Applied Pharmaceutical Sciences

The course is structured into five main modules, for a total of 56 hours (32 theory + 24 laboratory), and aims to provide specific knowledge and practical skills related to the production, processing, preparation, analysis, and evaluation of medicinal plant materials and their derivatives, with a focus on technological innovation and applied research. In the first part (4 h), general aspects of Pharmacognosy are examined, including brief notes on animal and mineral Pharmacognosy, variability and standardization of herbal drugs, and quality control. In the second part (10 h), the processes of herbal drug obtaining, the technological and biotechnological strategies applied to cultivation, in vitro production and use in the pharmaceutical field of herbal drugs are described. In addition, the herbal drug manufacturing and preparation processes, according to traditional and innovative methodologies, are described. The third part (8 hours) focuses on the control processes and chemical analysis of herbal drugs. The fourth part (10 hours) covers general aspects of biological assays on herbal drugs, with in-depth content on in vitro, ex vivo and in vivo methodologies for studying pharmacological and toxicological activities. The last part includes laboratory exercises (24 h), relating to the macroscopic and microscopic analysis of herbal drugs, to the spectrophotometric analysis and to the bibliographic research applied to medicinal plants (point 5). 1. Introduction to Applied Pharmacognosy (4 hours) Definition and scope of Applied Pharmacognosy. Principles of animal and mineral pharmacognosy. Differences between whole preparations and purified active principles: advantages and disadvantages. Objectives of applied research on medicinal plants and herbal preparations: rationalization of use, optimization of efficacy, scientific valorization. Literature searching applied to natural products with exercise: medical-scientific databases, analytical methods, search and selection criteria. 2. Production, Processing, and Preparation of Herbal Drugs (10 hours) Origin and harvesting of medicinal plants: wild and cultivated plants. Impact of edaphic and climatic factors. Traditional and innovative cultivation techniques for medicinal plants: organic, hydroponic, and microgravity cultivation. Environmental remediation technologies (bioremediation and phytoremediation) and their impact on the quality of medicinal plants. Post-harvest treatments: trimming, sanitization, storage, drying, lyophilization, processing of fresh plant drugs (aloe gel, manna, tea). Mechanical processing methods: crushing, cryo-crushing, shredding and powderization. Extraction methods of processing and preparations. Juices, essential oils, aromatic waters, mother tinctures, homeopathic mother tinctures, integral suspension of fresh drug, extracts, tinctures. Indicators of extracts: drug/solvent ratio (D/S), drug/extract ratio (DER). Special extracts. Introduction to plant biotechnologies: in vitro cultures, callus, micropropagation, plant cell and tissue cultures. 3. Control Processes for Plant-Based Products and Chemical Analysis (8 hours) Control of the production process (GACP, GHP, GMP, GLP, HACCP) and product analysis: identification, organoleptic examination. Microscopic analysis of herbal drugs with laboratory practice. Purity tests: swelling index, bitterness index, foam index. Chemical analyses: fingerprint and contaminant control (heavy metals, pesticides, mycotoxins). Introduction to chromatographic methods. Spectrophotometric analysis. Folin–Ciocalteu assay for total polyphenol determination and standard curve construction. 4. Study of the Biological Activity and Safety of Herbal Preparations (10 hours) Types of assays: qualitative and quantitative biological assays. Biological control assays: sterility test and microbial load. Spectrophotometric assays of biological activity: DPPH radical scavenging activity, inhibition of α-amylase enzyme. In vitro, in vivo and ex vivo studies: general aspects. In vitro techniques: cell cultures, sterilization, cryopreservation, cultivation and amplification, cytotoxicity tests. Ex vivo and in vivo techniques: ethical principles (3Rs), European regulations on animal experimentation. General toxicity evaluation (Irwin test), animal models (xenograft, orthotopic), functional assays (analgesic, anxiolytic, diuretic activity, metabolic cage). Studies on isolated organs: isolated atrium and trachea of guinea pig. 5. Laboratory Exercises (24 hours) Microscopic analysis of herbal drugs: starches (rice, potato, corn, wheat); roots and rhizomes (rhubarb, valerian, gentian, squill, liquorice); barks (buckthorn, cascara); leaves (witch hazel, foxglove, senna); flowers (marigold, chamomile). Spectrophotometric determination: total polyphenol content, construction of the calibration curve and calculation of equivalents. Scavenger activity of the DPPH and ABTS radicals. Use of medical-scientific databases (PubMed, Scopus, Google Scholar) for the personal research of bibliographic material on subjects relating to natural products.

To effectively follow and understand the topics covered in the course and to achieve the learning objectives, or to begin the study of the topics provided by the module, the students should possess key competences of general biology, plant biology, in particular with regard to the structure and physiology of vegetable cell and plant, inorganic and organic chemistry. Furthermore, possessing key competences in Pharmacognosy is a useful but not a main requirement, since the organization of the course is based on an introduction to the general challenges of pharmacognosy and herbal medicines, which can support the student to contextualize the practical aspects of the course.

- Heinrich M., Barnes J., Gibbons S., Williamson E.M. – Edizione italiana a cura di Galeotti N., Mazzanti G., Serafini M. (2015). Fondamenti di Farmacognosia e Fitoterapia. Edra S.p.a., Milano. - Pasqua G. (2011). Biologia cellulare & Biotecnologie vegetali. Piccin, Padova. - Ragazzi E., Dorigo P. (1999). Droghe Animali ed Enzimi. Casa Editrice CEDAM, Padova. - Farmacopea Europea

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.

Learning achievements will be evaluated through a practical laboratory test and an oral exam. The practical test (180 minutes) will be focused on the microscopic analysis of powdered herbal drugs: the students will have to identify unknown samples of herbal drugs (at least two samples out of four), taking advantage of the competences acquired during laboratory practices, and will indicate the microscopic elements identified. During the oral exam, the student will illustrate and critically discuss the topics covered by the syllabus of the course and explained in the classroom. The exam can be passed if the score is greater than or equal to 18/30. To achieve the minimum score, the student must demonstrate to have sufficient knowledge of the general problems of the quality control of herbal drugs and of the major methodology applied for preparing and analysing herbal drugs, and basic knowledge of the characteristics of the natural compounds and their identification assays. To achieve a score of 30/30 cum laude, the student must instead demonstrate that excellent knowledge of all the topics covered during the course and logical abilities have been acquired. 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.

The course is based on lectures (4 CFU) aimed at developing communication skills and technical language through the classroom interaction with the lecturer about Applied Pharmacognosy 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. In addition, the planned laboratory practices allow the student to acquire practical skills related to both macroscopic and microscopic analysis of herbal drugs, in order to detect any possible sophistication or falsification, and key competences about methodologies and instruments employed for preparing and analyse herbal drugs. Taking advantage of the lecturer support, the student will explore specific topics on botanicals by individual searching for suitable bibliographic materials through looking up medical and scientific databases.