Development of a formulation lyophilized for the obtention of a antimicrobial peptide Ubiquicidine labelled with 99m Tc

The 99m Tc-UBI 29-41 are a labelled fragment of the antimicrobial human peptide Ubiquicidine proposed as a new radiopharmaceutical able to differentiate an infectious process of an inflammatory one through the gamma graphic image. It has been demonstrated that the 99m Tc-UBI 29-41 unite to bacteria in vitro and that accumulates in infection sites in human with minimum captivation in inflammation sites. In this work the development of a pharmaceutical lyophilized formulation is presented for the instantaneous marked one of the UBI 29-41 with 99m Tc. The selection of the components of the formulation settled down by means of the employment of an experimental design of 3 factors with mixed levels, evaluating the effect of the diluent type, concentration of tinny chloride and the reaction volume. The obtained formulations showed to be stable until for 6 months, being obtained complexes of the radiolabelled peptide with radiochemical purity > 95 % in sterile form and apirogen. The developed pharmaceutical form, will facilitate the routinary use of this new radiopharmaceutical in the diverse hospital departments of nuclear medicine. (Author)