CA2012095C - 3'-tosylcytidine compounds and process for production thereof - Google Patents

3'-tosylcytidine compounds and process for production thereof

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Publication number
CA2012095C
CA2012095C CA 2012095 CA2012095A CA2012095C CA 2012095 C CA2012095 C CA 2012095C CA 2012095 CA2012095 CA 2012095 CA 2012095 A CA2012095 A CA 2012095A CA 2012095 C CA2012095 C CA 2012095C
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CA
Canada
Prior art keywords
group
compound
formula
compounds
tosylcytidine
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 - Fee Related
Application number
CA 2012095
Other languages
French (fr)
Other versions
CA2012095A1 (en
Inventor
Khashayar Karimian
Bruno Konrad Radatus
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.)
Apotex Pharmachem Inc
Original Assignee
Acic Canada Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority to CA 2012095 priority Critical patent/CA2012095C/en
Application filed by Acic Canada Inc filed Critical Acic Canada Inc
Priority to PCT/CA1991/000078 priority patent/WO1991013901A1/en
Priority to US07/930,605 priority patent/US5399682A/en
Priority to BR919106157A priority patent/BR9106157A/en
Priority to AT91906308T priority patent/ATE125265T1/en
Priority to HU9202905A priority patent/HUT61565A/en
Priority to DE69111438T priority patent/DE69111438T2/en
Priority to EP91906308A priority patent/EP0523080B1/en
Priority to AU74801/91A priority patent/AU7480191A/en
Publication of CA2012095A1 publication Critical patent/CA2012095A1/en
Priority to US08/191,192 priority patent/US5527782A/en
Priority to US08/356,498 priority patent/US5536824A/en
Priority to US08/469,506 priority patent/US5596093A/en
Application granted granted Critical
Publication of CA2012095C publication Critical patent/CA2012095C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H23/00Compounds containing boron, silicon or a metal, e.g. chelates or vitamin B12
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H19/00Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof
    • C07H19/02Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof sharing nitrogen
    • C07H19/04Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
    • C07H19/06Pyrimidine radicals

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Saccharide Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Novel compounds of Formula I, or pharmaceutically acceptable salts thereof, are provided:

Description

2~ 95 FIELD OF THE INVENTION

The present invention relates to novel 3'-tosylcytidine compounds and pharmaceutically acceptable salts thereof. Further, the present invention relates to a process for the production of 3'-tosylcytidine compounds.

BACKGROUND OF THE INVENTION
Fromageot et al (Tet. Lett., 3499-3505, (1966)) speculated production of N4 ,o3 ' ,o5 ' -triacetyl-3-O'-tosylcytidine by reacting an equilibrium mixture of N4, o3 ', 05 ' -triacetylcytidine and the corresponding N4 ~ o2 ~ o5 -isomer with a slight excess of p-toluenesulfonyl chloride in an anhydrous pyridine solution. The 3'-O-tosylcytidine derivative was assumed to be a product present in a dichloromethane phase after an arabinofuranosylcytosine derivative had been extracted from the reaction mixture with water.
However, the 3'-O-tosylcytidine derivative was not isolated nor is there any disclosure or suggestion of how to prepare this derivative.

Mizuno et al (Tet. Lett., 4579-4584 (1965)) teach the production of 3'-O-mesylcytidine via a four step process from N4-acetylcytidine. This corresponds to a five step process, overall, if cytidine is used as the starting material. Thus, it is not surprising that the overall yield of 3'-O-mesylcytidine produced in this manner is less that 10~ (even this low yield assumes theoretical yields for two of the five steps where yield was unreported).

2~2~9~

Heretofore, the Applicants are not aware of prior art which teaches the production of 3'-tosylcytidine.

SUMMARY OF THE INVENTION

It is an ob;ect of the present invention to provide novel 3'-tosylcytidine compounds.

It is another object of the present invention to provide a novel process for the production of cytidine compounds, including 3'-tosylcytidine compounds.

Accordingly, in one of its aspects, the present invention provides a compound of Formula I, or a pharmaceutically acceptable salt thereof:

N /

N (I) 25RZO-C ~ O y Y OH
wherein Y is selected from p-toluenesulfonyl and -SO2CF3, and R2 is selected from the group comprising hydrogen, trityl, methoxytrityl, dimethoxytrityl, acetyl, a C2-C6 alkylacyl group, a C6-Cg arylacyl group, allyl, 2,2,2-trichloroethyl, phosphate and salts thereof, tosyl and mesyl.

~_ 2 $ ~

In another of its aspects, the present invention provides a process for producing a compound of Formula II, or a pharmaceutically acceptable salt thereof:

N ~

~ N ~ (II) R2 O-C~O~J

wherein R6 is selected from the group comprising -CF3, a C1-C6 alkyl group and a C6-Cg aryl group, which comprises the step of reacting (i) a compound of Formula III:

~ N / (III) R2 O-C~O~) O~ ,0 ,Sn wherein R1 is a C1-C6 alkyl group and R2 is selected from the group comprising hydrogen, trityl, methoxytrityl, dimethoxytrityl, acetyl, a C2-C6 alkylacyl group, a C6-Cg arylacyl group, allyl, 2,2,2-2 ~ 3 trichloroethyl, phosphate and salts thereof, tosyl and mesyl, with (ii) an amine selected from the group comprising pyridine and amines having the general formula R3R4RsN

wherein R3, R4 and R5 can be the same or different and each of R3, R4 and R5 is selected from the group comprising a Cl-C6 alkyl group and a C6-Cg aryl group, in the presence of (iii) a sulfonyl compound having the general formula wherein R6 is selected from the group comprising -CF3, a C1-C6 alkyl group and a C6-C9 aryl group, and X is selected from a halogen and -SO3CF3, to produce a compound of Formula II.
DESCRIPTION OF THE PREFERRED EMBODIMENTS

Thus, the invention provides 3'-tosylcytidine compounds such as 3'-tosylcytidine or pharmaceutically acceptable salts thereof.

The compound of Formula III:

-2 ~ 9 5 N

N
R20-C ~ 0 ~

(III) ~Sn R1 `R1 is known. Generally, this compound may be prepared by reacting cytidine with the appropriate dialkyl-tin oxide.
In one preferred embodiment of the compound of Formula III, R1 is butyl and R2 is hydrogen. With these definitions for R1 and R2, the compound of Formula III
is 2',3'-O-dibutylstannylene cytidine.
An example of a suitable "C2-C6 alkylacyl group" for use as R2 is acetyl. Further, an example of a suitable ''C6-Cg arylacyl group" for use as R2 benzoyl.

Provided that it does not contain a hydrogen bonded to nitrogen, the amine suitable for use in the presence process is not particularly restricted and may be selected from the group comprising trimethylamine, triethylamine, pyridine, tripropylamine and tributylamine. The most preferred amine is triethylamine.

The reaction of the compound of Formula III
with the amine is conducted in the presence of a sulfonyl compound, preferably a sulfonyl chloride 2 ~

compound. More preferably, the sulfonyl chloride compound is one of p-toluenesulfonyl chloride and methanesulfonyl chloride. When p-toluene sulfonyl chloride is used, the product of the process is a 3'-tosylcytidine compound of Formula I (i.e. Y is p-toluenesulfonyl).

Typically, the reaction can be conducted at room temperature, preferably with agitation (such as stirring) of the reaction mixture. The reaction may be conducted in a suitable organic solvent system. Non-limiting examples of suitable organic solvents include alcohols, toluene, benzene, chloroform, dichloromethane and the like. The preferred organic solvents are alcohols, more preferably methanol.

The crude product may be separated from the reaction mixture and purified using conventional techniques within the purview of a person skilled in the art. For example, after the reaction is complete, the solvents may be evaporated under vacuum and the resulting solid suspended and refluxed in a suitable medium (e.g. water). Thereafter, the crude product may be recrystallized from a suitable solvent, such as ethanol.

Aspects of the present invention will be described with reference to the following example which should not be considered to limit the scope of the invention.

EXAMPLE

A 500 mL flask was charged with 50 mL
methanol, 1.95 g cytidine and 2 g dibutyl tin oxide.

-2 ~

The resulting suspension was refluxed for five hours and then stirred at room temperature for 12 hours. To the mixture was then added triethylamine (7.8 mL) followed by slow addition of p-toluenesulfonyl chloride (10.68 g). The resulting mixture was stirred for 12 hours at room temperature. Thereafter, the solvents were evaporated under vacuum and chloroform (100 mL) was added to the resulting white gum. The chloroform/white gum suspension was refluxed for 15 minutes and then cooled to room temperature. The resulting white precipitate was filtered and set aside. After concentration of the filtrate under vacuum, the resulting residue was suspended in water (15 mL) at room temperature for 3 hours and then at 6C for 12 hours.
The suspension was filtered and the solid was resuspended in 15 mL water and the mixture heated to 90C and then cooled to room temperature (producted remained in solution). The solution was filtered through Celite and the filtrate was stirred at 6C for 12 hours which resulted in precipitation of a solid.
The precipitate was filtered and dried under vacuum to afford 1 g of crude 3'-tosylcytidine tosylate salt. The crude 3'-tosylcytidine tosylate salt was suspended in 25 mL chloroform and stirred for one hour. The suspension was filtered and washed with 5 mL chloroform.
Thereafter, the precipitate was suspended in 25 mL
boiling ethanol, to which was added 1.8 mL t-butylamine (pH = 8-9). The hot mixture was filtered, and the filtrate stirred at 15C for 16 hours. The resulting precipitate was filtered, washed with ethanol and dried to afford 0.53 g (14.9~ yield) of pure 3'-tosylcytidine ethanol, a novel compound which had a melting point of 115-116.5C (bubbles) with decomposition occurring at 160-170.

-2~

A sample of the novel compound was converted to the corresponding hydrochloride salt by reaction with dilute aqueous hydrochloric acid. Using a 200 MHz NMR
spe~Lo".eter, an NMR spectrum of this hydrochloride salt was obtained in DMS0-d-6. The following data on peak shift, number of peaks and coupling constants was obt~neA from the spectrum and confirms the structure of the hydrochloride salt of 3'-tosylcytide:

2~:~2~

SHIFT (~) ASSIGNMENT

2.42, s 3H: CH3 3.37, dd lH; J~ 5; =2-24 Hz, J5; 5i=12.44 Hz: H-51 3.45, bs 3H; exchangeable: NH3 3.54, dd lH; J4 5 =2.59 Hz: H-52' 4.07, m lH; J3 4 =3.17 Hz: H-4' 4.26, t lH; Jl 2 =6-04 Hz, J2 3 4 93 Hz: H-2' 4.85, dd lH: H-3 ' 5.76, d lH: H-l ' 6.19, d lH; J56=7.80 Hz: H-5 7.48, d 2H; JT O 6 y l 23 =8.40: Tosyl H-3 7.84, d 2H: Tosyl H-2 8.13, d lH: H-6 8.75 9.85, 2 x s 2 x lH, exchangeable: C2'-OH
and C5 ' OH

Claims (8)

1. A process for the producing a compound of Formula II, or a pharmaceutically acceptable salt thereof:

(II) wherein R6 is selected from the group comprising -CF3, a C1-C6 alkyl group and a C6-C9 aryl group, which comprises the step of reacting (i) a compound of Formula III:

(III) wherein R1 is a C1-C6 alkyl group and R2 is selected from the group comprising hydrogen, trityl, methoxytrityl, dimethoxytrityl, acetyl, a C2-C6 alkylacyl group, a C6 -C9 arylacyl group, allyl, 2,2,2-trichloroethyl, phosphates and salts thereof, tosyl and mesyl, with (ii) an amine selected from the group comprising pyridine and amines having the general formula wherein R3, R4 and R5 can be the same or different and each of R3, R4 and R5 is selected from the group comprising a C1-C6 alkyl group and a C6-C9 aryl group, in the presence of (iii) a sulfonyl compound having the general formula wherein R6 is selected from the group comprising -CF3, a C1-C6 alkyl group and a C6-C9 aryl group, and X is selected from a halogen and -SO3CF3, to produce a compound of Formula II.
2. The process defined in claim 1, wherein R2 is hydrogen.
3. The process defined in claim 1, wherein X is chloride.
4. The process defined in claim 2, wherein said sulfonyl compound is selected from p-toluenesulfonyl chloride and methanesulfonyl chloride.
5. The process defined in claim 2, wherein said sulfonyl compound is p-toluenesulfonyl chloride.
6. The process defined in claim 4, wherein said amine is selected from the group comprising trlmethylamine, triethylamine, pyridine, trlpropylamine and trlbutylamlne.
7. The process deflned ln clalm 5, wherein said amlne is triethylamine.
8. The process defined in claim 7, wherein said step is conducted in the presence of methanol.
CA 2012095 1990-03-13 1990-03-13 3'-tosylcytidine compounds and process for production thereof Expired - Fee Related CA2012095C (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CA 2012095 CA2012095C (en) 1990-03-13 1990-03-13 3'-tosylcytidine compounds and process for production thereof
AU74801/91A AU7480191A (en) 1990-03-13 1991-03-13 3'-o-tosylcytidine and cytosine compounds, and process for production thereof
BR919106157A BR9106157A (en) 1990-03-13 1991-03-13 COMPOUNDS AND PROCESS 3'-O-TOSIL CYTIDINE AND CYTOSINE AND PROCESS FOR THE PRODUCTION OF THE SAME
AT91906308T ATE125265T1 (en) 1990-03-13 1991-03-13 2,3'-O-CYCLOCYTIDINES AND METHOD FOR THE PRODUCTION THEREOF.
HU9202905A HUT61565A (en) 1990-03-13 1991-03-13 Process for producing 2,3'-0-cyclocytidine and 1-(beta-d-xylopento-furanosyl)-cytosine derivatives and their analogous compounds, as well as 3'-0-(p-toluenesulfonyl)-cytidine derivatives
DE69111438T DE69111438T2 (en) 1990-03-13 1991-03-13 2,3'-O-CYCLOCYTIDINE AND METHOD FOR THE PRODUCTION THEREOF.
PCT/CA1991/000078 WO1991013901A1 (en) 1990-03-13 1991-03-13 3'-o-tosylcytidine and cytosine compounds, and process for production thereof
US07/930,605 US5399682A (en) 1990-03-13 1991-03-13 Process for preparing 2,3'-O-cyclocytidine
EP91906308A EP0523080B1 (en) 1990-03-13 1991-03-13 2,3'-o-cyclocytidines, and process for production thereof
US08/191,192 US5527782A (en) 1990-03-13 1994-02-02 5-halo-2,3'-O-cyclocytidines
US08/356,498 US5536824A (en) 1990-03-13 1994-12-15 Organosulfonyl salts of 2,3'-O-cyclocytidine
US08/469,506 US5596093A (en) 1990-03-13 1995-06-06 Process for preparing halogenated 2,3-O-cyclocytidine derivatives

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA 2012095 CA2012095C (en) 1990-03-13 1990-03-13 3'-tosylcytidine compounds and process for production thereof

Publications (2)

Publication Number Publication Date
CA2012095A1 CA2012095A1 (en) 1991-09-13
CA2012095C true CA2012095C (en) 1996-07-23

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CA 2012095 Expired - Fee Related CA2012095C (en) 1990-03-13 1990-03-13 3'-tosylcytidine compounds and process for production thereof

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