Cassia auriculata: Aspects of Safety Pharmacology and Drug Interaction

Amrutesh S Puranik,Ganesh Halade,Sandeep Kumar,Bhushan Patwardhan,Ranjan Mogre,Kishori Apte,Ashok D B Vaidya

doi:10.1093/ecam/nep237

Abstract

Safety pharmacology studies help in identifying preclinical adverse drug reactions. We carried out routine safety pharmacology with focus on cardiovascular variables and pharmacokinetic herb-drug interaction studies on rats fed with standardized traditional hydro-alcoholic extract and technology-based supercritical extract of Cassia auriculata for 12 weeks. Our studies indicate that both these extracts are pharmacologically safe and did not show any significant adverse reactions at the tested doses. The traditional hydro-alcoholic extract did not show any significant effect on pharmacokinetics; however, the technology-based supercritical extract caused a significant reduction in absorption of metformin. Our results indicate the need to include pharmacokinetic herb-drug interaction studies as evidence for safety especially for technology-based extracts.

Highlights

While the dietary botanical supplement market is growing, the need for more rigorous clinical and scientific research on herbal and traditional medicine is strongly advocated for larger acceptances and visibility [1]
Studies related to safety pharmacology and pharmacokinetic herb-drug interactions are more important when concurrent use of herbal and modern medicine is on rise
Polyphenols such as (–) epicatechin, procyanidin B1 and (–) catechin were quantified in Cassia auriculata (CA)-HA extract (Supplementary Figure 1), while (–) catechin and (–) epicatechin gallate in CA-supercritical fluid extracts (SFE) extract (Supplementary Figure 2)

Summary

Introduction

While the dietary botanical supplement market is growing, the need for more rigorous clinical and scientific research on herbal and traditional medicine is strongly advocated for larger acceptances and visibility [1]. Studies related to safety pharmacology and pharmacokinetic herb-drug interactions are more important when concurrent use of herbal and modern medicine is on rise. For chronic diseases including diabetes and cardiovascular conditions where long-term treatment is needed, co-administration of herbal and modern medicines may pose higher risk of adverse events and sufficient evidence of safety is necessary [8, 9]. In such situations, safety pharmacology is useful to predict the adverse drug reactions [10]. Increasing regulatory concerns in drug development have broadened the scope of safety to include general pharmacology, adverse drug reactions, cardiovascular pharmacology and pharmacokinetic herbdrug interactions [11] (Figure 2)

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Results

Conclusion