IP Library Granted Patent US 12,344,629
Granted Patent B2
US 12,344,629 · App. 17/576,699 · Granted Jul 1, 2025

Method of making nicotinamide ribofuranoside salts, nicotinamide ribofuranoside salts as such, and uses thereof

Inventors: Günter Schabert (Goldach, CH); Urs Spitz (St. Gallen, CH); Aysel Soydemir (Rorschach, CH); Iris Zimmermann (Bregenz, AT)
Assignee: BIOSYNTH AG
C07H19/048C07H1/06
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Quick Facts
Patent No.
US 12,344,629
App. No.
17/576,699
Filed
Jan 14, 2022
Granted
Jul 1, 2025
Kind
B2
Art Unit
1693
USPC
536/28.1
Abstract

The present invention relates to a method of making nicotinamide ribofuranoside salts, in particular pharmaceutically acceptable nicotinamide ribofuranoside salts. The invention further relates to the nicotinamide ribofuranoside salts as such, in particular carboxylic acid salts in crystalline form, and their use in nutritional supplements and pharmaceutical compositions.

Claims (30)

1. A method of making a nicotinamide-β-D-ribofuranoside salt, comprising steps (A) and (B):

(A) subjecting nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside bromide, chloride, iodide, triflate, nonaflate, fluorosulfonate or perchlorate to salt metathesis comprising counter-ion exchange to afford a nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside salt;

(B) deacylating the nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside salt to afford the nicotinamide-β-D-ribofuranoside salt,

wherein the counter-ion originates from an ammonium salt comprising the cation [NR 1 R 2 R 3 R 4 ] + or a phosphonium salt comprising the cation [PR 1 R 2 R 3 R 4 ] + wherein R 1 , R 2 , R 3 and R 4 are independently selected from H, C 1-12 alkyl and aryl,

wherein the salt metathesis is performed in a solvent comprising methanol, ethanol, propanol or butanol, or a mixture of two or more thereof, wherein the solvent optionally comprises water, and

wherein the counter-ion of the nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside salt obtained in step (A) via counter-ion exchange is a pharmaceutically acceptable ion selected from the group consisting of hydrogen sulfate, chloride, sulfate, dihydrogen phosphate, monohydrogen phosphate, phosphate, formate, acetate, oxalate, malonate, succinate, fumarate, maleate, citrate, malate, tartrate, ascorbate, α-ketoglutarate, glucuronate, benzoate, salicylate, mesylate camsylate, besylate and tosylate.

2. The method of claim 1 , comprising prior to step (A), step (X) and step (Y):

(X) subjecting a tetra-O-acyl-β-D-ribofuranose of formula

wherein each R is independently selected from alkyl carbonyl, aryl carbonyl and heteroaryl carbonyl, and wherein R is optionally independently substituted with one or more substituents selected from: C 1-6 alkyl, C 1-6 alkoxy, C 1-6 thioalkyl, halogen, nitro, cyano, NH(C 1-6 alkyl), N(C 1-6 alkyl), and SO 2 N(C 1-6 alkyl) 2 ,

to hydrogen bromide in acetic acid to afford a tri-O-acyl-D-ribofuranoside bromide of formula

(Y) reacting the tri-O-acyl-D-ribofuranoside bromide with nicotinamide

to afford a nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside bromide of formula

wherein nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside bromide formed in step (Y) is used in step (A).

3. The method of claim 1 , comprising prior to step (A), step (X):

(X) subjecting a tetra-O-acyl-β-D-ribofuranose of formula

wherein each R is independently selected from alkyl carbonyl, aryl carbonyl and heteroaryl carbonyl, and wherein R is optionally independently substituted with one or more substituents selected from: C 1-6 alkyl, C 1-6 alkoxy, C 1-6 thioalkyl, halogen, nitro, cyano, NH(C 1-6 alkyl), N(C 1-6 alkyl), and SO 2 N(C 1-6 alkyl) 2 ,

in the presence of trimethylsilyl chloride, trimethylsilyl bromide, trimethylsilyl iodide, trimethylsilyl triflate, trimethylsilyl nonaflate, trimethylsilyl fluorosulfonate or trimethylsilyl perchlorate to nicotinamide

to afford a nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside chloride, bromide, iodide, triflate, nonaflate, fluorosulfonate or perchlorate of formula

wherein nicotinamide-2,3,5-tri-O-acyl-β-D-ribofuranoside chloride, iodide, triflate, nonaflate, fluorosulfonate or perchlorate formed in step (X) is used in step (A).

4. The method of claim 1 , further comprising a pathway selected from (P2), wherein (P2) comprising steps (α), (β), (γ) and (δ):

(α) subjecting the nicotinamide-2,3,5-O-triacyl-β-D-ribofuranoside bromide, chloride, iodide, triflate, nonaflate, fluorosulfonate or perchlorate containing up to 5% of the α-anomer to salt metathesis to afford a nicotinamide-2,3,5-O-triacyl-β-D-ribofuranoside salt;

(β) isolating and optionally purifying the nicotinamide-2,3,5-O-triacyl-β-D-ribofuranoside salt;

(γ) cleaving the acyl groups in the nicotinamide-2,3,5-O-triacetyl-β-D-ribofuranoside salt to afford a nicotinamide-β-D-ribofuranoside salt; and

(δ) isolating and optionally purifying the nicotinamide-β-D-ribofuranoside salt.

5. The method of claim 1 , further comprising a pathway (P4), wherein (P4) comprising steps (α), (β), (γ) and (δ):

(α) subjecting the nicotinamide-2,3,5-O-triacyl-β-D-ribofuranoside bromide, chloride, iodide, triflate, nonaflate, fluorosulfonate or perchlorate containing up to 5% of the α-anomer to salt metathesis to afford a nicotinamide-2,3,5-O-triacyl-β-D-ribofuranoside salt;

(β) isolating and optionally purifying the nicotinamide-2,3,5-O-triacyl-β-D-ribofuranoside salt;

(γ) cleaving the acyl groups in the nicotinamide-2,3,5-O-triacetyl-β-D-ribofuranoside salt to afford a nicotinamide-β-D-ribofuranoside salt; and

(δ) isolating and optionally purifying the nicotinamide-β-D-ribofuranoside salt.

6. The method of claim 1 , wherein the nicotinamide-β-D-ribofuranoside salt is a malate or tartrate salt.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2022
From: SCHABERT, GUNTER; SPITZ, URS; SOYDEMIR, AYSEL; ZIMMERMANN, IRIS
To: BIOSYNTH AG
Reel/Frame 059804/0891 →
Priority Claims (2)
EP 19187314 · Jul 19, 2019 · regional
EP 19206542 · Oct 31, 2019 · regional
Continuity (2)
Continuation PCTEP2020070451 · Jul 20, 2020
Related Publication 20220135610A1 · May 5, 2022
References Cited (97)
US 7544497B2 · Sinclair et al. · 2009 [cited by applicant]
US 7652049B2 · Ali et al. · 2010 [cited by applicant]
US 7915271B2 · Ali et al. · 2011 [cited by applicant]
US 8106184B2 · Sauve et al. · 2012 [cited by applicant]
US 8114626B2 · Brenner et al. · 2012 [cited by applicant]
US 8197807B2 · Brenner · 2012 [cited by applicant]
US 8383086B2 · Brenner et al. · 2013 [cited by applicant]
US 8735435B2 · Ali et al. · 2014 [cited by applicant]
US 8846724B2 · Sinclair et al. · 2014 [cited by applicant]
US 8889126B2 · Milbrandt et al. · 2014 [cited by applicant]
US 9000147B2 · Sauve et al. · 2015 [cited by applicant]
US 9241916B2 · Sinclair et al. · 2016 [cited by applicant]
US 9295688B2 · Milbrandt et al. · 2016 [cited by applicant]
US 9321797B2 · Sauve et al. · 2016 [cited by applicant]
US 9597347B2 · Sinclair et al. · 2017 [cited by applicant]
US 9855289B2 · Normington et al. · 2018 [cited by applicant]
US 9861651B2 · Brown et al. · 2018 [cited by applicant]
US 9877981B2 · Sinclair et al. · 2018 [cited by applicant]
US 9919003B2 · Normington et al. · 2018 [cited by applicant]
US 9975915B1 · Migaud et al. · 2018 [cited by applicant]
US 10000520B2 · Migaud et al. · 2018 [cited by applicant]
US 10189872B2 · Carlson et al. · 2019 [cited by applicant]
US 10233207B2 · Carlson et al. · 2019 [cited by applicant]
US 10316054B2 · Szczepankiewicz et al. · 2019 [cited by applicant]
US 10323058B2 · Carlson et al. · 2019 [cited by applicant]
US 10548913B2 · Normington et al. · 2020 [cited by applicant]
US 10603334B2 · Wu et al. · 2020 [cited by applicant]
US 10689411B2 · Migaud et al. · 2020 [cited by applicant]
US 10934322B2 · Migaud et al. · 2021 [cited by applicant]
US 11242364B1 · Migaud et al. · 2022 [cited by applicant]
US 11274117B2 · Migaud et al. · 2022 [cited by applicant]
US 11584771B2 · Schabert et al. · 2023 [cited by applicant]
US 12043616B2 · Marcotulli et al. · 2024 [cited by applicant]
US 20150265642A1 · Sinclair et al. · 2015 [cited by applicant]
US 20160279161A1 · Wu et al. · 2016 [cited by applicant]
US 20170121746A1 · Velasquez · 2017 [cited by examiner]
US 20170146517A1 · Cohen et al. · 2017 [cited by applicant]
US 20170252362A1 · Vannini et al. · 2017 [cited by applicant]
US 20170312300A1 · Djouder et al. · 2017 [cited by applicant]
US 20180051253A1 · Chen · 2018 [cited by applicant]
US 20180118819A1 · Sinclair et al. · 2018 [cited by applicant]
US 20180134743A1 · Migaud et al. · 2018 [cited by applicant]
US 20180163243A1 · Wu et al. · 2018 [cited by applicant]
US 20180258127A1 · Migaud et al. · 2018 [cited by applicant]
US 20200046741A1 · Sinclair et al. · 2020 [cited by applicant]
US 20200069711A1 · Marcotulli et al. · 2020 [cited by applicant]
US 20220135610A1 · Schabert et al. · 2022 [cited by applicant]
US 20230348521A1 · Marcotulli et al. · 2023 [cited by applicant]
CN 105873937A · 2016 [cited by applicant]
CN 106536535A · 2017 [cited by applicant]
CN 107531738A · 2018 [cited by applicant]
CN 108774278A · 2018 [cited by applicant]
EA 026425B1 · 2017 [cited by applicant]
EP 3063163A1 · 2016 [cited by applicant]
EP 3149016A1 · 2017 [cited by applicant]
EP 3429354A1 · 2019 [cited by applicant]
EP 3538099A1 · 2019 [cited by applicant]
EP 3063163B1 · 2022 [cited by applicant]
JP 2016538271A · 2016 [cited by applicant]
TW 201802105A · 2018 [cited by applicant]
WO WO2010010454A2 · 2010 [cited by applicant]
WO WO2010083414A1 · 2010 [cited by applicant]
WO WO2015014722A1 · 2015 [cited by applicant]
WO WO2015066382A1 · 2015 [cited by applicant]
WO WO2015186068A1 · 2015 [cited by applicant]
WO WO2016014927A2 · 2016 [cited by applicant]
WO WO2016149395A1 · 2016 [cited by applicant]
WO WO2017161165A1 · 2017 [cited by applicant]
WO WO2017218580A1 · 2017 [cited by applicant]
WO WO2018089830A1 · 2018 [cited by applicant]
WO WO2019219895A1 · 2019 [cited by applicant]
WO WO2021013795A2 · 2021 [cited by applicant]
WO WO2021013795A3 · 2021 [cited by applicant]
Zhang, CN 108774278A, Nov. 19, 2018, machine translation. (Year: 2018). [cited by examiner]
Bastin, Richard J., et al., Salt Selection and Optimisation Procedures for Pharmaceutical New Chemical Entities. Organic Process Research and Development 4(5):427-435 (2000). [cited by applicant]
Bernstein, J. Polymorphism in molecular crystals. Moscow, Science, 2007, chapter 7.3.2. Bioavailability, p. 324-330. With English machine translation. [cited by applicant]
Bernstein, J. Polymorphism in Molecular Crystals, pp. 243-249. Clarendon Press, Oxford (2002). [cited by applicant]
Caira, Mino R., Crystalline Polymorphism of Organic Compounds. Topics in Current Chemistry 198:163-208 (1998). [cited by applicant]
Kummerer, Klaus, Pharmaceuticals in the environment. Annual review of environment and resources 35:57-75 (2010). [cited by applicant]
Kuznetsova, G.A., Methodical Recommendations, Irkutsk State University, Chapter General Physics, 28 pages (2005). With English machine translation. [cited by applicant]
Morisette, et al. High-throughput Crystallization: Polymorphs, Salts, Co-crystals and Solvates of Pharmaceutical Solids. Advanced Drug Delivery Reviews 56(3):275-300 (2004). [cited by applicant]
Rodriguez-Spong, Barbara, et al., General principles of pharmaceutical solid polymorphism: a supramolecular perspective. Advanced Drug Delivery Reviews 56:241-274 (2004). [cited by applicant]
Tyurina, L.E., et al., Food Additives. Ministry of Agriculture of the Russian Federation Krasnoyarsk State Agrarian University, Krasnoyarsk, 7 pages (2008). With English machine translation. [cited by applicant]
Variankaval, Narayan, et al., From form to function: Crystallization of active pharmaceutical ingredients. AlChE Journal 54(7):1682-1688 (2008). [cited by applicant]
Newman. Specialized Solid Form Screening Techniques. Org Process Res Dev 17:457-471 (Oct. 30, 2012). Special Issue: Polymorphism and Crystallization 2013. [cited by applicant]
Conze et al. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride)in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Scientific Reports … [cited by applicant]
Co-pending U.S. Appl. No. 17/711,799, inventors Schabert; Günter et al., filed Apr. 1, 2022. [cited by applicant]
Jarman et al. 4-Substituted Nicotinic Acids and Nicotinamides. Part II. The Preparation of 4-Methylnicotinamide Riboside. J Chem Soc (C), pp. 199-203 (1969). [cited by applicant]
Lee et al. A chemical synthesis of nicotinamide adenine dinucleotide (NAD+). Chem. Commun., 1999, 729-730. [cited by applicant]
Makarov et al. Syntheses and chemical properties of B-nicotinamide riboside and its analogues and derivatives. Beilstein J. Org. Chem. 2019, 15, 401-430. [cited by applicant]
PCT/EP2020/070451 International Preliminary Report on Patentability dated Jan. 25, 2022. [cited by applicant]
PCT/EP2020/070451 International Search Report and Written Opinion dated Jan. 18, 2021. [cited by applicant]
Tanimori et al. An efficient chemical synthesis of nicotinamide riboside (NAR) and analogues. Bioorganic & Medicinal Chemistry Letters 12 (2002) 1135-1137. [cited by applicant]
Yang et al. Syntheses of nicotinamide riboside and derivatives: effective agents for increasing nicotinamide adenine dinucleotide concentrations in mammalian cells. J. Med. Chem. 50:6458-61 (2007). [cited by applicant]
Gupta, Deepak, et al., Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations. Molecules 23(7):1719 (2018). [cited by applicant]
Patel, Viralkumar et al. Intestinal and renal effects of low-volume phosphate and sulfate cathartic solutions designed for cleansing the colon: pathophysiological studies in five normal subjects. Am J Gastroenterol 104(… [cited by applicant]
Co-pending U.S. Appl. No. 18/963,281, inventors Schabert; Gunter et al., filed Nov. 27, 2024. [cited by applicant]