Process for the preparation of tirzepatide or pharmaceutically acceptable salt thereof
AssigneeSun Pharmaceutical Industries Limited
InventorsArunkumar YADAV, Kunal PANDYA, Bhavna TAILOR, Brijesh PATEL, Jigar JOSHI, Vipulkumar PATEL, Mohan PRASAD
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Abstract
The present invention relates to tirzepatide or a pharmaceutically acceptable salt thereof. The present invention also relates to a process for the preparation of tirzepatide or pharmaceutically acceptable salt thereof. The present invention also relates to novel fragments as intermediates and use thereof in the preparation of tirzepatide.
Claims44
A process for the preparation of tirzepatide or a pharmaceutically acceptable salt thereof, comprising use of at least one polypeptide or a pharmaceutically acceptable salt thereof selected from the group consisting of SEQ ID NO. 1, SEQ ID NO. 2, SEQ ID NO. 3, SEQ ID NO. 4, SEQ ID NO. 5, SEQ ID NO. 6, SEQ ID NO. 7, SEQ ID NO. 8 or SEQ ID NO. 10.
Tirzepatide or a pharmaceutically acceptable salt thereof prepared by a process comprising use of at least one polypeptide or a pharmaceutically acceptable salt thereof selected from the group consisting of SEQ ID NO. 1, SEQ ID NO. 2, SEQ ID NO. 3, SEQ ID NO. 4, SEQ ID NO. 5, SEQ ID NO. 6, SEQ ID NO. 7, SEQ ID NO. 8 or SEQ ID NO. 10.
Tirzepatide or a pharmaceutically acceptable salt comprising less than 1% of a compound of SEQ ID NO. 22.
Tirzepatide or a pharmaceutically acceptable salt comprising less than 0.5% of a compound of SEQ ID NO. 22.
A compound of SEQ ID NO. 1 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 2 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 3 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 4 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 5 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 6 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 7 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 8 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 10 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 11 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 12 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 13 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 15 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 17 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 18 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 19 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 20 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 21 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 22 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 23 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 24 or a pharmaceutically acceptable salt thereof.
A compound of SEQ ID NO. 1, SEQ ID NO. 2, SEQ ID NO. 3, SEQ ID NO. 4, SEQ ID NO. 5, SEQ ID NO. 6, SEQ ID NO. 7, SEQ ID NO. 8, SEQ ID NO. 10 or pharmaceutically acceptable salt thereof for use in the synthesis of tirzepatide or a pharmaceutically acceptable salt thereof.
A compound that is a sodium salt of tirzepatide.
A compound that is a potassium salt of tirzepatide.
A compound that is an ammonium salt of tirzepatide.
A compound that is an acetate salt of tirzepatide.
Tirzepatide or a pharmaceutically acceptable salt thereof that is substantially free from impurities selected from the group consisting of SEQ ID NO. 11, SEQ ID NO. 12, SEQ ID NO. 13, SEQ ID NO. 15, SEQ ID NO. 17, SEQ ID NO. 18, SEQ ID NO. 19, SEQ ID NO. 20, SEQ ID NO. 21, SEQ ID NO. 22, SEQ ID NO. 23 or SEQ ID NO. 24.
Tirzepatide or a pharmaceutically acceptable salt thereof that is substantially free of an impurity of SEQ ID NO. 22.
The pharmaceutically acceptable salt according to any of the proceeding claims wherein the salt is selected from a sodium, potassium, ammonium and acetate salt of tirzepatide.
Dependencies are inferred from the claim text.