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AssigneeTroikaa Pharmaceuticals Limited
InventorsKetan R. Patel, Milan R. Patel, Prakashchandra J. Shah
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Disclosed herein are injectable compositions containing high concentration of paracetamol or its pharmaceutically acceptable salts wherein the concentration of paracetamol or its pharmaceutically acceptable salt is >150 mg/ml in a judiciously tailored solvent system comprising glycofurol, ethanol, water or a solvent system comprising glycofurol, ethanol, polyethylene glycol, water. The viscosity of the said injectables is <28 cps. Further disclosed is the process for preparing the said injectables. The injectables can be administered by intramuscular route, intravenous route or as intravenous infusion after diluting in one of the routinely used intravenous fluids, infusion solutions of antibacterial, antifungal and amoebicidal drugs and along with anxiolytics (Midazolam injection) or narcotic analgesics (Fentanyl Citrate injection etc) as they remain stable, clear and transparent at least for 6 hours after dilution.
High concentration parenteral compositions of paracetamol or its pharmaceutically acceptable salts delivering full therapeutic dose of 500 mg paracetamol in 2-3 ml in a solvent system wherein the concentration of paracetamol or its pharmaceutically acceptable salts is >150mg/ml and viscosity <28 cps
A process for preparation of parenteral compositions of paracetamol or pharmaceutically acceptable salts thereof having the active concentration in the range of about 166 to 250 mg/ml, comprises:
Dependencies are inferred from the claim text.