IP Library Granted Patent US 9,085,553
Granted Patent B2
US 9,085,553 · App. 13/950,807 · Granted Jul 21, 2015

LFA-1 inhibitor and methods of preparation and polymorph thereof

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Quick Facts
Patent No.
US 9,085,553
App. No.
13/950,807
Granted
Jul 21, 2015
Kind
B2
Abstract

Methods of preparation and purification of a compound of Formula I, intermediates thereof, a polymorph thereof, and related compounds are disclosed. Formulations and uses thereof in the treatment of LFA-1 mediated diseases are also disclosed.

Claims (24)

1. A method of synthesizing a compound of Formula I:

or a salt thereof, comprising the steps:

a) performing hydrolysis of Formula AA with a base under biphasic conditions:

wherein R is a carbon-containing moiety or a silyl-containing moiety; and

b) isolating said compound of Formula I or a salt thereof.

2. The method of claim 1 , wherein the biphasic conditions include aqueous acetone.

3. The method of claim 2 , wherein the aqueous acetone is about 30% aqueous acetone.

4. The method of claim 2 , wherein the aqueous acetone is present in an amount ranging from about 1:1 to about 5:1 by weight with respect to Formula AA.

5. The method of claim 1 , wherein the base is sodium hydroxide.

6. The method of claim 5 , wherein the sodium hydroxide is added in an amount ranging from about 1.0 to about 1.5 equivalents.

7. The method of claim 6 , wherein the sodium hydroxide is added in an amount of about 1.2 equivalents.

8. The method of claim 1 , further comprising a phase transfer catalyst.

9. The method of claim 8 , wherein said phase transfer catalyst is a quaternary ammonium salt.

10. The method of claim 9 , wherein said quaternary ammonium salt is tetrabutylammonium hydroxide.

11. The method of claim 8 , wherein said phase transfer catalyst is present in an amount ranging from about 0.01 equivalents to about 0.5 equivalents.

12. The method of claim 1 , wherein R is a substituted or unsubstituted group selected from lower alkyl, lower alkenyl, lower alkynyl, cyclo(lower)alkyl, cyclo(lower)alkenyl, aryl, aralkyl, heterocyclyl, and heteroaryl groups.

13. The method of claim 1 , wherein Formula AA is:

14. The method of claim 1 , further comprising purifying said compound of Formula I by recrystallization.

15. The method of claim 14 , wherein said recrystallization is performed with aqueous acetone.

16. A composition comprising a compound of Formula I:

wherein said compound is synthesized by a process comprising the following steps:

a) performing hydrolysis of Formula AA with a base under biphasic conditions:

wherein R is a carbon-containing moiety or a silyl-containing moiety; and

b) isolating said compound of Formula I or a salt thereof, and further wherein said compound has an optical purity of >98%.

Assignments (12)
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Dec 23, 2025
From: BAUSCH + LOMB IRELAND LIMITED
To: CITIBANK, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 074050/0709 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Dec 23, 2025
From: BAUSCH + LOMB IRELAND LIMITED
To: CITIBANK, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 074050/0682 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Dec 23, 2025
From: BAUSCH + LOMB IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 074050/0573 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2023
From: NOVARTIS PHARMACEUTICALS CORPORATION
To: BAUSCH + LOMB IRELAND LIMITED
Reel/Frame 065789/0853 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 22, 2020
From: NOVARTIS AG
To: NOVARTIS PHARMACEUTICALS CORPORATION
Reel/Frame 054134/0708 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2019
From: SARCODE BIOSCIENCE INC.
To: NOVARTIS AG
Reel/Frame 050900/0268 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2015
From: VENKATRAMAN, SRIPATHY; BROT, ELISABETH C.A.
To: ALBANY MOLECULAR RESEARCH INC.
Reel/Frame 035774/0194 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2015
From: ALBANY MOLECULAR RESEARCH INC.
To: SARCODE BIOSCIENCE INC.
Reel/Frame 035775/0229 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2015
From: ZELLER, JAMES ROBERT
To: SARCODE BIOSCIENCE INC.
Reel/Frame 035774/0975 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2015
From: VENKATRAMAN, SRIPATHY; BROT, ELISABETH C.A.; IYER, SUBASHREE; HALL, MICHAEL
To: ALBANY MOLECULAR RESEARCH INC.
Reel/Frame 035774/0713 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2015
From: ALBANY MOLECULAR RESEARCH INC.
To: SARCODE BIOSCIENCE INC.
Reel/Frame 035774/0470 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2015
From: ZELLER, JAMES ROBERT
To: SARCODE BIOSCIENCE INC.
Reel/Frame 035774/0367 →