HUP0201548A2 - Process for the preparation of n-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis[2-(4-morfolino)ethoxy]-2'-oxospiro[cyclohexan-1,3'[h]indol]1'(2'h)-yl]-sulfonyl]-3-methoxybenzamide and its salts - Google Patents

Process for the preparation of n-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis[2-(4-morfolino)ethoxy]-2'-oxospiro[cyclohexan-1,3'[h]indol]1'(2'h)-yl]-sulfonyl]-3-methoxybenzamide and its salts Download PDF

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HUP0201548A2
HUP0201548A2 HU0201548A HUP0201548A HUP0201548A2 HU P0201548 A2 HUP0201548 A2 HU P0201548A2 HU 0201548 A HU0201548 A HU 0201548A HU P0201548 A HUP0201548 A HU P0201548A HU P0201548 A2 HUP0201548 A2 HU P0201548A2
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HU
Hungary
Prior art keywords
ethoxy
indol
cis
formula
oxospiro
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HU0201548A
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Hungarian (hu)
Inventor
Goenczi Csaba Dr
Heja Gergely Dr
Lajos Nagy
Eva Csikos
Tiborne Szomor
Gyoergyne Szvoboda
Csutor Andrea Santane
Peter Sarosi
Dr Takacsy Tuende Eroesne
Judit Halasz
Hermecz Istvan Dr
Csilla Majlath
Simon Kalman Dr
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Sanofi Synthelabo
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Priority claimed from HU9902376A external-priority patent/HUP9902376A3/en
Application filed by Sanofi Synthelabo filed Critical Sanofi Synthelabo
Priority to HU0201548A priority Critical patent/HUP0201548A3/en
Publication of HUP0201548A2 publication Critical patent/HUP0201548A2/en
Publication of HUP0201548A3 publication Critical patent/HUP0201548A3/en

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  • Indole Compounds (AREA)

Abstract

Preparation of N-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis-[2-(4-morpholino)ethoxy]-2'-oxospiro[cyclohexan-1,3'-[3H]indol]-1'(2'H)-yl]-sulfonyl]-3-methoxybenzamide (I) or its salts comprises reacting spiro/cis-4-(beta -morpholino-ethyloxycyclohexan-1,3'-(5'-ethoxy)-[3H]indol-2'[1'H]one (II) with 2-methoxy-4-(N-t-butylaminocarbonyl)benzenesulfonyl chloride in presence of dimethyl sulfoxide at 10-40[deg]C. Preparation of N-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis-[2-(4-morpholino)ethoxy]-2'-oxospiro[cyclohexan-1,3'-[3H]indol]-1'(2'H)-yl]-sulfonyl]-3-methoxybenzamide of formula (I) or its salts comprises reacting a spiro/cis-4-(beta -morpholino-ethyloxycyclohexan-1,3'-(5'-ethoxy)-[3H]indol-2'[1'H]one of formula (II) with 2-methoxy-4-(N-t-butylaminocarbonyl)benzenesulfonyl chloride of formula (III), in the presence of dimethyl sulfoxide at 10-40[deg]C (preferably at room temperature), to give (I) which is optionally transformed into its salt. [Image] ACTIVITY : None given.

Description

Találmányunk tárgya új eljárás az I képletü N-(l,l-dimetiletil)-4-[[5’-etoxi-4-cw-[2(4-morfolino)-etoxi] -2 ’ -oxospiro [ciklohexán-1,3’- [3Z/]indol]-1 ’ (2 ’ 77)-y 1] -szulfonil]-3 metoxi-benzamid (SR 121463 ) és sói előállítására, mely anyag, vazopresszin V2 antagonista hatású. A WO 9715556 számú szabadalmi leírás szerint az I képletü vegyület előállítására a II képletü spiro/cis-4-(beta-morfolino-etiloxi)-ciklohexánl,3'-(5'-etoxi)-[37/]indol-2'[rH]-ont III képletü 2-metoxi-4-(N-t-butilaminokarbonil)-benzolszulfokloriddal reagáltatják kálium-/-butilát alkalmazásával tetrahidrofuránban.The subject of our invention is a new process for the preparation of N-(l,l-dimethylethyl)-4-[[5'-ethoxy-4-cw-[2(4-morpholino)-ethoxy]-2'-oxospiro [cyclohexane-1,3'- [3Z/]indole]-1' (2' 77)-y1]-sulfonyl]-3-methoxybenzamide (SR 121463) of formula I and its salts, which substance has vasopressin V2 antagonist activity. According to patent specification WO 9715556, to prepare the compound of formula I, spiro/cis-4-(beta-morpholinoethyloxy)cyclohexanel,3'-(5'-ethoxy)-[37/]indol-2'[rH]-one of formula II is reacted with 2-methoxy-4-(N-t-butylaminocarbonyl)benzenesulfonyl chloride of formula III using potassium-t-butylate in tetrahydrofuran.

Az eljárás a felhasznált oldószer (tetrahidrofurán) és az alkalmazott hőmérséklet (-60 °C -40 °C között) miatt üzemi körülmények között csak nehezen valósítható meg, a termelés gyenge, a termék szennyezett, tisztítása többszöri átkristályosítást igényel.Due to the solvent used (tetrahydrofuran) and the temperature used (between -60 °C and -40 °C), the process is difficult to implement under operational conditions, the production is poor, the product is contaminated, and its purification requires multiple recrystallizations.

Meglepő módon azt találtuk, hogy a reakció dimetil-szulfoxidban szobahőmérsékleten való keveréssel igen jó termeléssel (85 - 92%) végrehajtható. A reakcióelegy feldolgozása egyszerű, míg az eredeti eljárásban a terméket extrahálással nyerték ki, addig ezen eljárásban vízzel hígítva a reakcióelegyet a bázis csapadék formájában kiszűrhető. Az így nyert bázis tisztasága 93 - 96 %-os, belőle a kívánalmaknak megfelelő tisztaságú só képezhető.Surprisingly, we found that the reaction can be carried out in dimethyl sulfoxide at room temperature with stirring in very good yield (85 - 92%). The workup of the reaction mixture is simple, while in the original process the product was obtained by extraction, in this process the reaction mixture can be filtered off as a precipitate by diluting with water. The purity of the base thus obtained is 93 - 96%, and a salt of the desired purity can be formed from it.

Fentieknek megfelelően találmányunk tárgya eljárás I képletü vegyület és sói előállítására II és III képletü vegyület reagáltatásával azzal jellemezve, hogy a reakciót dimetil-szulfoxidban, 10-40 °C-on, előnyösen szobahőmérsékleten végezzük, majd a kapott I képletü bázist ismert módon sójává alakítjuk.Accordingly, the subject of our invention is a process for preparing a compound of formula I and its salts by reacting a compound of formula II and III, characterized in that the reaction is carried out in dimethyl sulfoxide at 10-40 °C, preferably at room temperature, and then the base of formula I obtained is converted into its salt in a known manner.

A találmányunk szerinti eljárást az alábbi példákkal illusztráljuk.The process according to our invention is illustrated by the following examples.

.példa:.example:

180 ml dimetil-szulfoxidban 26,7 g kálium-/-butilátot oldunk. 10 perc keverés után 74,9 g II képletű vegyületet adunk 20 - 25 °C között az elegyhez, majd teljes oldódásig keverjük. Ezután gyors ütemben 25 °C alatt III képletű vegyületet adagolunk az elegyhez. A kapott világosbarna szuszpenziót 1,5 órán át keverjük 25 °C-on, majd 700 ml jeges vízzel megbontjuk. A csapadékot 1 óra keverés után szűrjük, 2x500 ml vízzel felszuszpendálva mossuk. Alapos leszívatás után 2x 100 ml 96 %-os etanollal mossuk. 117 g 95,2 %-os hatóanyag tartalmú (HPLC) I. képletű vegyületet kapunk. A termelés 90,8 %.26.7 g of potassium-/-butylate are dissolved in 180 ml of dimethyl sulfoxide. After stirring for 10 minutes, 74.9 g of compound of formula II are added to the mixture between 20 - 25 °C, then stirred until complete dissolution. Then, compound of formula III is added to the mixture at a rapid rate below 25 °C. The resulting light brown suspension is stirred for 1.5 hours at 25 °C, then dissolved with 700 ml of ice water. After stirring for 1 hour, the precipitate is filtered, suspended in 2x500 ml of water and washed. After thorough suction, it is washed with 2x100 ml of 96% ethanol. 117 g of compound of formula I with an active ingredient content of 95.2% (HPLC) are obtained. The yield is 90.8%.

. példaexample

Mól I. képletű bázist 3-5-szörös mennyiségű etanolban szuszpendálunk és 1.05-1 mól savat adunk a rendszerhez. Oldódás után az oldatot csontszénnel derítjük, szűrjük. Az oldatból lehűtésre kivált sót szűrjük, kevés hideg alkohollal fedjük, szárítjuk. Termelés 87-95% között mozog.Mole of base of formula I is suspended in 3-5 times the amount of ethanol and 1.05-1 mole of acid is added to the system. After dissolution, the solution is clarified with charcoal and filtered. The salt that precipitates from the solution upon cooling is filtered, covered with a little cold alcohol and dried. The yield ranges between 87-95%.

Dihidrogén-foszfát-monohidrát-só: Op.: 164.5°C Hidrogén-maleát-só: Op.: 184-185°CDihydrogen phosphate monohydrate salt: M.p.: 164.5°C Hydrogen maleate salt: M.p.: 184-185°C

Hidrogén-fumarát-só: Op.: 182-183°CHydrogen fumarate salt: M.p.: 182-183°C

Claims (1)

Szabadalmi igénypontokPatent claims 1 .) Eljárás I képletű vegyület és sói előállítására II és III képletű vegyület reagáltatásával azzal jellemezve, hogy a reakciót dimetil-szulfoxidban, 10-40 °C-on, előnyösen szobahőmérsékleten végezzük, majd a kapott I képletű bázist ismert módon sójává alakítjuk.1.) Process for preparing a compound of formula I and its salts by reacting a compound of formula II and III, characterized in that the reaction is carried out in dimethyl sulfoxide at 10-40 °C, preferably at room temperature, and then the base of formula I obtained is converted into its salt in a known manner. Bejelentő helyett a MeghatalmazottInstead of the notifier, the Authorized
HU0201548A 1999-07-15 2000-07-13 Process for the preparation of n-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis[2-(4-morfolino)ethoxy]-2'-oxospiro[cyclohexan-1,3'[h]indol]1'(2'h)-yl]-sulfonyl]-3-methoxybenzamide and its salts HUP0201548A3 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
HU0201548A HUP0201548A3 (en) 1999-07-15 2000-07-13 Process for the preparation of n-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis[2-(4-morfolino)ethoxy]-2'-oxospiro[cyclohexan-1,3'[h]indol]1'(2'h)-yl]-sulfonyl]-3-methoxybenzamide and its salts

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HU9902376A HUP9902376A3 (en) 1999-07-15 1999-07-15 Process for producing n-(1,1-dimethyl)-4-[[s'-ethoxi-4-cis-[2-(4-morpholino)-ethoxi]-2'-oxospiro[cyclohexane-1,3'-[3h]indole]-1'(2'h)yl]-sulfonyl]-3-methoxybenzamide and its salts
HU0201548A HUP0201548A3 (en) 1999-07-15 2000-07-13 Process for the preparation of n-(1,1-dimethylethyl)-4-[[5'-ethoxy-4-cis[2-(4-morfolino)ethoxy]-2'-oxospiro[cyclohexan-1,3'[h]indol]1'(2'h)-yl]-sulfonyl]-3-methoxybenzamide and its salts

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HUP0201548A2 true HUP0201548A2 (en) 2002-09-28
HUP0201548A3 HUP0201548A3 (en) 2003-03-28

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