Bioassay-tracked temperature-stress-induced chemical degradation of bio-active wound healing antibacterial extract of Dissotis theifolia stem dispersed in a pharmaceutical cream and ointment

Summary: Owing to the present upsurge in the utilization of medicinal herbal preparations, routine quality control assessment for their continued efficacy and safety is essential if the products are to continue to maintain their pharmacological usefulness under harsh use and storage temperature normally experienced, particularly in the tropics. As herbal medicinal products are complex mixtures which originate from biological sources and are therefore very variable and difficult to characterize, great efforts are necessary to guarantee a constant and adequate quality of potency and safety through selection of an appropriate analytical method for the monitoring of the active ingredient content of such products. Dissotis theifolia is a commonly used plant in traditional herbal medicine for the treatment of several medical ailments, including topical bacterial infections, among several communities in Nigeria. In this present study, the quality control monitoring of the content of active ingredient of pharmaceutical cream and ointment containing the methanol extract of the stem exposed to variegated temperatures was established using a specific microbiological assay method. Results showed reduction of potency of the formulated extracts due to chemical degradation through the first order reaction pathway. The ointment formulation demonstrated a longer half-life and shelf-life being more stable than the cream. Industrial relevance: Herbal medicine, a form of complimentary and alternative medicine, is becoming increasingly popular in both developing and developed countries. However, there appear to be limited data on their temperature-induce chemical stability/instability profile which correspondingly impinges on their efficacy and safety. In view of this study involving stem extract of D. theifolia formulated as cream and ointment, appropriate bioassay-based techniques can be employed in monitoring the potency of herbal preparations and can serve as a lead to a possible safety problem that could be the outcome of any such degradation process due to formation of toxic metabolites. The longer shelf-life shown by the ointment over the cream formulation clearly demonstrates the role of formulation type in determining the overall stability of the herbal preparation. Necessary pre-formulation and pilot studies which help to furnish data on quality monitoring, right choice of formulation and medicinal products chemical stability design are usually industry-based with some participation from the academia and government. Also, the present scenario where very few data