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Solid Compositions Comprising A Glp 1 Agonist And A Salt Of N (8 (2 Hydroxybenzoyl)amino)caprylic Acid

Abstract: The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
19 November 2019
Publication Number
48/2019
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
nncp-in@novonordisk.com
Parent Application

Applicants

Novo Nordisk A/S
Novo Allé, DK-2880 Bagsværd,

Inventors

1. SAUERBERG, Per
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd, Denmark
2. BJERREGAARD, Simon
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd, Denmark
3. NIELSEN, Flemming Seier
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Specification

A tablet comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein said tablet comprises at least 60% (w/w), such as at least 70% (w/w) or at least 75% (w/w), of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid; and additional pharmaceutically ac¬ceptable excipient; and wherein said GLP-1 agonist is semaglutide.
The tablet as claimed in claim 1, wherein said tablet comprises at least 70% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
The tablet as claimed in claim 1, wherein said tablet comprises at least 75% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
The tablet as claimed in claims 1-3, wherein the weight of the tablet is in the range of 175 mg to 1000 mg.
The tablet as claimed in claims 1-4, wherein said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
The tablet as claimed in claims 1-5, wherein said GLP-1 agonist is in the is in the range of 1 to 20 mg.
The tablet as claimed in claims 1-6, wherein said excipient is selected from one or more from the group consisting of binders, fillers, dis-integrants and lubri¬cants and/or glidants.
The tablet as claimed in claims 1-7, wherein said tablet comprises 0.1-10% (w/w), such as 0.2-4% (w/w) or 0.5-3% (w/w), of binder.
The tablet as claimed in claims 1-8, wherein said tablet comprises 5-40% (w/w), such as 10-30% (w/w) or 5-25% (w/w), of filler.
The tablet as claimed in claims 1-9, wherein said tablet comprises 0.1-10% (w/w) or 0.5-5% (w/w) lubricant and/or a glidant.

The tablet as claimed in claims 1-10, wherein said tablet comprises at least 60% (w/w) SNAC, less than 10% (w/w) binder, 5-40% (w/w) filler, and less than 10% (w/w) lubricant and/or glidant.
The tablet as claimed in claims 1-11, wherein said tablet has a disintegration time in the range of 7-15 minutes.
The tablet as claimed in claims 1-11, wherein said tablet has a hardness of at least 50 N.

Documents

Application Documents

# Name Date
1 201948047102-STATEMENT OF UNDERTAKING (FORM 3) [19-11-2019(online)].pdf 2019-11-19
2 201948047102-SEQUENCE LISTING(PDF) [19-11-2019(online)].pdf 2019-11-19
3 201948047102-SEQUENCE LISTING [19-11-2019(online)].txt 2019-11-19
4 201948047102-PRIORITY DOCUMENTS [19-11-2019(online)].pdf 2019-11-19
5 201948047102-POWER OF AUTHORITY [19-11-2019(online)].pdf 2019-11-19
6 201948047102-FORM 18 [19-11-2019(online)].pdf 2019-11-19
7 201948047102-FORM 1 [19-11-2019(online)].pdf 2019-11-19
8 201948047102-DECLARATION OF INVENTORSHIP (FORM 5) [19-11-2019(online)].pdf 2019-11-19
9 201948047102-COMPLETE SPECIFICATION [19-11-2019(online)].pdf 2019-11-19
10 201948047102-FORM-26 [18-12-2019(online)].pdf 2019-12-18
11 201948047102-Proof of Right [18-05-2020(online)].pdf 2020-05-18
12 201948047102-FORM 3 [18-05-2020(online)].pdf 2020-05-18
13 201948047102-FORM 3 [06-11-2020(online)].pdf 2020-11-06
14 201948047102-FORM 3 [04-05-2021(online)].pdf 2021-05-04
15 201948047102-OTHERS [25-08-2021(online)].pdf 2021-08-25
16 201948047102-Information under section 8(2) [25-08-2021(online)].pdf 2021-08-25
17 201948047102-FORM 3 [25-08-2021(online)].pdf 2021-08-25
18 201948047102-FER_SER_REPLY [25-08-2021(online)].pdf 2021-08-25
19 201948047102-CLAIMS [25-08-2021(online)].pdf 2021-08-25
20 201948047102-Information under section 8(2) [27-09-2021(online)].pdf 2021-09-27
21 201948047102-FER.pdf 2021-10-18
22 201948047102-Information under section 8(2) [17-02-2022(online)].pdf 2022-02-17
23 201948047102-FORM 3 [17-02-2022(online)].pdf 2022-02-17
24 201948047102-Information under section 8(2) [12-08-2022(online)].pdf 2022-08-12
25 201948047102-FORM 3 [12-08-2022(online)].pdf 2022-08-12
26 201948047102-RELEVANT DOCUMENTS [09-12-2022(online)].pdf 2022-12-09
27 201948047102-POA [09-12-2022(online)].pdf 2022-12-09
28 201948047102-FORM 13 [09-12-2022(online)].pdf 2022-12-09
29 201948047102-Information under section 8(2) [10-02-2023(online)].pdf 2023-02-10
30 201948047102-FORM 3 [10-02-2023(online)].pdf 2023-02-10
31 201948047102-PRE GRANT OPPOSITION FORM [15-02-2023(online)].pdf 2023-02-15
32 201948047102-PRE GRANT OPPOSITION DOCUMENT [15-02-2023(online)].pdf 2023-02-15
33 201948047102-OTHERS [15-02-2023(online)].pdf 2023-02-15
34 201948047102-Correspondence_Pre Grant Opposition_20-02-2023.pdf 2023-02-20
35 201948047102-FORM-26 [29-06-2023(online)].pdf 2023-06-29
36 201948047102-Information under section 8(2) [09-08-2023(online)].pdf 2023-08-09
37 201948047102-FORM 3 [09-08-2023(online)].pdf 2023-08-09
38 RV - 201948047102 - PG Hearing Notice - 25.08.2023.pdf 2023-08-29
39 201948047102-FORM-26 [19-10-2023(online)].pdf 2023-10-19
40 201948047102-Statement and Evidence [22-11-2023(online)].pdf 2023-11-22
41 201948047102-Annexure [22-11-2023(online)].pdf 2023-11-22
42 201948047102-PreGrant-HearingNotice-(HearingDate-11-01-2024).pdf 2023-12-19
43 201948047102-Response to office action [27-12-2023(online)].pdf 2023-12-27
44 201948047102-Response to office action [28-12-2023(online)].pdf 2023-12-28
45 201948047102-Annexure [28-12-2023(online)].pdf 2023-12-28
46 201948047102-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [03-01-2024(online)].pdf 2024-01-03
47 201948047102-PreGrant-ExtendedHearingNotice-(HearingDate-08-02-2024).pdf 2024-01-05
48 201948047102-Representation,including the statement and evidence [23-01-2024(online)].pdf 2024-01-23
49 201948047102-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [05-02-2024(online)].pdf 2024-02-05
50 201948047102-PreGrant-ExtendedHearingNotice-(HearingDate-05-03-2024).pdf 2024-02-08
51 201948047102-RELEVANT DOCUMENTS [28-02-2024(online)].pdf 2024-02-28
52 201948047102-REQUEST FOR INFORMATION [14-04-2025(online)].pdf 2025-04-14

Search Strategy

1 ssE_01-02-2021.pdf
2 201948047102AE_24-12-2021.pdf