IP Library › Granted Patent US 11,622,996
Granted Patent B2
US 11,622,996 · App. 17/053,511 · Granted Apr 11, 2023

Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid

Inventors: Simon Bjerregaard (Hilleroed, DK); Ulrik Lytt Rahbek (Charlottenlund, DK); Philip Jonas Sassene (Copenhagen V, DK); Jorrit Jeroen Water (Frederiksberg, DK); Andreas Vegge (Frederiksberg, DK)
Assignee: Novo Nordisk A/S
A61K38/26A61K9/0053A61K47/10A61K47/14A61K47/183A61K47/22
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Quick Facts
Patent No.
US 11,622,996
App. No.
17/053,511
Granted
Apr 11, 2023
Kind
B2
Abstract

The invention relates to pharmaceutical compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. The invention further relates to processes for the preparation of such compositions, and their use in medicine.

Claims (19)

1. A composition comprising

i) semaglutide,

ii) sodium salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC), and

iii) nicotinamide, wherein the nicotinamide increases the solubility of SNAC at least 5-fold when the solubility is measured at a concentration of 200 mg/ml of the nicotinamide at a pH of 6.

2. The composition according to claim 1 , wherein the ratio of the SNAC/nicotinamide (w/w) (w/w) is 0.5-10.

3. The composition according to claim 2 , wherein the ratio of the SNAC/nicotinamide (w/w) is 0.5-8.

4. The composition according to claim 3 , wherein the ratio of the SNAC/nicotinamide (w/w) is 0.5-5.

5. The composition according to claim 4 , wherein the composition further comprises a lubricant selected from the group consisting of magnesium stearate and glyceryl dibehenate.

6. The composition according to claim 3 , wherein the composition further comprises a lubricant selected from the group consisting of magnesium stearate and glyceryl dibehenate.

7. The composition according to claim 1 , wherein the composition further comprises a lubricant.

8. The composition according to claim 7 , wherein a unit dosage is:

i) 0.1-30 mg of the semaglutide,

ii) 50-600 mg of the SNAC,

iii) 20-200 mg of the nicotinamide, and

iv) 0-10 mg of the lubricant.

9. The composition according to claim 8 , wherein the lubricant is selected from the group consisting of magnesium stearate and glyceryl dibehenate.

10. The composition according to claim 7 , wherein the lubricant is selected from the group consisting of magnesium stearate and glyceryl dibehenate.

11. The composition according to claim 1 , wherein the composition is a solid composition.

12. The composition according to claim 1 wherein the composition is a pharmaceutical composition suitable for oral administration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 6, 2021
From: BJERREGAARD, SIMON; RAHBEK, ULRIK LYTT; SASSENE, PHILIP JONAS; WATER, JORRIT JEROEN; VEGGE, ANDREAS
To: NOVO NORDISK A/S
Reel/Frame 056157/0285 →
Priority Claims (1)
EP 18171046 · May 7, 2018 · regional
Continuity (1)
Related Publication 20210236601A1 · Aug 5, 2021
Cited By (2)
US 12,616,738 US 12,636,250