Tablet Formulation with Galactomannan Binding Agent and Acute Toxicity Test from Terminalia catappa L.

Nilsya Febrika Zebua, Tandra Alexandro, Virda Widya Pratiwi, Syarifah Nadia, Supran Hidayat, Muflihah Fujiko, Muharni Saputri, Tedy Kurniawan Bakri, Nerdy

Abstract

Ketapang is one of the many medicinal plant species that grow in Indonesia and is used to treat various diseases. Ketapang leaves contain flavonoids, tannins, saponins, and terpenoids that have anti-inflammatory, antioxidant, antiviral, and antimicrobial properties. This study aimed to determine the LD50 and histopathology of Liver and kidney damage before the formulation of tablets containing galactomannan-binding agents. The toxicity determination method was carried out in vivo in experimental animals at doses of 4g/kg BW, 8g/kg BW and 16g/kg BW, and Liver and kidney histopathology was carried out before formulation into tablet preparations using the wet granulation method with various concentrations of binders and disintegrants, namely F1(8:0), F2(0:8), F3(4:4), F4(2:6), and F5(6:2). The results of the toxicity test showed an LD50 of 15.9959, liver damage at a dose of 4 g/kg BW hepatocyte karyorrhexis cells, central vein constriction, sinusoidal dilatation, a dose of 8 g/kg BW hepatocyte karyorrhexis, significant venous congestion, sinusoidal dilatation, a dose of 16 g/kg BW hepatocyte cells, karyolysis, dilated central veins, and dilated sinusoids. The results of the tablet mass preformulation test meet the requirements: the flow time test was 1.48-2.14 g/second, the angle of repose test was 24.60°-30.60°, and the tab index test was 5.33%-9.33%. The results of the tablet evaluation test were as follows: the tablet hardness test was 3.8-8.6 kg, the tablet friability test was 0.167-0.64%, and the tablet disintegration time test was 29.06-107.51 minutes.

References

Abubakar, A. R. and M. Haque (2020). Preparation of Medicinal Plants: Basic Extraction and Fractionation Procedures for Experimental Purposes. Journal of Pharmacy & Bioallied Sciences, 12(1); 1–5

Andayani, N. K. P. S., I. Setyawati, and M. Joni (2018). Kidney Histopathology of Gallus gallus domesticus Infected by E. coli in Denpasar, Bali. Advances in Tropical Biodiversity and Environmental Sciences, 2(1); 14–17

Aslan, A., M. C. van den Heuvel, C. A. Stegeman, E. R. Popa, A. M. Leliveld, G. Molema, J. G. Zijlstra, J. Moser, and M. van Meurs (2018). Kidney Histopathology in Lethal Human Sepsis. Critical Care, 22(1); 1–12

BPOM RI (2020). Peraturan Badan Pengawas Obat Dan Makanan Tentang Pedoman Uji Toksisitas Praklinik Secara in Vivo. Journal of Chemical Information and Modeling, 53(9); 21–25 (in Indonesia)

Cerqueira, M. A., A. C. Pinheiro, L. M. Pastrana, and A. A. Vicente (2019). Amphiphilic Modified Galactomannan as a Novel Potential Carrier for Hydrophobic Compounds. Frontiers in Sustainable Food Systems, 3; 17

Departemen Kesehatan Republik Indonesia (2020). Farmakope Indonesia Edisi VI. Jakarta: Direktorat Jendral Bina Kefarmasian dan Alat Kesehatan Republik Indonesia (in Indonesia)

Doughari, J. H. (2012). Phytochemicals: Extraction Methods,Basic Structures and Mode of Action as Potential Chemotherapeutic Agents. INTECH Open Access Publisher Rijeka, Croatia

Eisa, A. M., N. A. El-Megrab, and H. M. El-Nahas (2022). Formulation and Evaluation of Fast Dissolving Tablets of Haloperidol Solid Dispersion. Saudi Pharmaceutical Journal, 30(11); 1589-1602

Erhirhie, E. O., C. P. Ihekwereme, and E. E. Ilodigwe (2018). Advances in Acute Toxicity Testing: Strengths, Weaknesses and Regulatory Acceptance. Interdisciplinary Toxicology, 11(1); 5–12

Gasmi, B. and D. E. Kleiner (2020). Liver Histology: Diagnostic and Prognostic Features. Clinics in Liver Disease, 24(1); 61–74

Hayaza, S., S. Istiqomah, R. J. K. Susilo, B. Inayatillah, A. N. M. Ansori, D. Winarni, S. A. Husen, and W. Darmanto (2019). Antidiabetic Activity of Ketapang (Terminalia catappa L.) Leaves Extract in Streptozotocin-Induced Diabetic Mice. Indian Veterinary Journal, 96(12); 11–13

Ho Kim, C., B. Jin Lim, Y. Sung Bae, Y. Eun Kwon, Y. Ly Kim, K. Heon Nam, K. Sook Park, S. Yeong An, H. Mo Koo, and F. Mee Doh (2014). Using the Oxford Classification of IgA Nephropathy to Predict Long-Term Outcomes of Henoch–Schönlein Purpura Nephritis in Adults. Modern Pathology, 27(7); 972–982

Hoa, V. T., B. Huong, and N. D. H. Do Quang Duong (2018). Cause-Effect Relations and Optimization of Tablet Containing Eucommia Ulmoides and Gardenia Jasminoides Spray Dried Extracts. International Journal of Pharmacy and Pharmaceutical Sciences,, 10(7); 33

Hodgson, E. and P. E. Levi (1987). A Textbook of Modern Toxicology, volume 274. Elsevier New York

Ibrahim, K. E., M. G. Al-Mutary, A. O. Bakhiet, and H. A. Khan (2018). Histopathology of the Liver, Kidney, and Spleen of Mice Exposed to Gold Nanoparticles. Molecules, 23(8); 1848

Lachman, L., H. A. Lieberman, and J. L. Kanig (1994). Teori dan Praktek Farmasi Industri Edisi III. Jakarta: Penerbit Universitas Andalas

Mirhosseini, H. and B. T. Amid (2012). A Review Study on Chemical Composition and Molecular Structure of Newly Plant Gum Exudates and Seed Gums. Food Research International, 46(1); 387–398

Nnamani, N. D. and T. J. Okonkwo (2017). Optimization of Metronidazole Tablet Formulation Using Manihot utilissima Starch and a Combination of Processing Techniques. Future Journal of Pharmaceutical Sciences, 3(1); 65–70

OECD (2002). Test No. 423: Acute Oral Toxicity-Acute Toxic Class Method. OECD Publishing

Pawar, H. and R. Geevarghese (2013). Development and Evaluation of Mucoadhesive Patch Using a Natural Polysaccharide Isolated from Cordia dichotoma Fruit. Journal of Molecular Pharmaceutics & Organic Process Research, 02(03); 91–98

Pharmacopoeia, B. (2008). British Pharmacopoeia Volume 1 & 2. London: The British Pharmacopoeia Commission

Priya, N. L. and G. Asuntha (2022). Formulation and Evaluation of Sitagliptin Liposomes. World Journal of Pharmaceutical Sciences; 191–207

Saleh, R., B. H. Merghani, and W. Awadin (2017). Effect of High Fructose Administration on Histopathology of Kidney, Heart and Aorta of Rats. Journal of Advanced Veterinary and Animal Research, 4(1); 71–79

Sequeira-Cordero, A., A. Salas-Bastos, J. Fornaguera, and J. Brenes (2019). Behavioural Characterisation of Chronic Unpredictable Stress Based on Ethologically Relevant Paradigms in Rats. Scientific Reports, 9(1); 1–21

Sharp, J., T. Zammit, T. Azar, and D. Lawson (2003). StressLike Responses to Common Procedures in Individually and Group-Housed Female Rats. Journal of the American Association for Laboratory Animal Science, 42(1); 9–18

Ta, W., A. Chawla, and J. Pollard (2013). Origins and Hallmarks of Macrophages: Development, Homeostasis, and Disease. Nature, 496(7446); 445–455

Tamaki, Y., T. Teruya, and M. Tako (2010). The Chemical Structure of Galactomannan Isolated from Seeds of Delonix Regia. Bioscience, Biotechnology, and Biochemistry, 74(5); 1110–1112

United States Pharmacopeia (USP) Convention (2009). United States Pharmacopeia (USP) National Formulary 40 NF-35

Zohra, S. F., B. Meriem, S. Samira, and M. Muneer (2012). Phytochemical Screening and Identification of Some Compounds from Mallow. Journal of Natural Product and Plant Resources, 2(4); 512–516

Authors

Nilsya Febrika Zebua
nf.zebua@gmail.com (Primary Contact)
Tandra Alexandro
Virda Widya Pratiwi
Syarifah Nadia
Supran Hidayat
Muflihah Fujiko
Muharni Saputri
Tedy Kurniawan Bakri
Nerdy
Zebua, N. F., Alexandro, T., Virda Widya Pratiwi, Syarifah Nadia, Supran Hidayat, Fujiko, M., Muharni Saputri, Bakri, T. K., & Nerdy. (2023). Tablet Formulation with Galactomannan Binding Agent and Acute Toxicity Test from Terminalia catappa L. Science and Technology Indonesia, 8(1), 129–136. https://doi.org/10.26554/sti.2023.8.1.129-136

Article Details

Most read articles by the same author(s)