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ACUTE TOXICITY ASSESSMENT OF GRAPTOPHYLLUM PICTUM (L.) GRIFF. LEAVES ETHANOLIC EXTRACT AND ITS NANOFORMULATIONS: COMPARATIVE STUDY OF PHYTOSOME AND CYCLODEXTRIN INCLUSION COMPLEX

IDHA KUSUMAWATI 1,2*, SUBHAN RULLYANSYAH 1, MEGA FERDINA WARSITO 3, MUHAMMAD ZDULQORNAIN 1, FIRDAUSYAH NURAINI 1, AISYAH FARAH RIZKA 1, YUSUF ALIF PRATAMA 1, RETNO WIDYOWATI 1, EKA PRAMYRTHA HESTIANAH 4, KATSUYOSHI MATSUNAMI 5

1Department of Pharmaceutical Science, Faculty of Pharmacy, Universitas Airlangga, Nanizar Zaman Joenoes Building, Jl.
Mulyorejo, Surabaya, 60115, East Java, Indonesia
2 Natural Product Drug Discovery and Development Research Group, Faculty of Pharmacy, Universitas Airlangga, Nanizar
Zaman Joenoes Building, Jl. Mulyorejo, Surabaya, 60115, East Java, Indonesia
3 Research Center for Applied Microbiology, National Research and Innovation Agency (BRIN), Komplek CSC-LIPI, Jl. Raya Bogor Km 46, Cibinong 16911, West Java, Indonesia
4 Veterinary Anatomy Department, Faculty of Veterinary, Universitas Airlangga, Jl. Mulyorejo, Surabaya 60115, East Java, Indonesia
5 Department of Pharmacognosy, Graduate School of Biomedical & Health Sciences, Hiroshima University 1-2-3, Kasumi, Minami-ku, Hiroshima, Japan

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Graptophyllum pictum (L.) Griff has been used in traditional medicine to treat various diseases and shows great potential for clinical use, but is often limited by poor oral bioavailability and lack of information regarding its safety. In this study, the herbal extract was developed into two forms e.g., phytosome and cyclodextrin complex in order to enhance its bioavailability. This study also examines the toxicity of G. pictum leaves ethanolic extract (GPLE) and its nanoformulations. The GPLE phytosome (GPLE-P) was formed using hydration method. The GPLE cyclodextrin inclusion complex (GPLECDIC) was produced through co-precipitation methods. Both formulations produced vesicle in nanometer size. The formation of the vesicles was confirmed through FT-IR and differential scanning calorimetry (DSC) analysis. The in vitro toxicity test showed that GPLE and GPLE-P caused erythrocyte morphological changes at 500 μg/mL, while GPLE-CDIC at 250 μg/mL. Oral administration of all formulations did not cause any erythrocyte morphological changes. The complete blood cell analysis showed no significant difference in the number of blood components from the untreated group compared to the treated group. Both formulations can be safely administered orally without any immediate unwanted effect.