったところでヘプタン添加を止めた。1時間かけて室温に冷却した後、固体を濾過し、10%のIPA−ヘプタン(100mL)で洗浄した。濾過及び乾燥後、表題化合物を白色固体として分離した。
(2S)−(−)−N−(6−クロロ−2,3−ジヒドロ−ベンゾ[1,4]ジオキシン−2−イルメチル)−スルファミド(9.3kg)と活性炭(0.3kg)とイソプロパノール(15.5kg)とn−ヘプタン(15.4kg)とを反応器に充填した。得られた混合物を加熱して還流させ、加熱濾過した。イソプロパノール(1.7kg)とn−ヘプタン(1.7kg)との高温混合物でフィルターを洗浄した。濾液を50〜54℃に冷却し、所望の多形体形態(0.02kg)で埋め込んだ。得られた混合物を50〜54℃で30分間にわたって撹拌した。次に、n−ヘプタン(14.4kg)を50〜54℃にて20分間にかけて混合物に添加した。得られた混合物を1時間かけて0〜5℃に冷却し、次にこの温度で2時間にわたって撹拌した。得られた混合物を濾過し、フィルターケーキをn−ヘプタンで洗浄し、50〜60℃において減圧下で乾燥させて表題化合物を所望の多型形態(粉末XRDにより測定されるように)で得た。
経口組成物の具体的な実施形態として、実施例1又は2で調製した結晶形態100mgを、十分な微粉乳糖と共に配合して、580〜590mgの合計量を得て、サイズOの硬質ゲルカプセル剤に充填した。
Claims (11)
- 製薬上許容できる担体と請求項1に記載の結晶形態とを含む、医薬組成物。
- 請求項1に記載の結晶形態と製薬上許容できる担体とを混合することにより製造される、医薬組成物。
- 請求項1に記載の結晶形態と製薬上許容できる担体とを混合することを含む、医薬組成物の製造方法。
- 必要のある対象に、治療的に有効な量の請求項1に記載の結晶形態を投与することを含む、不安及び関連障害、双極性躁鬱病、鬱病、癲癇及び関連障害、癲癇原性、ブドウ糖関連障害、脂質関連障害、片頭痛、肥満、疼痛並びに薬物乱用からなる群から選択される障害の治療方法、又は、神経保護方法。
- 前記障害が、鬱病、癲癇及び関連障害、並びに、ブドウ糖関連障害からなる群から選択される、請求項7に記載の方法。
- 必要のある対象に、治療的に有効な量の請求項4に記載の組成物を投与することを含む、不安及び関連障害、双極性躁鬱病、鬱病、癲癇及び関連障害、癲癇原性、ブドウ糖関連障害、脂質関連障害、片頭痛、肥満、疼痛並びに薬物乱用からなる群から選択される障害の治療方法、又は、神経保護方法。
- 前記障害が、鬱病、癲癇及び関連障害、並びに、ブドウ糖関連障害からなる群から選択される、請求項9に記載の方法。
- 必要のある対象における、(a)不安及び関連障害、(b)双極性鬱病、(c)躁病、(d)鬱病、(e)癲癇及び関連障害、(f)癲癇原性、(g)ブドウ糖関連障害、(h)脂質関連障害、(i)片頭痛、(j)肥満、(k)疼痛、(l)薬物乱用を治療するための、並びに(m)神経保護のための、医薬品の調製への請求項1に記載の結晶形態の使用。
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US7478308P | 2008-06-23 | 2008-06-23 | |
PCT/US2009/048026 WO2010008776A2 (en) | 2008-06-23 | 2009-06-19 | Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems |
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JP2012530682A true JP2012530682A (ja) | 2012-12-06 |
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JP2011516478A Pending JP2012530682A (ja) | 2008-06-23 | 2010-08-12 | (2s)−(−)−n−(6−クロロ−2,3−ジヒドロ−ベンゾ[1,4]ジオキシン−2−イルメチル)−スルファミドの結晶形態 |
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US (1) | US8809385B2 (ja) |
EP (1) | EP2340246A2 (ja) |
JP (1) | JP2012530682A (ja) |
AR (1) | AR072961A1 (ja) |
AU (1) | AU2009271362B2 (ja) |
BR (1) | BRPI0915890A2 (ja) |
CA (1) | CA2729056A1 (ja) |
CL (1) | CL2010001540A1 (ja) |
CO (1) | CO6341554A2 (ja) |
CR (1) | CR20110042A (ja) |
EA (1) | EA018567B1 (ja) |
EC (1) | ECSP10010707A (ja) |
HN (1) | HN2010002735A (ja) |
IL (1) | IL210138A0 (ja) |
MX (1) | MX2011000090A (ja) |
NI (1) | NI201000226A (ja) |
NZ (1) | NZ590682A (ja) |
PE (1) | PE20110060A1 (ja) |
TW (1) | TW201012807A (ja) |
UY (1) | UY31934A (ja) |
WO (1) | WO2010008776A2 (ja) |
ZA (1) | ZA201100570B (ja) |
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- 2009-06-19 NZ NZ590682A patent/NZ590682A/xx not_active IP Right Cessation
- 2009-06-19 US US12/488,079 patent/US8809385B2/en not_active Expired - Fee Related
- 2009-06-19 PE PE2010001185A patent/PE20110060A1/es not_active Application Discontinuation
- 2009-06-19 CA CA2729056A patent/CA2729056A1/en not_active Abandoned
- 2009-06-19 EA EA201170079A patent/EA018567B1/ru not_active IP Right Cessation
- 2009-06-19 BR BRPI0915890A patent/BRPI0915890A2/pt not_active IP Right Cessation
- 2009-06-19 MX MX2011000090A patent/MX2011000090A/es active IP Right Grant
- 2009-06-19 EP EP09798447A patent/EP2340246A2/en not_active Withdrawn
- 2009-06-22 TW TW098120874A patent/TW201012807A/zh unknown
- 2009-06-23 UY UY0001031934A patent/UY31934A/es unknown
- 2009-06-23 AR ARP090102301A patent/AR072961A1/es not_active Application Discontinuation
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2010
- 2010-08-12 JP JP2011516478A patent/JP2012530682A/ja active Pending
- 2010-12-21 IL IL210138A patent/IL210138A0/en unknown
- 2010-12-22 EC EC2010010707A patent/ECSP10010707A/es unknown
- 2010-12-22 HN HN2010002735A patent/HN2010002735A/es unknown
- 2010-12-22 NI NI201000226A patent/NI201000226A/es unknown
- 2010-12-23 CL CL2010001540A patent/CL2010001540A1/es unknown
- 2010-12-28 CO CO10163416A patent/CO6341554A2/es not_active Application Discontinuation
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2011
- 2011-01-21 ZA ZA2011/00570A patent/ZA201100570B/en unknown
- 2011-01-24 CR CR20110042A patent/CR20110042A/es not_active Application Discontinuation
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BRPI0915890A2 (pt) | 2015-11-03 |
US8809385B2 (en) | 2014-08-19 |
CA2729056A1 (en) | 2010-01-21 |
HN2010002735A (es) | 2014-07-31 |
AR072961A1 (es) | 2010-10-06 |
AU2009271362A2 (en) | 2011-05-19 |
WO2010008776A9 (en) | 2011-02-10 |
PE20110060A1 (es) | 2011-01-31 |
NZ590682A (en) | 2012-09-28 |
AU2009271362A1 (en) | 2010-01-21 |
ECSP10010707A (es) | 2011-01-31 |
CR20110042A (es) | 2011-07-06 |
MX2011000090A (es) | 2011-03-02 |
TW201012807A (en) | 2010-04-01 |
IL210138A0 (en) | 2011-03-31 |
EA201170079A1 (ru) | 2011-06-30 |
ZA201100570B (en) | 2012-06-27 |
WO2010008776A2 (en) | 2010-01-21 |
WO2010008776A3 (en) | 2011-04-07 |
UY31934A (es) | 2010-01-05 |
CL2010001540A1 (es) | 2011-09-23 |
NI201000226A (es) | 2011-08-01 |
EA018567B1 (ru) | 2013-08-30 |
CO6341554A2 (es) | 2011-11-21 |
AU2009271362B2 (en) | 2014-03-13 |
EP2340246A2 (en) | 2011-07-06 |
US20090318544A1 (en) | 2009-12-24 |
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