Safety study of carboxymethylated Basella alba mucilage: a subchronic oral toxicity evaluation in Wistar albino rats

Authors

  • Moumita Chowdhury Guru Nanak Institute of Pharmaceutical Science and Technology, 157/F Nilgunj Road, Panihati, Sodepur, Kolkata 114, WB
  • Pintu Kumar De JIS Institute of Pharmacy, Phase III, Block A, Kalyani, West Bengal 741235
  • Himangshu Sekhar Maji Department of Pharmaceutical Technology, JIS University, 81, Nilgunj Road, Agarpara, Kolkata -700109, West Bengal
  • Dibya Das Department of Pharmaceutical Technology, JIS University, 81, Nilgunj Road, Agarpara, Kolkata -700109, West Bengal

DOI:

https://doi.org/10.18231/j.joapr.2024.12.2.16.26

Keywords:

Basella alba, carboxymethylation, mucilage, sub-chronic toxicity

Abstract

Background: The evaluation of toxicity is of paramount importance in the screening of a new compound. Basella alba mucilage possesses a versatile excipient property that can be innovated with its chemical modification to get the functionalized mucilage. A few pharmacological activities of Basella alba mucilage have also been reported earlier, but its toxicity study in rats has yet to be discussed. Aim: The study aims to assess the in vivo toxicity of carboxymethylated Basella alba mucilage in Wistar albino rats for 28 days. Material and Methods: In the current investigation, Carboxymethylated Basella alba mucilage is taken, and its subchronic toxicity study is carried out in forty-eight healthy rats (twenty-four male rats and 24 female rats), divided into four groups containing six rats of each sex. All the biochemical and hematological parameters and histopathological investigation were estimated for all the animal groups. Result: The subchronic toxicity study reveals that the modified mucilage is safe for all doses (20mg/kg body weight, 40mg/kg body weight, 80 mg/kg body weight). The study showed no significant difference in the dose group's behavioral toxicity, nephrotoxicity, and hepatotoxicity compared to the control. All the hematological and biochemical parameters lay in the normal range. The histopathological examination of treatment groups showed no abnormality or lesion in the tissue samples of internal organs. Conclusion: The study confirms the safety of Carboxymethylated Basella alba mucilage for use in pharmaceutical formulations.

Downloads

Download data is not yet available.

References

Wang XY, Yin JY, Hu JL, Nie SP, Xie MY. Gastroprotective polysaccharide from natural sources: Review on structure, mechanism, and structure–activity relationship. Food Frontiers, 3(4), 560-591 (2022).

Ngwuluka NC, Ochekpe NA, Aruoma OI. Naturapolyceutics: The Science of Utilizing Natural Polymers for Drug Delivery. Polymers, 6(5), 1312-1332 (2014).

Deshmukh SA and Gaikwad DK. A review of the taxonomy, ethnobotany, phytochemistry and pharmacology of Basella alba (Basellaceae). Journal of Applied Pharmaceutical Science, 4(1), 153-165 (2014).

Chowdhury M, De PK. Novel gastroprotective activity of Basella alba mucilage-based hydrogel beads on diclofenac sodium induced gastric ulcer. Journal of Medical Pharmaceutical and Allied Sciences, 12(5), 6082 – 6090 (2023).

Chowdhury M, De PK, Maji HS. Exploration of Basella alba mucilage as a novel adjuvant in Pharmaceutical Formulation. Research Journal of Pharmacy and Technology, 15(6), 2609- 2615 (2022).

Deshmane G, Dhawale S, Dhonde S. Assessment of oral toxicity study for functionalized tamarind for safer use in drug delivery system. European Chemical Bulletin, 12(7), 4215-4231 (2023).

Kaur L, Raj R, Thakur AK, Singh I. Development of chitosan-catechol conjugates as mucoadhesive polymer: assessment of acute oral toxicity in mice. Environmental Analysis Health and Toxicology, 35(3), e2020014 (2020).

Kausar S, Erum A, Tulain R, Hussain M, Farid-ul-Haq M, Malik N, Rashid A. Formulation, In Vitro Evaluation, and Toxicity Studies of A. vulgaris-co-AAm Carrier for Vildagliptin. Advances in Polymer Technology, 8(1), 1-17 (2021).

Sumaira, Tulain UR, Erum A, Hussain MA, Sidra, Malik NS, Rashid A, Kausar R, Gohar N, Shahid N, Siddiqui M. Fabrication, Characterization and Toxicity Evaluation of Chemically Cross linked Polymeric Network for Sustained Delivery of Metoprolol Tartrate. Designed Monomers and Polymers, 24(1), 351-361 (2021).

Pasha AZ, Bukhari SA, Mustafa G, Anjum F, Nisa M, Qari SH, Evaluation of Modified Date Palm (Phoenix dactylifera L.) Mucilage as a Potential Pharmaceutical Excipient. Journal of Food Quality, 3923812, 1-12 (2022).

Das S, Ghosh A, Changder A, Nandi G, Ghosh LK. Quality-by-design approach for development of sustained-release multiple-unit beads of lamotrigine based on ion-cross-linked composite of pectin and okra mucilage: An in vitro appraisal. International Journal of Biological Macromolecules, 163(1), 842-853 (2020).

Chowdhury M, Kumar De P. Tailored Basella alba mucilage-based bipolymeric hydrogel beads for controlled release of Diclofenac sodium. International Journal of Applied Pharmaceutics, 15(5), 106–116 (2024).

OECD. 2018. Guideline for the testing of chemicals, No. 407, Repeated dose 28-day oral toxicity study in rodents. Adopted 3rd October 2008. Organization for Economic Cooperation and Development, Paris (2018).

Sutrisni N, Soewandhi S, Adnyana IK, Sasongko L. Acute and Subchronic (28-day) Oral Toxicity Studies on the Film Formulation of k-Carrageenan and Konjac Glucomannan for Soft Capsule Application. Scientia Pharmaceutica, 87(2), 1-12 (2019).

Adi-Dako O, Ofori-Kwakye K, Kukuia K, Asiedu-Larbi J, Nyarko A, Kumadoh D, Osei Asare C. Subchronic toxicity studies of cocoa pod husk pectin intended as a pharmaceutical excipient in Sprague Dawley rats. Journal of Pharmacy & Pharmacognosy Research, 6(4), 271-284 (2018).

Arunachalam, K., Sasidharan, S.P. General Considerations and Collection of Animal Blood. In: Bioassays in Experimental and Preclinical Pharmacology. Springer Protocols Handbooks. Humana, New York, pp. 51-55 (2021).

Dan S, Chatterjee N, Mandal P, Das A, Ghosh B and Pal TK. Repeated dose Toxicity Study in Rats of the Formulation Containing Metformin and Sitagliptin using Microwave Assisted Acrylamide Grafted Cassia tora as Polymer, The Natural Products Journal, 6(2), 152-160 (2016).

Kangle Z, Liqing W, Zhangjing H, Bin Y, Yi Y, Measurement of the total protein in serum by biuret method with uncertainty evaluation, Measurement, 112(1), 16-21(2017).

Chiranthanut N, Lertprasertsuke N, Srisook E, Srisook K, Acute and subchronic oral toxicity assessment of extract from Etlingera pavieana rhizomes, Toxicology Reports, 9, 1472-1483 (2022).

Rasyid SA, Armayani, Yuniati, Lio TMP. Analysis of Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase Levels in Tuberculosis Patients Who Are Undergoing Oat Treatment in Kendari City General Hospital, Kota Kendari, Indonesia. Infectious Disease Reports, 12(s1), 8737 (2020).

Rodrigues A, Beresford L, Scudamore CL, Yon M. A guide to post-mortem examination procedure in mouse models. Laboratory Animals, 56(5), 466-470 (2022).

Kusuma Dewi A, Purwanto B, Widjiati. Introduction of Histopathology. Molecular Histopathology and Cytopathology. Intech Open (2023).

Arika W, Nyamai D, Ndile M, Ngugi M, Njagi E. Hematological Markers of In Vivo Toxicity. Journal of Hematology & Thromboembolic Diseases, 4(2), 1-7 (2016).

Olayode OA, Daniyan MO, Olayiwola G. Biochemical, hematological and histopathological evaluation of the toxicity potential of the leaf extract of Stachytarpheta cayennensis in rats. Journal of Traditional and Complement Medicine, 10(6), 544-554 (2019).

Wang, M, Guckland, A, Murfitt, R, Ebeling M, Sprenger D, Foudoulakis M, Koutsaftis A. Relationship between magnitude of body weight effects and exposure duration in mammalian toxicology studies and implications for ecotoxicological risk assessment. Environmental Sciences Europe, 31(1), 1-7 (2019).

Silva-Santana G, Bax JC, Fernandes DCS, Bacellar DTL, Hooper C, Dias AASO, Silva CB, de Souza AM, Ramos S, Santos RA, Pinto TR, Ramao MA, Mattos-Guaraldi AL. Clinical hematological and biochemical parameters in Swiss, BALB/c, C57BL/6 and B6D2F1 Mus musculus. Animal Models and Experimental Medicine, 3(4), 304-315 (2020).

Zahkouk SA, El-Gendy A, Eid FA, Eltahawy NA, El-Shamy SA. Physiological and Histological Studies on the Heart of Male Albino Rats Exposed to Electromagnetic Field and the Protective Role of Silymarin and/Orvitamin E. The Egyptian Journal of Hospital Medicine, 58(1), 94-108 (2015).

Safitri A, Tirto Sari DR, Refsilangi B, Roosdiana A, Fatchiyah F. Histopathological Profiles of Rats (Rattus norvegicus) Induced with Streptozotocin and Treated with Aqueous Root Extracts of Ruellia tuberosa L. Veterinary Medicine International, 6938433, 1-9 (2021).

Dhouib H, Jallouli M, Draief M, Bouraoui S, El-Fazaa S. Oxidative damage and histopathological changes in lung of rat chronically exposed to nicotine alone or associated to ethanol. Pathologie Biologie (Paris), 63(6), 258-267 (2015).

Maynard RL, Downes N. Anatomy and Histology of the Laboratory Rat in Toxicology and Biomedical Research, ISBN 9780128118375. 1st edition. Academic Press, pp.147-158 (2019).

Published

2024-04-30

How to Cite

Chowdhury, M., De, P. K., Maji, H. S., & Das, D. (2024). Safety study of carboxymethylated Basella alba mucilage: a subchronic oral toxicity evaluation in Wistar albino rats. Journal of Applied Pharmaceutical Research, 12(2), 16-26. https://doi.org/10.18231/j.joapr.2024.12.2.16.26

Issue

Section

Articles