Acute and Sub-Acute Toxicity Studies of Starch Hyaluronate in Wistar Rats http://www.doi.org/10.26538/tjnpr/v7i5.19

Main Article Content

Santosh K. Rada
Anusha Kusuma

Abstract

Starch hyaluronate is used as a new superdisintegrating agent in the development of fastdissolving tablets of poorly soluble drugs because of its improved biocompatibility, and hydrophilicity. The purpose of this study is to assess the acute and subacute toxicity profiles of starch hyaluronate in Wistar rats. The starch hyaluronate was administered to Wistar rats in a single-dose acute study and monitored for seven days. Wistar male and female rats were used in a 28-day sub-acute study that examined the effects of oral doses of 100, 200, and 600 mg/kg body weight/day on body weight, food intake, mortality, biochemical analysis, and histopathological
evaluation. An acute study revealed that the synthesized starch hyaluronate minimal oral fatal dose for rats was larger than 2000 mg/kg body weight. The subacute toxicity evaluation found no significant changes when compared to the control group, and there was no change in hematological or biochemical parameters. The weights of the liver, kidneys, and pancreas remained constant. Based on the findings, it was concluded that starch hyaluronate at 600mg/kg body weight/day was neither immunogenic nor sensitizing, and was not a reproductive or developmental toxicant, implying that it is relatively safe when taken orally. 

Article Details

How to Cite
Rada, S. K., & Kusuma, A. (2023). Acute and Sub-Acute Toxicity Studies of Starch Hyaluronate in Wistar Rats: http://www.doi.org/10.26538/tjnpr/v7i5.19. Tropical Journal of Natural Product Research (TJNPR), 7(5), 2965–2968. Retrieved from https://tjnpr.org/index.php/home/article/view/1975
Section
Articles

References

Anusha K, Rada SK. Oral disintegrating tablets: best approach for faster therapeutic action of poorly soluble drugs. Egyptian Pharmaceutical J. 2021; 20: 105-114.

Mozhgan Sadeghi, Salar Hemmati, Hamed Hamishehka. Synthesis of a novel superdisintegrant by starch derivatization with polysuccinimide and its application for the development of Ondansetron fast dissolving tablet. Drug Dev Ind Pharm. 2015;1-7.

http://dx.doi.org/10.3109/03639045.2015.1075029

Santhosh Kumar R, Mudili S, Acute and Sub-Acute Toxicity Studies of Starch Glutamate: A Novel Superdisintegrant, J Drug Deliv Therapeu. 2019; 9(4):307-310.

Abrantes CG, Duarte D. Reis CP. An overview of pharmaceutical excipients: safe or not safe?J. Pharm. Sci. 2016; 105: 2019−2026.

Kaur L. Singh J. Starch: Modified Starches. In Encyclopedia of Food and Health, 1st ed. Caballero, B. Finglas, P. M. Toldra, F.Eds. Academic Press: Oxford, United Kingdom. 2016;152−159.

Warditiani NK, Sari PMNA, Yustiantara PS, Wirasuta IMAG. Acute and Sub-Acute Oral Toxicity Profile of Purified Tomato Extract on the Liver and Kidney Functions of Male Wistar Rats. Trop J Nat Prod Res. 2021; 5(11):1962- 1965.

Bhar K, Mondal S, Seru G. Acute and Sub-Acute Toxicity Studies of Dhatupaushtik Churna. Trop J Nat Prod Res. 2021; 5(10):1760-1765.

Mayank Kumar Malik, Pankaj Bhatt, Jaspal Singh, Rajneesh Dutt Kaushik, Gaurav Sharma, and Vipin Kumar. Preclinical Safety Assessment of Chemically Cross-Linked Modified Mandua Starch: Acute and Sub-Acute Oral Toxicity Studies in Swiss Albino Mice. ACS Omega. 2022; 7: 35506−35514.

Santosh Kumar R, Ankita Gosh. Design, optimisation and evaluation of piroxicam fast dissolving tablets employing starch tartrate-a new superdisintegrant. Int J Appl Pharm. 2019;11: 89-97.

Santosh Kumar R, Hari Om Prakash Rao A, Shambhavi K. Optimization of starch crotonate as a novel superdisintegrant in the formulation of fast dissolving tablets through. 23factorialdesign. Int J Appl Pharm. 2021; 13: 247-256.

Anonymous (2000) OECD Guidelines for the Testing of Chemicals, Revised Draft Guidelines423: Acute Oral toxicity-Acute Toxic Class Method, Revised Document. Govt. of India: CPCSEA, Ministry of Social Justice and Empowerment.

OECD (2008) Test No. 407: repeated Dose 28- day oral toxicity study in rodents. In: OECD Guidelines For the Testing of Chemicals, Section 4: Health Effects. OECD Publishing

Sharaibi OJ, Ogundipe OT, Magbagbeola OA, Kazeem ME, Afolayan ME. Acute and sub-acute toxicity profile of aqueous leaf extract of Nymphaea lotus linn (Nymphaeaceae) in wister rats: Trop. J. Pharmaceut. Res. 2015; 14(7):1231- 1238.

Uddin MA, Akter F, Chowdhury IH, Asha UH, Tanny SZ, Sony TA, Neon N, Saha S, Sikder MM, Yesmine S. Toxicological studies of Leaf extract of Stevia rebaudiana Bertoni in Sprague-Dawley Rats. Trop J Nat Prod Res. 2022; 6(5):714-720.

Nyblom H, Björnsson E, Simrén M, Aldenborg F, Almer S, Olsson R. The AST/ALT ratio as an indicator of cirrhosis in patients with PBC. Liver Int. 2006; 26(7): 840-845.

Taqi SA, Sami SA, Sami LB, Zaki SA. A review of artifacts in histopathology. J Oral Maxillofac Pathol. 2018; 22(2):279