Thiosens liposomal dosage form technology development and photodynamic efficiency assessment

Authors have developed the composition, technology of preparation, dosage form and sucrose-protected lyophilization protocol for formulation for systemic administration of near-infrared range photosensitizer thiosens based on PEG-liposomal formulation of aluminum hydroxide tetra-3-phenylthiophthalocyanine derivative. Optimization of preparations allowed to formulate the quality control and standardization criteria for the drug “thiosens liposomal lyophilisate for injection 1.5 mg” and establish a pharmacopoeia monograph for the drug candidate. Preclinical studies of chosen pharmachemical criteria and photodynamic efficiency of photosensitizer on a number of transplanted mice tumor models in vivo demonstrated stability of antitumor activity and quality consistency of the photosensitizer over about 1.5 year what allow to recommend the shelf life at least of 1 year.