Preformulation and formulation development of orodispersible tablets containing phikud navakot herbal extract

Abstract

The main purpose of this research was to develop orodispersible tablets containing Phikud Navakot Extract (NVK-E) with consistent quality and convenience. Phikud Navakot is a traditional Thai herbal medicine that has been used in Thailand for more than 100 years. Preformulation studies of NVK-E and excipients were carried out. High performance liquid chromatography (HPLC) method was validated according to AOAC Guidelines for Dietary Supplements and Botanicals to determine existing three analytical markers, i.e. gallic acid, vanillic acid and ferulic acid. The viscous NVK-E was transformed to more processable powder by adsorption on the selected excipient. Orodispersible tablets containing NVK-E were developed by direct compression method using three superdisintegrants, i.e. Polyplasdone® XL-10, Explotab® and Ac-Di-Sol® at different percentages of 2%, 6% and 10% in formulations. Quality control of tablets were performed. The stability study of the chosen formulation was evaluated in the intended package for commercialization according to ASEAN Guideline on Stability Study of Drug Product under accelerated and long term storage conditions. At 3 months under accelerated storage condition, more than 5% deviated from initial values which failed to meet the requirement. However, at 3 and 6 months under long term storage condition, analytical markers still retained values of not more than 5% from initial values. Thus, their values must be monitored real-time up to 12 months under long term storage condition for the conclusion on shelf-life of the finished product.