Stable parenteral dosage form of cetrorelix acetate
AssigneeSun Pharmaceutical Industries Limited
InventorsJaydip Joshi, Rakesh Thummar, Sudeep Agrawal, Subhas Balaram Bhowmick, Arunkumar Yadav, Rajamannar Thennati
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Abstract
The present invention relates to a stable parenteral dosage form with a ready-to-inject sterile stable aqueous solution of cetrorelix acetate. The invention also relates to an injection device prefilled with the ready-to-inject sterile stable aqueous solution of cetrorelix acetate. The present invention relates a method of inhibiting premature luteinizing hormone surges in women undergoing controlled ovarian stimulation comprising a stable parenteral dosage form with a ready-to-inject sterile stable aqueous solution of cetrorelix acetate.
Claims19
A parenteral dosage form comprising a stable aqueous solution comprising:
- (i) cetrorelix or a pharmaceutically acceptable salt thereof;
- and
- (ii) lactic acid,
- wherein the pH of the solution is 4 to 5, and the solution contains an impurity of Formula I in an amount less than 1% w/v of cetrorelix base,
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19-22. (canceled)
Dependencies are inferred from the claim text.