US2021230208A1PendingUtilityA1

Inorganic salts of nicotinamide mononucloetide as anti-aging agents

55
Assignee: LIFE BIOSCIENCES INCPriority: May 15, 2018Filed: May 15, 2019Published: Jul 29, 2021
Est. expiryMay 15, 2038(~11.8 yrs left)· nominal 20-yr term from priority
C12N 5/0609A61K 31/706C12N 2500/40A61P 15/08C07H 1/00C07H 19/048C12N 5/0603C07F 9/65586C12N 2517/10C12N 2501/999C12N 2500/33C12N 2500/32
55
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Claims

Abstract

The present invention relates to inorganic salts of nicotinamide mononucleotides and compositions of Formula I, useful in the treatment of disorders and diseases associated with deficiencies in NAD + : wherein A, M, k, R 1 and R 2 are as described herein.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A salt of Formula (I): 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8, 
 
         provided M 1  is not Na. 
       
     
     
         2 . The salt of  claim 1 , wherein M 1  is a cation selected from the group consisting of Li + , K + , Rb + , Cs + , Be 2+ , Mg 2+ , Ca 2+ , Sr 2+ , Zn 2+ , and Ba 2+ . 
     
     
         3 . The salt of any one of  claims 1  to  2 , wherein M 1  is K + . 
     
     
         4 . The salt of any one of  claims 1  to  2 , wherein M 1  is Li + . 
     
     
         5 . The salt of any one of  claims 1  to  2 , wherein M 1  is Rb + . 
     
     
         6 . The salt of any one of  claims 1  to  5 , wherein R 1  is H. 
     
     
         7 . The salt of any one of  claims 1  to  5 , wherein R 1  is C 1 -C 3 alkyl. 
     
     
         8 . The salt of any one of  claims 1  to  5 , wherein R 2  is H. 
     
     
         9 . The salt of any one of  claims 1  to  5 , wherein R 2  is C 1 -C 3 alkyl. 
     
     
         10 . The salt of  claim 1 , selected from the group consisting of: 
       
         
           
           
               
               
           
         
       
     
     
         11 . A pharmaceutical composition comprising a salt of any one of  claims 1  to  10  and a pharmaceutically acceptable carrier. 
     
     
         12 . A method of treating or preventing an age-related infertility comprising administering to a subject in need thereof, an effective amount of a salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8. 
 
       
     
     
         13 . A method of treating or preventing infertility comprising administering to a subject in need thereof, an effective amount of a salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 3 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8. 
 
       
     
     
         14 . A method of improving oocyte or blastocyst quality and maturation comprising contacting the oocyte or blastocyst with an effective amount of a salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 1 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 1 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8 
 
         prior to implantation into a subject in need of treatment of age-related infertility. 
       
     
     
         15 . A method of improving oocyte or blastocyst quality and maturation comprising contacting
 the oocyte or blastocyst with an effective amount of a salt of   
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8 
 
         prior to implantation into a subject in need of treatment of age-related infertility. 
       
     
     
         16 . The method of  claim 14  or  15  where the oocyte or blastocyst is cultured in an IVF media containing the salt. 
     
     
         17 . Use of a salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8 
 
         in the manufacture of a medicament for treating an age-related disorder. 
       
     
     
         18 . Use of a salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8 
 
         in the manufacture of a medicament for treating infertility. 
       
     
     
         19 . Use of a salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8 
 
         in the manufacture of a medicament for treating age related infertility. 
       
     
     
         20 . A process for the preparation of a salt of Formula I: 
       
         
           
           
               
               
           
         
         comprising contacting the compound of Formula II 
       
       
         
           
           
               
               
           
         
         with a metal-alkali hydroxide under conditions effective to produce the product salt of Formula I. 
       
     
     
         21 . The process of  claim 20 , wherein the metal-alkali hydroxide is added dropwise into a solution of the compound of Formula II. 
     
     
         22 . A cell culture medium for in vitro fertilization comprising:
 a salt of Formula I:   
       
         
           
           
               
               
           
         
       
       or enantiomer, stereoisomer, or tautomer thereof, 
       wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8; and
 culturing agents. 
 
 
     
     
         23 . The cell culture medium of  claim 22 , wherein the culturing agent is an inorganic salt, an energy substrate, an amino acid, a chelator, a pH indicator, an antibiotic, a serum, a vitamin, a growth factor, or any combination thereof. 
     
     
         24 . The cell culture medium of  claim 23 , wherein the inorganic salt is calcium chloride, magnesium chloride, magnesium sulfate, potassium chloride, sodium bicarbonate, sodium chloride, monosodium phosphate, disodium phosphate, or any combination thereof. 
     
     
         25 . The cell culture medium of  claim 23 , wherein the energy substrate is glucose, pyruvate, lactate, pyruvate, or any combination thereof. 
     
     
         26 . The cell culture medium of  claim 23 , wherein the amino acid is an essential amino acid. 
     
     
         27 . The cell culture medium of  claim 26 , wherein the essential amino acid is arginine, cysteine, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, threonine, tryptophan, tyrosine, valine, or any combination thereof. 
     
     
         28 . The cell culture medium of  claim 23 , wherein the amino acid is a non-essential amino acid. 
     
     
         29 . The cell culture medium of  claim 28 , wherein the non-essential amino acid is alanine, asparagine, aspartate, glutamate, proline, serine, or any combination thereof. 
     
     
         30 . The cell culture medium of  claim 23 , wherein the chelator is clathro chelate, acetyl acetone, amino polycarboxylic acid, ATMP, BAPTA, BDTH2, citric acid, cryptand, deferasirox, 2,3-dihydrobenzoic acid, 2,3-dimercapto-1-propane sulfonic acid, dimercapto succinic acid, DOTA, DTPMP, EDDHA, EDDS, EDTMP, etidronic acid, fura-2, gluconic acid, homocitric acid, imino diacetic acid, Indo-1, nitrile triacetic acid, pentetic acid (DTPA), phosphonate, phytochelati, poly aspartic acid, sodium poly aspartate, trisodium citrate, transferrin, EDTA, EGTA, or any combination thereof. 
     
     
         31 . The cell culture medium of  claim 23 , wherein the pH indicator is phenol red, bromothymol blue, alizarin red, 9-aminoacridine, or any combination thereof. 
     
     
         32 . The cell culture medium of  claim 23 , wherein the antibiotic is actinomycin D, ampicillin, carbenicillin, cefotaxime, fosmidomycin, gentamicin, kanamycin, neomycin, penicillin, polymyxin B, streptomycin, or any combination thereof. 
     
     
         33 . The cell culture medium of  claim 23 , wherein the serum is human serum albumin, bovine serum albumin, fetal bovine serum, synthetic serum, or any combination thereof. 
     
     
         34 . The cell culture medium of  claim 23 , wherein the vitamin is ascorbic acid, biotin, menadione sodium bisulfite, mitomycin C, pyridoxamine dihydrochloride, retinyl acetate, (−)-riboflavin, (+)-sodium L-ascorbate, (+)-α-tocopherol, vitamin B 12 , thiamine hydrochloride, i-inositol, pyridoxal hydrochloride, nicotinamide, folic acid, D-calcium pantothenate, choline chloride, or any combination thereof. 
     
     
         35 . The cell culture medium of  claim 23 , wherein the growth factor is adrenomedullin, angiopoietin, bone morphogenetic proteins, macrophage colony-stimulating factor (M-CSF), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), epidermal growth factor, ephrins, erythropoietin, fibroblast growth factor, growth differentiation factor-9, hepatocyte growth factor, insulin, insulin-like growth factors, interleukins, keratinocyte growth factor, migration-stimulating factor, macrophage-stimulating protein, myostatin, neurotrophins, t-cell growth factor, thrombopoietin, transforming growth factor, tumor necrosis factor-alpha, vascular endothelial growth factor, or any combination thereof. 
     
     
         36 . The cell culture medium of  claim 22 , wherein the cell culture medium further comprises an oocyte, zygote, blastocyst, or any combination thereof. 
     
     
         37 . A salt of Formula I: 
       
         
           
           
               
               
           
         
         or enantiomer, stereoisomer, or tautomer thereof, 
         wherein
 A is NR a R b ; 
 M 1  is an inorganic cation; 
 R 1  and R 2  are independently H, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, (C 0 -C 3 alkylene)C(O)C 1 -C 6 alkyl, —C(O)OR a , —C(O)NR a R b , or —[CH 2 —CH 2 —O] n —R a , 
 or R 1  and R 2 , together with the atom to which they are attached, form a 5-membered heterocyclic ring optionally substituted with one or more substituents selected from C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 R a  and R b  are independently, at each occurrence, H, or C 1 -C 6 alkyl, wherein the alkyl is optionally substituted with one or more substituents selected from (C 0 -C 3 alkylene)C 3 -C 8 cycloakyl, (C 0 -C 3 alkylene)heterocycloakyl, (C 0 -C 3 alkylene)C 6 -C 14 aryl, and (C 0 -C 3 alkylene)heteroaryl; 
 k is 1 or 2; and 
 n is an integer from 1 to 8. 
 
         made by the process of  claim 20 . 
       
     
     
         38 . The salt of  claim 37 , wherein the salt is

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