Technopharmaceutical study of antibodies drug conjugated marketed in Spain
DOI:
https://doi.org/10.30827/ars.v65i2.29301Keywords:
cytotoxic, monoclonal antibody, linker, compounding, antibody-drug conjugated, payload, ADCAbstract
Introduction: cancer treatment is one of the great challenges facing today’s scientific society. In this health fight, drug-conjugated antibodies (ADCs) are being developed, drugs capable of causing cell death by transporting and releasing cytotoxic compounds into tumor cells. They are composed of a monoclonal antibody (of protein nature) linked to a cytotoxic drug (of lipophilic character) through a linker. Formulations must be designed to maintain this binding during storage and administration.
Objective: identify the medicines marketed in Spain whose active ingredient is an antibody-drug conjugate, studying techno pharmaceutical aspects, especially the components of their formulations
Method: since this type of drugs belongs to the ATC group L01F, they have been identified through the search engine of the Spanish Agency of Medicines and Health Products. The search for their technical sheets, along with articles of review and research related to the topic, as well as the Handbook of Pharmaceuticals Excipients, has enabled the execution of the techno pharmaceutical study.
the formulation of the tested conjugates to drugs marketed in Spain belonging to the ATC L01F group corresponding to “monoclonal antibodies and tested conjugated to drugs” identified through the search engine of the Spanish Agency of Medicines and Health Products has been studied.
Results: different aspects of this group of drugs have been analyzed, such as the pharmaceutical form, the route of administration, conservation and especially the techno pharmaceutical formulation. The nature of the active ingredient and the requirements of the formulations based on their characteristics have been studied in depth.
Conclusions: the eight antibody-drug conjugates approved in Spain are presented in the form of lyophilized powder in a vial and should be stored between 2-8 ºC. For administration, they are reconstituted, initially obtaining a concentrate, which is then diluted and administered as an intravenous infusion or drip. Their typical formulation includes a lyoprotector, an antiaggregant, a pH regulator, and eventually antioxidants or viscosity reducers.
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