IP Library › Granted Patent US 12,616,738
Granted Patent B2
US 12,616,738 · App. 17/988,271 · Granted May 5, 2026

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, 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 12,616,738
App. No.
17/988,271
Granted
May 5, 2026
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 (32)

1 . A composition comprising

i) a GLP-1 agonist,

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

iii) a hydrotrope, wherein the hydrotrope increases the solubility of SNAC at least 2-fold when the solubility is measured at a concentration of 200 mg/ml of the hydrotrope at a pH of 6.

2 . The composition according to claim 1 , wherein the hydrotrope is selected from the group consisting of nipecotamide, nicotinamide, p-hydroxybenzoic acid sodium, N,N dimethyl urea, N,N dimethyl benzamide, N,N diethyl nicotinamide, sodium salicylate, resorcinol, sodium benzoate, sodium xylenesulfonate, sodium p-toluenesulfonate, 1-methylnicotinamide, pyrogallol, pyrocathecol, epigallocatechin gallate, tannic acid and gentisic acid sodium salt hydrate.

3 . The composition according to claim 2 , wherein the composition further comprises a lubricant.

4 . The composition according to claim 3 , wherein the lubricant is selected from the group consisting of magnesium stearate and glyceryl dibehenate.

5 . The composition according to claim 3 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-10.

6 . The composition according to claim 5 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-8.

7 . The composition according to claim 6 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-5.

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

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

10 . The composition according to claim 9 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-5.

11 . The composition according to claim 1 , wherein the GLP-1 agonist comprises at least one albumin binding substituent.

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

13 . The composition according to claim 1 , wherein the lubricant is selected from the group consisting of magnesium stearate and glyceryl dibehenate.

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

15 . The composition according to claim 14 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-10.

16 . The composition according to claim 15 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-8.

17 . The composition according to claim 16 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-5.

18 . The composition according to claim 14 , wherein the hydrotrope is selected from the group consisting of nipecotamide, nicotinamide, p-hydroxybenzoic acid sodium, N,N dimethyl urea, N,N dimethyl benzamide, N,N diethyl nicotinamide, sodium salicylate, resorcinol, sodium benzoate, sodium xylenesulfonate, sodium p-toluenesulfonate, 1-methylnicotinamide, pyrogallol, pyrocathecol, epigallocatechin gallate, tannic acid and gentisic acid sodium salt hydrate.

19 . The composition according to claim 18 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-10.

20 . The composition according to claim 19 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-8.

21 . The composition according to claim 20 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-5.

22 . The composition according to claim 14 , wherein the composition further comprises a lubricant.

23 . The composition according to claim 22 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-10.

24 . The composition according to claim 23 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-8.

25 . The composition according to claim 24 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-5.

26 . The composition according to claim 1 , wherein the composition is a pharmaceutical composition suitable for use in a method of treating diabetes and/or obesity.

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

28 . The composition according to claim 27 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-8.

29 . The composition according to claim 28 , wherein the ratio of SNAC/hydrotrope (w/w) is 0.5-5.

Priority Claims (1)
EP 18171046 · May 7, 2018 · regional
Continuity (2)
Continuation 17053511
Related Publication 20230087952A1 · Mar 23, 2023
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