Author(s):
Devlina Pal, Himangshu Sekhar Maji, Sugata Paul, Dibya Das, Sushomasri Maji
Email(s):
hsmaji@jisuniversity.ac.in
DOI:
10.52711/0974-360X.2025.00815
Address:
Devlina Pal1, Himangshu Sekhar Maji1*, Sugata Paul1, Dibya Das1, Sushomasri Maji2
1Department of Pharmaceutical Technology, JIS University, Kolkata, India.
2Institute of Pharmacy, Bankura, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 12,
Year - 2025
ABSTRACT:
The objective of this research work is to perform dermal toxicity studies of PVA-gelatin hydrogel sheet incorporated with Ziziphus oenoplia extract and hydrogel films without extract on adult New Zealand white rabbits in order to observe their safety profile on dermal application for wound healing. Fifteen adult healthy rabbits (male and female) were divided into groups of three each and were applied with the hydrogel formulations. Hydrogels without extract (4 g/kg body weight), with extract (1 g/kg, 2 g/kg and 4 g/kg body weight of animals) and control (0.9 % NaCl solution) were applied on the dorsolateral trunk of the rabbits. The animals were observed during time intervals of 24 h, 48 h and 72 h for evaluation of mortality or morbidity, body weight variations, food consumption and any skin reactions such as erythema or edema formation. After performing the tests no clinical signs of intoxication were found in all the 5 groups of rabbits. It has been observed that no mortality or morbidity, skin reactions or no drastic change in body weight and food consumption could be seen on the groups of animals treated with hydrogel formulations without extract, with extract as well as the control. From this study it can be concluded that the hydrogel formulations were devoid of toxic effects and were safe to be used dermally on animal models.
Cite this article:
Devlina Pal, Himangshu Sekhar Maji, Sugata Paul, Dibya Das, Sushomasri Maji. In vivo Evaluation of Dermal toxicity of Ziziphus oenoplia extract loaded Herbal hydrogel Films on New Zealand white rabbits. Research Journal Pharmacy and Technology. 2025;18(12):5645-0. doi: 10.52711/0974-360X.2025.00815
Cite(Electronic):
Devlina Pal, Himangshu Sekhar Maji, Sugata Paul, Dibya Das, Sushomasri Maji. In vivo Evaluation of Dermal toxicity of Ziziphus oenoplia extract loaded Herbal hydrogel Films on New Zealand white rabbits. Research Journal Pharmacy and Technology. 2025;18(12):5645-0. doi: 10.52711/0974-360X.2025.00815 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-12-5
REFERENCES:
1. Parasuraman S, Balamurugan S, Vanishya R. Overview of safety assessment and toxicological screening of dermal formulations. SBV Journal of Basic, Clinical and Applied Health Science. 2020 Jul 1; 3(3): 96-103. DOI: 10.5005/jp-journals-10082-02258
2. Baidya M, Maji HS, Bhatt S, Das D. In-vitro evaluation of the thrombolytic and anti-inflammatory activity of Capparis sepiaria root extracts. J. Med. Pharm. Allied sci. 2022; 11: 4166-71. DOI: 10.22270/jmpas.V11I1.1879
3. Byeon JC, Ahn JB, Jang WS, Lee SE, Choi JS, Park JS. Recent formulation approaches to oral delivery of herbal medicines. Journal of Pharmaceutical Investigation. 2019 Jan 15; 49: 17-26. https://doi.org/10.1007/s40005-018-0394-4
4. Kuruvilla A. Herbal formulations as pharmacotherapeutic agents. Indian J Exp Biol. 2002 Jan; 40(1): 7-11.
5. Shukla A, Garg A, Mourya P, Jain CP. Zizyphus oenoplia Mill?: a review on Pharmacological aspects. Advance Pharmaceutical Journal. 2016; 1(1): 12.
6. Fan L, Yang H, Yang J, Peng M, Hu J. Preparation and characterization of chitosan/gelatin/PVA hydrogel for wound dressings. Carbohydr. Polym. 2016 Aug 1; 1(146): 427-34. doi:10.1016/j.carbpol.2016.03.002.
7. Potaraju A, Samanthula KS, Gadda KY. Evaluation of Wound Healing and Anti-inflammatory Activities of Leaves of Ziziphus oenoplia. Int. J. Pharm. Biol. Sci. 2019; 9: 1502-12. DOI: 10.21276/ijpbs.2019.9.2.180
8. Pal K, Banthia AK, Majumdar DK. Preparation and characterization of polyvinyl alcohol-gelatin hydrogel membranes for biomedical applications. AAPS Pharmscitech. 2007 Mar; 8: E142-6. https://doi.org/10.1208/pt080121
9. Khan BA, Ullah S, Khan MK, Uzair B, Menaa F, Braga VA. Fabrication, physical characterizations, and in vitro, in vivo evaluation of ginger extract-loaded gelatin/poly (vinyl alcohol) hydrogel films against burn wound healing in animal model. AAPS PharmSciTech. 2020 Nov 16; 21(8): 323. doi: 10.1208/s12249-020-01866-y.
10. Chakrabarti S, Islam J, Hazarika H, Mazumder B, Raju PS, Chattopadhyay P. Safety profile of silversulfadiazine-bFGF loaded hydrogel for partial thickness burn wounds. Cutan. Ocul. Toxicol. 2018 Feb; 37: 258–266. doi.org/10.1080/15569527.2018.1442843.
11. Xu L, Pan J, Chen Q, Yu Q, Chen H, Xu H, Qiu Y, Yang X. In vivo evaluation of the safety of triptolide-loaded hydrogel-thickened microemulsion. Food and Chemical Toxicology. 2008 Dec 1; 46(12): 3792-9. https://doi.org/10.1016/j.fct.2008.09.065
12. Kulshrestha S, Chawla R, Alam MT, Adhikari JS, Basu M. Efficacy and dermal toxicity analysis of Sildenafil citrate based topical hydrogel formulation against traumatic wounds. Biomedicine and Pharmacotherapy. 2019 Apr 1; 112: 108571. https://doi.org/10.1016/j.biopha.2019.01.032
13. Zhang L, Huang T, Bi J, Zheng Y, Lu C, Hui Q, Wang X, Lin X. Long-term toxicity study of topical administration of a highly-stable rh-aFGF carbomer 940 hydrogel in a rabbit skin wound model. Frontiers in Pharmacology. 2020 Feb 21;11: 58. https://doi.org/10.3389/fphar.2020.00058
14. Lodhi BA, Hussain MA, Ashraf MU, Farid-Ul-Haq M, Haseeb MT, Tabassum T. Acute toxicity of a polysaccharide-based hydrogel from seeds of Ocimum basilicum. Cell. Chem. Technol. 2020 Mar 1; 54 (3-4): 291-9. 10.35812/CelluloseChemTechnol.2020.54.31
15. Haseeb MT, Bashir S, Hussain MA, Ashraf MU, Erum A, Naeem-ul-Hassan M. Acute toxicity study of a polysaccharide based hydrogel from linseed for potential use in drug delivery system. Brazilian Journal of Pharmaceutical Sciences. 2018;54(02):e17459. https://doi.org/10.1590/s2175-97902018000217459
16. Pal D, Das P, Das D, Yadav RK, Ghosh A, Maji HS. Assessment of Subchronic Dermal Toxicity of Ziziphus oenoplia extract incorporated Carbopol hydrogel on New Zealand White Rabbits. Research J. Pharm. and Tech 2023; 16(9): 4229-4233. DOI: 10.52711/0974-360X.2023.00692
17. Pal D, Halder A, Das D, Maji HS. Promising Pharmacological Activities of Ziziphus Herbal Extract and its Formulations. Research J. Pharm. and Tech. 2023 Jul; 16(7): 3300-3304. DOI: 10.52711/0974-360X.2023.00544.