Polyherbal tablet based on Iranian traditional medicine

Background: Medicinal plants have important role for prevention and treatment of diseases regarding their traditional uses. In Iranian traditional medicine (ITM), herbal medicines have been considered as the key agents in the treatment of wide ranges of disorders. Traditional preparations can be reformulated to achieve pharmacopoeia standards as modern medicines. Objective: In this research, a polyherbal tablet namely “Monzej-e-balgham”, which is widely used for treating different diseases, has been formulated and quality control assessments done to present a proper formulation. Methods: Onopordum and Foeniculum Mill. were extracted with water, filtered, concentrated and dried with spray drying method. Thirteen tablets formulations by direct compression and pre- and post- formulation analyses were prepared. Finally, the most proper formulation was selected and evaluated physicochemically and microbiologically according to standard protocols. The total phenol content as marker of the tablets was determined and accelerated stability tests were conducted (40 °C/75 % RH) as per ICH guidelines for six months. Results: For the selected formulation (F2), the hardness, weight variation, friability, disintegration time and drug release were determined as 6.78 ± 0.28 kg/cm 2 , 714.36 ± 1.71 mg, 0.79 ± 0.05 %, 10.18 ± 0.39 min and 97.67 ± 0.16% in one hour, respectively. The amount of total phenol was found to be 25.15 ± 0.13 mg/tablet. Microbial levels were in agreement with requirements. In the accelerated stability tests, no significant changes were observed. Total phenol content decreased 1.03 % during 6 months. Conclusion: After completing complementary tests such as in vivo and clinical trials, the formulated tablet (F2) could be presented for mass production.