Stable parenteral dosage form of cetrorelix acetate
AssigneeSun Pharmaceutical Industries Limited
InventorsJaydip Joshi, Rakesh Thummar, Sudeep Agrawal, Subhas Balaram Bhowmick, Arunkumar Yadav, Rajamannar Thennati
Life of this patent
Estimating the term…
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.
Claims20
A parenteral dosage form comprising:
- a ready-to-inject sterile, stable aqueous solution comprising:
- (i) cetrorelix in an amount of 0.25 mg/ml, or a pharmaceutically acceptable salt thereof;
- (ii) lactic acid in a concentration sufficient to adjust the pH in the range of 4.0 to 5.0;
- and
- (iii) water for injection, wherein the osmolality of the solution is about 250 to about 375 mOsm/kg;
- and
- after 6 months of storage at 25 °C and 60% relative humidity, the solution contains an Impurity A, a decapeptide of Formula I in an amount less than 0.5% w/v of cetrorelix base,
Dependencies are inferred from the claim text.