1. Il monitoraggio terapeutico della Cannabis medica nei pazienti pediatrici: l'esperienza dell'Istituto Giannina Gaslini.
- Author
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Cafaro, Alessia, Pigliasco, Federica, Barco, Sebastiano, Riva, Antonella, Striano, Pasquale, Manfredini, Luca, Barabino, Paola, Mattioli, Francesca, Pichini, Simona, Busardò, Francesco Paolo, and Cangemi, Giuliana
- Abstract
The growing interest in medical Cannabis-based therapies has increased in recent years and treatment of drugresistant epilepsy is one of the most relevant applications. In Italy, the use of medical Cannabis is regulated by Ministerial Decree 9/11/2015. Medical Cannabis consists of dried female flowering tops that contain, among others, at least 90 cannabinoids. D9-tetrahydrocannabinol (THC) is the main psychotropic compound and cannabidiol (CBD) is the main non-psychotropic component. In recent years, a plant-derived pharmaceutical formulation of purified CBD in oral solution (Epidiolex®) has been approved as adjunctive therapy in combination with clobazam for drugresistant seizures associated with Dravet or Lennox-Gastaut syndrome. As of 2017, several Cannabis preparations, both magistral (oils and decoctions) and Epidyolex®, have been prescribed at Giannina Gaslini Pediatric Institute. To meet the clinical and regulatory needs, several Ultra High Performance Liquid Chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS) methods have been developed and validated in our laboratory according to international guidelines for the validation of bioanalytical methods for the quantification of CBD, THC, cannabidiolic acid (CBD-A), tetrahydrocannabinolic acid (THC-A) and their main metabolites from various matrices (decoctions, oil preparations, plasma, volumetric absorptive microsampling devices). Results highlight the high inter-individual variability and large differences in bioavailability between purified and galenic preparations which underscore the need to implement Therapeutic Drug Monitoring (TDM) for personalization of medical Cannabis treatments. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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