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ES2690177B2 - PROCEDURE FOR THE PREPARATION OF ENANTIOSELECTIVA DE PROFENOS Y FENIDATOS - Google Patents
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ES2690177B2 - PROCEDURE FOR THE PREPARATION OF ENANTIOSELECTIVA DE PROFENOS Y FENIDATOS - Google Patents

PROCEDURE FOR THE PREPARATION OF ENANTIOSELECTIVA DE PROFENOS Y FENIDATOS Download PDF

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ES2690177B2
ES2690177B2 ES201830342A ES201830342A ES2690177B2 ES 2690177 B2 ES2690177 B2 ES 2690177B2 ES 201830342 A ES201830342 A ES 201830342A ES 201830342 A ES201830342 A ES 201830342A ES 2690177 B2 ES2690177 B2 ES 2690177B2
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phenyl
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epoxysulfone
nhch
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Adelantado Florenci Vicent Gonzalez
Pastor Santiago Rodriguez
Iserte Lledo Bou
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Universitat Jaume I de Castello
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    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C57/00Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms
    • C07C57/30Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms containing six-membered aromatic rings
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B53/00Asymmetric syntheses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D211/00Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings
    • C07D211/04Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D211/06Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members
    • C07D211/08Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms
    • C07D211/18Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms with substituted hydrocarbon radicals attached to ring carbon atoms
    • C07D211/34Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms with substituted hydrocarbon radicals attached to ring carbon atoms with hydrocarbon radicals, substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals

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Description

DESCRIPCIÓNDESCRIPTION

PROCEDIMIENTO DE PREPARACIÓN ENANTIOSELECTIVA DE PROFENOS Y FENIDATOSPROCEDURE FOR THE PREPARATION OF ENANTIOSELECTIVA DE PROFENOS Y FENIDATOS

Campo de la invenciónField of the invention

La presente invención se encuadra en general en el sector farmacéutico, y en particular se refiere a un procedimiento para la síntesis de fármacos antiinflamatorios, analgésicos y fármacos indicados para el tratamiento del déficit de atención por hiperactividad (ADHD).The present invention is generally framed in the pharmaceutical sector, and in particular it relates to a process for the synthesis of anti-inflammatory drugs, analgesics and drugs indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Estado de la técnicaState of the art

Los profenos, como el ibuprofeno, y los fenidatos, son fármacos ampliamente comercializados. Sin embargo aunque solamente una de las formas enantioméricas es activa, algunos de los profenos como el ibuprofeno se comercializan como una mezcla de los dos enantiómeros, en otros casos se comercializa únicamente el enantiómero activo. En aquellos casos en que se comercializa la mezcla es porque el enantiómero que no es activo no es tóxico y porque no existen síntesis enantioselectivas industriales efectivas. Por ejemplo se sabe que el enantiómero d-threo del dexmetil fenidato es más activo que el enantiómero l-treo (Pharmacol. Exp. Ther. 1970, 173, 158-165).Profens, such as ibuprofen, and fenidates, are widely marketed drugs. However, although only one of the enantiomeric forms is active, some of the profanes such as ibuprofen are marketed as a mixture of the two enantiomers, in other cases only the active enantiomer is marketed. In those cases in which the mixture is commercialized, it is because the enantiomer that is not active is not toxic and because there are no effective industrial enantioselective syntheses. For example, it is known that the d-threo enantiomer of dexmethylphenidate is more active than the l-threo enantiomer (Pharmacol, Exp, Ther, 1970, 173, 158-165).

Existen publicadas síntesis enantioselectivas de profenos (Tetrahedron: Asymmetry 1992, 3, 163-192; Tetrahedron Letters 1989, 30, 2825-2828; J. Am. Chem. Soc. 1989, 111, 7650-7651; Synlett 1992, 48-50). Sin embargo estas síntesis tienen la limitación de tratarse de síntesis que emplean reactivos sofisticados lo cual dificulta mucho su implantación a nivel industrial.There are published enantioselective syntheses of profenos (Tetrahedron: Asymmetry 1992, 3, 163-192, Tetrahedron Letters 1989, 30, 2825-2828, J. Am. Chem. Soc. 1989, 111, 7650-7651; Synlett 1992, 48-50 ). However, these syntheses have the limitation of being syntheses that use sophisticated reagents, which makes it very difficult to implement them on an industrial level.

Una forma habitual empleada por la industria para la preparación de fármacos en una forma enantiomérica es prepararlo como racemato y después llevar a cabo una resolución. Por ejemplo el dexmetilfenidato (focalin) se prepara por resolución (Int. J. Res. Pharm. L. Sci. 2014, 4, 1066-1069.). Sin embargo la resolución tiene la limitación de que la mitad del producto se pierde.A common way used by the industry for the preparation of drugs in an enantiomeric form is to prepare it as a racemate and then carry out a resolution. For example, dexmethylphenidate (focalin) is prepared by resolution (Int. J. Res. Pharm. L. Sci. 2014, 4, 1066-1069.). However, the resolution has the limitation that half of the product is lost.

Jin-Mo Ku, et al. Asymmetric synthesis of a,p-epoxysulfones via phase-transfer catalytic Darzens reaction. Tetrahedron 63 (2007) 8099-8103, describe el uso de catalizadores de transferencia de fase, PTC (Phase Transfer Catalysis) para preparar epoxisulfonas de forma enantioselectiva. Sin embargo, mediante el procedimiento descrito en este documetno, sólo se obtienen un tipo particular de epoxisulfonas, con una enantioselectividad y rendimiento químico bajos.Jin-Mo Ku, et al. Asymmetric synthesis of a, p-epoxysulfones via phase-transfer catalytic Darzens reaction. Tetrahedron 63 (2007) 8099-8103, describes the use of phase transfer catalysts, PTC (Phase Transfer Catalysis) to prepare epoxysulfones enantioselectively. However, by the procedure described in this document, only one particular type of epoxysulfones is obtained, with an enantioselectivity and chemical yield low.

Existe pues la necesidad de proporcionar un procedimiento para la preparación de profenos y fenidatos de forma enantioselectiva a nivel industrial, que sea sencillo y que solucione los problemas descritos en el estado de la técnica.There is therefore a need to provide a method for the preparation of prophenes and fenidates in an enantioselective manner at industrial level, which is simple and which solves the problems described in the state of the art.

Breve descripción de la invenciónBRIEF DESCRIPTION OF THE INVENTION

La presente invención soluciona los problemas descritos en el estado de la técnica ya que proporciona un procedimiento sencillo para la síntesis enantioselectiva de profenos y fenidatos, mediante unas reacciones químicas basadas en la apertura reductiva de epoxisulfonas ópticamente activas. El procedimiento consta de una primera reacción de síntesis enantioselectiva de epoxisulfonas empleando catalizadores quiral de tipo PTC (catalizador de transferencia de fase (Phase Transfer Catalysis) y una segunda etapa de transformación de las epoxisulfonas en profenos o fenidatos, según cuál sea la epoxisulfona. Por otro lado, al utilizarse pequeñas cantidades de catalizadores tipo PTC, no se generan residuos tóxicos y se obtiene un producto final sin trazas de contaminantes de metales tóxicos, que puede ser usado en la industria farmacéutica.The present invention solves the problems described in the state of the art since it provides a simple procedure for the enantioselective synthesis of prophenes and fenidates, through chemical reactions based on the reductive opening of optically active epoxysulfones. The process consists of a first enantioselective synthesis reaction of epoxysulfones using PTC-type chiral catalysts (Phase Transfer Catalysis) and a second stage of transformation of the epoxysulfones into prophenes or phenytodates, depending on the epoxysulfone. On the other hand, when using small quantities of PTC type catalysts, no toxic residues are generated and a final product without traces of toxic metal contaminants is obtained, which can be used in the pharmaceutical industry.

Así pues en un primer aspecto, la presente invención se refiere a un procedimiento para la preparación enantioselectiva de profenos y fenidatos (de aquí en adelante, procedimiento de la presente invención) que comprende las siguientes etapas:Thus in a first aspect, the present invention relates to a process for the enantioselective preparation of prophenes and fenidates (hereinafter, process of the present invention) comprising the following steps:

a) Síntesis enantioselectiva de una epoxisulfona de fórmula general (I) y/o formas isoméricas de las mismas, mediante la reacción de una cetona de fórmula general (II) y una sulfona de fórmula general (III), en presencia de un catalizador PTC y una base:a) Enantioselective synthesis of an epoxysulfone of general formula (I) and / or isomeric forms thereof, by the reaction of a ketone of general formula (II) and a sulfone of general formula (III), in the presence of a PTC catalyst and a base:

Figure imgf000003_0001
Figure imgf000003_0001

Donde:Where:

Ar1 es seleccionado de entre fenilo, i-butilfenilo y 2-piridilo;Ar 1 is selected from phenyl, i-butylphenyl and 2-pyridyl;

Ar2 es seleccionado de entre fenilo y fenilo sustituido; Ar 2 is selected from phenyl and substituted phenyl;

R1 es seleccionado entre -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3,-SCH2CH2CH3, -Cl, -Br, -I y 2-piridilo; R1 is selected from -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3, -SCH2CH2CH3, -Cl, -Br, -I and 2-pyridyl;

X es seleccionado entre Cl, Br, e I.X is selected from Cl, Br, and I.

En la presente invención y tal y como lo entendería un experto en la materia, por base se refiere a cualquier sustancia que en disolución acuosa aporta iones hidroxilo al medio.In the present invention and as understood by a person skilled in the art, by base refers to any substance that in aqueous solution contributes hydroxyl ions to the medium.

b) reducción de la epoxisulfona de fórmula general (I) obtenida en la etapa a) para obtener el correspondiente aldehído de fórmula general (IV) o alcohol de fórmula general (V):b) reduction of the epoxysulfone of the general formula (I) obtained in step a) to obtain the corresponding aldehyde of the general formula (IV) or alcohol of the general formula (V):

Figure imgf000004_0001
Figure imgf000004_0001

c) oxidación del compuesto obtenido en la etapa b) para dar lugar al profeno de fórmula general (VI) o fenidato de fórmula general (VII):c) oxidation of the compound obtained in step b) to give the prophene of general formula (VI) or fenidate of general formula (VII):

Figure imgf000004_0002
Figure imgf000004_0002

En la presente invención, por formas isoméricas de la epoxisulfona de fórmula general (I) se refiere a cualquiera forma isomérica de la epoxisulfona, en particular, se refiere a cualquiera de las siguientes fórmulas:In the present invention, isomeric forms of the epoxysulfone of the general formula (I) refers to any isomeric form of the epoxysulfone, in particular, it refers to any of the following formulas:

Figure imgf000004_0003
Figure imgf000004_0003

En una realización particular, el catalizador tipo PTC de la etapa a) del procedimiento de la presente invención, es un catalizador PTC de fórmula general (VIII): In a particular embodiment, the PTC catalyst of step a) of the process of the present invention is a PTC catalyst of general formula (VIII):

Figure imgf000005_0001
Figure imgf000005_0001

Donde:Where:

R5 es seleccionado de entre -H, -CH3, -CH2CH3, - CH2CH2CH3, Bn, etilo, alilo y vinilo;R5 is selected from -H, -CH3, -CH2CH3, - CH2CH3 CH2, Bn, ethyl, allyl and vinyl;

R6 es seleccionado de entre -H, -CH3, -CH2CH3, - CH2CH2CH3, Bn, etilo, alilo y vinilo;R6 is selected from -H, -CH3, -CH2CH3, -CH2CH2CH3, Bn, ethyl, allyl and vinyl;

R7 es seleccionado de entre etilo y vinilo;X es seleccionado entre Cl, Br, e I.R7 is selected from ethyl and vinyl, X is selected from Cl, Br, and I.

Más en particular, el catalizador PTC de la etapa a) del procedimiento de la presente invención es seleccionado de entre un catalizador del tipo N-alquil cinchonino, cinchonidinio, quininio y quinidinio.More particularly, the PTC catalyst of step a) of the process of the present invention is selected from a catalyst of the N-alkyl cinchonino, cinchonidinium, quininium and quinidinium type.

En otra realización particular, el agente reductor de la etapa b) del procedimiento de la presente invención es seleccionado de entre NaBH4, LiAlH4, Dibal-H, Zn(BH4)2, BH3, Bu3SnH, LiBH4 y H2 In another particular embodiment, the reducing agent of step b) of the process of the present invention is selected from NaBH4, LiAlH4, Dibal-H, Zn (BH4) 2, BH3, Bu3SnH, LiBH4 and H2

Más en particular, la etapa b) del procedimiento de la presente invención comprende un catalizador metálico, más en particular el catalizador metálico es seleccionado de entre Pd/C y Pt/C.More particularly, step b) of the process of the present invention comprises a metal catalyst, more in particular the metal catalyst is selected from Pd / C and Pt / C.

En otra realización particular, el agente oxidante de la etapa c) del procedimiento de la presente invención es seleccionado de entre NaClO, H2O2 y KMnO4.In another particular embodiment, the oxidizing agent of step c) of the process of the present invention is selected from NaClO, H2O2 and KMnO4.

En una realización particular, la presente invención se refiere a un procedimiento para la síntesis enantioselectiva de profenos de fórmula general (VI) que comprende las siguientes etapas:In a particular embodiment, the present invention relates to a method for the enantioselective synthesis of prophenes of general formula (VI) comprising the following steps:

Figure imgf000005_0002
Figure imgf000005_0002

Donde: Where:

Ar1 es seleccionado de entre fenilo, i-butilfenilo y 2-piridilo;Ar 1 is selected from phenyl, i-butylphenyl and 2-pyridyl;

Ar2 es seleccionado de entre fenilo y fenilo sustituido;Ar2 is selected from phenyl and substituted phenyl;

R1 es seleccionado entre -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3,-SCH2CH2CH3, -Cl, -Br e -I;R1 is selected from -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3, -SCH2CH2CH3, -Cl, -Br and -I ;

X es seleccionado entre Cl, Br, e I.X is selected from Cl, Br, and I.

En otra realización particular, la presente invención se refiere a un procedimiento para la síntesis enantioselectiva de fenidatos de fórmula general (VII) que comprende las siguientes etapas:In another particular embodiment, the present invention relates to a method for the enantioselective synthesis of fenidates of general formula (VII) comprising the following steps:

Figure imgf000006_0001
Figure imgf000006_0001

Donde:Where:

Ar1 es seleccionado de entre fenilo, i-butilfenilo y 2-piridilo;Ar 1 is selected from phenyl, i-butylphenyl and 2-pyridyl;

Ar2 es seleccionado de entre fenilo y fenilo sustituido.Ar2 is selected from phenyl and substituted phenyl.

R1 es seleccionado entre -H, -CH3 , -CH2CH3 , -CH2CH2CH3 , -OCH3 , -OCH2CH3 , -OCH2CH2CH3 -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3,-SCH2CH2CH3, -Cl, -Br, -I y 2-piridilo; R 1 is selected from -H, -CH 3 , -CH 2 CH 3 , -CH 2 CH 2 CH 3 , -OCH 3 , -OCH 2 CH 3 , -OCH 2 CH 2 CH 3 -NHCH 3 , -NHCH 2 CH 3 , NHCH 2 CH 2 CH 3 , -SCH 3, -SCH 2 CH 3, -SCH 2 CH 2 CH 3, -Cl, -Br, -I and 2-pyridyl;

X es seleccionado entre Cl, Br, e I.X is selected from Cl, Br, and I.

R4 es seleccionado de entre -H, -CH3, -CH2CH3, Bn, Alilo y Vinilo. En otro aspecto, la presente invención se refiere a un compuesto de fórmula general (VI) ó (VII) obtenido mediante el procedimiento de la presente invención.R4 is selected from -H, -CH3, -CH2CH3, Bn, Allyl and Vinyl. In another aspect, the present invention relates to a compound of general formula (VI) or (VII) obtained by the process of the present invention.

Descripción detallada de la invención.Detailed description of the invention.

Los siguientes ejemplos ilustran realizaciones específicas de la presente invención, pero de ningún modo con carácter limitativo.The following examples illustrate specific embodiments of the present invention, but not by way of limitation.

Ejemplo 1: síntesis de profenosExample 1: synthesis of professes

La acetofenona y la 4-isobutil acetofenona se transformaron en la correspondientes epoxisulfonas como una mezcla de diastereoisómeros los cuales al mismo tiempo son una mezcla de enantiómeros enriquecidos en uno de los dos posibles enantiómeros. La mezcla de epoxisulfonas se transformó en el alcohol primero el cual después se convirtió en el profeno correspondiente por oxidación, tal y como se muestra en el esquema I:Acetophenone and 4-isobutyl acetophenone were converted into the corresponding epoxysulfones as a mixture of diastereoisomers which at the same time are a mixture of enantiomers enriched in one of the two possible enantiomers. The mixture of epoxysulfones was converted to the alcohol first which was then converted to the corresponding profen by oxidation, as shown in Scheme I:

Figure imgf000007_0001
Figure imgf000007_0001

Para ello, se trató una disolución de clorometil fenil sulfona (2 mmol) en dietil éter (6 mL) a temperatura ambiente, con la correspondiente acetofenona (2.4 mmol), el catalizador de transferencia de fase N-(4-trifluoromethylbenzyl)quininium bromide (0.2 mmol) y finalmente con hidróxido de potasio (7.8 mmol). La mezcla resultante se agitó a temperatura ambiente durante 16 horas. Pasado este tiempo, la mezcla de reacción se filtró a través de celite lavando con acetato de etilo, el filtrado se concentró en el rotavapor y el residuo resultante se purificó mediante cromatografía empleando mezclas de hexano-acetato de etilo.For this, a solution of chloromethyl phenyl sulfone (2 mmol) in diethyl ether (6 mL) was treated at room temperature, with the corresponding acetophenone (2.4 mmol), the N- (4-trifluoromethylbenzyl) quininium bromide phase transfer catalyst. (0.2 mmol) and finally with potassium hydroxide (7.8 mmol). The resulting mixture was stirred at room temperature for 16 hours. After this time, the reaction mixture was filtered through celite washing with ethyl acetate, the filtrate was concentrated in the rotary evaporator and the resulting residue was purified by chromatography using mixtures of hexane-ethyl acetate.

A una suspensión de litio aluminio hidruro (0.63 mmol) en tetrahidrofurano recién destilado (3 mL) bajo atmósfera inerte de nitrógeno y enfriado con un baño de hielo se añadió una disolución de la epoxisulfona obtenida anteriormente (0.21 mmol) en tetrahidrofurano (1 mL). La mezcla resultante se agitó a temperatura ambiente durante 16 horas. Después de este tiempo, se añadió acetato de etilo (1 mL) y se agitó durante 15 minutos. A continuación, se añadió acetato de etilo (6 mL) y una disolución 0.1M de HCl (12 mL) y se vertió en un embudo de extracción. La fase acuosa se extrajo con acetato de etilo (3 x 15 mL), los extractos orgánicos se juntaron, se secaron (MgSO4) y se concentraron en el rotavapor. El residuo aceitoso resultante se purificó mediante cromatografía con hexano/acetato de etilo.To a suspension of lithium aluminum hydride (0.63 mmol) in freshly distilled tetrahydrofuran (3 mL) under an inert atmosphere of nitrogen and cooled with an ice bath was added a solution of the epoxysulfone obtained above (0.21 mmol) in tetrahydrofuran (1 mL). . The resulting mixture was stirred at room temperature for 16 hours. After this time, ethyl acetate (1 mL) was added and stirred for 15 minutes. Then, ethyl acetate (6 mL) and 0.1M HCl solution (12 mL) were added and poured into an extraction funnel. The aqueous phase was extracted with ethyl acetate (3 x 15 mL), the organic extracts were combined, dried (MgSO 4) and concentrated in the rotary evaporator. The resulting oily residue was purified by chromatography with hexane / ethyl acetate.

A una disolución del alcohol (0.4 mmol) en acetonitrilo (3 mL) se añadió una disolución de clorito de sodio (1.6 mmol) en agua (0.8 mL), luego 2,2,6,6-tetrametil-1-piperidiniloxi (0.016 mmol), tampón fosfato (0.67 M, 3 mL) y finalmente una disolución de hipoclorito de sodio (5.25%, 21 mL) diluida con agua (0.4 mL). La reacción se monitoreó mediante cromatografía por capa fina y una vez finalizada se enfrió en un baño de hielo y se añadió agua (6 mL), una disolución saturada de bicarbonato de sodio hasta pH 8 y sulfito de sodio (2.8 mmol). Tras agitar la mezcla durante media hora, se añadió acetato de etilo y se agitó quince minutos más. A continuación, la mezcla de reacción se vertió en un embudo de extracción y la fase orgánica se descartó, entonces la fase acuosa se enfrió en un baño de hielo, se llevó a pH 2 y entonces vertió en un embudo de extracción donde se extrajo con acetato de etilo (2 x 3 mL), los extractos orgánicos se juntaron, se secaron (sulfato de sodio), se filtró y se concentró en el rotavapor para dar lugar al correspondiente profeno o fenidato.To a solution of the alcohol (0.4 mmol) in acetonitrile (3 mL) was added a solution of sodium chlorite (1.6 mmol) in water (0.8 mL), then 2,2,6,6-tetramethyl-1-piperidinyloxy (0.016). mmol), phosphate buffer (0.67 M, 3 mL) and finally a solution of sodium hypochlorite (5.25%, 21 mL) diluted with water (0.4 mL). The reaction was monitored by thin layer chromatography and after completion was cooled in an ice bath and water (6 mL), a saturated solution of sodium bicarbonate to pH 8 and sodium sulfite (2.8 mmol) were added. After stirring the mixture for half an hour, ethyl acetate was added and stirred an additional fifteen minutes. Then, the reaction mixture was poured into an extraction funnel and the organic phase was discarded, then the aqueous phase was cooled in an ice bath, brought to pH 2 and then poured into an extraction funnel where it was extracted with ethyl acetate (2 x 3 mL), the organic extracts were combined, dried (sodium sulfate), filtered and concentrated in the rotary evaporator to give the corresponding profene or fenidate.

Ejemplo 2: Síntesis de fenidatosExample 2: Synthesis of fenidates

La fenil piridinil cetona se transformó en la correspondiente epoxisulfona como una mezcla de diastereoisómeros los cuales al mismo tiempo son una mezcla de enantiómeros enriquecidos en uno de los dos posibles enantiómeros. La mezcla de epoxisulfonas se sometió a hidrogenación a elevada presión para dar lugar al correspondiente piperidín alcohol el cual después se convirtió en el fenidato por oxidación, tal y como se muestra en el esquema II:The phenyl pyridinyl ketone was converted into the corresponding epoxysulfone as a mixture of diastereomers which at the same time are a mixture of enantiomers enriched in one of the two possible enantiomers. The mixture of epoxysulfones was subjected to hydrogenation under high pressure to give rise to the corresponding piperidine alcohol which was then converted to the fenidate by oxidation, as shown in Scheme II:

Figure imgf000008_0001
Figure imgf000008_0001

El paso 1 y 3 siguen el mismo procedimiento que los pasos 1 y 3 indicados arriba para la síntesis de profenos.Step 1 and 3 follow the same procedure as steps 1 and 3 indicated above for the synthesis of profens.

A una suspensión del catalizador Pt/C (20 mg) en ácido acético (2 mL) se añadió una disolución de la epoxisulfona (2 mmol) en ácido acético (6 mL) a temperatura ambiente. La mezcla resultante se agitó a temperatura ambiente durante 18 horas bajo atmósfera de hidrógeno. Pasado este tiempo, la mezcla de reacción se trató con una disolución saturada de bicarbonato de sodio con precaución y a continuación se llevó a pH 9 con una disolución acuosa de sosa 2M. Finalmente se vertió en un embudo de extracción donde se extrajo con acetato de etilo (2 x 3 mL), los extractos orgánicos se lavaron con una disolución acuosa de ácido clorhídrico 1M y luego con salmuera, luego se secaron (sulfato de sodio), se filtró y se concentró en el rotavapor para dar lugar al correspondiente alcohol. To a suspension of the catalyst Pt / C (20 mg) in acetic acid (2 mL) was added a solution of the epoxysulfone (2 mmol) in acetic acid (6 mL) at room temperature. The resulting mixture was stirred at room temperature for 18 hours under a hydrogen atmosphere. After this time, the reaction mixture was treated with a saturated solution of sodium bicarbonate with caution and then brought to pH 9 with an aqueous solution of 2M soda. Finally it was poured into an extraction funnel where it was extracted with ethyl acetate (2 x 3 mL), the organic extracts were washed with an aqueous solution of 1M hydrochloric acid and then with brine, then dried (sodium sulfate), filtered and concentrated on the rotavapor to give rise to the corresponding alcohol.

Claims (8)

REIVINDICACIONES 1. Procedimiento para la preparación enantioselectiva de profenos y fenidatos que comprende las siguientes etapas:1. Procedure for the enantioselective preparation of prophenes and fenidates comprising the following steps: a) Síntesis enantioselectiva de una epoxisulfona de fórmula general (I) y/o formas isoméricas de las mismas, mediante la reacción de un epóxido de fórmula general (II) y una sulfona de fórmula general (III), en presencia de un catalizador PTC y una base:a) Enantioselective synthesis of an epoxysulfone of general formula (I) and / or isomeric forms thereof, by the reaction of an epoxide of general formula (II) and a sulfone of general formula (III), in the presence of a PTC catalyst and a base:
Figure imgf000009_0002
Figure imgf000009_0002
Donde:Where: Ar1 es seleccionado de entre fenilo, i-butilfenilo y 2-piridilo;Ar 1 is selected from phenyl, i-butylphenyl and 2-pyridyl; Ar2 es seleccionado de entre fenilo y fenilo sustituido.Ar 2 is selected from phenyl and substituted phenyl. R1 es seleccionado entre -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3, -SCH2CH2CH3, -Cl, -Br, -I y 2-piridilo; R 1 is selected from -H, -CH 3 , -CH 2 CH 3 , -CH 2 CH 2 CH 3 , -OCH 3 , -OCH 2 CH 3 , -OCH 2 CH 2 CH 3 , -NHCH 3 , -NHCH 2 CH 3 , NHCH 2 CH 2 CH 3 , -SCH 3 , -SCH 2 CH 3 , -SCH 2 CH 2 CH 3 , -Cl, -Br, -I and 2-pyridyl; X es seleccionado entre Cl, Br, e I.X is selected from Cl, Br, and I. b) reducción de la epoxisulfona de fórmula general (I) obtenida en la etapa a) para obtener el correspondiente aldehído de fórmula general (IV) o alcohol de fórmula general (V), en presencia de un catalizador metálico:b) reduction of the epoxysulfone of the general formula (I) obtained in step a) to obtain the corresponding aldehyde of the general formula (IV) or alcohol of the general formula (V), in the presence of a metal catalyst:
Figure imgf000009_0001
Figure imgf000009_0001
c) oxidación del compuesto obtenido en la etapa b) para dar lugar al profeno de fórmula general (VI) o fenidato de fórmula general (VII):c) oxidation of the compound obtained in step b) to give the prophene of general formula (VI) or fenidate of general formula (VII):
Figure imgf000010_0001
Figure imgf000010_0001
2. Procedimiento según la reivindicación 1, donde el catalizador tipo PTC de la etapa a) es un catalizador PTC de fórmula general (VIII):2. Method according to claim 1, wherein the PTC type catalyst of step a) is a PTC catalyst of general formula (VIII):
Figure imgf000010_0002
Figure imgf000010_0002
Donde:Where: R5 es seleccionado de entre -H, -CH3, -CH2CH3, - CH2CH2CH3, Bn, etilo, alilo y vinilo;R 5 is selected from -H, -CH 3 , -CH 2 CH 3 , -CH 2 CH 2 CH 3 , Bn, ethyl, allyl and vinyl; R6 es seleccionado de entre -H, -CH3, -CH2CH3, - CH2CH2CH3, Bn, etilo, alilo y vinilo;R6 is selected from -H, -CH 3 , -CH 2 CH 3 , -CH 2 CH 2 CH 3 , Bn, ethyl, allyl and vinyl; R7 es seleccionado de entre etilo y vinilo;R 7 is selected from ethyl and vinyl; X es seleccionado de entre Cl, Br, e I;X is selected from among Cl, Br, and I;
3. Procedimiento según cualquiera de las reivindicaciones anteriores, donde el catalizador PTC de la etapa a) es seleccionado de entre un catalizador del tipo N-alquil cinchonino, cinchonidinio, quininio y quinidinio. 3. Method according to any of the preceding claims, wherein the PTC catalyst of step a) is selected from a catalyst of the N-alkyl cinchonino, cinchonidinio, quininio and quinidinio type. 4 . Procedimiento según cualquiera de las reivindicaciones 1-3 , donde el agente reductor de la etapa b) es seleccionado de entre NaBH4, LiAlH4 y H2. 4. Process according to any of claims 1 to 3, wherein the reducing agent of step b) is selected from NaBH4, LiAlH4 and H2. 5 . Procedimiento según cualquiera de las reivindicaciones anteriores, donde el catalizador metálico de la etapa b) es seleccionado de entre Pd/C y Pt/C. 5. Process according to any of the preceding claims, wherein the metal catalyst of step b) is selected from Pd / C and Pt / C. 6 . Procedimiento según cualquiera de las reivindicaciones anteriores, donde el agente oxidante es seleccionado de entre NaClO, H2O2 y KMnO4. 6. Process according to any of the preceding claims, wherein the oxidizing agent is selected from NaClO, H2O2 and KMnO4. 7. Procedimiento para la síntesis enantioselectiva de profenos de fórmula general (VI) según cualquiera de las reivindicaciones anteriores, que comprende las siguientes etapas: 7. Process for the enantioselective synthesis of prophenes of general formula (VI) according to any of the preceding claims, comprising the following steps: a) Síntesis enantioselectiva de una epoxisulfona de fórmula general (I) y/o formas isoméricas de las mismas, mediante la reacción de un epóxido de fórmula general (II) y una sulfona de fórmula general (III), en presencia de un catalizador PTC y una base:a) Enantioselective synthesis of an epoxysulfone of general formula (I) and / or isomeric forms thereof, by the reaction of an epoxide of general formula (II) and a sulfone of general formula (III), in the presence of a PTC catalyst and a base:
Figure imgf000011_0002
Figure imgf000011_0002
Donde:Where: Ari es seleccionado de entre fenilo, i-butilfenilo y 2-piridilo; Ari is selected from phenyl, i-butylphenyl and 2- pyridyl; Ar2 es seleccionado de entre fenilo y fenilo sustituido.Ar2 is selected from phenyl and substituted phenyl. Ri es seleccionado entre -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3, -SCH2CH2CH3, -Cl, -Br e -I;Ri is selected from -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3, -SCH2CH2CH3, -Cl, -Br and -I ; X es seleccionado entre Cl, Br, e I.X is selected from Cl, Br, and I. b) reducción de la epoxisulfona de fórmula general (I) obtenida en la etapa a) para obtener el correspondiente aldehido de fórmula general (IV):b) reduction of the epoxysulfone of the general formula (I) obtained in step a) to obtain the corresponding aldehyde of the general formula (IV):
Figure imgf000011_0001
Figure imgf000011_0001
c) oxidación del compuesto obtenido en la etapa b) para dar lugar al profeno de fórmula general (VI):c) oxidation of the compound obtained in step b) to give rise to the profen of general formula (VI):
Figure imgf000012_0001
Figure imgf000012_0001
8. Procedimiento para la síntesis enantioselectiva de fenidatos de fórmula general (VII) según cualquiera de las reivindicaciones anteriores, que comprende las siguientes etapas8. Process for the enantioselective synthesis of fenidates of general formula (VII) according to any of the preceding claims, comprising the following steps a) Síntesis enantioselectiva de una epoxisulfona de fórmula general (I) y/o formas isoméricas de las mismas, mediante la reacción de un epóxido de fórmula general (II) y una sulfona de fórmula general (III), en presencia de un catalizador PTC y una base:a) Enantioselective synthesis of an epoxysulfone of general formula (I) and / or isomeric forms thereof, by the reaction of an epoxide of general formula (II) and a sulfone of general formula (III), in the presence of a PTC catalyst and a base:
Figure imgf000012_0002
Figure imgf000012_0002
Donde:Where: Ar1 es seleccionado de entre fenilo, i-butilfenilo y 2-piridilo;Ar 1 is selected from phenyl, i-butylphenyl and 2-pyridyl; Ar2 es seleccionado de entre fenilo y fenilo sustituido.Ar 2 is selected from phenyl and substituted phenyl. R1 es seleccionado entre -H, -CH3, -CH2CH3, -CH2CH2CH3, -OCH3, -OCH2CH3, -OCH2CH2CH3, -NHCH3, -NHCH2CH3, NHCH2CH2CH3, -SCH3, -SCH2CH3, -SCH2CH2CH3, -Cl, -Br, -I y 2-piridilo; R 1 is selected from -H, -CH 3 , -CH 2 CH 3 , -CH 2 CH 2 CH 3 , -OCH 3 , -OCH 2 CH 3 , -OCH 2 CH 2 CH 3 , -NHCH 3 , -NHCH 2 CH 3 , NHCH 2 CH 2 CH 3 , -SCH 3 , -SCH 2 CH 3 , -SCH 2 CH 2 CH 3 , -Cl, -Br, -I and 2-pyridyl; X es seleccionado entre Cl, Br, e I.X is selected from Cl, Br, and I. b) reducción de la epoxisulfona de fórmula general (I) obtenida en la etapa a) para obtener el correspondiente alcohol de fórmula general (V):b) reduction of the epoxysulfone of the general formula (I) obtained in step a) to obtain the corresponding alcohol of the general formula (V):
Figure imgf000012_0003
Figure imgf000012_0003
c) oxidación del compuesto de fórmula general (V) obtenido en la etapa b) para dar lugar al fenidato de fórmula general (VII):c) oxidation of the compound of general formula (V) obtained in step b) to give rise to the fenidate of general formula (VII):
Figure imgf000013_0001
Figure imgf000013_0001
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