Abstract: The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01 %(w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.
CLAIMS
1. A liquid pharmaceutical composition comprising semaglutide and no more than 0.01
%(w/w) phenol, wherein said composition
a. is for parenteral administration;
5 b. is an aqueous solution comprising at least 60 %w/w water; or
c. further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent.
2. The composition according to claim 1, wherein said composition comprises no phenol.
3. The composition according to any one of the preceding claims, wherein said composition
0 is an aqueous solution comprising at least 60 %w/w water.
4. The composition according to any one of the preceding claims, wherein the concentration of semaglutide is 0.5-10 mg/ml or 0.01-5 mg/ml of said composition.
5. The composition according to any one of the preceding claims, wherein said composition comprises one or more pharmaceutically acceptable excipients.
5 6. The composition according to claim 5, wherein said one or more pharmaceutically
acceptable excipients are selected from the group consisting of a buffer or an isotonic
agent. 7. The composition according to any one of the preceding claims, wherein said composition
comprises no preservative. 0 8. The composition according to any one of the preceding claims, wherein said composition
has a pH in the range of 6.0-10.0, such as pH 7.0-7.8.
9. The composition according to any one of the preceding claims, wherein said composition
is for parenteral administration.
10. The composition according to claim 9, wherein said parenteral administration is
5 subcutaneous administration.
11. A kit comprising a liquid pharmaceutical composition comprising semaglutide and no more than 0.01 %(w/w) and instructions for use.
12. A kit comprising a liquid pharmaceutical composition comprising semaglutide and no more than 0.01 %(w/w) phenol and an injection device for administration of said
0 composition to a subject, wherein said injection device is selected from the group
consisting of a durable pen and a prefilled pen.
13. The kit according to claim 11 or 12, wherein said pharmaceutical composition is as
defined in any one of claims 1-10.
14. A pharmaceutical composition as defined in any one of the preceding claims for use in
5 medicine.
15. The pharmaceutical composition as defined in any one of the preceding claims for use in the treatment of diabetes or obesity.
| # | Name | Date |
|---|---|---|
| 1 | 202047010224.pdf | 2020-03-10 |
| 2 | 202047010224-STATEMENT OF UNDERTAKING (FORM 3) [10-03-2020(online)].pdf | 2020-03-10 |
| 3 | 202047010224-PRIORITY DOCUMENTS [10-03-2020(online)].pdf | 2020-03-10 |
| 4 | 202047010224-POWER OF AUTHORITY [10-03-2020(online)].pdf | 2020-03-10 |
| 5 | 202047010224-FORM 18 [10-03-2020(online)].pdf | 2020-03-10 |
| 6 | 202047010224-FORM 1 [10-03-2020(online)].pdf | 2020-03-10 |
| 7 | 202047010224-DECLARATION OF INVENTORSHIP (FORM 5) [10-03-2020(online)].pdf | 2020-03-10 |
| 8 | 202047010224-COMPLETE SPECIFICATION [10-03-2020(online)].pdf | 2020-03-10 |
| 9 | 202047010224-FER.pdf | 2020-07-27 |
| 10 | 202047010224-Proof of Right [06-08-2020(online)].pdf | 2020-08-06 |
| 11 | 202047010224-Information under section 8(2) [08-09-2020(online)].pdf | 2020-09-08 |
| 12 | 202047010224-FORM 3 [08-09-2020(online)].pdf | 2020-09-08 |
| 13 | 202047010224-Certified Copy of Priority Document [23-10-2020(online)].pdf | 2020-10-23 |
| 14 | 202047010224-OTHERS [22-01-2021(online)].pdf | 2021-01-22 |
| 15 | 202047010224-FER_SER_REPLY [22-01-2021(online)].pdf | 2021-01-22 |
| 16 | 202047010224-CLAIMS [22-01-2021(online)].pdf | 2021-01-22 |
| 17 | 202047010224-Information under section 8(2) [05-03-2021(online)].pdf | 2021-03-05 |
| 18 | 202047010224-FORM 3 [05-03-2021(online)].pdf | 2021-03-05 |
| 19 | 202047010224-Information under section 8(2) [01-09-2021(online)].pdf | 2021-09-01 |
| 20 | 202047010224-FORM 3 [01-09-2021(online)].pdf | 2021-09-01 |
| 21 | 202047010224-Information under section 8(2) [17-02-2022(online)].pdf | 2022-02-17 |
| 22 | 202047010224-FORM 3 [17-02-2022(online)].pdf | 2022-02-17 |
| 23 | 202047010224-PRE GRANT OPPOSITION FORM [08-06-2022(online)].pdf | 2022-06-08 |
| 24 | 202047010224-PRE GRANT OPPOSITION DOCUMENT [08-06-2022(online)].pdf | 2022-06-08 |
| 25 | 202047010224-OTHERS [08-06-2022(online)].pdf | 2022-06-08 |
| 26 | 202047010224-Information under section 8(2) [12-08-2022(online)].pdf | 2022-08-12 |
| 27 | 202047010224-FORM 3 [12-08-2022(online)].pdf | 2022-08-12 |
| 28 | 202047010224-FORM-26 [22-09-2022(online)].pdf | 2022-09-22 |
| 29 | 202047010224-RELEVANT DOCUMENTS [15-12-2022(online)].pdf | 2022-12-15 |
| 30 | 202047010224-POA [15-12-2022(online)].pdf | 2022-12-15 |
| 31 | 202047010224-FORM 13 [15-12-2022(online)].pdf | 2022-12-15 |
| 32 | 202047010224-Information under section 8(2) [09-02-2023(online)].pdf | 2023-02-09 |
| 33 | 202047010224-FORM 3 [09-02-2023(online)].pdf | 2023-02-09 |
| 34 | 202047010224-RELEVANT DOCUMENTS [29-06-2023(online)].pdf | 2023-06-29 |
| 35 | 202047010224-FORM-26 [29-06-2023(online)].pdf | 2023-06-29 |
| 36 | 202047010224-FORM 13 [29-06-2023(online)].pdf | 2023-06-29 |
| 37 | 202047010224-Information under section 8(2) [08-08-2023(online)].pdf | 2023-08-08 |
| 38 | 202047010224-FORM 3 [08-08-2023(online)].pdf | 2023-08-08 |
| 39 | 202047010224-US(14)-HearingNotice-(HearingDate-14-03-2024).pdf | 2024-02-05 |
| 40 | 202047010224-Information under section 8(2) [07-02-2024(online)].pdf | 2024-02-07 |
| 41 | 202047010224-FORM 3 [07-02-2024(online)].pdf | 2024-02-07 |
| 42 | 202047010224-Response to office action [23-02-2024(online)].pdf | 2024-02-23 |
| 43 | 202047010224-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [11-03-2024(online)].pdf | 2024-03-11 |
| 44 | 202047010224-Statement and Evidence [04-05-2024(online)].pdf | 2024-05-04 |
| 45 | 202047010224-Response to office action [06-09-2024(online)].pdf | 2024-09-06 |
| 46 | 202047010224-PRE GRANT OPPOSITION FORM [07-10-2025(online)].pdf | 2025-10-07 |
| 47 | 202047010224-PRE GRANT OPPOSITION DOCUMENT [07-10-2025(online)].pdf | 2025-10-07 |
| 1 | 224searchstrtegyE_14-07-2020.pdf |