A pharmaceutical product containing pamidronate and other diphosphonate solutions 5 in an appropriate container, a pH of between 5 and 8 and without organic acid buffer or polyethylene glycol. The container may be treated glass or made of other appropriate material. Coated elastomeric stoppers are also included. A method of producing a pharmaceutical product comprising steps of making a suspension of pamadronic acid, adding sodium hydroxide, to form a solution adjusting the pH to 10 between 5 an...

A staff 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 co...

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 i...

Biphosphonates and especially disodium pamidronate are becoming more and more important for the therapy of a wide variety of diseases. Pure and stable disodium pamidronate is a prerequisite for the manufacture of the respective pharmaceutical formulations. In the literature there is a controversy on the stability of the various hydrates of disodium 10 pamidronate. The present invention presents a facile easy to scale-up method of producing disodium pamidronate pentahydrate of high purity and hig...