PHARMACEUTICAL PRODUCTS CONTAINING BIPHOSPHONATES Russian patent published in 2009 - IPC A61K31/663 A61K47/12 A61K47/02 A61K47/26 A61K9/08 A61P19/08 A61P19/10 A61P35/04 

FIELD: medicine.

SUBSTANCE: there is disclosed pharmaceutical product as prepared solution. The pharmaceutical product comprises a reservoir filled with dissolved zoledronic acid or its pharmaceutically acceptable salt. At least the internal surface of said reservoir contains plastic material that is polyolefin. The product is exposed to thermal sterilisation, preferentially to moist thermal sterilisation. Besides the product can contain a buffer component, preferentially the buffer organic base. Additionally, the product can contain an isotonic component, preferentially mannitol. The invention provides product sterilisation at high temperature 121°C during 150 minutes without visible deformations and damages of sealed integral reservoir, as well as decomposition of pharmaceutical substance.

EFFECT: thermal stability allows for multiple sterilisation cycle that leads to sterility assurance level at least 10^-12.

38 cl, 19 ex