Assuring security of supply for phyto-APIs
Phytochemical active pharmaceutical ingredients (APIs) provide significant therapeutic effects that help patients with many different diseases. Isolation of these complex molecules from plants continues to be the only means for accessing these important drug substances because no practical, cost-effective chemical synthetic routes have yet been developed. This can lead to significant security of supply challenges.
Environmental factors can impact both the harvest and the quality of the plant material, while extraction and purification of these complex and often sensitive and/or toxic compounds is also typically quite difficult. Phytochemical concentrations in plants are generally quite low and highly influenced by growing conditions including soil nutrients, temperature, and moisture/humidity.
Plants grown in different geographic locations on plantations that use diverse fertilisation practices will have variable phytochemical compositions. Excessive drought or rain and the timing of the harvest can also have large impacts on the levels of phytochemicals in plants.
For these reasons, it is necessary to combine many different batches comprising large quantities of dried plant material to produce commercial quantities of the purified API. Extraction and purification are not simple, either. Typically, many different often structurally similar phytochemicals are extracted together. The desired compound must then be separated from these compounds, which can require multiple steps.