Metabolite Profiling, Stability Testing, Pharmacokinetics, and In Vivo Pattern Recognition Analysis of Arq-e-Keora: A Traditional Unani Formulation.

BACKGROUND

Arq-e-Keora is a liquid formulation of the Unani system of medicine and used since long for the management of weakness of heart, palpitations, etc.

OBJECTIVE

The study was carried out to generate a scientific data for its metabolite profiling, stability testing, pharmacokinetics, and pattern recognition analysis of Arq-e-Keora.

METHOD: Arq-e-Keora has been prepared as water distillate of male wpadix of Pandanus odoratissimus L.f. TLC profiling of Arq-e-Keora was performed using hexane and acetone (7:3, v/v) as a solvent system. The metabolic profiling of volatile compounds was carried out using GC-MS. Pharmacokinetic analysis was performed through GC-MS to evaluate how quickly it absorbs and distributes in plasma. The pattern recognition analysis was performed in order to recognize the pattern and fate of metabolites in rat plasma up to 24 h after single oral administration of Arq-e-Keora.

RESULTS

TLC and GC-MS analysis resulted in profiling of 11 and 21 metabolites, respectively. GC-MS analysis revealed that phenethyl alcohol, alpha-terpinolene, beta terpinene, alpha terpinene, beta fenchyl alcohol, hexadecanoic acid, and octadecanoic acid are the major metabolites found in Arq-e-Keora. The stability analysis showed that most of the compounds are stable at refrigerator temperature during their consumption. Pharmacokinetics data of phenethyl alcohol showed its absorption was rapid, with Tmax occurring within 1 h after oral administration of Arq-e-Keora. In vivo pattern recognition analysis suggests that some metabolite expression was altered after its oral administration.

CONCLUSIONS

As a result, our model could be used for quality, stability, and pharmacokinetic evaluation of various Unani formulations mentioned in Unani Pharmacopoeia of India.

HIGHLIGHTS: This is the first study of pharmacokinetic analysis and metabolite pattern of traditional Unani formulation after its oral administration in Wistar rats.