IP Library Granted Patent US 12,201,638
Granted Patent B2
US 12,201,638 · App. 18/621,023 · Granted Jan 21, 2025

Pharmaceutical compositions comprising (2S)-n-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl}-1,4-oxazepane-2-carboxamide

Inventors: Håkan Wikström (Mölndal, SE); Jufang Wu Ludvigsson (Mölndal, SE); Thomas Andersson (Mölndal, SE)
Assignee: ASTRAZENECA AB
A61K31/553A61K9/2009A61K9/2013A61K9/2054A61K9/2059A61K31/675A61K45/06C07K16/241C07K16/2887
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Quick Facts
Patent No.
US 12,201,638
App. No.
18/621,023
Granted
Jan 21, 2025
Kind
B2
Abstract

The present disclosure relates to pharmaceutical compositions suitable for oral administration, and more particularly to pharmaceutical compositions, including pharmaceutical tablet compositions, containing (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl}-1,4-oxazepane-2-carboxamide (Compound A) or a pharmaceutically acceptable salt thereof.

Claims (15)

1. A pharmaceutical composition comprising:

(a) from about 3 wt % to about 15 wt % of (2S)-N-{(1S)-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl) phenyl]ethyl}-1,4-oxazepane-2-carboxamide (Compound A);

(b) from about 55 wt % to about 70 wt % microcrystalline cellulose;

(c) from about 18 wt % to about 22 wt % dibasic calcium phosphate dihydrate;

(d) from about 3.5 wt % to about 4.5 wt % sodium starch glycolate;

(e) from about 0.05 wt % to about 0.50 wt % silicon dioxide; and

(f) from about 2.5 wt % to about 7 wt % glycerol behenate;

and wherein the weights of components (a)-(f) add up to 100 wt %.

2. The pharmaceutical composition of claim 1 , wherein the composition is in tablet form.

3. The pharmaceutical composition of claim 2 , wherein the composition further comprises a tablet coat.

4. The pharmaceutical composition of claim 1 , wherein Compound A is present at from about 5 mg to about 50 mg in the composition.

5. The pharmaceutical composition of claim 1 , wherein Compound A is present at from about 10 mg to about 40 mg in the composition.

6. The pharmaceutical composition of claim 1 , wherein Compound A is present at 10 mg in the composition.

7. The pharmaceutical composition of claim 1 , wherein Compound A is present at 25 mg in the composition.

8. The pharmaceutical composition of claim 1 , wherein Compound A is present at 40 mg in the composition.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2024
From: WIKSTRÖM, HÅKAN; LUDVIGSSON, JUFANG WU; ANDERSSON, THOMAS
To: ASTRAZENECA AB
Reel/Frame 066998/0673 →
Continuity (3)
Continuation 16975292
Provisional Application 62636944 · Mar 1, 2018
Related Publication 20240252512A1 · Aug 1, 2024
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Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on Aug. 16, 2022, 6 pages. [cited by applicant]
Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on Jul. 27, 2022, 6 pages. [cited by applicant]
Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on Jul. 5, 2022, 6 pages. [cited by applicant]
Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on Jun. 7, 2022, 6 pages. [cited by applicant]
Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on May 16, 2022, 6 pages. [cited by applicant]
Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on Oct. 19, 2022, 5 pages. [cited by applicant]
Clinical Trials Identifier: NCT05355935. ClinicalTrials.gov submitted on Sep. 9, 2022, 6 pages. [cited by applicant]
Clinical Trials Identifier: NCT05517525. ClinicalTrials.gov submitted on Aug. 24, 2022, 5 pages. [cited by applicant]
Clinical Trials Identifier: NCT05517525. ClinicalTrials.gov submitted on Nov. 7, 2022, 4 pages. [cited by applicant]
Clinical Trials Identifier: NCT05517525. ClinicalTrials.gov submitted on Oct. 17, 2022, 4 pages. [cited by applicant]
Clinical Trials Identifier: NCT05517525. ClinicalTrials.gov submitted on Sep. 21, 2022, 5 pages. [cited by applicant]
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