# US 12,594,326 B2 · Compositions of GLP-1 peptides and preparation thereof

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- Number: US 12,594,326 B2
- Document ID: US12594326B2
- Status: Granted
- Kind: B2
- Application number: 19/071,109
- Filed: 2025-03-05
- Published: 2025-06-19
- Granted: 2026-04-07
- Earliest claimed: 2012-03-22
- Assignees: Novo Nordisk A/S
- Applicants: Novo Nordisk A/S
- Inventors: Thomas Kvistgaard Vilhelmsen; Helle Eliasen; Tue Hansen
- Web page: https://patentgrep.com/patent/US12594326B2

## CPC

- A61K 38/26: Glucagons
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2077: {Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets}
- A61K 31/20: having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.

## Claims

### Claim 1

A pharmaceutical composition comprising a first type and a second type of granules,
wherein the first type of granules comprises at least 70% (w/w) of sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC) and less than 10% (w/w) of a lubricant, and
wherein the second type of granules comprises semaglutide, at least 15% (w/w) of a filler, and less than 40% (w/w) of a binder.

### Claim 2 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the lubricant is magnesium stearate.

### Claim 3 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the filler is microcrystalline cellulose.

### Claim 4 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the binder is povidone.

### Claim 5 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the first type of granules does not comprise semaglutide.

### Claim 6 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the second type of granules does not comprise SNAC.

### Claim 7 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the first type of granules does not comprise semaglutide, and wherein the second type of granules does not comprise SNAC.

### Claim 8 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the lubricant is magnesium stearate, wherein the filler is microcrystalline cellulose, and wherein the binder is povidone.

### Claim 9 (depends on 8)

The pharmaceutical composition according to claim 8, wherein the first type of granules does not comprise semaglutide.

### Claim 10 (depends on 8)

The pharmaceutical composition according to claim 8, wherein the second type of granules does not comprise SNAC.

### Claim 11 (depends on 8)

The pharmaceutical composition according to claim 8, wherein the first type of granules does not comprise semaglutide, and wherein the second type of granules does not comprise SNAC.