IP Library › Granted Patent US 12,403,140
Granted Patent B2
US 12,403,140 · App. 18/468,266 · Granted Sep 2, 2025

Pharmaceutical compositions of nilotinib

Inventors: Paras P. Jain (Maharashtra, IN); Ajay Kumar Singh (Princeton, NJ); Keerthi Priya (Telangana, IN); Girish Kumar Jain (Maharashtra, IN); Girish G. Kore (Maharashtra, IN); Sandeep Jain (Madhya Pradesh, IN); Hanimi Reddy Bapatu (Telangana, IN)
Assignee: AZURITY PHARMACEUTICALS, INC.
A61K31/4985A61K9/10A61K9/2095
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Quick Facts
Patent No.
US 12,403,140
App. No.
18/468,266
Granted
Sep 2, 2025
Kind
B2
Abstract

Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., C max , AUC 0-t and/or AUC 0-infinity ) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

Claims (15)

1. A pharmaceutical composition comprising:

(i) nilotinib tartrate;

(ii) pharmaceutically acceptable carrier selected from the group consisting of hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine and vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl methylcellulose, (HPMC), polyethylene glycol (PEG), hydroxypropyl cellulose (HPC), carboxymethyl cellulose (CMC), polyvinyl pyrrolidine (PVP), and combinations thereof; and

(iii) one or more pharmaceutically acceptable excipients;

wherein an administered amount equivalent to nilotinib is about 50% less than a dose required for delivering a therapeutically effective amount equivalent to nilotinib in a fasted state using a reference formulation.

2. The pharmaceutical composition according to claim 1 , wherein said nilotinib tartrate is substantially in amorphous form.

3. The pharmaceutical composition according to claim 1 , wherein the weight ratio of the nilotinib tartrate to the pharmaceutically acceptable carrier is from about 1:6 to about 1:1.

4. The pharmaceutical composition according to claim 1 , wherein a dose of nilotinib administered in the pharmaceutical composition is from 125 mg to 150 mg.

5. The pharmaceutical composition according to claim 1 , wherein a dose of nilotinib administered in the pharmaceutical composition is from 175 mg to 200 mg.

6. The pharmaceutical composition according to claim 1 , wherein a dose of nilotinib administered in the reference composition is 300 mg.

7. The pharmaceutical composition according to claim 1 , wherein a dose of nilotinib administered in the reference composition is 400 mg.

8. The pharmaceutical composition according to claim 1 , wherein an amount equivalent to nilotinib in a unit dosage form of said pharmaceutical composition is from 50 mg to 75 mg.

9. The pharmaceutical composition according to claim 1 , wherein an amount equivalent to nilotinib in a unit dosage form of said pharmaceutical composition is from 75 mg to 100 mg.

10. The pharmaceutical composition according to claim 1 , wherein an amount equivalent to nilotinib in a unit dosage form of said pharmaceutical composition is about 75 mg.

11. The pharmaceutical composition according to claim 1 , wherein an amount equivalent to nilotinib in a unit dosage form of said pharmaceutical composition is about 100 mg.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2025
From: SLAYBACK PHARMA LIMITED LIABILITY COMPANY
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 070877/0696 →
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Mar 17, 2025
From: ARBOR PHARMACEUTICALS, LLC; AZURITY PHARMACEUTICALS, INC.; AZURITY PHARMACEUTICALS IRELAND LIMITED; SILVERGATE PHARMACEUTICALS, INC.
To: HPS INVESTMENT PARTNERS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 070531/0487 →
RELEASE OF SECURITY INTEREST Recorded Mar 14, 2025
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: AZURITY PHARMACEUTICALS, INC.; SILVERGATE PHARMACEUTICALS, INC.; ARBOR PHARMACEUTICALS, LLC; SLAYBACK PHARMA LIMITED LIABILITY COMPANY
Reel/Frame 070521/0299 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2024
From: JAIN, PARAS P.; SINGH, AJAY KUMAR; PRIYA, KEERTHI; JAIN, GIRISH KUMAR; KORE, GIRISH G.; JAIN, SANDEEP; BAPATU, HANIMI REDDY
To: SLAYBACK PHARMA LLC
Reel/Frame 066166/0495 →
Priority Claims (1)
IN 201941006393 · Feb 18, 2019 · national
Continuity (3)
Continuation 16953728 · Nov 20, 2020
Continuation 16793833 · Feb 18, 2020
Related Publication 20240009188A1 · Jan 11, 2024
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