Abstract
Sceletium tortuosum is one of the most promising medicinal plant species for treating anxiety and depression. Traditionally, aerial parts are chewed (masticatory herbal medicine) providing fast relief and rendering the masticatory route for delivery, ideal. This study intended formulating novel medicated chewing gum containing S. tortuosum to alleviate depression and anxiety. S. tortuosum extract was formulated into directly compressed medicated chewing gum (MCG) containing different Health-in-Gum® (HIG) bases through process optimization with the SeDeM Diagram Expert System. Physical properties of MCGs were characterized, and specialized drug release studies performed. According to the manufacturer, only HIG-03 was specifically developed for direct compression; however, the SeDeM System was successfully applied to all HIG-bases investigated. HIG-01 and HIG-04 are also considered useful in direct compression as no considerable differences in these MCG formulations’ physical properties were recognized. Inclusion of a lubricant, however, is deemed essential, and MCG comprising HIG-01, most suited for direct compression. Dissolution experiments found only two alkaloids used as markers, mesembrine and mesembrenone, were released in quantifiable concentrations regardless formulation constituents. Novel directly compressed MCG-containing S. tortuosum extract was successfully formulated by which the biologically active phytochemicals of S. tortuosum can be scientifically delivered through the traditionally applied mastication method.
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Acknowledgements
The authors would like to sincerely thank the Centre of excellence for Pharmaceutical Sciences, Faculty of Health Sciences, North-West University, South Africa, for the financial contribution to this project. We also thank Prof. Alvaro Viljoen for his kind donation of S. tortuosum plant materials and extracts as well as Dr Weiyang Chen for assisting with UPLC analysis (Tshwane University of Technology (TUT), Pretoria, South Africa). The authors gratefully acknowledge the assistance of Prof. Eugene Olivier (Tshwane University of Technology (TUT), Pretoria, South Africa) who provided his facilities and apparatus to conduct the extract release studies on the medicated chewing gum units.
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Viljoen, J.M., van der Walt, S. & Hamman, J.H. Formulation of Medicated Chewing Gum Containing Sceletium tortuosum and Process Optimization Utilizing the SeDeM Diagram Expert System. AAPS PharmSciTech 22, 102 (2021). https://doi.org/10.1208/s12249-021-01961-8
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DOI: https://doi.org/10.1208/s12249-021-01961-8