Liquid pharmaceutical formulations of palonosetron
View Patent ↗The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
1. A pharmaceutically stable isotonic intravenous solution of palonosetron hydrochloride for reducing emesis or reducing the likelihood of emesis comprising
a) from about 0.03 mg/mL to about 0.2 mg/mL palonosetron as palonosetron hydrochloride,
b) a sterile pharmaceutically acceptable aqueous carrier comprising mannitol as a tonicity agent, at a pH of from 4.0 to 6.0, and
c) EDTA in an amount of from 0.005 to 1.0 mg/mL.
2. The solution of claim 1 wherein the palonosetron is in a concentration of about 0.05 mg/mL as palonosetron hydrochloride.
3. The solution of claim 1 wherein the pH is from 4.5 to 5.5.
4. The solution of claim 1 wherein the pharmaceutically acceptable carrier further comprises citric acid.
5. The solution of claim 1 wherein:
a) said palonosetron is present in a concentration of 0.05 mg/ml, as palonosetron hydrochloride; and
b) said EDTA is present in a concentration of from 0.005 to 1.0 mg/ml.
6. The solution of claim 5 wherein said pH is from 4.5 to 5.5.