MultiSom - Multivariate formulations of DOTATATE peptide as a precursor for the preparation of radiopharmaceuticals
Synthetic analogues of somatostatin, the regulatory peptide responsible for important functions of human body, are widely used in medicine. In addition, the radiolabelled octa-peptide analogues add to the diagnostic and therapeutic applications available for treatment of patients suffering from neuroendocrine tumors expressing somatostatin receptors with high density. Currently, the peptide known as DOTATATE (DOTA-Tyr3-octreotate), the synthetic analogue of somatostatin is used clinically when labelled with radionuclides. The goal of this project is to develop various pharmaceutical formulations of DOTATATE peptide, in the form of sterile freeze-dried kits which contain the appropriate mass of the peptide and appropriate excipients for each of the indications and each of the chemical form of the radionuclide. The composition of these kits will be optimized in order to assure the one step synthesis of the radiolabeled peptide, without the need of post-labelling purification and ready to be injected into the patient. The kits will be manufactured under GMP conditions supported by safety and stability data. Such kits will be offered to clinical partners providing them the easy access to the sterile peptide and excipient in the kit form. In this way the work load related to the preparation of the radiopharmaceutical at the hospital will be reduced and the requirements of Good Radiopharmacy Practice will be met at the reduced cost. In addition, the flexibility in preparing patient doses directly at the clinical site depending on the current indications for the individual patient in terms of the individually calculated dose will be assured. The goal of this project is to meet the demand of the national nuclear medicine as well as customers out of Poland. The presented approach addresses the modern theranostic and personalized medicine challenges.