READY TO USE COMPOSITIONS OF CETRORELIX ACETATE
The present application discloses a ready-to-use liquid parenteral pharmaceutical composition, that has Cetrorelix or Cetrorelix acetate. The composition also has Cetrolix or its pharmaceutically acceptable salt, ethanol, and water for injection, and a pH adjusting agent. The composition may also contain pharmaceutically acceptable excipients. The Cetrolix or Cetrolix acetate preparation can have a pH lower than 7.
1 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration, comprising:
a. Cetrorelix or its pharmaceutically acceptable salt in a range of 0.01-0.1% w/v,
b. Ethanol,
c. Water for Injection and a pH adjusting agent, and optionally other pharmaceutically acceptable excipients.
2 . The pharmaceutical preparation as claimed in claim 1 , wherein the Cetrorelix or Cetrorelix acetate preparation has a pH lower than 7.
3 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration, comprising:
a. Cetrorelix 0.01-0.1% w/v,
b. Mannitol,
c. Water for Injection, a pH adjusting agent, and a pH lower than 7.
4 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration, comprising:
a. Cetrorelix 0.01-0.1% w/v,
b. Sucrose,
c. Water for Injection, a pH adjusting agent, and a pH lower than 7.
5 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration, comprising:
a. Cetrorelix 0.01-0.1% w/v,
b. Lactose,
c. Water for Injection, a pH adjusting agent, a pH lower than 7.
6 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration as claimed in claim 1 , wherein the preparation is stable for a period of more than 5 months at 25° C./60% RH (relative humidity).
7 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration as claimed in claim 1 , wherein the preparation is stable for a period of more than 5 months at 5° C.±3° C.
8 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration as claimed in claim 1 , wherein the preparation is stable for a period of more than 3 months at 40° C./75% RH (relative humidity).
9 . A ready-to-use liquid pharmaceutical preparation of Cetrorelix or Cetrorelix acetate for parenteral administration, comprising:
Cetrorelix acid lower than 1%,
Desalanine Cetrorelix acid lower than 1%,
Nona Cetrorelix acid lower than 1%,
Hexa Cetrorelix lower than 2%,
Hepta Cetrorelix lower than 2%, and
Nal Cetrorelix acid lower than 1%.
10 . A pharmaceutical composition of Cetrorelix or Cetrorelix acetate for parenteral administration, comprising:
Cetrorelix acid lower than 1%,
Desalanine Cetrorelix acid lower than 1%,
Nona Cetrorelix acid lower than 1%,
Hexa Cetrorelix lower than 2%,
Hepta Cetrorelix lower than 2%, and
Nal Cetrorelix acid lower than 1%.