LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
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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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41 Claims
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1-9. -9. (canceled)
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10. A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises:
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palonosetron hydrochloride at a concentration of 0.05 mg/mL based on the weight of the palonosetron free base; from 10 mg/mL to 80 mg/mL mannitol; and from 0.3 mg/mL to 0.7 mg/mL EDTA. - View Dependent Claims (11, 12, 13, 14, 15, 16, 40)
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17. A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises:
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palonosetron hydrochloride at a concentration of 0.05 mg/mL based on the weight of the palonosetron free base; and from 10 mg/mL to 80 mg/mL mannitol; wherein the pharmaceutical sterile aqueous intravenous solution has a pH of 4.0 to 6.0. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 41)
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27-39. -39. (canceled)
Specification