Pharmacokinetic, toxicological, and antidiabetic evaluation of a novel polyherbal formulation
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Sony Rajan
,
Svenia P. Jose
Abstract
Objectives
The current study aimed to formulate and analyze a novel polyherbal formulation (NPF) comprising of Terminalia arjuna, Centella asiatica and Embelia ribes.
Methods
NPF was prepared and subjected to preliminary phytochemical screening and FTIR to characterize its bioactive compounds and functional groups. To assess the safety, oral toxicity studies were carried out in Wistar rats. The antidiabetic efficacy was evaluated using the OGTT. Additionally, computational ADME analysis was carried out for the major active molecules – arjunolic acid, embelin, and asiaticoside – to evaluate the pharmacokinetic properties and drug-likeness.
Results
Presence of various secondary metabolites such as alkaloids, flavonoids, phenolic compounds, saponins, terpenoids, cardiac glycosides, and carbohydrates were confirmed by the phytochemical screening. Key prominent functional groups such as hydroxyl, amine, carbonyl, and alkyne stretching vibrations were detected upon FTIR analysis. Toxicity evaluations indicated no adverse effects, confirming the safety of NPF. Among diabetic rats, groups treated with 200 mg/kg body weight of NPF indicated a significant improvement in glucose tolerance as demonstrated by the OGTT results. ADME profiling showed favorable drug-likeness properties for arjunolic acid and embelin compared to asiaticoside.
Conclusions
NPF exhibited significant antidiabetic potential and demonstrated safety in animal models.
Funding source: University Grants Commission
Award Identifier / Grant number: UGC Ref. No.: 869/ (CSIR-UGC NET DEC, 2018)
Acknowledgement
We express our sincere gratitude to the Council of Scientific and Industrial Research- University Grants Commission (CSIR-UGC) for providing research fellowship under UGC Ref. No.: 869/ (CSIR-UGC NET DEC, 2018).
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Research ethics: The study protocol was approved by the Institutional Animal Ethics Committee of the Indian Institute of Science (Approval No.: CAF/Ethics/837/2021).
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Informed consent: Not applicable.
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Author contributions: Sony Rajan: Contributed substantially to the conception and design of the work and to data interpretation; participated in critical revisions of the manuscript. Ratheesh M.: Participated in the conception and design, carried out the acquisition and analysis of data, drafted and revised the manuscript critically for intellectual content; approved the final version and is accountable for all aspects of the work. Svenia P. Jose: Involved in data collection and interpretation; provided important intellectual input during manuscript drafting and revisions. Sheetal S.: Participated in data acquisition and analysis, and contributed to manuscript preparation and approval. Sandya S.: Assisted in data analysis and interpretation; contributed to manuscript revision and approved the final draft. Aditya Ashish: Supported data interpretation and revision of the manuscript for important intellectual content.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: The author states no conflict of interest.
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Research funding: Research funding was provided by the University Grants Commission (UGC) through a research fellowship under UGC Ref. No.: 869/ (CSIR-UGC NET DEC, 2018). The funding organization played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Data availability: The data that support the findings of this study are available from the corresponding author, [R.M], upon reasonable request.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/jcim-2025-0258).
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