Abstract
The production of plant-based extracts is significantly influenced by traditional techniques and the natural variability of feedstock. For that reason, the discussion of innovative approaches to improve the manufacturing of established products and the development of new products within the regulatory framework is essential to adapt to shifting quality standards. This perspective of members of the DECHEMA/ProcessNet working group on plant-based extracts outlines extraction business models and the regulatory framework regarding the extraction of traditional herbal medicines as complex extracts. Consequently, modern approaches to innovative process design methods like QbD (Quality by Design) and quality control in the form of PAT (Process Analytical Technology) are necessary. Further, the benefit of standardized laboratory equipment combined with physico-chemical predictive process modelling and innovative modular, flexible batch or continuous manufacturing technologies which are fully automated by advanced process control methods are described. A significant reduction of the cost of goods, i.e., by a factor of 4–10, and decreased investments of about 1–5 mil. € show the potential for new products which are in line with market requirements.
Highlights
Patients have accepted traditional herbal medicines for a long time for treatment of mostly minor diseases
The scope of this paper is to provide the reader with an overview of the topic of plant-based product extraction and purification, and to analyze future trends
The status quo and trends in phytomedicines are proposed for discussion from an engineering point of view, taking market and regulatory aspects into account
Summary
Patients have accepted traditional herbal medicines for a long time for treatment of mostly minor diseases. An assessment of small-molecule pharmaceuticals which were approved between 1950 and 2010 shows that approximately one third are either natural products or natural product derivatives. Counting the synthetic drugs which were “inspired by nature” increases the count to almost 50%. Manufacturers of herbal medicinal products suffer from major problems such as increasing market pressure by, e.g., the food supplement sector, increasing regulations, and the costs of production. Due to increasingly strict regulation and approval procedures, innovation is seldom observed, and the methods used in process development are outdated [1]. The history of pharmaceuticals has been plant-based for several thousand years, and may be closely related time- and skill-wise to the origins of wine growing, i.e., over 9000 years in Georgia
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
