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CA1178965A - Polycyclic fused pyrazole compounds useful as anti- inflammatory agents and preparation thereof - Google Patents

Polycyclic fused pyrazole compounds useful as anti- inflammatory agents and preparation thereof

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Publication number
CA1178965A
CA1178965A CA000411268A CA411268A CA1178965A CA 1178965 A CA1178965 A CA 1178965A CA 000411268 A CA000411268 A CA 000411268A CA 411268 A CA411268 A CA 411268A CA 1178965 A CA1178965 A CA 1178965A
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CA
Canada
Prior art keywords
methyl
pyrazole
fluorophenyl
compound
ethenyl
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000411268A
Other languages
French (fr)
Inventor
Malcolm R. Bell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis France
STWB Inc
Original Assignee
Sterling Drug Inc
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Filing date
Publication date
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Priority to CA000411268A priority Critical patent/CA1178965A/en
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Publication of CA1178965A publication Critical patent/CA1178965A/en
Expired legal-status Critical Current

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Abstract

ABSTRACT
The compounds of the formulas and where R and R' are lower-alkyl possess glucocorticoid activity, and are prepared by reacting the compound of the formula

Description

~.~ 7t~ 5 The present invention relates to novel polycyclic fuaed pyrazole compounds, useful as anti-inflammatory agents, and the preparation thereof.
Typical glucocorticoid activity is rarely found 5 in structures which do not possess an intact steroid nucleus.
Such activity is found in naturally occurring steroids such as cortisone, hydrocortisone and aldosterone, as well as numerous synthetic modifications thereof, all containing the intact steroid nucleus. An example of a synthetic 10 cortical steroid having high activity is a fluorophenylpyrazole derivative reported by Fried et al., J. Am. Chem. Soc. 85, 236 (1963), having the structure f H2H
C=O

...CH3 ~, r F

t ~

The pxesent invention relates to compounds having the formulas:
o and ~(CO~2 II
wherein R and R' are lower-alkyl groups. Said compounds 5 can be used in a pharmaceutical composition for treating inflammation in mammals which comprises an anti-inflammatorily effective amount of said compound of Formula I or II and a pharmaceutically acceptable carrier. One can reduce inflammation in a mammal by administering to said mammal 10 an anti-inflammatorily effective amount of a compound of Formula I or II.
The invention also relates to an intermediate for use in the preparation of the compounds of Formulas I and II, said intermediate having the formula:

¢~
F
III

7~6~

One can prepare the compounds of Formulas I or II
by reacting the compound of Formula III with a compound of the formula RCOCE~=CHCOR or CH2=C ~COOR')2, respectîvely.
The novel intermediate of Formula III is prepared 5 from a known starting material, 5-ethenyl-4,4a,7,8-tetrahydro-4a-methyl-2(3~)-naph~halenone (cf. Bell et al~
U.S. Patent 4,157,349, June 5, 1979) in accordance with the following reactions:
CH=CH2 c~ NaOCH3 CH=CH2 NHNH
CH ¦ 1 2 ~lOC~ ~ ~
l o ~; J +

'rhe trienone starting material i8 reacted with methyl formate in the presence of sodium methoxide in an i~ert solvent such as tetrahydrofuran to afford 5-ethenyl-3-hydroxymethylene-4,4a,7,8-tetrahydro-4a-methyl-2 (3H~-15 naphthalenone, and the latter is then reacted with 4-fluorophenylhydrazine or an acid-addition salt thereof în the presence of acetic acid to give the compound of Formula III.
The preparation of a compound of Formula I by 20 reacting the compound of Formula III wi~h an unsaturated diketone of *he formula RCOCH=CHCOR takes place by heating the reactants in an inert solvent at a temperature between about 50 and 150C. Similarly, a compound of Formula II
îs prepared by heating III with a di-lower-alkyl 25 methylenemalonate [CH2=C (COOR')2]. In order to suppress the tendency of the diene to polymerize, a small quantity of a free radical chain reaction inhibitor such as 1,2,3-1~7~

benzenetriol (pyrogallol), may be added.
The lower-alkyl groups R and R' preferably ha~e from one to four carbon atoms, including, for example, methyl, ethyl, propyl, isopropyl, butyl and isobutyl.
The compounds of Formulas I and II exhibit an endocrinological profile characteristic of compounds pos6es~ing glucocorticoid properties and systemic and~or topical anti-inflammatory activity; cf. R.H. Sil~er, The Biology of Anti-inflammatory Steroids, Annals of the 10 New York Academy of Sciences, Vol. 82, Art. 4. pp. 821-828.
When the compounds of Formulas I and II are administered orally to rats they cause a significant depression in thymus weight, adrenal weight and body weight gain without a change in food consumption.
The compound of Formula I where R is methyl ha~
al~o been found to posses~ oral glucocorticoid activity by the liver glycogen deposition test and anti-inflammatory a¢tivity by the a-tocopherol pouch test in rats.
The test procedures u3ed to determine the 20 biological activities of the cQmpounds of the invention were ¢arried out a~ follows:
Endocrino Profile: Mature female rats with an average body weight of 202 g and a body weight range of 15 g or le~s were medicated orally with test compound for 2 weeks. The 25 test compound was prepared as a solution or ~uspens$on in 1% gum tragacanth or 0.75% methyl cellulose. On the day following the last medication, the rats were killed and the thymus and adrenal of each rat were removed, cleaned, and weighed. Body weights and food consumptions were also 30 re¢orded.
Anti-inflammatory Activity ~a-tocop~erol pouch test):
Male rats which weighed 120 g were selected for testing.
A rapid subcutaneous injection of 25 mL of air was made b~bæen t~e s~api~e of each rat. This resulted in the 35 e~tablishment of an airfilled pouch into which 0.5 mL of dl-~-tocopherol was injected. The te~t compound was administered in daily oral doses for 7 days beginning on ";

1~78g~5 the day of pouch formation. The compound to be tested ~as suspended in 1% gum tragacanth. Twenty-four hours a~ter the last medication, the pouches were dissected free, and the fluid volume was measured. The inhibition of liquid 5 exudate is a measure of the anti-inflammatory activity.
Glycogenic Activity: Mature male rats were bilaterally adrenalectomized 5 days prior to the test. These rats were medicated orally with the test compound for 5 days. Seven hours after the last medication, the rats (which have been 10 fasted overnight) were anesthetized with sodium pentobarbital and a portion of one lobe of the liver was removed and frozen on dry ice for subsequent glycogen determination.
The compounds of the invention can be formulated for topical application by solution of dispersion in a lS conventional pharmaceutically acceptable liquid, cream or ointment base. The effective ingredient is preferably pre~ent in a concentration of 0.01% to 5.0~ by weight.
The compounds of the invention can be formulated ~or oral administration in tablet or capsule form w~th 20 conventional excipients. The active ingredient i8 pre-~erably present in an amount of 1 mg to 100 mg per unit dosage form, The followlng examples will further illustrate the invention.
Example 1 (a~ 5-Ethenyl-3-hydroxymethylene-4,4a,7,8-tetrahydro-4a-me ~ l-2~3H)-naphthalenone.
A solution of 50.0 g (0.265 mol) of 5-ethenyl-4, 4a,7,8-tetrahydro-4a-methyl-2(3H)-naphthalenone in 350 mL
30 of tetrahydrofuran was cooled to -5C. in an ice-methanol bath and stirred under nitrogen while 57.2 g (1.06 mol) of sodium methoxide was added. The resulting mixture wa~
stirred for 30 min at -5C. and then a solution of 114 mL
~1.85 mol) of methyl formate in 100 mL of tetrahydrofuran 35 was added slowly. The mixture was stirred overnight at room temperature and then poured onto a mixture of ice-water ~1500 mL) and 6N hydrochloric acid (265 mL). The ~ ~ 7~96~

product was extracted with ether and the combined extracts were washed with water. The dried extract was dried over anhydrous magnesium sulfate and concentrated ln vacuo to afford an oil. This oil was triturated with hexane 5 (4 x 250 mL) and the combined triturates were dried over magne~ium sulfate and concentrated ln vacuo to afford 55.37 g of a red oil, consisting essentially of the above-entitled compound as established by proton NMR (PMR) spectral data.
(b~ l-Ethenyl-6-(4-fluorophenyl)-3,4,9,9a-tetrahydro-9a-10 ~ (III).
4-Fluorophenylhydrazine hydrochloride (45.85 g, 0.282 mol~ and sodium acetate (23.14 g, 0.282 mol~ were added to a solution of 55.37 g (0.256 mol) of the product obtained in part (a) above in 225 mL of glacial acetic acid.
15 The mixture ~as stirred overnight at room temperature and then concentrated in vacuo to afford a semi-solid. This material was suspended in ether (1 L) and filtered to remove sodium chloride. The ether filtrate was washed with water (4 x 250 mL), saturated sodium bicarbonate (until weakly 20 ba~ic) and ~aturated sodium chloride (100 mL). The extract was dried over anhydrous magnesium sulfate, decolorized with charcoal and concentrated ln vacuo to afford an oil.
~h~s oil was triturated with 1:2 ether-hexane (3 x 750 mL) to afford 69.58 g of a dark brown oil. An analytical sample 25 was prepared by using high-performance li~uid chromatography ~ith 1:3 ether-hexane as solvent. The resulting yellow oil was triturated with pentane to afford 1-ethenyl-6-(4-fluorophenyl)-3~4~9~9a-tetrahydro-9a-methyl-6H-naphtho [2,3-c]pyrazole as a yellow solid, m.p. 70-72C., with a 30 consistent PMR spectrum.
Example~ 2 ~ [8-(4-Fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-lla-methyl-8~ henanthro[2,3-c]pyrazole-3,4-diyl~bis[ethanone]
(~; R = CH3).
A solution of 20 g (0.065 mol) of 1-ethenyl-6-(4-fluorophenyl)-3,4,9,9a-tetrahydro-9a-methyl-6H-naphthol [2,3-c]-pyrazole in 200 mL benzene and 8.07 g (0.072 mol) li7~g6S

of 3-hexene-2,5-dione was stirred at reflux for 40 hours under nitrogen. The cooled reaction mixture was filtered through silica gel and concentrated in vacuo. The resultant oil was triturated with ether to afford 7.54 g of a gold 5 solid as a mixture of isomers, m.p. 138-142C., as determined by PUR spectroscopy. Five g of this mixture of isomers was separated using high-performance liquid chromatography with 1:4 ethyl acetate-hexane. The major isomer was recrystallîzed from CH2C12-isooctane to afford 3.0 g of 1,1'-[8-(4-10 fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-lla-methyl-8H-phenanthro[2,3-c]pyrazole-3,4-diyl]bis~ethanone], a white ~olid, m.p. 157-159C., a single isomer as determined by PMR spectro~copy.
In the endocrine profile determination, Compound I
15 (R - CH3) at a dose level of 5 mg/kg caused a 59~ reduction in weight of the thymus, 40% reduction in adrenal weight and 80% reduction in body weight gain as compared with the control~. In the ~-tocopherol pouch test, Compound I (R = CH
was active with ED50 = 23 mg/kg. In the glycogenic activity 20 test, Compound I (R = CH3) at dose levels of 9 and 27 mg/kg/day x 5 produced liver glycogen deposition values of 9.42 + 0.65 and 25.48 + 3.39 mg/g of tissue, respectively, as compared to 1.75 + 0.04 mg/g for the vehicle ~ethanol:
cottonseed oil 1:9 v/v) alone.
By replacing the 3-hexene-2,5 dione in the procedure of Example 2 by a molar equivalent amount of 4-octene-3,6-dione, 5-decene-4,7-dione or 6-dodecene-5,8-dione, it is contemplated that there can be obtained 1,1'-18-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-lla-30 methyl-8H- phenanthro[2,3-c]-pyrazole-3,4-diyl]bis[propanone]
(I~ R = CH2CH3), 1,1'-[8-(4-fluorophenyl)-2,3,4,4a,5,6,11, lla-octahydro-lla-methyl-8H- phenanthro[2~3-c]pyrazole-3~4 diyl]bis[butanone] (I; R = CH2CH2CH3), or 1,1'-[8-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-lla-methyl-35 8H-ph~nthro[2,3-c]pyrazole-3,4-diyl]bis-[pentanone]
(I; R = CH2CH2CH2CH3), respectively 1~'7~9~;5 Example 3 Die~thyl 8-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-lla-methy~-8H~ enanthro[2,3-c]pyrazole-4,4-dicarboxylate (II; R = CH2CH3).
A solution of 25.81 g (0.084 mol~ of 1-ethenyl-6-(4-fluorophenyl)-3,4,9,9a-tetrahydro-9a-methyl-6H-naphtho [2,3-c]-pyrazole, 18.1 g (O.lOS mol) of diethyl methylenemalonate and S00 mg of 1,2,3-benzenetriol in 200 mL
of xylene was refluxed for 20 hours. The cooled reaction 10 mixture was filtered through silica gel and concentrated in vacuo to afford 41.93 g of a brown oil. The oil was purified by uQing high-performance liquid chromatography ~ith 3.97 ethyl acetate-CH2C12 followed by recrystallization ~rom methanol to afford 10.98 g of diethyl 8-(4-fluoro-15 phenyl)-2~3~4~4a~5~6~ lla-octahydro-lla-methyl-8H-phenanthro-[2,3-c]pyrazole-4,4-dicarboxylate as a colorles6 solid, m.p. 133-135C. m e PMR spectrum was consistent with the a3signed ~tructure.
In the endocrine profile determination, Compound II
20 (R ~ CH2CH3) at a dose level of 100 mg/kg caused an 80%
reduction in thymus weight, 47% reduction in adrenal weight and 186~ reduction in body weight gain as compared with ; the controls. Compound II (R = CH2CH3) was inactive in the ~-tocopherol pouch test at 100 mg/kg.
By replacing the diethyl methylenemalonate in the procedure of Example 3 by a molar equivalent amount of dimethyl methylenemalonate, dipropyl methylenemalonate or dibutyl methylenemalonate, it i8 contemplated that there can be obtained dimethyl 8-~4-fluorophenyl)-2,3,4,4a,5,6, 30 ll,lla-octahydro-lla-methyl-8H- phenanthro[2,3-c]pyrazole-4,4-dicarboxylate (II; R = CH3), dipropyl 8-(4-fluorophenyl~-
2,3,4,4a,5,6,11,11a-octahydro-lla-methyl-8H-phenanthro[2,3-c]
pyrazole-4,4-dicarboxylate (II; R = CH2CH2CH3), or dibutyl 8-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-lla-methyl-35 8H-phenanthrol[2,3-c]pyrazole-4,4-dicarboxylate (II; R =
CH2CH2CH2CH3 ), re8pectively .

..,i

Claims (6)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A process for preparing a compound having the Formula I or II:

or I II

wherein R and R' are each lower-alkyl which comprises reacting 1-ethenyl-6-(4-fluorophenyl)-3,4,9,9a-tetrahydro-9a-methyl-6H-naphtho[2,3-c]pyrazole with a compound of the formula RCOCH=CHCOR or CH2=C(COOR')2, respectively.
2. A process according to claim 1, for preparing 1,1'-[8-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-11a-methyl-8H-phenanthro[2,3-c]pyrazole-3,4-diyl]bis-[ethanone], which comprises reacting 1-ethenyl-6-(4-fluorophenyl)-3,4,9,9a-tetrahydro-9a-methyl-6H-naphtho[2,3-c]pyrazole with 3-hexene-2,5-dione.
3. A process according to claim 1, for preparing diethyl 8-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-11a-methyl-8H-phenanthro[2,3-c]pyrazole-4,4-dicarboxylate, which comprises reacting 1-ethenyl-6-(4-fluorophenyl)-3,4,9, 9a-tetrahydro-9a-methyl-6H-naphtho[2,3-c]pyrazole with diethyl methylenemalonate.
4. A process according to claim 1, wherein the 1-ethenyl-6-(4-fluorophenyl)-3,4,9,9a-tetrahydro-9a-methyl-6H-naphtho[2,3-c]pyrazole is prepared by reacting 5-ethenyl-3-hydroxymethylene-4,4a,7,8-tetrahydro-4a-methyl-2(3H)-naphthalenone with 4-fluorophenylhydrazine or an acid-addition salt thereof in the presence of acetic acid.
5. A compound of the Formula I or II as defined in claim 1, when prepared by the process according to claim 1 or 4 or by an obvious chemical equivalent thereof.
6. 1,1'-18-(4-Fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-11a-methyl-8H-phenanthro[2,3-c]pyrazole-3,4-diyl]
bis-[ethanone] or diethyl 8-(4-fluorophenyl)-2,3,4,4a,5,6,11,11a-octahydro-11a-methyl-8H-phenanthro[2,3-c]pyrazole-4,4-dicarboxylate, when prepared by the process according to claim 2 or 3, respect-ively, or by an obvious chemical equivalent thereof.
CA000411268A 1982-09-13 1982-09-13 Polycyclic fused pyrazole compounds useful as anti- inflammatory agents and preparation thereof Expired CA1178965A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004026248A3 (en) * 2002-09-20 2004-07-15 Merck & Co Inc Octahydro-2-h-naphtho[1,2-f] indole-4-carboxamide derivatives as selective glucocorticoid receptor modulators
US7947726B2 (en) 2002-01-22 2011-05-24 The Regents Of The University Of California Non-steroidal ligands for the glucocorticoid receptor, and compositions thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7947726B2 (en) 2002-01-22 2011-05-24 The Regents Of The University Of California Non-steroidal ligands for the glucocorticoid receptor, and compositions thereof
WO2004026248A3 (en) * 2002-09-20 2004-07-15 Merck & Co Inc Octahydro-2-h-naphtho[1,2-f] indole-4-carboxamide derivatives as selective glucocorticoid receptor modulators
JP2006503107A (en) * 2002-09-20 2006-01-26 メルク エンド カムパニー インコーポレーテッド Octahydro-2-H-naphtho [1,2-f] indole-4-carboxamide derivatives as selective glucocorticoid receptor modulators
AU2003270783B2 (en) * 2002-09-20 2009-12-24 Merck Sharp & Dohme Corp. Octahydro-2-H-naphtho[1,2-F] indole-4-carboxamide derivatives as selective glucocorticoid receptor modulators
AU2003270783C1 (en) * 2002-09-20 2010-05-20 Merck Sharp & Dohme Corp. Octahydro-2-H-naphtho[1,2-F] indole-4-carboxamide derivatives as selective glucocorticoid receptor modulators

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