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AssigneeDabur Pharma Limited
InventorsDhiraj Khattar, Manish Grover, Mukesh Kumar, Prasanna Kumar Srinivasa Jonnala, Shobhit Singh, Rama Mukherjee, Anand Burman
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A stable pharmaceutical composition comprising a solution of disodium pamidronate in an aqueous solvent and a process for the preparation thereof. The solution of disodium pamidronate is free of particulate matter and has an alkaline pH. The process for preparation of the stable pharmaceutical composition comprises adding disodium pamidronate and optionally a sugar into an aqueous solvent; heating the said mixture at a temperature in the range of 50° C. to 90° C. to obtain a clear solution. It is cooled to ambient temperature, filtered, filled and stored in a conventional and untreated glass container and sealed with normal elastomeric closure. The sealed container is sterilized by steam sterilization.
A stable pharmaceutical composition comprising disodium pamidronate in an aqueous solvent having an alkaline pH of above 8.0, filled and stored in a conventional, untreated glass container, wherein the aqueous solvent is in contact with a glass surface of the container.
A stable pharmaceutical composition comprising disodium pamidronate in an aqueous solvent having an alkaline pH of above 8.0, filled and stored in a conventional, untreated glass container and sled with an elastomeric closure, wherein the aqueous solvent is in contact with a glass surface of the container.
3-4. (canceled)
A pharmaceutical composition according to claim 30, wherein the conventional, untreated glass container is selected from ampoules, vials, ready-to-use syringes and carpoules.
A pharmaceutical composition according to claim 42 wherein the elastomeric rubber closure is a halobutyl rubber closure.
A process according to claim 34, wherein autoclaving is performed at a pressure ranging from about 1 to 5 bar.
Dependencies are inferred from the claim text.