Stable oral liquid compositions of enalapril
AssigneeHetero Labs Limited
InventorsParthasaradhi Reddy BANDI, Khadgapathi PODILE, Sunil Deviprasad TIWARI, Prakash SHETIYA, Satyanarayana Rao PATCHIGOLLA, Ravi Chandra Gupta CHIDARA
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Abstract
The present invention relates to pharmaceutical compositions of enalapril, particularly stable oral liquid compositions comprising enalapril, one or more buffering agents and at least one pharmaceutically acceptable excipient.
Claims10
A stable liquid composition for oral administration comprising 1 mg/mL of enalapril maleate and a buffer comprising citric acid in an amount of 1 mg/mL to 3 mg/mL and disodium hydrogen phosphate in an amount of 0.01 mg/mL to 0.3 mg/mL.
A stable liquid composition for oral administration comprising 1 mg/mL enalapril maleate and a buffer comprising citric acid in an amount of 1 mg/mL to 3 mg/mL and disodium hydrogen phosphate in an amount of 0.01 mg/mL to 0.3 mg/mL, wherein the composition has less than 1.5% of total impurities after storage for 15 months at 2-8° C.
A stable liquid composition for oral administration comprising 1 mg/mL enalapril maleate and a buffer comprising citric acid in an amount of 1 mg/mL to 3 mg/mL and disodium hydrogen phosphate in an amount of 0.01 mg/mL to 0.3 mg/mL;
- wherein the composition has less than 5% of total impurities after storage for 6 months at 25° C.
Dependencies are inferred from the claim text.