ABSTRACT
BACKGROUND: Traditional medicinal herbs are widely consumed in developing countries to treat diabetes as they are perceived to be safer, less expensive, and have fewer side effects as compared to the conventional medicines. Diabecon (DB), Himalaya Herbal Healthcare, India is herbal over-the-counter formulation which contains several herbs that are reported in the traditional texts for the treatment of diabetes. The majority of these herbs have been investigated and found to interfere with the cytochrome pathway. The most common oral antihyperglycemic drug used today in clinical practice is Glimepiride (GP).The CYP2C9 enzyme is mainly responsible for the metabolism of GP. Herein we hypothesize that the co-administration of GP with DB may result in possible Herb-Drug Interactions (HDIs) as DB has the potential to significantly inhibit the CYP2C9 enzyme. OBJECTIVE: In the current study, the pharmacokinetic and pharmacodynamic interactions of GP (0.82 mg/kg) with DB (110.95 mg/kg) was investigated in diabetes induced (Nicotinamide-STZ) rats by co-administering both drugs orally for 21 days. MATERIALS AND METHODS: For the study of the HDI, Bioanalytical RP-HPLC/PDA method for quantifying GP in plasma of rats was developed and validated as per US-FDA guidelines. In vivo pharmacokinetic and pharmacodynamic parameters were studied on day 1 and day 21 post administration. RESULTS: The RP-HPLC/PDA method was successfully employed for quantification of GP in the PK studies. The co-administration of GP and DB in diabetic rats resulted in beneficial pharmacodynamic interactions, but there were no notable changes in the pharmacokinetic parameters of GP. CONCLUSION: This current investigation in an animal model suggests that co-administration of GP and DB may have significant therapeutic benefits in the treatment of diabetes; however, additional research, randomized clinical trials or case studies in humans, is needed.
ABSTRACT
Global diabetes epidemic is the major cause of fatality and lethality. As per IDF 2019 report, diabetes caused 4.2 million deaths, approximately 463 million people are living with diabetes and by 2045, this will rise to 700 million. Nowadays, the physicians and common people in both developed and developing countries are using medicinal plants and their formulations to treat diseases with the postulation that organic commodities are safe for consumption. These plants may act as inhibitors or inducers of the Cytochrome P450 or transport and efflux proteins or both and may alter gastrointestinal, renal functions leading to Herb-Drug Interactions. This review intends to focus on the frequently employed medicinal plants, their traditional uses, their Cytochrome P450 inhibition or induction activity, phytochemical, and pharmacological effects, established HDI with the help of in vitro tools, in vivo pharmacokinetics and pharmacodynamics studies to understand the impact of herbs on ADME of the drug and whether it is beneficial, harmful or has no effect respectively. This review will help the physicians and other health care professionals as a reference guide to update their knowledge and expertise about HDI. However, more quality research in this area is needed to evaluate the efficacy of many herbal medicines, thereby reducing side effects and improving the safety of patients.
