Pre-Clinical Safety and Efficacy Evaluation of a Herbal Nanoemulsion-Based Formulation for Treating Inflammatory Bowel Disease.

Abstract

Inflammatory bowel disease (IBD) is a chronic autoimmune sickness that affects the gastrointestinal tract (GIT). Currently available treatment regimens have various adverse effects and create a financial burden. This paper presents the development of an oral liquid formulation containing a nanoemulsion (NE) of herbal extracts for the treatment of IBD. A NE-based formulation was prepared and characterized. Stability studies based on the physical appearance, viscosity, pH, total microbial count, and assay were performed. The antioxidant activity of the individual extract, mixture, and formulation was compared by the DPPH method. In order to assess both the efficacy and the safety of the formulation, a TNBS-induced colitis model was used. A herbal extract of fennel, anise, chamomile, linseed, and pomegranate fruit peel was used as the oil phase, PEG as a surfactant, Tween 80 as a co-surfactant, and benzalkonium chloride (0.001% w/v) as a preservative in the NE. Average particle size, PDI, viscosity, and pH were 283 nm, 0.33, 48 cp, and 5.9, respectively. Assay of the product by standard marker anethole was 99.6%. It was established that the formulation remains stable at least for 6 months. The antioxidant activity of the combined extract was higher than the individual extracts. The colon mucosa damage index (CMDI) from the formulation was negligible and similar to that of the control group. The results suggest that it is worthwhile developing the NE of herbal extracts for treating IBD. Additionally, the benefit of selecting a multi-herb extract for NE formulation is demonstrated by the antioxidant activity of the combined extracts. This study revealed that the NE of the herbal extract is a promising approach for IBD treatment. A patent related to the work is published in the Indian Official Journal of the Patent Office (14/2021).