IP Library Granted Patent US 11,453,658
Granted Patent B2
US 11,453,658 · App. 16/850,771 · Granted Sep 27, 2022

Synthesis of antibacterial aminoglycoside analogs

Inventors: Raissa Trend (Warren, NJ); Michael Dappen (Warren, NJ); Christopher E. Henry (Warren, NJ); Adam Aaron Goldblum (Warren, NJ); James Bradley Aggen (Warren, NJ); Ricardo Filipe de Jesus Gonçalves Mendonça (Warren, NJ); João Carlos Falcão Sardinha (Warren, NJ)
Assignee: CIPLA USA, INC.
C07D407/12C07B2200/13
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Quick Facts
Patent No.
US 11,453,658
App. No.
16/850,771
Granted
Sep 27, 2022
Kind
B2
Abstract

The present disclosure relates to novel methods for preparing antibacterial aminoglycoside compounds, as well as to related intermediates, and crystal forms thereof, useful in such methods.

Claims (30)

1. A compound selected from the group consisting of

(i) a compound of formula (4):

or a salt thereof, or a solvate thereof, or an enantiomer thereof, or a diastereomer thereof;

(ii) a compound of formula (4a):

or a salt thereof, or a solvate thereof;

(iii) crystalline tert-butyl ((2S,3R)-2-(((1R,2S,3 S,4R,6S)-6-((tert-butoxycarbonyl)amino)-4-((S)-4-((tert-butoxycarbonyl)amino)-2-hydroxybutanamido)-3-(((2R,3R,4R,5R)-3,5-dihydroxy-5-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-6-(((((4-nitrobenzyl)oxy)carbonyl)amino)methyl)-3,4-dihydro-2H-pyran-3-yl)carbamate, Formula (4a), or a solvate thereof;

(iv) crystalline tert-butyl ((2R,3R,4R,5R)-2-(((1S,2S,3R,4S,6R)-3,4(2S,3R)-6-(aminomethyl)-3-((tert-butoxycarbonyl)amino)-3,4-dihydro-2H-pyran-2-yl)oxy)-4-((tert-butoxycarbonyl)amino)-6-((S)-4-((tert-butoxycarbonyl)amino)-2-hydroxybutanamido)-2-hydroxycyclohexyl)oxy)-3,5-dihydroxy-5-methyltetrahydro-2H-pyran-4-yl)(methyl)carbamate, Formula (6a), or a solvate thereof;

(v) a compound of formula (7):

or a salt thereof, or solvate thereof, or an enantiomer thereof, or a diastereomer thereof;

(vi) a compound of formula (7a):

or a salt thereof, or a solvate thereof; and

(vii) crystalline tert-butyl ((2R,3R,4R,5R)-2-(((1S,2S,3R,4S,6R)-4-((tert-butoxycarbonyl)amino)-6-((S)-4-((tert-butoxycarbonyl)amino)-2-hydroxybutanamido)-3-(((2S,3R)-3-((tert-butoxycarbonyl)amino)-6-(((2-hydroxyethyl)amino)methyl)-3,4-dihydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-3,5-dihydroxy-5-methyltetrahydro-2H-pyran-4-yl)(methyl)carbamate, Formula (7a), or a solvate thereof.

2. A process for preparing the compound of claim 1 , wherein the compound is crystalline tert-butyl ((2S,3R)-2-(((1R,2S,3S,4R,6S)-6-((tert-butoxycarbonyl)amino)-4-((S)-4-((tert-butoxycarbonyl)amino)-2-hydroxybutanamido)-3-(((2R,3R,4R,5R)-3,5-dihydroxy-5-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-6-(((((4-nitrobenzyl)oxy)carbonyl)amino)methyl)-3,4-dihydro-2H-pyran-3-yl)carbamate, Formula (4a), or a solvate thereof, wherein the process comprises:

(a) treating Formula (4a), or a salt thereof, or a solvate thereof, with acetonitrile to produce a solution;

(b) heating the solution from step (a);

(c) adding water to the heated solution of step (b);

(d) cooling the solution from step (c);

(e) charging the solution from step (d) with a seed crystal; and

(f) isolating the resulting solids to yield crystalline Formula (4a), or a solvate thereof.

3. A process for preparing the compound of claim 1 , wherein the compound is crystalline tert-butyl ((2R,3R,4R,5R)-2-(((1S,2S,3R,4S,6R)-3-(((2S,3R)-6-(aminomethyl)-3-((tert-butoxycarbonyl)amino)-3,4-dihydro-2H-pyran-2-yl)oxy)-4-((tert-butoxycarbonyl)amino)-6-((S)-4-((tert-butoxycarbonyl)amino)-2-hydroxybutanamido)-2-hydroxycyclohexyl)oxy)-3,5-dihydroxy-5-methyltetrahydro-2H-pyran-4-yl)(methyl)carbamate, Formula (6a), or a solvate thereof, wherein the process comprises:

(a) treating Formula (6), or a salt thereof, or a solvate thereof, with isopropyl acetate (IPAc) to produce a solution;

(b) adding water to the solution of step (a) to produce a mixture;

(c) adding dichloromethane to the mixture from step (b) to produce a mixture;

(d) charging the mixture from step (c) with a seed crystal;

(e) isolating the resulting solids to yield crystalline Formula (6a), or a solvate thereof.

4. A process for preparing the compound of claim 1 , wherein the compound is crystalline tert-butyl ((2R,3R,4R,5R)-2-(((1 S,2 S,3R,4 S,6R)-4-((tert-butoxycarbonyl)amino)-6-((S)-4-((tert-butoxycarbonyl)amino)-2-hydroxybutanamido)-3-(((2 S,3R)-3-((tert-butoxycarbonyl)amino)-6-(((2-hydroxyethyl)amino)methyl)-3,4-dihydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-3,5-dihydroxy-5-methyltetrahydro-2H-pyran-4-yl)(methyl)carbamate, Formula (7a), or a solvate thereof, wherein the process comprises:

(a) treating Formula (7a), or a salt thereof, or a solvate thereof, with isopropyl acetate (IPAc) to produce a solution;

(b) adding acetonitrile to the solution of step (a) to produce a mixture;

(c) charging the mixture from step (b) with a seed crystal;

(d) isolating the resulting solids to yield crystalline Formula (7a), or a solvate thereof.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: MENDONÇA, RICARDO FILIPE DE JESUS GONÇALVES; SARDINHA, JOÃO CARLOS FALCÃO
To: HOVIONE FARMACIENCIA SA
Reel/Frame 055773/0466 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: HOVIONE FARMACIENCIA SA
To: HOVIONE INTER LTD
Reel/Frame 055773/0490 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: HOVIONE INTER LTD
To: ACHAOGEN, INC.
Reel/Frame 055773/0500 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: TREND, RAISSA; DAPPEN, MICHAEL; HENRY, CHRISTOPHER E.; GOLDBLUM, ADAM AARON; AGGEN, JAMES BRADLEY
To: ACHAOGEN, INC.
Reel/Frame 055776/0043 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: ACHAOGEN, INC.
To: CIPLA USA, INC.
Reel/Frame 055776/0059 →
Continuity (3)
Continuation PCTUS2018056536 · Oct 18, 2018
Provisional Application 62574544 · Oct 19, 2017
Related Publication 20200317652A1 · Oct 8, 2020