Liquid pharmaceutical formulations of palonosetron
DC CAFCFirst Claim
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1. A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising:
- a) from 0.03 mg/mL to 0.2 mg/mL palonosetron hydrochloride, based on the weight of the free base;
b) a sterile injectable aqueous carrier at a pH of from 4 to 6;
c) a tonicifying effective amount of mannitol; and
d) from 0.005 mg/mL to 1.0 mg/mL EDTA.
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Abstract
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.
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2 Claims
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1. A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising:
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a) from 0.03 mg/mL to 0.2 mg/mL palonosetron hydrochloride, based on the weight of the free base; b) a sterile injectable aqueous carrier at a pH of from 4 to 6; c) a tonicifying effective amount of mannitol; and d) from 0.005 mg/mL to 1.0 mg/mL EDTA.
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2. A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising:
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a) 0.05 mg/mL palonosetron hydrochloride, based on the weight of the free base, in a sterile injectable aqueous carrier at a pH of from 4.5 to 5.5; b) from 0.005 mg/mL to 1.0 mg/mL EDTA; and c) mannitol in an amount sufficient to tonicify said solution, in a concentration of from about 10 mg/ml to about 80 mg/ml.
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Specification