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