Pharmaceutical Biotechnology

The Pharmacognostic Biotechnologies module is organized into five fundamental parts. In the first part (6 hours), general aspects of Pharmacognosy are examined, including an introduction to animal and mineral Pharmacognosy, the classification of natural products (herbal medicines, dietary supplements, herbal products, etc.), and related issues such as complexity, variability, and bioequivalence of natural products. The second and third parts (6 h + 4 h) describe the processes involved in obtaining herbal drugs, including traditional and innovative cultivation, biotechnological techniques, processing, preparation, and extraction. The fourth part (4 h) addresses the issue of quality control of herbal drugs and the related testing methods. In the fifth part (4 h), the major classes of natural compounds are presented, along with examples of monographs of selected medicinal plants. 1. General Pharmacognosy (6 hours) Definition and Fundamental Concepts. Introduction to pharmacognosy, zoopharmacognosy, basic concepts of plant pharmacognosy (medicinal plant, herbal drug, whole preparation, active principle, phytocomplex, balsamic period). Basic notions of animal and mineral pharmacognosy. Differences between whole preparations and purified principles (bioavailability, pharmacodynamic activity, routes of administration, dosage). Product Classification. Classification of plant-based products: herbal products, phytotherapeutics, herbal medicinal products (traditional and well-established use), nutraceuticals, dietary supplements, novel foods, functional foods, and medical devices. Quality and Standardization. Bioequivalence of natural products. Standardization and titration using chemical or pharmacological markers. Monographs from the European Pharmacopoeia and the EMA (European Medicines Agency). 2. Production and Processing of Herbal Drugs (6 hours) Origin and Harvesting of Medicinal Plants. Methods for harvesting medicinal plants; differences between wild and cultivated species; processes of domestication and selection. Agronomic challenges: influence of soil and climatic factors. Organic farming and innovative cultivation practices (e.g., hydroponics, microgravity). Environmental remediation techniques for pollutants, heavy metals, and parasites: bioremediation and phytoremediation. Biotechnologies Applied to Medicinal Plants. Callus and protoplast culture techniques. Use of growth regulators. In vitro propagation methods for medicinal plants: micropropagation, organogenesis, and somatic embryogenesis. Plant Molecular Farming. Introduction to the use of genetically engineered plants for the production of recombinant proteins and valuable secondary metabolites for pharmaceutical purposes. 3. Processing and Preparation of Herbal Drugs (4 hours) Post-Harvest Processing. Harvesting, trimming, sanitizing, and preserving herbal drugs. Processing of fresh plant materials (e.g., manna, aloe gel, green and black tea). Processing Techniques. Mechanical methods. Extraction techniques: maceration, percolation, pressing, steam distillation. Solvent evaporation methods. Extractive preparations: juices, fluid, soft, and dry extracts, tinctures, infusions, decoctions, essential oils, aromatic waters. Special extracts. Key indicators: drug/solvent ratio (D/S), drug/extract ratio (DER). 4. Quality Control of Herbal Drugs (4 hours) Definition and Objectives. Importance of quality control in herbal drugs. Identification of alteration causes: adulteration, sophistication, deterioration, substitution. Standards and Good Practices. Overview of GACP (Good Agricultural and Collection Practices), GHP (Good Hygiene Practices), GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and HACCP. Operational Phases of Quality Control. Identification of herbal drugs through macroscopic and microscopic analysis, organoleptic tests, purity tests (ash content, foreign matter, moisture, swelling index, bitterness index), and physicochemical analyses. 5. Natural Compounds and Case Studies of Herbal Drugs of Pharmaceutical Interest (4 hours) Phytoconstituents. General characteristics, properties, and recognition tests for alkaloids, glycosides, mucilages, terpenes, and polyphenols. Examples of Herbal Drugs. Medicinal plants such as psyllium, aloe, rhubarb, tea tree essential oil, coffee, and St. John's wort are presented, with information on their phytoconstituents, biological activity, mechanism of action, therapeutic uses, and safety. Safety and Toxicity Issues. Toxicological risks of plant-based preparations and possible pharmacological interactions.

To effectively understand the topics covered in the Biotechnologies in Pharmacognosy module and achieve the expected learning outcomes, the student should have a basic knowledge of general biology and plant biology, with particular reference to the structure and physiology of plant cells and whole plants. A preliminary knowledge of inorganic and organic chemistry is also required.

- Capasso F. (2011). Farmacognosia - Botanica, chimica e farmacologia delle piante medicinali. Springer, Milano. - G. Sacchetti, G. Paganetto. Biotecnologie delle piante medicinali. UTET Università, 2021 (ISBN:9788860086426). - Didactic material provided by the teacher.

Class attendance is recommended, although this is optional. In fact, the lectures will allow the student not only to acquire specific knowledge but also to develop communication skills and technical language through the interaction in the classroom with the lecturer on topics related to the course. The student will also be stimulated to formulate judgments and to critically evaluate the challenges and problems about the topic under study, particularly the herbal drug quality, the rational use and the possible adverse reactions.

Learning achievements will be evaluated through an oral test, during which the student will be asked to describe and critically discuss the topics covered by the syllabus and covered during classroom. In order to pass the exam, a minimum grade of 18/30 is required. To obtain the minimum score, the student must demonstrate a sufficient understanding of the general issues of Pharmacognosy, herbal drugs, and the biotechnological applications in the field of medicinal plants, as well as a basic knowledge of the properties of natural compounds and the monographs of the medicinal plants discussed. A grade of 30/30 with honors will be awarded to students who demonstrate excellent and comprehensive knowledge of all course topics, expressed in a coherent and critical way with the ability to make interdisciplinary connections. Assessment methods and criteria are the same for attending and non-attending students. A voluntary written self-assessment test may be proposed at the end of the course, upon agreement with the instructor, to help students verify their level of preparation and guide them in view of the final oral exam.

- Heinrich, M., Barnes, J., Prieto-Garcia, J., Gibbons, S., & Williamson, E. M. (2023). Fundamentals of Pharmacognosy and Phytotherapy (4th ed.). Edinburgh: Elsevier. - Stewart, C. N., Jr. (Ed.). (2016). Plant Biotechnology and Genetics: Principles, Techniques, and Applications (2nd ed.). Hoboken, NJ: John Wiley & Sons.

The course is based on lectures aimed at developing communication skills and technical language through the classroom interaction with the lecturer about Pharmacognostic biotechnology and the related challenges. The course will also allow the student to develop communication skills and autonomy of learning, useful for further training courses or for the self-updating.