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GB2390849A - 3-Acyl-1,4-dihydro-1,4-di(phenyl/azinyl/diazinyl)pyridine derivatives for use as human neutrophil elastase inhibitors - Google Patents

3-Acyl-1,4-dihydro-1,4-di(phenyl/azinyl/diazinyl)pyridine derivatives for use as human neutrophil elastase inhibitors Download PDF

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GB2390849A
GB2390849A GB0216664A GB0216664A GB2390849A GB 2390849 A GB2390849 A GB 2390849A GB 0216664 A GB0216664 A GB 0216664A GB 0216664 A GB0216664 A GB 0216664A GB 2390849 A GB2390849 A GB 2390849A
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amino
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alkoxy
alkyl
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GB0216664D0 (en
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Heike Gielen
Volkhart Min-Jian Li
Ulrich Rosentreter
Dr Karl-Heinz Schlemmer
Mary Fitzgerald
Kevin Nash
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Bayer AG
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Bayer AG
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Priority to PCT/EP2002/013931 priority patent/WO2003053930A1/en
Priority to CA002470813A priority patent/CA2470813A1/en
Priority to AU2002361992A priority patent/AU2002361992A1/en
Priority to DE60214428T priority patent/DE60214428T2/en
Priority to ES02796589T priority patent/ES2271365T3/en
Priority to US10/498,967 priority patent/US7199136B2/en
Priority to EP02796589A priority patent/EP1458682B1/en
Priority to JP2003554646A priority patent/JP4486817B2/en
Publication of GB2390849A publication Critical patent/GB2390849A/en
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/04Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • AHUMAN NECESSITIES
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    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
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    • 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
    • C07D211/80Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D211/84Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms, with at the most one bond to halogen directly attached to ring carbon atoms
    • C07D211/90Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen

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Abstract

Compounds of the general formula (I) wherein <DL TSIZE=27> <DT>R<1>, R<2>, R<3>, R<8>, R<9> and R<10><DD>independently from each other represent hydrogen, halogen, nitro, cyano, trifluoromethyl, C1-C6-alkyl, C1-C6-alkanoyl, hydroxy, C1-C6-alkoxy, trifluoromethoxy, amino, mono- or di-C1-C6-alkylamino, C1-C6-acylamino, C1-C6-alkoxycarbonylamino, carboxyl, C1-C6-alkoxycarbonyl or phenyl, wherein C1-C6-alkyl, C1-C6-alkanoyl, C1-C6-alkoxy, mono- or di-C Ü -C6-alkylamino and C1-C6-acylamino can be further substituted with one to three identical or different radicals selected from the group consisting of hydroxy, C1-C4-alkoxy, amino, mono- and di-C1-C4-alkylamino, <DT>R<4><DD>represents C1-C6-alkyl, trifluoromethyl or phenyl, <DT>R<5><DD>represents C1-C4-alkyl, which can be substituted with one to three identical or different radicals selected from the group consisting of hydroxy, C1-C4-alkoxy, amino, mono- and di-C1-C4-alkylamino, <DT>R<6><DD>represents cyano, aminocarbonyl mono- and di-C1-C4-alkylaminocarbonyl, carboxyl or C1-C6-alkoxycarbonyl, wherein the alkoxy moiety can be further substituted with a radical selected from the group consisting of hydroxy, C1-C4-alkoxy amino, mono- and di-C1-C4-alkylamino, or <DT>R<6><DD>represents a moiety of the formula wherein R<A> is selected from the group consisting of hydrogen and C1-C6-alkyl, and the symbol * next to a bond denotes the point of attachment in the molecule, <DT>R<7><DD>represents hydrogen, C1-C4-alkyl or amino, <DT>X<1>, X<2>, X<3> and X<4><DD>independently from each other represent CH or N, wherein ring A contains either 0, 1 or 2 nitrogen atoms, and <DT>Y<1>, Y<2>, Y<3>, Y<4> and Y<5><DD>independently from each other represent CH or N, </DL> ```wherein ring B contains either 0, 1 or 2 nitrogen atoms show human neutrophil elastase (HNE) inhibitory activity and are therefore suitable for the treatment of diseases associated with HNE activity, namely the treatment of acute and chronic inflammatory processes, such as rheumatoid arthritis, atherosclerosis, and especially of acute and chronic pulmonary diseases, such as lung fibrosis, cystic fibrosis, pneumonia, acute respiratory distress syndrome (ARDS), in particular pulmonary emphysema, including smoking-induced emphysema, and chronic obstructive pulmonary diseases (COPD). They may also provide an effective treatment of brain trauma, cancer and other conditions in which neutrophil participation is involved. They may be formulated as a pharmaceutical composition.

Description

1 2390849
1,4-Dihvdro-1,4-dinhenvlpvridine derivatives The present invention relates to novel 1,4-dihydro-1,4-diphenylpyridine derivatives, processes for their preparation, and their use in medicaments, especially for the treat 5 ment of chronic obstructive pulmonary diseases.
The fibrous protein elastin, which comprises an appreciable percentage of all protein content in some tissues, such as the arteries, some ligaments and the lungs, can be hydrolysed or otherwise destroyed by a select group of enzymes classified as elastases.
10 Human leukocyte elastase (HLE, EC 3.4.21.37), also known as human neutrophil elastase (HNE), is a glycosylated, strongly basic serine protease and is found in the azurophilic granules of human polymorphonuclear leukocytes (PMN). HNE is released from activated PMN and has been implicated causally in the pathogenesis of acute and chronic inflammatory diseases. HNE is capable of degrading a wide range of matrix 15 proteins including elastin, and in addition to these actions on connective tissue HNE has a broad range of inflammatory actions including upregulation of IL-8 gene expression, oedema formation, mucus gland hyperplasia and mucus hypersecretion.
Pulmonary diseases where HNE is believed to play a role include lung fibrosis, pneumonia, acute respiratory distress syndrome (ARMS), pulmonary emphysema, 20 including smoking-induced emphysema, chronic obstructive pulmonary diseases (COPD) and cystic fibrosis. HNE has also been causally implicated in rheumatoid arthritis, atherosclerosis, brain trauma, cancer and related conditions in which neutrophil participation is involved. Thus, inhibitors of HLE activity can be potentially useful in the treatment of a number of inflammatory diseases, especially of chronic 25 obstructive pulmonary diseases [R.A. Stockley, Neutrophils and protease/antiprotease imbalance, Am. J. Respir. Crit. Care 160, S49-S52 (1999)].
Certain cationic amphiphilic 1,4-dihydropyridine derivatives useful for delivery of nucleotide containing compounds are disclosed in WO-AI01/62946. Ethyl 6-arnino 30 1,4-bis(4-chlorophenyl)-5-cyano-2-methyl-1,4dthydro-3-pyridinecarboxylate has been
- - synthesized and tested for potential antimicrobial activity as described in A.W. Erian et al., Pharrnazie 53 (11), 748-751 (1998).
The present invention relates to compounds of the general fonnula (I) R. R2 AR3 OXX 4JR6 R l Rs N R7 Ri YRa (I), wherein R', R2, R3, R8, R9 and R' independently from each other represent hydrogen, halogen, nitro, cyano, trifluoromethyl, Cl-C6-alkyl, C-C6-alkanoyl, hydroxy, I O C,-C6alkoxy, trifluoromethoxy, amino, mono- or di-C-C6-alkylamino, C -C6acylarnino, C -C6-alkoxycarbonylarnino, carboxyl, C, -C6-alkoxy carbonyl or phenyl, wherein C'-C6-alkyl, C,-C6-alkanoyl, C-C6-alkoxy, mono- or diC'-C6-alkylamino and C-C6-acylamino can be further substituted with one to three identical or different radicals selected from the 15 group consisting of hydroxy, C,-C4-alkoxy, amino, mono- and di-C,-C4-alkyl amno, R4 represents C,-C6-alkyl, trifluoromethyl or phenyl, 20 Rs represents CC4-alkyl, which can be substituted with one to three identical or different radicals selected from the group consisting of hydroxy, C-C4 alkoxy, amino, mono- and di-C'-C4-alkylamino,
- 3 R6 represents cyano, arninocarbonyl, mono- and di-C,-C4alkylaminocarbonyl, carboxyl or C-C6-alkoxycarbonyl, wherein the alkoxy moiety can be further substituted with a radical selected from the group consisting of hydroxy, C,- = 5 CJ,-alkoxy, amino, mono- and di-C-C4alkylamino, or R6 represents a moiety of the formula NR6A to or wherein RA is selected from the group consisting of hydrogen and C-Cc 1 5 alkyl, R7 represents hydrogen, C'-C4-alkyl or amino, Xt, X2, X3 and X4 independently from each other represent CH or N. wherein ring A 20 contains either 0, 1 or 2 nitrogen atoms, and yt, y2, y3, y4 and Y5 independently from each other represent CH or N. wherein 25 ring B contains either 0, 1 or 2 nitrogen atoms.
In another embodiment, the present invention relates to compounds of general formula (I), wherein
- 4 R' represents hydrogen, R2, R3, R9 and R' independently from each other represent hydrogen, halogen, nitro, 5 cyano, trifluoromethyl, Cl-C4alkyl, C-C4-alkanoyl, hydroxy, C-C4-alkoxy, trifluoromethoxy, amino, C rC4-dialkylamino, C -C4-acylamino, methoxy carbonylamino, tert.butoxycarbonylarnino, carboxyl, methoxycarbonyl or ethoxycarbonyl, wherein Cr-C4-alkyl, C-C4-alkanoyl, C,-C4-alkoxy, C,-C4 dialkylamino and C-C4-acylamino can be further substituted with one to two 10 identical or different radicals selected from the group consisting of hydroxy, methoxy, ethoxy, amino, dimethylamino and diethylamino, R4 represents methyl, ethyl, trifluoromethyl or phenyl, 15 R5 represents methyl or ethyl, Rfi represents cyano, aminocarbonyl, methylarninocarbonyl, dimethylaminocarb onyl, carboxyl or C-C4-alkoxycarbonyl, wherein the alkoxy moiety can be fiurther substituted with a radical selected from the group consisting of 20 hydroxy, methoxy, ethoxy, amino, mono- and di- C-C4-alkylamino, R7 represents hydrogen, methyl, ethyl or amino, R represents hydrogen, X', x2 and X3 represent CH, X4 represents CH or N. 30 and
( - 5
y y2 y3 y4 end Y5 represent CH In another embodiment, the present invention relates to compounds of general formula (l), wherein Rt and R2 represent hydrogen, R3 represents fluoro, chloro, bromo, nitro, cyano, trifluoromethyl, methyl, meth oxy or hydroxy, R4 represents methyl or trifluoromethyl, Rs represents methyl, l S R6 represents cyano, aminocarbonyl, methylaminocarbonyl, dimethylamino carbonyl, carboxyl, methoxycarbonyl or ethoxycarbonyl, R7 represents hydrogen, methyl or amino, 20 Rg and R9 represent hydrogen, R represents fluoro, chloro, bromo, nitro, cyano, trifluoromethyl or methyl, X', X2, X3 and X4 represent CH, and yl y2 y3 y4 and Y5 represent CH.
30 In another embodiment, the present invention relates to compounds according to general formula (I), which have the following structure:
- - - R4JR5 R5 N R7
R10RB FAX R9 and wherein R', R2, R3, R8, R9 and R' independently from each other represent hydrogen, 5 halogen, nitro, cyano, trifluoromethyl, Cl-C6-alkyl, C-C6-alkanoyl, hydroxy, C'-C6-alkoxy, triQuoromethoxy, amino, mono- or di-C-C6 alkylamino, C-C6-acylarnino, C-C6-alkoxycarbonylamino, carboxyl, C-C6-alkoxycarbonyl or phenyl, wherein C'-Cs-alkyl, C-C6alkanoyl, C-C6-alkoxy, mono- or di-C-C6-alkylarnino and C-C6-acylamino 10 can be farther substituted with one to three identical or different radicals selected from the group consisting of hydroxy, C-C4-alkoxy, amino, mono- and di-C-C4-alkylamino, R4 represents C'-C6-alkyl, trifluoromethyl or phenyl, R5 represents C-C4-alkyl, R6 represents cyano, carboxyl or C'-C6-alkoxycarbonyl, wherein the alkoxy moiety can be further substituted with a radical selected from 20 the group consisting of hydroxy, C'-C4-alkoxy, amino, mono- and di C -C4-alkylamino, and
- 7 R7 represents hydrogen, C-C.-alkyl or amino.
5 In another embodiment, the present invention relates to compounds according to general formula (1), wherein R3 is cyano, which is located in pare-position relativ to the 1,4-dihydropyridine ring.
In another embodiment, the present invention relates to compounds according to 10 general fonnula (I), wherein R4 is methyl.
In another embodiment, the present invention relates to compounds according to general formula (1), wherein R5 is methyl.
15 In another embodiment, the present invention relates to compounds according to general fonnula (I), wherein R6 is methoxycarbonyl or ethoxycarbonyl.
In another embodiment, the present invention relates to compounds according to general formula (I), wherein R7 is hydrogen, methyl or amino.
In another embodiment, the present invention relates to compounds according to general formula (I), wherein R is trifluoromethyl, which is attached to y2 The compounds according to this invention can also be present in the form of their 25 salts, hydrates and/or solvates.
Physiologically acceptable salts are preferred in the context of the present invention.
Physiologically acceptable salts according to the invention are non-toxic salts which 30 in general are accessible by reaction of the compounds (I) with an inorganic or organic base or acid conventionally used for this purpose. Non-limiting examples of
( - 8 pharrnaccutically acceptable salts of compounds (I) include the alkali metal salts, e.g. lithium, potassium and sodium salts, the alkaline earth metal salts such as magne sium and calcium salts, the quaternary ammonium salts such as, for example, triethyl ammonium salts, acetates, benzene sulphonates, benzoates, Bicarbonates, disulphates, 5 ditartrates, berates, bromides, carbonates, chlorides' citrates, dihydrochlorides, fumarates, gluconates, glutamates, hexyl resorcinates, hydrobromides, hydro chlorides, hydroxynaphthoates, iodides, isothionates, lactates, laurates, malates, maleates, mandelates, mesylates, methylbromides, methylaitrates, methylsulphates, nitrates, oleates, oxalates, palmitates, pantothenates, phosphates, diphosphates, 10 polygalacturonates, salicylates, stearates, sulphates, succinates, tartrates, tosylates, valerates, and other salts used for medicinal purposes.
Hydrates of the compounds of the invention or their salts are stoichiometric com positions of the compounds with water, such as for example hem)-, mono-, or 1 5 dihydrates.
Solvates of the compounds of the invention or their salts are stoichiometric compositions of the compounds with solvents.
20 The present invention includes both the individual enantiomers or diastereomers and the corresponding racemates or diastereomeric mixtures of the compounds according to the invention and their respective salts. In addition, all possible tautomeric forms of the compounds described above are included according to the present invention.
The diastereomeric mixtures can be separated into the individual isomers by 25 chromatographic processes. The racemates can be resolved into the respective enantiomers either by chromatographic processes on chiral phases or by resolution.
In the context of the present invention, the substituents, if not stated othervise, in general have the following meaning:
( Alkyl in general represents a straight-chain or branched hydrocarbon radical having I to 6, preferably I to 4 carbon atoms. Non-limiting examples include methyl, ethyl, n propyl, isopropyl, n-butyl, isobutyl, sec.-butyl, tert.-butyl, pentyl, isopentyl, hexyl, isohexyl. The same applies to radicals such as alkoxy, alkylamino, alkoxycarbonyl 5 and alkoxycarbonylamino.
Acyl or Alkanoyl in general represents a straight-chain or branched hydrocarbon radical having I to 6, preferably 1 to 4 carbon atoms which has a carbonyl function at the position of attachment. Non-limiting examples include forrnyl, acetyl, n-propionyl, 10 n-butyryl, isobutyryl, pivaloyl, n-hexanoyl. The same applies to radicals such as acylamino. Alkylarnino represents an alkylarnino radical having one or two (independently selected) alkyl substituents, illustratively and preferably representing methylarnino, 15 ethylamino, n-propylarnino, isopropylarnino, tert-butylarnino, n-pentylarnino, n-hexyl amino, N,N- dimethylarnino, N,N-diethylamino, N-ethyl-N-methylarnino, N-methyl-N n- propylarnino, Nisopropyl-N-n-propylarnino, N-t-buty l-N-methylarn ino, N- ethyl-N n-pentylarnino and N-n-hexyl-N-methylamino.
20 ylannocarbonyl represents an alkylaminocarbonyl radical having one or two (independently selected) alkyl substituents, illustratively and preferably representing methylaminocarbonyl, ethylaminocarbonyl, npropylarninocarbonyl, isopropylamino carbonyl, tert-butylaminocarbonyl, npentylaminocarbonyl, n-hexylaminocarbonyl, N,N-dimethylaminocarbonyl, N,Ndiethylarninocarbonyl, N-ethyl-N-methylamino 25 carbonyl, N-methyl-N-npropylaminocarbonyl, N-isopropyl-N-n-propylarninocarbonyl, N-t-butyl-Nmethylarninocarbonyl, N-ethyl-N-n-pentylarnino-carbonyl and N-n-hexyl Nmethylaminocarbonyl. When stated, that X, X2, X3 and X4 as well as y, y2, y3, y4 and Y5 represent CH or 30 N. CH shall also stand for a ring carbon atom, which is substituted with a substituent Ri, R2, R3 or R8, R9 and Ri , respectively.
( - 10
A * symbol next to a bond denotes the point of attachment in the molecule.
The letters A and B are used to designate the different rings and, for the purpose of 5 clarity, are not shown in all structures.
In another embodiment, the present invention relates to processes for synthesizing the compounds of general formula (I), characterized in that either 10 [A] compounds of the general formula (II) R8 R9 y\Y4;y3 to Q HN Y
R4Rs (11), wherein R4, R5, R8, R9, Rid and YE to Y5 have the meaning described above, 15 are condensed in the presence of a base, in a threecomponent-reaction, with compounds of the general formulas (III) and (IV) R' ORE
I:R X jx3 (111) NC R" (IV), H O wherein Rt, R2, R3 and X' to X4 have the meaning described above, and
f - It -
R" represents cyano or C'-C6-alkoxycarbonyl, to give compounds of the general fonnula (la) XIR3 R4R1 1
Rs N NH2 R' RB (Ia), S or [B] compounds of the general formulas (II) and (III) are condensed in the presence of an acid, in a three-componentreaction, with compounds of the general formula (V) H /< oR,2 (V), wherein Ri2 represents C-C6-alkyl, I S to give compounds of the general formula (Ib)
( - 12
4 3 R4';,DlOR12 R5 N H
R1R8 (Ib), or [C] compounds of the general formula (VI) -N:Y'- 3:
R120R,3 (VI),
wherein R8, R9, R' , Ri2 and Y' to Y5 have the meaning described above, to and Ri3 represents C-C4-alkyl, are condensed in the presence of an acid or a base, in a three-component l S reaction, with compounds of the general formulas (111) and (VII) O O (VII),
(- 13 wherein R4 and R5 have the meaning described above, to give compounds of the general formula (Ic) s XIR3 oX::X3 0 R4 40R'2
R5 N R13
R10: R8 (Ic).
The processes can be illustrated by the following schemes [A] to [C]:
( - 14
Scheme FA1 to fC1 ti R'0 OR' ' HN y + X jX + NCR" R R4Rs H'4O Rs NH2 0 Y' Ys a R\ B1 Xl'l^X4 R3 _ oR'2 R4 R H O H ';y' 8 tCl R1RZ HNR:R10 j R3 R4Rs R oR12 R120);R'3 H O R9
Suitable solvents for the processes [A] to [C] are generally customary organic solvents 5 which do not change under the reaction conditions. These include ethers such as diethyl ether, diisopropyl ether, 1,2dimethoxyethane, dioxan or tetrahydrofuran, ethylacetate, acetone, acetonitrile, dimethylsulfoxide, dimethylformarnide, or alcohols such as methanol, ethanol, n-propanol, isopropanol, n-butanol or t-butanol, or hydrocarbons such as pentane, hexane, cyc lohexane, benzene, to luene or xylene, or halo geno-hydro
! - 15
carbons such as dichloromethane, dichloroethane, trichloromethane or chlorobenzene.
For process [B] and [C] also acetic acid can be employed as solvent. It is also possible to use mixtures of the above-mentioned solvents. Preferred for process [A] is ethanol or a mixture of n-propanol and dimethylsulfoxide. For process [B] and [C] acetic acid or 5 diisopropyl ether are preferred.
Suitable bases for process [A] and [C] are generally inorganic or organic bases. These preferably include cyclic arnines, such as, for example, piperidine, morpholine, N methylmorpholine, pyridine or 4-N,Ndimethylaminopyridine, or (C-C4)-trialkyl 10 arnines, such as, for example, triethylarnine or diisopropylethylamine. Preference is given to piperidine. The base is employed in an amount from 0.1 mol to lOmol, preferably from I mol to 3 mol. relative to I mat of the compound of the general formula (II).
15 Suitable acids for process [B] and [C] are generally inorganic or organic acids. These preferably include carboxylic acids, such as, for example acetic acid or trifluoroacetic acid, or sulfonic acids, such as, for example, methanesulfonic acid or p-toluenesulfonic acid. Preference for process [B] and [C] is given to acetic acid or trifluoroacetic acid.
The acid is employed in an amount from 0.25 mol to 100 mol. relative to 1 mol of the 20 compounds of the general formulas (V) and (VII), respectively.
The processes [A] to LC] are in general carried out in a temperature range from +20 C to +150 C, preferably from +60 C to +130 C.
25 The processes [A] to [C] are generally carried out at normal pressure. However, it is also possible to carry them out at elevated pressure or at reduced pressure (for example in a range from 0.5 to 5 bar).
The compounds of general formula (II) can be synthesized by reacting compounds of 30 general formula (VII) with compounds of the general (VIII)
f - 16 --R' 1yl.Y (VIII), wherein R8, R9 R and Yt to Y5 have the meaning described above, 5 in the presence of an acid, such as acetic acid or p-toluenesulfonic acid, under water removing conditions.
The compounds of general formula (VI) can be synthesized analogously.
10 The compounds of the general formulas (III), (IV), (V), (VU) and (VIII) are known per se, or they can be prepared by customary methods.
Surprisingly, the compounds of the present invention show human neutrophil elastase (HNE) inhibitory activity and are therefore suitable for the preparation of 15 medicaments for the treatment of diseases associated with HNE activity. They may thus provide an effective treatment of acute and chronic inflammatory processes, such as rheumatoid arthritis, atherosclerosis, and especially of acute and chronic pulmonary diseases, such as lung fibrosis, cystic fibrosis, pneumonia, acute respiratory distress syndrome (ARDS), in particular pulmonary emphysema, including smoking-induced 20 emphysema, and chronic obstructive pulmonary diseases (COPD). They may also provide an effective treatment of brain trauma, cancer and other conditions in which neutrophil participation is involved.
The compounds of formula (I) according to the invention can therefore be used as 25 active compound components for the production of medicaments. For this, they can be converted into the customary formulations such as tablets, coated tablets, aerosols, pills, granules, syrups, emulsions, suspensions and solutions in a known manner using inert, non-toxic, pharmaceutically suitable excipients or solvents. Preferably,
( - 17
the compounds according to the invention are used here in an amount such that their concentration in the total mixture is approximately 0.5% to approximately 90% by weight, the concentration, inter alla, being dependent on the corresponding indication of the medicament.
The above mentioned formulations are produced, for example, by extending the active compounds with solvents and/or excipients having the above properties, where, if appropriate, additionally emulsifiers or dispersants and, in the case of water as the solvent, alternatively an organic solvent, have to be added.
Administration is camed out in a customary manner, preferably orally, transdennally or parenterally, for example perlingually, buccally, intravenously, nasally, rectally or by inhalation. 15 For human use, in the case of oral administration, it is recommendable to administer doses of from 0.001 to 50 mglkg, preferably of 0.01 mg/kg to 20 mg/kg. In the case of parenteral administration, such as, for example, intravenously or via mucous membranes nasally, buccally or inhalationally, it is recommendable to use doses of 0.00 I mg/kg to 0.5 mglkg.
In spite of this, if appropriate, it may be necessary to depart from the amounts mentioned above, namely depending on the body weight or the type of admini-
stration route, on the individual response towards the medicament, the maimer of its formulation and the time or interval at which administration takes place. Thus, in 25 some cases it may be sufficient to manage with less than the above mentioned minimum amount, while in other cases the upper limit mentioned must be exceeded.
In the case of the administration of relatively large amounts, it may be recom mendable to divide these into several individual doses over the course of the day.
- 18 A. Evaluation of physiological activity The potential of the compounds of the invention to inhibit neutrophil elastase activity may be demonstrated, for example, using the following assays: 5 I. In vitro assays of human neutronhil elastase (HNE) Assay contents assay buffer: 0. 1 M HEPES-NaOH buffer pH 7.4, 0.5 M NaCI, 0.1% (w/v) bovine 10 serum albumin; suitable concentration (see below) of HNE (18 U/mg Iyophil., #20927.01, SEEIVA Electrophoresis GmbH, Heidelberg, Germany) in assay buffer; suitable concentration (see below) of substrate in assay buffer; suitable concentration of test compounds diluted with assay buffer from a 10 mM 15 stock solution in DMSO.
Example A
In vitro inhibition of HNE using a fluorogenic peptide substrate (continuous 20 read-out signal, 384 MTP assay format): In this protocol, the elastase substrate MeOSuc-Ala-Ala-Pro-Val-AMC (#324740, CalbiochemNovabiochem Corporation, Merck KgaA, Darmstadt, Germany) is used.
The test solution is prepared by mixing 10 foul of test compound dilution, 20 pi of 25 HNE enzyme dilution (final concentration 8 - 0.4 pU/ml, routinely 2.1 IlU/ml) and 20 pi of substrate dilution (final concentration I rnM - I M, routinely 20 '1M), respectively. The solution is incubated for 0 - 2 hrs at 37 C (routinely one hour). The fluorescence of the liberated AMC due to the enzymatic reaction is measured at 37 C (TECAN spectra fluor plus plate reader). The rate of increase of the fluorescence (ex.
30 395 nrn, em. 460 nm) is proportional to elastase activity. IC50 values are determined
- 19 by RFU-versus-[1] plots. Km and K,r,(app) values are determined by Lineweaver-Burk plots and converted to Kj values by Dixon plots.
The preparation examples had IC50 values within the range of 20 nM '1M in this 5 assay. Representative data are given in table 1: Example No. IC50 [nM 3 200 4 40 8 330 10 230
12 180
13 30 14 20 15 120
17 9000
18 30 table 1
Example B
In vitro inhibition of HNE using a fluorogenic, unsoluble elastin substrate (discontinuous read-out signal, 96 MTP assay format) In this protocol the elastase substrate elastin-fluorescein (#100620, ICN Biomedicals 15 GmbH, Eschwege, Germany) is used. The test solution is prepared by mixing 3 Ill of test compound dilution, 77 Al of HNE enzyme dilution (final concentration 0.22 U/ml - 2.2 mU/ml, routinely 21.7 pU/ml) and 80 Ill substrate suspension (final concentration 2 mg/ml). The suspension is incubated for 0 - 16 hrs at 37 C (routinely four hours) under slightly shaking conditions. To stop the enzymatic reaction, 160 Ill 20 of 0.1 M acetic acid are added to the test solution (final concentration 50 mM). The
- 20 polymeric elastin-fluorescein is pulled down by centrifugation (Eppendorf 5804 centrifuge, 3.000 rpm, 10 min). The supernatant is transferred into a new MTP and the fluorescence of the liberated peptide fluorescein due to the enzymatic reaction is measured (BMG Fluostar plate reader). The rate of fluorescence (ex. 490 nm, em.
5 520 nm) is proportional to elastase activity. ICso values are determined by RFU versus-[1] plots.
11. In vitro PMN elastolysis assay 10 This assay is used to determine the elastolytic potential of human polymorphonuclear cells (PMNs) and assess the proportion of degradation due to neutrophil elastase [cf.
Z.W. She et al., Am. J. Respir. Cell. Mol. Biol. 9, 386-392 (1993)].
Tritiated elastin, in suspension, is coated on to a 96 well plate at 10 leg per well. Test 15 and reference [ZD-0892 (J. Med. Chem. 40, 1876-1885, 3173-3181 (1997), WO 95/21855) and al protease inhibitor (alPI)] compounds are added to the wells at the appropriate concentrations. Human PMNs are separated from peripheral venous blood of healthy donors and resuspended in culture media. The neutrophils are added to the coated wells at concentrations ranging between I x 106 to I x 105 cells per 20 well. Porcine pancreatic elastase (1.3 M) is used as a positive control for the assay, and oIPI (1.2 M) is used as the positive inhibitor of neutrophil elastase. The cellular control is PMNs without compound at each appropriate cell density. The cells plus compounds are incubated in a humidified incubator at 37 C for 4 hours.
The plates are centrifuged to allow the harvest of cell supernatant only. The 25 supernatant is transferred in 75 pI volumes to corresponding wells of a 96 well Lumaplate_ (solid scintillant containing plates). The plates are dried until no liquid is visible in the wells and read in a beta counter for 3 minutes per well.
Elastolysis of the 3H-elastin results in an increase in counts in the supernatant. An 30 inhibition of this elastolysis shows a decrease, from the cellular control, of tritium in the supernatant. alPI gave 83.46 3. 97% (mean s.e.m.) inhibition at 1.2 '1M (n =
f - 21 3 different donors at 3.6 x 105 cells per well). ICso values were obtained for the reference compound ZD-0892 of 45.50 7.75 nM (mean i s.e. m.) (n = 2 different donors at 3.6 x 105 cells per well).
5 Given that ZD-0892 is a selective inhibitor of PMN elastase along with the data from Al PI inhibition, these results indicate that the majority of elastin degradation by PMNs is due to the release of neutrophil elastase, and not to another elastolytic enzyme such as matrix metalloproteases (MMPs). The compounds of this invention were evaluated for their inhibitory activity in this HNE-dependent model of neutro 10 phil elastolysis.
111. In viva model of acute lung in jury in the rat Instillation of human neutrophil elastase (HNE) into rat lung causes acute lung 15 damage. The extent of this injury can be assessed by measuring lung haemorrhage.
Rats are anaesthetised with HypnormlHypnovel/water and instilled with HNE or saline delivered by microsprayer into the lungs. Test compounds are administered by intravenous injection, by oral gavage or by inhalation at set times prior to the 20 administration of HNE. Sixty minutes after the administration of elastase animals are killed by an anaesthetic overdose (sodium pentobarbitone) and the lungs ravaged with 2 ml heparinised phosphate buffered saline (PBS). Bronchoalveolar ravage (BAL) volume is recorded and the samples kept on ice. Each BAL sample is centrifuged at 900 r.p.m. for 10 minutes at 4-10 C. The supernatant is discarded and 25 the cell pellet resuspended in PBS and the sample spun down again. The supematant is again discarded and the cell pellet resuspended in I ml 0. 1% cetyltrimethyl ammonium bromide (CTAB) / PBS to Iyse the cells. Samples are frozen until blood content is assayed. Prior to the haemorrhage assay the samples are defrosted and mixed. 100 pi of each sample are placed into a separate well of a 96 well flat 30 bottomed plate. All samples are tested in duplicate. 100 ill 0.1% CTAB/PBS is included as a blank. The absorbance of the well contents is measured at 415 nm using
( - 22 a spectrophotometer. A standard curve is constructed by measuring the OD at 415 rim of different concentrations of blood in 0.1% CTAB/PBS. Blood content values are calculated by comparison to the standard curve (included in each plate) and normalised for the volume of BAL fluid retrieved.
The compounds of this invention were evaluated intravenously, orally or by in-
halation for their inhibitory activity in this model of HNE-induced haemorrhage in the rat.
- 23 B. Examples
Abbreviations: c = concentration 5 DMSO = dimethylsulfoxide HPLC = high performance liquid chromatography LC-MS = liquid chromatography-coupled mass spectroscopy NMR = nuclear magnetic resonance spectroscopy tic = thin layer chromatography LC-MS Method: solvent A: acetonitrile solvent B: 0.3 g 30% HC1/L water 15 column oven: 50 C column: Symmetry C18 2.1 x 150 mm gradient: time [mind MA %B flow [ml/mind 0 10 90 0.9
3 90 10 1.2
20 6 90 1 0 1.2
Startine Materials: 25 Examole 1A 4-[(3 -Nitrophenyl)amino] -3 -penten-2 one H3C rNórNO2 O CH3
- 24 36.24 g (362 mmol) Acetylacetone, 10.00 g (72 mmol) 3-nitroaniline,and 1.25 g (7.2 mmol) 4-toluenesulfonic acid are dissolved in 100 ml toluene. The reaction mixture is reflexed overnight with a Dean-Stark trap to remove water. After cooling down to room temperature, the solvent is removed in vacuo and the residue is 5 purified by column chromatography on silica with eluent dichloromethane.
Yield: 12.0 g (75%) tH-NMR (400 MHz, DMSO): - 2.0 (s, 3H); 2.1 (s, 3H); 5. 4 (s, 1H); 7.7 (m, 2H); 8.0 (m, 2H); 12.5 (s, IH) ppm.
10 Example 2A
4- { [3-(Trifluoromethyl)phenyl]arnino} -3-pen/en-2-one H H3C no O CH3 15 15.53 g (155 mmol) Acetylacetone, 5.00 g (31 mmol) 3trifluoromethylaniline, and 0.53 g (3.1 mmol) 4-toluenesulfonic acid are dissolved in 50 ml toluene. The reaction mixture is reflexed overnight with a Dean-Stark trap to remove water. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with cyclohexane/ethylacetate mixtures 20 as eluent.
Yield: 5.46 g (72%) H-NMR (200 MHz, DMSO): = 2.0 (s, 3H); 2.1 (s, 3H); 5. 3 (s, IH); 7.5 (m, 4H); 12.5 (s, 1H) ppm.
( - 25
Example 3A
Ethyl (2E)-3- { [3-(trifluoromethyl)phenyl]amino} -2-butenoate CF3 H CO::N; 3
4.0 g (31 mmol) Ethyl 3-orobutanoate, 5.0 g (31 mmol) 3trifluoromethylaniline, and 1.86 g (31 mmol) acetic acid are dissolved in 50 ml toluene. The reaction mixture is reflexed overnight with a DeanStark trap to remove water. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by 10 column chromatography on silica with cyclohexane/ethylacetate mixtures as eluent.
Yield: 2.28 g (27%) H-NMR (300 MHz, DMSO): = 1.2 (t, 3H); 2.0 (s, 3H); 4. 1 (q, 2H); 4.8 (s, IH); 7.5 (m, 4H); 10.4 (s, 1H) ppm.
15 Example 4A
4- {[3-(Methyl)phenyl]amino} -3-pen/en-2-one H3C:rN CH3 O CH3 20 23.36 g (233 mmol) Acetylacetone, 5.00 g (47 mmol) 3-methylaniline, and 0.8 g (4. 7 mmol) 4-toluenesulfonic acid are dissolved in 50 ml toluene. The reaction mixture is refluxed overnight with a Dean-Stark trap to remove water. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with cyclohexane/ethylacetate mixtures 25 as eluent.
- 26 Yield: 7.7 g (87%) IH-NMR(300 MHz, DMSO): = 2.0 (2 s, 6H); 2.3 (s, 3H); 5.2 (s, IH); 7.0 (m, 3H); 7.2 (m, IH) ppm.
S ExamoIe SA 4- { [3 -Iodo-5 -(tn fluoromethyl)pheny l] amino} -3-penten2 -one H3C j' - N CF3 O CH3 10 1.38 g (13.8 mmol) Acetylacetone, 3.95 g (13.8 mmol) 3-iodo-5-tnfluoromethyl aniline, and 0.1 g (1.6 mmol) 4toluenesulfonic acid are dissolved in 150 ml toluene.
The reaction mixture is refluxed for 7 h with a Dean-Stark trap to remove water.
After cooling down to room temperature, the suspension is filtered. The solid is purified by recrystallisation from ethanol.
15 Yield: 1.8 g (34%) IH-NMR (300 MHz, DMSO): = 2.0 (s, 3H); 2.1 (s, 3H); 5.3 (s, IH); 7.6 (s, IH); 7.8 (s, IH); 7.9 (s, IH); 12.4 (s, IH) ppm.
Example 6A
20 4-( {3-[(Diethylamino)methyl]phenyl amino)-3-penten-2-one C:H3 J H3
O CHs 1.00 g (9.99 mmol) Acetylacetone, 1.78 g (9.99 mmol) 3[(diethylamino)methyl] 25 aniline, and 0.15 g (2.5 mrnol) 4toluenesulfonic acid are dissolved in 100 ml
( - 27 toluene. The reaction mixture is reflexed overnight with a DeanStark trap to remove water. 0.05 g (0.83 mrnol) 4-toluenesulfonic acid are again added and the mixture is reflexed overnight. As tic control showed that there is some 3-[(diethylamino) methyl]aniline left, 0.2 g (2 mmol) acetylacetone are added and refluxing is 5 continued for 4 h. To drive the reaction to completion, 0.6 ml (9.98 mmol) acetic acid and 0.2 g (2 mmol) acetylacetone are added and the mixture is reflexed overnight with a Dean-Stark trap. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with dichloromethane/methanol mixtures as eluent.
10 Yield: 1.97 g (76%) iH-NMR (200 MHz, CDCI3): = 1.0 (t, 6H); 2.0 (s, 3H) , 2.1 (s, 3H); 2.5 (q, 4H); 3.5 (s, 2H); 5.2 (s, IH); 7.0 (m, IH); 7.1-7. 3 (m, 3H); 12.5 (s, IH) ppm.
Example 7A
15 4- { [3-Methoxy-5-(trifluoromethyl)phenyl]amino} -3-pen/en-2-one H3C FAWN:CF3
O CH3 CH3 1.57 g (15.7 mmol) Acetylacetone, 3.00 g (15.7 mmol) 3-methoxy5-(trilluoro 20 methyl)aniline, and 0.1 g (1.6 mmol) 4-toluenesulfonic acid are dissolved in 150 ml toluene. The reaction mixture is reflexed for 7 h with a Dean-Stark trap to remove water. After cooling down to room temperature, the suspension is filtered. The solid is purified by recrystallization from ethanol.
Yield: 2.8 g (60%) 25 tH-NMR (300 MHz, DMSO): = 2.0 (s, 3H); 2.1 (s, 3H); 3.8 (s, 3H); 5.3 (s, 1H); 7.1 (m, 3H); 12.4 (s, IH) ppm.
( - 28 ExampIe 8A 4-[(3-Arnino-5-trifluoromethylphenyl)amino]-3-penten-2one O CH3 CF3
NH2 1.71 g (17.0 mmol) Acetylacetone, 3.00 g (17.0 rnmol) 3-amino-5(trifluoromethyl)-
phenylamine, and 0.1 g (1.6 mmol) 4-toluenesulfonic acid are dissolved in 150 ml toluene. The reaction mixture is reflexed overnight with a DeanStark trap to remove water. After cooling down to room temperature, the solvent is removed in VACUO and 10 the residue is purified by column chromatography on silica with cyclohexane/ ethylacetate mixtures as eluent. The solid obtained by column chromatography is recrystallized from cyclohexane.
Yield: 0.35 g (8%) IH-NMR (200 MHz, DMSO): = 2.0 (s, 3H); 2.1 (s, 3H); 5. 2 (s, IH); 5.7 (s, 2 h); 15 6.5 (m, 2H); 6.6 (s, IH); 12.4 (s, IH) ppm.
- 29 Preparation Examples: Example l
()-Ethyl 5 - acetyl-2 -amino-4-(4-bromophenyl)-6-methyl- 1-( 3 nitrophenyl)- I,4-di 5 hydro-3-pyridinecarboxylate Br H3CO CH3
H3C N NH2
NO2 4.8 g (21.8 mmol) of Example 1A are dissolved in 30 ml ethanol, 4.0 g (21.8 mmol) 10 4-bromobenzaldehyde, 2.47 g (21.8 rnmol) ethyl cyanoacetate, and 3.71 g (43.6 mmol) piperidine are added. The reaction mixture is stirred under reflux overnight. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with eluent dichloromethane. 15 Yield: 1.8 g ( 17%) IH-NMR (300 MHz, DMSO): 0 = 1.2 (t, 3H); 1.9 (s, 3H); 2.2 (s, 3H); 4.0 (m, 2H); 4.9 (s, 1H); 6.8 (br.s, 2H); 7.3 (m, 2H); 7.5 (m, 2H); 7.8 (m, 2H); 8.2 (m, IH); S.4 (m, 1 H) ppm.
- 30 ExamDIe 2 (-)-Ethyl 5-acetyl-2-amino-4-(4-bromophenyl)-6-methyl- 1 (3-nitrophenyl)- 1,4-di hydro-3-pyridinecarboxylate 5 The enantiomers of Example I are separated by chiral HPLC [silane modified poly(Nmethacryloyl-L-leucin-l-menthylamide) fixed on silica; 250 x 20 mm column] with iso-hexane/ethylacetate 4:1 as eluent (20 ml/min).
[a]20 = -97.6 (\ = 589 nm, methanol, c = 456.5 mg / 100 ml) tH-NMR identical with Example 1.
Example 3
()-Ethyl 5-acetyl-2-amino-4-(4-bromophenyl)-6-methyl- 1 -[3(trifluoromethyl) phenyl]- I,4-dihydro-3-pyridinecarboxylate Br H3C:O CH3
H3C N NH2
CF3 150 mg (0.62 mmol) of Example 2A are dissolved in 2 ml ethanol, 114 mg (0.62 mmol) 4-bromobenzaldehyde, 70 mg (0.62 mmol) ethyl cyanoacetate, and 105 mg (1.23 mmol) piperidine are added. The reaction mixture is stirred under 20 reflux overnight. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with eluent dichloromethane. Yield: 43 mg (13%)
- 31 1H-NMR (300 MHz, DMSO): = 1.2 (t, 3H); 1.8 (s, 3H); 2.2 (s, 3H); 4.0 (m1 2H); 4.9 (s, IH); 6.7 (br.s, 2H); 7.3 (m, 2H); 7.5 (m, 2H); 7.7 (m, IH); 7.8 (m, IH); 7.8 (m, IH); 7.9 (m, IH) ppm.
5 ExampIe 4 ()-Ethyl 5-acetyl-2-amino-4-(4-cyanophenyl)-6-methyl- 1 -[3(tri fluoromethyl)-phen yl]- I,4-dihydro-3 -pyridinecarboxylate H3CO CH3
H3C N NH2
CF3 100 mg (0.41 mmol) of Example 2A are dissolved in 2 ml ethanol, 54 mg (0.41 mmol) 4-cyanobenzaldehyde, 47 mg (0.41 mmol) ethyl cyanoacetate, and 70 mg (0.82 mmol) piperidine are added. The reaction mixture is stirred under reflux overnight. After cooling down to room temperature, the solvent is removed in vacuo 15 and the residue is purified by column chromatography on silica with eluent dichloromethane. Yield: 26 mg (14%) tH-NMR (400 MHz, DMSO): = 1.2 (t, 3H); 1.8 (s, 3H); 2.2 (s, 3H); 4.0 (m, 2H); 5.0 (s, IH); 6.7 (br.s, 2H); 7.5 (m, 2H); 7.7 (m, IH); 7.8 (m, 4H); 7.9 (m, IH) ppm.
- 32 Examule 5 and Example 6 (+) and (-)-Ethyl 5-acetyl-2-amino-4-(4cyanophenyl)-6-methyl-1-[3-(trifluoro-meth-
yl)phenyl] - I,4-dihydro-3-pyridinecarboxylate 5 The enantiomers of Example 4 are separated by chiral HPLC [silane modified poly(Nmethacryloyl-L-leucin-l-menthylamide) fixed on silica; 250 x 20 mm column] with iso-hexane/ethylacetate 4:1 as eluent (20 ml/min).
(+)-Enantiomer (Example 5): []20 = +88.4 (\ = 589 nm, methanol, c = 453. 5 mg / 100 ml) IO (-)-Enantiomer (Example 6): [a]20 = -91.2 (\ = 589 nm, methanol, c = 471.5 mg / 100 ml) H-NMRs for Example 5 and 6 identical with Example 4.
Example 7
15 (i)-Ethyl 5-acetyl-4-(4-bromophenyl)-6-methyl-1-[3-(trifluoromethyl) phenyl]-1,4 dihydro-3 -pyridinecarboxylate Or H3CO CH3
H3C N 20 150 mg (0.62 mmol) of Example 2A are dissolved in 2 ml acetic acid, 114 mg (0.62 mmol) 4-bromobenzaldehyde, and 60 mg (0.62 mmol) ethyl propiolate are added. The reaction mixture is stirred under reflux overnight. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with eluent dichloromethane.
- 33 Yield: 56 m8 (18%) lH-NMR (300 MHz, DMSO): = 1.1 (t, 3H); 1.9 (s, 3H) ; 2.2 (s, 3H); 4.1 (m, 2H); 5.0 (s, 1H); 7.3 (m, 3H); 7.5 (m, 2H); 7.7 (m, 2H); 7.8 (m, IH); 7.9 (s, 1H) ppm.
5 ExamnIe 8 ()-Ethyl 5-acetyl-4-(4-cyanophenyl)-6-methyl- 1 -[3(trifluoromethyl)phenyl]- 1,4 dihydro-3-pyridinecarboxylate H3COCH3
H3C N 100 mg (0.41 mmol) of Example 2A are dissolved in 2 ml acetic acid, 54 mg (0.41 mmol) 4-cyanobenzaldebyde, and 40 mg (0.41 mmol) ethyl propiolate are added. The reaction mixture is stirred under reflux ovemight. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by 15 column chromatography on silica with eluent dichloromethane.
Yield: 20 mg (11%) tH-NMR (300 MHz, DMSO): 0 = 1.1 (t, 3H); 2.0 (s, 3H); 2.2 (s, 3H); 4.1 (m, 2H); 5.1 (s, IH); 7.3 (s, IH); 7.6 (m, 2H); 7.8 (m, 4H); 7.8 (m, 1H); 8.0 (s, IH) ppm.
- 34 Examrle 9 ()-Ethyl 5-acetyl-4-(4-cyanophenyl)-2,6-dimethyl- 1-(3 methylphenyl)- I,4-dihydro 3-pyridinecarboxylate CN 06 0 H3C 4OCH3
H3C N CH3
5 CH3 100 mg (0.46 mrnol) Ethyl (2E)-3-{[3-(methyl)phenyl]amino}-2butenoate, 75 mg (0.57 mmol) 4-cyanobenzaldehyde, 38 mg (0.38 mmol) 2,4pentanedione, and 87 mg (0.76 mmol) trifluoroacetic acid are dissolved in 2 ml diisopropyl ether. The reaction 10 mixture is stirred under reflux overnight. After cooling down to room temperature, the solvent is removed n vacuo and the residue is purified by preparative HPLC.
Yield: 11 mg (7%) H-NMR (300 MHz, DMSO): = 1.2 (t, 3H); 2.0 (s, 3H); 2.0 (s, 3H); 2.2 (s, 3H); 2.4 (s, 3H); 4.1 (q, 2H); 5.1 (s, IH); 7.0 (m, 2H); 7.3 (m, IH); 7.4 (m, IH); 7.5 (m, 2H); l5 7.8 (m, 2H)ppm.
- 35 Example 10
()-Ethyl 5-acetyl-4-(4-cyanophenyl)-2,6-dimethyl- 1 -[3-(tri fluoromethyl) phenyl] I,4-dihydro-3 -pyridinecarboxylate CN 06 0 H3C 4O CH3
H3C N CH3
CF 100 mg (0.37 mmol) of Example 3A, 60 mg (0.46 mmol) 4cyanobenzaldehyde, 31 mg (0.31 mmol) 2,4-pentanedione, and 70 mg (0.61 mmol) trifluoroacetic acid are dissolved in 2 ml diisopropyl ether. The reaction mixture is stirred under reflux over 10 night. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by preparative HPLC.
Yield: 7 mg (5%) H-NMR (300 MHz, DMSO): -1.2 (t, 3H); 1.9 (s, 3H); 2.0 (s, 3H); 2.3 (s, 3H); 4.1 (q, 2H); 5.1 (s, IH); 7.5 (m, 2H); 7.6 (m, IH); 7. 7 (m, IH); 7.8 (m, 3H); 7.9 (m, IH) t 5 ppm.
- 36 Example 1 1
Ethyl 5-acetyl-2-amino-4-(4-(trifluoromethyl)phenyl)-6-methyl-1-[3(trifluorometh-
yl)phenyl]- 1,4-dihydro-3-pyridinecarboxylate F3 H3COCH3
H3C N NH2
5 CF3 100 mg (0.41 mmol) of Example 2A are dissolved in 2 ml ethanol, 72 mg (0.41 mmol) 4-(trifluoromethyl)benzaldehyde, 47 mg (0.41 mmol) ethyl cyano acetate, and 70 mg (0.82 mmol) piperidine are added. The reaction mixture is stirred 10 under reflux ovemight. Aflcer cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with eluent dichloromethane.
Yield: 46 mg (22%) IH-NMR (300 MHz, DMSO): = 1.2 (t, 3H); 1.9 (s, 3H); 2. 2 (s, 3H); 4.0 (m, 2H); 15 5.0 (s, IH); 6.8 (br. s, 2H); 7.5 (m, 2H); 7.7 (m, 3H); 7.7 (m, 1H); 7.8 (m, IH); 7.9 (m, 1 H) ppm.
- 37 Example 12
Ethyl 5-acetyl-2-amino-4-(4-cyanophenyl)-6-methyl- 1 -[3-methylphenyl]- 1, 4-di hydro-3 -pyridinecarboxylate CN H3COCH3
H3C N NH2
CH3 100 mg (0.53 mmol) of Example 4A are dissolved in 2 ml ethanol, 69 mg (0.53 mmol) 4-cyanobenzaldehyde, 60 mg (0.53 mrnol) ethyl cyanoacetate, and 90 mg (1.06 mmol) pipendine are added. The reaction mixture is stirred under reflux 10 overnight. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with eluent dichloro methane. Yield: 21 mg (10%) tH-NMR (200 MHz, DMSO): = 1.2 (t, 3H); 1.9 (s, 3H); 2.2 (s, 3H); 4.0 (m, 2H); 15 5.0 (s, IH); 6.7 (br. s, 2H); 7.2 (m, 2H); 7.3 (m, IH); 7.5 (m, 3H); 7.8 (m, 2H) ppm.
- 38 Example 13
5-Acetyl-2-amino-4-(4-cyanophenyl)-6-methyl- 1 -[3-(trifluoromethyl) phenyl]- 1,4-
dihydro-3-pyridinecarboxamide CN H3C:NH2
H3C N NH2
CF3 s 750 mg (3.08 mmol) of Example 2A are dissolved in 5 ml ethanol, 404 mg (3.08 mmol) 4-cyanobenzaldehyde, 260 mg (3.08 mmol) cyanoacetamide, and 26 mg (0.31 mmol) piperidine are added. The reaction mixture is stirred under reflux 10 overnight. ADer cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by column chromatography on silica with eluent dichloromethane. Yield: 160 mg (12%) lH-NMR (300 MHz, DMSO): 0 = 1.8 (s, 3H); 2.2 (s, 3H); 4.9 (s, IH); 6.7 (br. s, 2H); 15 6.9 (br. s, 2H); 7.5 (m, 3H); 7.8 (m, 2H); 7.9 (m, IH), 8. 0 (m, 2H) ppm.
- 39 Examnle 14 5-Acetyl-4-(4-cyanophenyl)-2-imino-N,N,6-trimethyl- 1 -[3(trifluoromethyl)phenyl] 1,2,3,4-tetrahydro-3 -pyndinecarboxamide ON H3C 3 1 CF3 s 750 mg (3.08 mmol) of Example 2A are dissolved in 5 ml ethanol, 404 mg (3.08 mmol) 4-cyanobenzaldehyde, 260 mg (3.08 mrnol) 2-cyano-N,N dimethylacetamide, and 26 mg (0.31 mmol) piperidine are added. The reaction 10 mixture is stirred under reflux overnight. After cooling down to room temperature, the solvent is removed in vacua and the residue is purified by column chromatography on silica with eluent dichloromethane.
Yield: 88 mg (6%) H-NMR (300 MHz, DMSO): =2.0 (s, 3H); 2.1 (s, 3H), 2.5 (s, 3H); 2.9 (s, 3H); 4.1 15 (d, IH); 4.5 (d, IH); 7.6 (m, 3H); 7.7 (m, IH); 7.8 (m, 3H); 8.2 (s, IH) ppm.
- 40 Example lS
5-Acetyl-2-amino-4-(4-cyanophenyl)-6-methyl- 1 -[3-(trifluoromethyl) phenyl]- 1,4 dihydro-3 -pyridinecarbonitrile ON H3CJCN
H3C N NH2
CF3 750 mg (3.08 rnmol) of Example 2A are dissolved in 5 ml ethanol, 404 mg (3.08 mmol) 4-cyanobenzaldehyde, 204 mg (3.08 mmol) malononitrile, and 26 mg (0.31 mrnol) piperidine are added. The reaction mixture is stirred under reflex 10 overnight. After cooling down to room temperature, the solvent is removed in vacua and the residue is purified by column chromatography on silica with eluent cylclo hexane/ethyl acetate.
Yield: 43 mg (3%) LC-MS: retention time 3.17 min., rn/z = 423 [M+H]+.
( - 41
Example 16
Ethyl 5 -acetyl-2-amino-4-(4-cyanophenyl)- 1- [ 3 -iodo- 5 -(tri fluoromethyl)phenyl] -6-
methyl- I,4-dihydro-3-pyridinecarboxylate H3C 0 CH3
H3C N NH2
s 200 mg (0.54 mmol) of Example 5A are dissolved in 2.5 ml ethanol, 71.1 mg (0.54 mmol) 4-cyanobenzaldehyde, 61.3 mg (0.54 mmol) ethyl cyanoacetate, and 4.6 mg (0.05 mmol) piperidine are added. The reaction mixture is stirred under reflux 10 for 30 h. After cooling down to room temperature, the solvent is removed in vacua and the residue is purified by column chromatography on silica with eluent cylclo hexane/ethyl acetate. The solid obtained by column chromatography is dissolved in ethanol. Water is added until a solid precipitates. The suspension is filtered and the solvent of the filtrate is removed in vacuo.
15 Yield: 18 mg (5%) lH-NMR (300 MHz, DMSO): =1.1 (t, 3H); 1.8 (s, 3H); 2. 2 (s, 3H); 4.0 (q, 2H); 4.9 (s, IH); 6.9 (s, 2H); 7.5 (d, 2H); 7.7 (d, 2H) ; 7.8 (s, IH); 8.1 (s, IH); 8.2 (s, IH) ppm.
( - 42 Example 17
Ethyl 5-acetyl-2-amino-4-(4-cyanophenyl)- 1- { 3-[(diethylamino)methyl] phenyl} -6-
methyl- I,4-dihydro-3-pyridinecarboxylate CN H3C OCH3
H3C N NH2
CH3 5 N'CH3
500 mg (1.92 mmol) of Example 6A are dissolved in 3.0 ml ethanol, 265 mg (1.92 mmol) 4-cyanobenzaldehyde, 217 mg (1.92 mmol) ethyl cyanoacetate, and 49 mg (0.58 mmol) piperidine are added. The reaction mixture is stirred under reflux 10 for 48 h. 115 mg (1.34 mmol) piperidine are added and the mixture is stirred under reflux for another 6 h. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by preparative HPLC with eluent acetonitrile/water. Yield: 57 mg (5%) 15 tH-NMR (200 MHz, DMSO): =1.0 (t, 6H); 1.2 (t, 3H); 1.9 (s, 3H); 2.2 (s, 3H); 2.5 (m, 4H); 3.6 (s, 2H); 4.0 (q, 2H); 5.0 (s, IH); 6.7 (br. s, 2H); 7.2 (m, 2H); 7.5 (m, 4H); 7.8 (d, 2H) ppm.
( - 43
Example 18
Ethyl 5-acetyl-2-amino-4-(4-cyanophenyl)-1-3-methoxy-5-(trifluoromethyl) phenyl] 6-methyl- 1,4-dihydro-3-pyridinecarboxylate CN H3CJ5OCH3
H3C N NH2
H3Co,:CF3 200 mg (0.73 mmol) of Example 7A are dissolved in 2.5 ml ethanol, 95.9 mg (0.73 mmol) 4-cyanobenzaldehyde, 82.8 mg (0.73 mrnol) ethyl cyanoacetate, and 6.2 mg (0.07 rrunol) piperidine are added. The reaction mixture is stirred under reflux 10 ovemight. After cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by preparative HPLC with eluent acetonitrile/water.
Yield: S9 mg (15%) H-NMR (300 MHz, DMSO): =1.2 (t, 3H); 1.9 (s, 3H); 2.2 (s, 3H); 3.9 (s, 3H); 4.0 (q, 2H); 5.0 (s, IH); 6.8 (br. s, 2H); 7.3 (m, 2H); 7.4 (s, IH); 7.5 (d, 2H); 7.8 (d, 2H) IS ppm.
- 44 Example 19
Ethyl 5-acetyl-2-amino- 1 -3-amino-5-(trifluoromethyl)phenyl]-4-(4cyanophenyl)-6 methyl- I,4-dihydro-3-pyridinecarboxylate CN 04 0 H3C J4o CH3 H3C N NH2
5H2N:9CF3
200 mg (0.77 mmol) of Example 8A are dissolved in 2.5 ml ethanol, 107 mg (0.77 mmol) 4-cyanobenzaldehyde, 87.6 mg (0.77 mmol) ethyl cyanoacetate, and 20 mg (0.23 mmol) piperidine are added. The reaction mixture is stirred under reflux 10 ovemight. ADer cooling down to room temperature, the solvent is removed in vacuo and the residue is purified by preparative HPLC with eluent acetonitrile/water.
Yield: 50.5 mg (12%) H-NMR (300 MHz, DMSO): 0 =1.2 (t, 3H); 2.0 (s, 3H); 2.3 (s, 3H); 4.1 (q, 2H); 5.0 (s, 1H); 6.0 (s, 2H); 6.7 (s, 2H); 6.8 (s, 2H); 7.1 (s, IH); 7.4 (d, 2H); 7.7 (d, 2H) ppm.
( - 45 ExamnIe 20 Ethyl 5'-acetyl-2'-amino-6'-methyl- 1'-[3 -(tri fluoromethyl)phenyl]- I ',4'-dihydro-3,4' bipyridine-3'-carboxylate H3COCH3
H3C N NH2
5 CF3 100 mg (0.41 rnmol) of Example 2A are dissolved in 5 ml ethanol, 44 mg (0.41 mmol) nicotinaldehyde, 47 mg (0.41 mmol) ethyl cyanoacetate, and 70 mg (0.82 mmol) piperidine are added. The reaction mixture is stirred under reflux 10 overnight. After cooling down to room temperature, the solvent is removed in vacua and the residue is purified by column chromatography on silica with eluent dichloromethane. Yield: 19 mg (10%) H-NMR (300 MHz, DMSO): =2.0 (s, 3H); 1.8 (s, 3H); 2.2 (s, 3H); 4.0 (m, 2H) ; 15 4.9 (s, IH); 6.7 (m, 2H); 7.3 (m, IH); 7.7 (m, 2H); 7.8 (m, 2H); 7.9 (m, IH); 8.4 (m, IH); 8.5 (m, IH) ppm.
- 46 C. Operative examples relating to pharmaceutical compositions The compounds according to the invention can be converted into pharmaceutical preparations as follows: Tablet:
Composition: 100 mg of the compound of Example 1, 50 mg of lactose (monohydrate), 50 mg of maize starch (native), 10 mg of polyvinylpyrrolidone (PVP 25) (from BASE, 10 Ludwigshafen, Gennany) and 2 mg of magnesium stearate.
Tablet weight 212 ma, diameter 8 mm, curvature radius 12 mm.
Preparation: The mixture of active component, lactose and starch is granulated with a 5% solution 15 (rum) of the PVP in water. After drying, the granules are mixed with magnesium stearate for 5 min. This mixture is moulded using a customary tablet press (tablet format, see above). The moulding force applied is typically 15 kN.
Orallv administrable suspension: 20 Composition: 1000 mg of the compound of Example 1, 1000 mg of ethanol (96%), 400 mg of Rhodigel (xanthan gum from FMC, Pennsylvania, USA) and 99 g of water.
A single dose of 100 mg of the compound according to the invention is provided by 10 ml of oral suspension.
Preparation: The Rhodigel is suspended in ethanol and the active component is added to the suspension. The water is added with stirring. Stirring is continued for about 6h until the swelling of the Rhodigel is complete.

Claims (17)

( - 47 We claim I. Compounds of the general formula (I) R'R3 OXwX R4óJ\R6 R5 N R R10 YR8 (I), D 5. wherein Ri, R2, R3, R8, R9 and R independently from each other represent hydrogen, halogen, nitro, cyano, trifluoromethyl, C! CG alkyd, C! C6 alkanOYI, 10 hydroxy, C-C6-alkoxy, trifluoromethoxy, amino, mono- or di-C-C6 alkylamino, C-C6-acylamino, C-C6-alkoxycarbonylarnino, carboxyl, C'-C6-alkoxycarbonyl or phenyl, wherein C'-C6-alkyl, C-C6- alkano yl, C-C6-alkoxy, mono- or di-C-C6-alkylamino and C-C6-acylamino can be further substituted with one to three identical or different 15 radicals selected from the group consisting of hydroxy, C-C4-alkoxy, amino, mono- and di-C-C4-alkylamino, R4 represents C-C6-alkyl, trifluoromethyl or phenyl, 20 R5 represents C-C4-alkyl, which can be substituted with one to three identical or different radicals selected from the group consisting of hydroxy, C,-C4-alkoxy, amino, mono- and di- C'-C4-alkylarnino, - 48 R represents cyano, aminocarbonyl, mono- and di-C-C4-alkylamino carbonyl, carboxyl or C-C6-alkoxycarbonyl, wherein the alkoxy moiety can be further substituted with a radical selected from the group consisting of hydroxy, C-C4-alkoxy, amino, mono- and di-C- S C4-alkylamino, or R6 represents a moiety of the formula O O NR6A So or wherein RA is selected from the group consisting of hydrogen and C-
1 5 C6-alkyl, R1 represents hydrogen, C-C4-alkyl or amino, X', X2, X3 and X4 independently from each other represent CH or N. wherein 20 ring A contains either 0, 1 or 2 nitrogen atoms, and yt, y2, y3, y4 and Y5 independently from each other represent CH or N. 25 wherein ring B contains either 0, 1 or 2 nitrogen atoms.
2. Compounds of general formula (l) according to claim 1, wherein
( - 49 R' represents hydrogen, R2, R3, R9 and Rt independently from each other represent hydrogen, halogen, nitro, cyano, trifluoromethyl, Cl-C4alkyl, C-C4-alkanoyl, 5 hydroxy, C-C4-alkoxy, trifluoromethoxy, amino, CC4-dialkylarnino, C, -C4-acylarnino, methoxy-carbonylamino, tert.butoxycarbonyl amino, carboxyl, methoxycarbonyl or ethoxycarbonyl, wherein C,-C4 alkyl, C,-C4-alkanoyl, C,-C4-alkoxy, C,-C4-dialkylamino and C,-C4 acylamino can be further substituted with one to two identical or 10 different radicals selected from the group consisting of hydroxy, meth oxy, ethoxy, amino, dimethylamino and diethylamino, R4 represents methyl, ethyl, trifluoromethyl or phenyl, 15 R5 represents methyl or ethyl, R6 represents cyano, arninocarbonyl, methylaminocarbonyl, dimethyl arninocarbonyl, carboxyl or C,-C4-alkoxycarbonyl, wherein the alkoxy moiety can be further substituted with a radical selected from 20 the group congisting of hydroxy, methoxy, ethoxy, amino, mono- and all-C -C4alkylarnino, R7 represents hydrogen, methyl, ethyl or amino, 25 R represents hydrogen, X', x2 and X3 represent CH, X4 represents CH or N. and
- so- Y\, Y2, Y3, Y4 and Y. represent CH.
3. Compounds of general formula (I) according to claim 1 or 2, wherein R and R2 represent hydrogen, R3 represents fluoro, chloro, bromo, nitro, cyano, tri fluoromethyl, methyl, methoxy or hydroxy, R4 represents methyl or trifluoromethyl, R5 represents methyl, 15 R6 represents cyano, aminocarbonyl, methylaminocarbonyl, dimethyl aminocarbonyl, carboxyl, methoxycarbonyl or ethoxycarbonyl, R7 represents hydrogen, methyl or amino, 20 R and R9 represent hydrogen, R' represents fluoro, chloro, bromo, nitro, cyano, trifluoromethyl or methyl, 25 X', X2, X3 and X4 represent CH, and yl yZ y3, Y4 and Y5 represent CH.
( - 51
4. Compounds of general formula (I) according to claim 1, 2 or 3, wherein R3 is cyano, which is located in pare-position relativ to the 1,4dihydropyridine nng.
5 5. Compounds of general formula (I) according to claim 1, 2 or 3, wherein R4 is methyl.
6. Compounds of general formula (I) according to claim 1, 2 or 3, wherein R5 is methyl.
7. Compounds of general formula (I) according to claim 1, 2 or 3, wherein R6 is methoxycarbonyl or ethoxycarbonyl.
8. Compounds of general formula (I) according to claim 1, 2 or 3, wherein R7 is 15 hydrogen, methyl or amino.
9. Compounds of general formula (I) according to claim 1, 2 or 3, wherein Ri is trifluoromethyl, which is attached to y2.
20
10. Processes for synthesizing the compounds of general formula (I) according to claim 1, 2 or 3, characterized in that either [A] compounds of the general formula (II) Y; iR10 1yl.Y (II), R4 R5 wherein R4, R5, R8, R9, R and Y' to Y5 have the meaning described in claim 1,
- 52 are condensed in the presence of a base with compounds of the general formulas (III) and (IV) R R2 Xll R3 xX (III) NCR (IV), H O s wherein Rt, R2, R3 and Xt to X4 have the meaning described in claim l, and to R" represents cyano or C-C6-alkoxycarbonyl, to give compounds of the general formula (la) R' R2 44 3 I R ,3 O R4R R5 N NH2
R'RB (la), R or [B] compounds of the general formulas (II) and (III) are condensed in the presence of an acid with compounds of the general formula (V)
1
11 _ _I
( - 53 H /< oR,2(V), wherein Ri2 represents Cj-Ce-alkyl, 5 to give compounds of the general formula (lb) R3 XWA O R4oR'2 R5 N H
R' Yl iR3 (lb), Rg/Y3 or 10 [C] compounds of the general formula (Vl) R:R' 1y'Y R'20J:R,3 (VI),
wherein R8, R9, R' , Ri2 and Y' to Y5 have the meaning described in claim 1, and
! - 54 R'3 represents C'-C4-alkyl, are condensed in the presence of an acid or a base with compounds of the general fonulas (111) and (VII) R4R5 n 1l (VII), wherein R4 and Rs have the meaning described in claim l, 10to give compounds of the general formula (Ic) R,wR2 R4oR42 R5 N R13
R1 - R8 (Ic).
R 11. The composition containing at least one compound of general formula (I) l 5 according to claim l, 2 or 3 and a pharmacologically acceptable diluent.
12. A composition according to claim l l for the treatment of acute and chronic inflmnmatory processes.
20
13. The process for the preparation of compositions according to claim l 1 and 12 characterized in that the compounds of general formula (I) according to claim l,
( - 55 2 or 3 together with customary auxiliaries are brought into a suitable application form.
14. Use compounds of general formula (1) according to claim 1, 2 or 3 for the 5 preparation of medicaments.
15. Use according to claim 14 for the preparation of medicaments for the treat ment of acute and chronic inflammatory processes.
I 0
16. Use according to claim 15, wherein the process is chronic obstructive pulmonary disease.
17. Process for controlling chronic obstructive pulmonary disease in humans and animals by administration of an neutrophil elastase inhibitory amount of at 15 least one compound according to any of Claims I to 3.
GB0216664A 2001-12-20 2002-07-17 3-Acyl-1,4-dihydro-1,4-di(phenyl/azinyl/diazinyl)pyridine derivatives for use as human neutrophil elastase inhibitors Withdrawn GB2390849A (en)

Priority Applications (9)

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GB0216664A GB2390849A (en) 2002-07-17 2002-07-17 3-Acyl-1,4-dihydro-1,4-di(phenyl/azinyl/diazinyl)pyridine derivatives for use as human neutrophil elastase inhibitors
JP2003554646A JP4486817B2 (en) 2001-12-20 2002-12-09 1,4-dihydro-1,4-diphenylpyridine derivative
DE60214428T DE60214428T2 (en) 2001-12-20 2002-12-09 1, 4-DIHYDRO-1, 4-DIPHENYLPYRIDINE DERIVATIVES
CA002470813A CA2470813A1 (en) 2001-12-20 2002-12-09 1,4-dihydro-1,4-diphenylpyridine derivatives
AU2002361992A AU2002361992A1 (en) 2001-12-20 2002-12-09 1,4-dihydro-1,4-diphenylpyridine derivatives
PCT/EP2002/013931 WO2003053930A1 (en) 2001-12-20 2002-12-09 1,4-dihydro-1,4-diphenylpyridine derivatives
ES02796589T ES2271365T3 (en) 2001-12-20 2002-12-09 DERIVATIVES OF 1,4-DIHIDRO-1,4-DIFENYLPIRIDINE.
US10/498,967 US7199136B2 (en) 2001-12-20 2002-12-09 1,4-dihydro-1,4-diphenylpyridine derivatives
EP02796589A EP1458682B1 (en) 2001-12-20 2002-12-09 1,4-dihydro-1,4-diphenylpyridine derivatives

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