Development of oral pharmaceutical formulation of standardized crude ethanolic extract of Atractylodes lancea (Thunb) DC.

Abstract

Cholangiocarcinoma (CCA), the adenocarcinoma of the biliary duct, is commonly reported in Asia with the highest incidence in northeastern Thailand. Chemotherapy of this type of cancer is limited due to the lack of effective chemotherapeutic drugs. A series of previous studies support further research and development of Atractylodes lancea (Thunb) DC. (AL) as a potential candidate for the treatment of CCA as a crude ethanolic extract. In the present study, we aimed to develop an oral pharmaceutical formulation (capsule) of the standardized AL crude ethanolic extract for further clinical development in patients with CCA. Major steps included macroscopic and microscopic authentication of the AL rhizomes, preparation of standardized AL extract, preparation of oral pharmaceutical formulation (capsule) of the standardized AL extract, quantitative and qualitative analysis of the marker compound (atractylodin) in the formulated AL extract, evaluation of contaminations of heavy metals, pesticides residues, and microorganisms in the ground AL rhizomes and the formulated (capsule) powder of AL, physicochemical and pharmaceutical properties of the formulated AL extract/capsule, and cytotoxicity evaluation of the formulated AL extract. Results of all evaluations confirmed satisfactory pharmaceutical properties of oral (capsule) formulation of the standardized AL extract.