Applied Pharmaceutical Sciences

The course includes a general part (points 1 and 2), two parts dedicated to specific concepts of phytotherapy (point 3) and phyto-surveillance (point 4). In the general part (point 1) introductory concepts to pharmacognosy are carried out, including: a "glossary" of specific (botanicals, phytotherapy, nutraceuticals, etc.), and a part relating to the phytochemical classification of herbal drugs (point 2), which will be further carried out in the part referring to phytotherapy (point 3) of minor pathologies, on which the herbalist can give useful advice and for which the scientific informant can provide specific information. Phytovigilance (point 4) will increase the competence of both professional figures on a conscious use of products containing medicinal plants. In particular, in the part relating to phyto-surveillance (point 4) specific examples of plants and/or commercial products responsible for adverse reactions are made, and case reports are discussed. This is useful to train the figure of the scientific informant also from a toxicological point of view and to empower the herbalist in the advice they give. The articulation in the various thematic nuclei of the teaching is deeply interconnected, as the plants that are described from the phytochemical point of view (point 2) are also contextualized in their eventual application in phytotherapy (point 3) and evaluated in case of specific updates related to their safety (point 4). According to the needs presented by the students in the classroom, an articulation of the various topics can be foreseen in the following number of hours: point 1 = 20 hours; point 2 = 20 hours; point 3-4 = 32 hours. PROGRAM 1. Introduction. Drug concept in Pharmacognosy. Historical background: from ethnobotany to phytotherapy in clinical practice. Total preparations and pure principles: differences and specific use. Phytotherapy principles: therapeutic value; safe use of medicinal plants; definition and marketing of herbal products, food supplements, nutraceuticals, cosmetics, "cosmeceuticals", herbal medicinal products of consolidated and traditional use and related examples. EMA monographs and monographs F.U. Quality control. Variability of medicinal plants. Preparation and storage of herbal preparations. Observations on the use of herbal products in particular physiopathological conditions (pregnancy, lactation, pediatric age, elderly patients) - The problem of interactions (e.g., hypericum, grapefruit). 2. Vegetal drugs described according to the phytochemical category they belong to. The following subdivision is carried out on pharmacognostic bases useful also for didactic purposes, but it should always be remembered that each drug could contain numerous substances, also very different from each other in phytochemical terms and relative biological activity. - Carbohydrates and derivatives: plant sources, uses - Monosaccharides, Oligosaccharides and polysaccharides. Honey, propolis, royal jelly, starch, gums, mucilage. Some specific examples of the main drugs: Triticum turgidum, algae, aloe, altea, flax, manna, psyllium, Amorphophallus konjak. - Lipids: vegetable sources, general methods of production, uses- Saturated and unsaturated fatty acids, essential fatty acids- Vegetable and animal oils and fats (e.g., cocoa butter, edible oils, almond oil, oenotera oil). Other drugs of pharmaceutical or cosmetic interest for their lipid content: serenoa, African prunus, argan. - Drugs containing anthraquinones: Aloe, cascara, buckthorn, rhubarb, senna. - Drugs containing tannins: witch hazel, green tea, ratania. - Drugs containing essential oils: general methods of obtaining, uses, guidelines for use, warnings. Main drugs (e.g. anise, bitter orange, wormwood, bergamot, chamomile, camphor, eucalyptus, fennel, lavender, lemon balm, mint, melaleuca, pine, thyme, valerian). - Drugs containing saponins: centella, horse chestnut, licorice, ginseng. - Drugs containing flavonoids: Biological activities, mechanisms of action, therapeutic and herbal uses of flavonoids. Main drugs (e.g., bitter orange, blueberry, blackcurrant, red vine, ginkgo). - Selected drugs containing alkaloids (this part of the program requires knowledge of the central and autonomic nervous system). Sympathomimetic drugs (e.g., coca, ephedra), sympatholytic (e.g., rauwolfia), parasympathomimetic (e.g., Amanita muscaria, Calabar bean, jaborandi), parasympatholytic (e.g., belladonna). Other drugs of specific interest (e.g. coca, opium) -Counts on some complementary and/or alternative Medicine (e.g., Traditional Chinese Medicine). General principles of homeopathy. Methods of preparation of the homeopathic product. 3. SPECIAL SECTION: Phytotherapy Vegetable drugs and their preparations used as sedatives, anxiolytics, antidepressants. Vegetable drugs and their preparations used as adaptogens and immunostimulants Drugs and their derivatives used in disorders of the upper airways. Vegetable drugs and their preparations used as eupeptic, choleretic and hepatoprotectors. Vegetable drugs and their preparations used as used as hypolipidemic agents. Vegetable drugs and their preparations used as vasoprotectors. Vegetable drugs and their preparations used as laxatives and purgatives. Vegetable drugs and their preparations used for the control of body weight: drugs stimulating lipolysis and / or thermogenesis, drugs inducing satiety; drugs reducing lipogenesis; purifying drugs. Drugs and their preparations used as disinfectants of the lower urinary tract. Drugs and their preparations used in disorders related to benign prostatic hyperplasia. Drugs and their preparations used in menopause disorders, premenstrual syndrome and dysmenorrhea. Drugs and their preparations used in dermatological disorders (e.g., skin inflammations, wounds, burns, bruises). 4. Phytosurveillance Definitions, adverse reactions and related examples. Factors responsible for adverse reactions (product dependent, user dependent). The system of phytosurveillance in Italy: report form.

The student must not have to absolve particular prerequisites. However, in order to better understand some specific concepts (e.g., drugs containing alkaloids, mechanism of action of medicinal plants, phytotherapy of specific diseases) and to more easily achieve the learning objectives, it would be important to know subjects such as: human anatomy, general physiology, biochemistry, general pathology and general pharmacology and pharmacotherapy. Where the student can not attend the lessons, he/she must absolutely inform himself of what was made available and/or reported by the teacher, as material useful for learning purposes. The above mentioned must not be considered as an indispensable obligation, but as a prerequisite recommended to optimize the successful passing of the exam, to be taken at the end of the course.

1. Farmacognosia e Fitoterapia. Basi farmacologiche e aspetti applicativi. Mazzanti G., Dell'Agli M., Izzo A.A. Ed. Piccin (2020). 2. Farmacognosia – Botanica, chimica e farmacologia della piante medicinali. Capasso F. II° Ed. Springer-Verlag (2011). 3. Fitoterapia – Impiego razionale delle droghe vegetali. Capasso F., Grandolini G., Izzo A.A. Ed. Springer (2006). 4. Fondamenti di Farmacognosia e Fitoterapia. A cura di N. Galeotti, G. Mazzanti, M. Serafini. Ed. Edra (2015). In order to help the student (in terms of method), the integrated distribution of the recommended texts along the duration of the course could be hypothesized as follows: Text 1 is useful for the general part of the program (see point 1 and 2 of the same, in the "teaching program" section); Text 2 is instead more useful for the special part (see point 3 of the program) concerning the phytotherapy of specific mild diseases. Text 3 is a book that summarizes the essential concepts in a transversal way. Text 4 is the most updated, it can replace the integration between book 1 and 2; is a more in-depth text than text 3. The part related to the Phytovigilance is carried out on the basis of the consultation of dedicated websites and literature data that the teacher illustrates during the various lessons.

The adopted teaching method provides (for the greater number of hours, and compatibly with emergency measures,) lectures. However, exercises, related to the analysis of case reports of Phytovigilance and the simulations of bibliographic research in the drafting of papers, using telematic supports (specific to the field of pharmacognosy and phytotherapy) are also foreseen. The teaching methods, chosen by the teacher, contribute not only to the achievement of the planned training objectives, but are also methods easily usable in the real working life, as they provide quick and free access to databases and websites of the medicinal plants sector and its uses and warnings. Where, due to the covid emergency, distance learning becomes essential, the methods of development will be appropriately reshaped in order to achieve the same educational objectives.

Attendance at lessons has become formally optional by the Degree Program Board of 13 October 2017. However, for acquiring the competences provided by the course objectives, it is highly recommended. In fact, during the lectures, a useful interactivity is provided for cognitive purposes of websites, articles of literature, analysis of case reports (not otherwise achievable in case of non-attendance to the course, by the student). At the discretion of the teacher and for the evaluation of the achievement of a valid method of the study, according to pre-established and previously communicated modalities, the attendance to the Course could be verified.

The actual achievement of the expected learning outcomes by the student, in accordance with the training objectives, is evaluated through an oral exam. Among the aspects that contribute to the formation of the final judgment, beyond the specific preparation of the student on topics of examination, her/his reasoning ability is also assessed, on the basis of the study that it is conducted independently, which should not be based only on the mnemonic abilities. The duration of the test, as an oral one, is difficult to define and depends essentially on the degree of preparation and the relative exhibition skills of the student. An average duration of about 20 minutes is conceivable. The teaching, as established by Manifesto, does not provide for intermediate tests but only a test at the end of the teaching provision. This test, on almost a monthly basis (except for the month of August), have pre-established dates and are communicated annually to the Secretariats and published via e-learning and via Infostud websites. In any case, the student has the opportunity of a sort of "self-assessment" during the course because "ad hoc moments" of review and questions on the concepts developed are dedicated. To pass the exam it is need to achieve a grade of not less than 18/30. The student must demonstrate that has acquired sufficient knowledge of the general and special topics and that she/he is able to provide useful application of information on use, warnings, and undesired effects of products containing medicinal plants. To achieve a score of 30/30 cum laude, the student must instead demonstrate that has acquired excellent knowledge of all the topics covered during the course (including those of a regulatory and/or of more updated topics), and she/he is able to connect them in a logical and coherent way.

The reference Bibliography shown below is instead usable in the part relating to in-depth studies (point 4) and / or topics of greater relevance. However, it is advisable to specify that the student's preparation must not be sectorialized, but must provide for the capacity for reasoned integration between the different parts of the program, in the various sources of information. Website list Photocopies delivered in class and/or included on the course website (http://elearning2.uniroma1.it/). hhttp://www.salute.gov.it/ http://www.epicentro.iss.it/focus/erbe/sorv_reaz-avv.asp https://www.ncbi.nlm.nih.gov/pubmed/ http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp&mid=WC0b01ac058001fa1d https://www.farmacovigilanzasif.org/topics/aggiornamenti/

The adopted teaching method provides (for the greater number of hours, and compatibly with emergency measures,) lectures. However, exercises, related to the analysis of case reports of Phytovigilance and the simulations of bibliographic research in the drafting of papers, using telematic supports (specific to the field of pharmacognosy and phytotherapy) are also foreseen. The teaching methods, chosen by the teacher, contribute not only to the achievement of the planned training objectives, but are also methods easily usable in the real working life, as they provide quick and free access to databases and websites of the medicinal plants sector and its uses and warnings. Where, due to the covid emergency, distance learning becomes essential, the methods of development will be appropriately reshaped in order to achieve the same educational objectives.

The course includes a general part (points 1 and 2), two parts dedicated to specific concepts of phytotherapy (point 3) and phyto-surveillance (point 4). In the general part (point 1) introductory concepts to pharmacognosy are carried out, including: a "glossary" of specific (botanicals, phytotherapy, nutraceuticals, etc.), and a part relating to the phytochemical classification of herbal drugs (point 2), which will be further carried out in the part referring to phytotherapy (point 3) of minor pathologies, on which the herbalist can give useful advice and for which the scientific informant can provide specific information. Phytovigilance (point 4) will increase the competence of both professional figures on a conscious use of products containing medicinal plants. In particular, in the part relating to phyto-surveillance (point 4) specific examples of plants and/or commercial products responsible for adverse reactions are made, and case reports are discussed. This is useful to train the figure of the scientific informant also from a toxicological point of view and to empower the herbalist in the advice they give. The articulation in the various thematic nuclei of the teaching is deeply interconnected, as the plants that are described from the phytochemical point of view (point 2) are also contextualized in their eventual application in phytotherapy (point 3) and evaluated in case of specific updates related to their safety (point 4). According to the needs presented by the students in the classroom, an articulation of the various topics can be foreseen in the following number of hours: point 1 = 20 hours; point 2 = 20 hours; point 3-4 = 32 hours. PROGRAM 1. Introduction. Drug concept in Pharmacognosy. Historical background: from ethnobotany to phytotherapy in clinical practice. Total preparations and pure principles: differences and specific use. Phytotherapy principles: therapeutic value; safe use of medicinal plants; definition and marketing of herbal products, food supplements, nutraceuticals, cosmetics, "cosmeceuticals", herbal medicinal products of consolidated and traditional use and related examples. EMA monographs and monographs F.U. Quality control. Variability of medicinal plants. Preparation and storage of herbal preparations. Observations on the use of herbal products in particular physiopathological conditions (pregnancy, lactation, pediatric age, elderly patients) - The problem of interactions (e.g., hypericum, grapefruit). 2. Vegetal drugs described according to the phytochemical category they belong to. The following subdivision is carried out on pharmacognostic bases useful also for didactic purposes, but it should always be remembered that each drug could contain numerous substances, also very different from each other in phytochemical terms and relative biological activity. - Carbohydrates and derivatives: plant sources, uses - Monosaccharides, Oligosaccharides and polysaccharides. Honey, propolis, royal jelly, starch, gums, mucilage. Some specific examples of the main drugs: Triticum turgidum, algae, aloe, altea, flax, manna, psyllium, Amorphophallus konjak. - Lipids: vegetable sources, general methods of production, uses- Saturated and unsaturated fatty acids, essential fatty acids- Vegetable and animal oils and fats (e.g., cocoa butter, edible oils, almond oil, oenotera oil). Other drugs of pharmaceutical or cosmetic interest for their lipid content: serenoa, African prunus, argan. - Drugs containing anthraquinones: Aloe, cascara, buckthorn, rhubarb, senna. - Drugs containing tannins: witch hazel, green tea, ratania. - Drugs containing essential oils: general methods of obtaining, uses, guidelines for use, warnings. Main drugs (e.g. anise, bitter orange, wormwood, bergamot, chamomile, camphor, eucalyptus, fennel, lavender, lemon balm, mint, melaleuca, pine, thyme, valerian). - Drugs containing saponins: centella, horse chestnut, licorice, ginseng. - Drugs containing flavonoids: Biological activities, mechanisms of action, therapeutic and herbal uses of flavonoids. Main drugs (e.g., bitter orange, blueberry, blackcurrant, red vine, ginkgo). - Selected drugs containing alkaloids (this part of the program requires knowledge of the central and autonomic nervous system). Sympathomimetic drugs (e.g., coca, ephedra), sympatholytic (e.g., rauwolfia), parasympathomimetic (e.g., Amanita muscaria, Calabar bean, jaborandi), parasympatholytic (e.g., belladonna). Other drugs of specific interest (e.g. coca, opium) -Counts on some complementary and/or alternative Medicine (e.g., Traditional Chinese Medicine). General principles of homeopathy. Methods of preparation of the homeopathic product. 3. SPECIAL SECTION: Phytotherapy Vegetable drugs and their preparations used as sedatives, anxiolytics, antidepressants. Vegetable drugs and their preparations used as adaptogens and immunostimulants Drugs and their derivatives used in disorders of the upper airways. Vegetable drugs and their preparations used as eupeptic, choleretic and hepatoprotectors. Vegetable drugs and their preparations used as used as hypolipidemic agents. Vegetable drugs and their preparations used as vasoprotectors. Vegetable drugs and their preparations used as laxatives and purgatives. Vegetable drugs and their preparations used for the control of body weight: drugs stimulating lipolysis and / or thermogenesis, drugs inducing satiety; drugs reducing lipogenesis; purifying drugs. Drugs and their preparations used as disinfectants of the lower urinary tract. Drugs and their preparations used in disorders related to benign prostatic hyperplasia. Drugs and their preparations used in menopause disorders, premenstrual syndrome and dysmenorrhea. Drugs and their preparations used in dermatological disorders (e.g., skin inflammations, wounds, burns, bruises). 4. Phytosurveillance Definitions, adverse reactions and related examples. Factors responsible for adverse reactions (product dependent, user dependent). The system of phytosurveillance in Italy: report form.

The student must not have to absolve particular prerequisites. However, in order to better understand some specific concepts (e.g., drugs containing alkaloids, mechanism of action of medicinal plants, phytotherapy of specific diseases) and to more easily achieve the learning objectives, it would be important to know subjects such as: human anatomy, general physiology, biochemistry, general pathology and general pharmacology and pharmacotherapy. Where the student can not attend the lessons, he/she must absolutely inform himself of what was made available and/or reported by the teacher, as material useful for learning purposes. The above mentioned must not be considered as an indispensable obligation, but as a prerequisite recommended to optimize the successful passing of the exam, to be taken at the end of the course.

1. Farmacognosia e Fitoterapia. Basi farmacologiche e aspetti applicativi. Mazzanti G., Dell'Agli M., Izzo A.A. Ed. Piccin (2020). 2. Farmacognosia – Botanica, chimica e farmacologia della piante medicinali. Capasso F. II° Ed. Springer-Verlag (2011). 3. Fitoterapia – Impiego razionale delle droghe vegetali. Capasso F., Grandolini G., Izzo A.A. Ed. Springer (2006). 4. Fondamenti di Farmacognosia e Fitoterapia. A cura di N. Galeotti, G. Mazzanti, M. Serafini. Ed. Edra (2015). In order to help the student (in terms of method), the integrated distribution of the recommended texts along the duration of the course could be hypothesized as follows: Text 1 is useful for the general part of the program (see point 1 and 2 of the same, in the "teaching program" section); Text 2 is instead more useful for the special part (see point 3 of the program) concerning the phytotherapy of specific mild diseases. Text 3 is a book that summarizes the essential concepts in a transversal way. Text 4 is the most updated, it can replace the integration between book 1 and 2; is a more in-depth text than text 3. The part related to the Phytovigilance is carried out on the basis of the consultation of dedicated websites and literature data that the teacher illustrates during the various lessons.

The adopted teaching method provides (for the greater number of hours, and compatibly with emergency measures,) lectures. However, exercises, related to the analysis of case reports of Phytovigilance and the simulations of bibliographic research in the drafting of papers, using telematic supports (specific to the field of pharmacognosy and phytotherapy) are also foreseen. The teaching methods, chosen by the teacher, contribute not only to the achievement of the planned training objectives, but are also methods easily usable in the real working life, as they provide quick and free access to databases and websites of the medicinal plants sector and its uses and warnings. Where, due to the covid emergency, distance learning becomes essential, the methods of development will be appropriately reshaped in order to achieve the same educational objectives.

Attendance at lessons has become formally optional by the Degree Program Board of 13 October 2017. However, for acquiring the competences provided by the course objectives, it is highly recommended. In fact, during the lectures, a useful interactivity is provided for cognitive purposes of websites, articles of literature, analysis of case reports (not otherwise achievable in case of non-attendance to the course, by the student). At the discretion of the teacher and for the evaluation of the achievement of a valid method of the study, according to pre-established and previously communicated modalities, the attendance to the Course could be verified.

The actual achievement of the expected learning outcomes by the student, in accordance with the training objectives, is evaluated through an oral exam. Among the aspects that contribute to the formation of the final judgment, beyond the specific preparation of the student on topics of examination, her/his reasoning ability is also assessed, on the basis of the study that it is conducted independently, which should not be based only on the mnemonic abilities. The duration of the test, as an oral one, is difficult to define and depends essentially on the degree of preparation and the relative exhibition skills of the student. An average duration of about 20 minutes is conceivable. The teaching, as established by Manifesto, does not provide for intermediate tests but only a test at the end of the teaching provision. This test, on almost a monthly basis (except for the month of August), have pre-established dates and are communicated annually to the Secretariats and published via e-learning and via Infostud websites. In any case, the student has the opportunity of a sort of "self-assessment" during the course because "ad hoc moments" of review and questions on the concepts developed are dedicated. To pass the exam it is need to achieve a grade of not less than 18/30. The student must demonstrate that has acquired sufficient knowledge of the general and special topics and that she/he is able to provide useful application of information on use, warnings, and undesired effects of products containing medicinal plants. To achieve a score of 30/30 cum laude, the student must instead demonstrate that has acquired excellent knowledge of all the topics covered during the course (including those of a regulatory and/or of more updated topics), and she/he is able to connect them in a logical and coherent way.

The reference Bibliography shown below is instead usable in the part relating to in-depth studies (point 4) and / or topics of greater relevance. However, it is advisable to specify that the student's preparation must not be sectorialized, but must provide for the capacity for reasoned integration between the different parts of the program, in the various sources of information. Website list Photocopies delivered in class and/or included on the course website (http://elearning2.uniroma1.it/). hhttp://www.salute.gov.it/ http://www.epicentro.iss.it/focus/erbe/sorv_reaz-avv.asp https://www.ncbi.nlm.nih.gov/pubmed/ http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/herbal_search.jsp&mid=WC0b01ac058001fa1d https://www.farmacovigilanzasif.org/topics/aggiornamenti/

The adopted teaching method provides (for the greater number of hours, and compatibly with emergency measures,) lectures. However, exercises, related to the analysis of case reports of Phytovigilance and the simulations of bibliographic research in the drafting of papers, using telematic supports (specific to the field of pharmacognosy and phytotherapy) are also foreseen. The teaching methods, chosen by the teacher, contribute not only to the achievement of the planned training objectives, but are also methods easily usable in the real working life, as they provide quick and free access to databases and websites of the medicinal plants sector and its uses and warnings. Where, due to the covid emergency, distance learning becomes essential, the methods of development will be appropriately reshaped in order to achieve the same educational objectives.