TECNOLOGIA DEI PRODOTTI ERBORISTICI E DELLA SALUTE - LEGISLAZIONE DEI PRODOTTI ERBORISTICI E DELLA SALUTE

Module TECNOLOGIA DEI PRODOTTI ERBORISTICI E DELLA SALUTE

1. Knowledge and understanding

• Correlation with assessment: Typically assessed through oral examinations aimed at verifying the mastery of the subject and specific terminology.
• Typical verbs used: Define, describe, identify, illustrate, recognize.
• Expected outcomes in the Syllabus:

-The student will be able to describe the main extraction, purification, and distillation techniques of herbal drugs.

-The student will know how to identify the unit operations (concentration, drying, lyophilization, spray drying) necessary for formulation manufacturing.

- The student will be able to illustrate and define the requirements for stability, preservation, and Good Preparation Practices (NBP).

2. Applying knowledge and understanding

• Correlation with assessment: Measured through practical tests and laboratory sessions where students must demonstrate the application of specific techniques and methods.
• Typical verbs used: Apply, calculate, formulate, execute.
• Expected outcomes in the Syllabus:

-Upon completion of the course, the student will know how to formulate and practically execute the phyto-galenical preparations learned in the laboratory, such as syrups, ointments, and capsules.

-The student will be able to calculate specific technological parameters such as the alcoholic strength by volume.

-The student will know how to apply safety regulations and behavioral protocols correctly within the laboratory environment.

3. Making judgements

• Correlation with assessment: Verified during the examination interview and the discussion of practical laboratory experiences, evaluating the student's ability to critically analyze methodologies and make reasoned choices.
• Typical verbs used: Analyze, evaluate, compare, interpret.
• Expected outcomes in the Syllabus:

-The student will be able to critically evaluate the quality and suitability of plant raw materials (herbal drugs) and finished products.

-The student will know how to compare the effectiveness of various extractive and technological strategies to select the optimal process based on the specific phytocomplex treated.

-The student will be able to interpret stability data of preparations to justify the choice of correct packaging materials and preservation methods.

4. Communication skills

• Correlation with assessment: Assessed through the quality of the exposition and the proper use of technical language during the final exam.
• Typical verbs used: Communicate, present, argue, expose, illustrate orally.
• Expected outcomes in the Syllabus:

-The student must be capable of exposing the phases of the learned technological and extractive processes with scientific rigor and terminological propriety.

-The student will be able to argue and illustrate orally the methodological and herbal choices made during laboratory practical exercises.

5. Learning skills

• Correlation with assessment: Monitored through the progression of learning and the ability to independently consult official sources during study and laboratory activities.
• Typical verbs used: Deepen, retrieve (sources), update, study independently.
• Expected outcomes in the Syllabus:

-The student will develop skills to independently retrieve material from specialized texts (e.g., Pharmacopoeias).

The course is delivered through a combination of theoretical lectures and supervised practical laboratory activities.

In accordance with Article 12 of the University Teaching Regulations (RDA) concerning the calculation of university credits (CFUs), the workload is organised as follows:

• Lectures: 7 hours of classroom teaching per CFU, complemented by individual study.
• Laboratory activities/Practical exercises: 12 hours of supervised laboratory activities for each CFU allocated to practical training, complemented by individual review and consolidation.

Note on the use of technology: Students may use Artificial Intelligence (AI) tools as a support for their learning and study activities, in compliance with current legislation, including copyright and intellectual property regulations, and in accordance with Section 5.1 of the University guidelines.

1. Method of lecture delivery

• Face-to-face lectures

2. Descriptive text for course delivery mode

The training activity is structured to combine the theoretical learning of technological principles with practical application in the herbal and phyto-galenical fields. In line with the nature of the discipline and the standard workload of 25 hours per CFU (Art. 12 RDA), the course is divided into two macro-types of activities:

• Erogative Didactics (DE): Includes face-to-face lectures in the classroom (equal to 7 hours for each theoretical CFU) aimed at the organic presentation of the program content. Through displays supported by slides and technical diagrams, the instructor illustrates the properties of herbal drugs, unit operations, extraction mechanisms, and regulatory frameworks (NBP). This mode contributes directly to the achievement of Knowledge and understanding (Descriptor 1).
• Interactive Didactics (DI): Includes assisted practical exercises mandatory carried out within the chemical-technological laboratories (12 hours per practical CFU). In this phase, students actively operate in the first person, executing the calculation of technological parameters (e.g., alcoholic strength by volume) and the manual preparation of syrups, ointments, and capsules. DI also includes moments of classroom discussion and critical review of the applied protocols. This mode is directly oriented towards the development of Applying knowledge and understanding (Descriptor 2) and Making judgements (Descriptor 3), while also fostering Communication skills (Descriptor 4) during the review of lab experiences.

(Use of Artificial Intelligence): Students may use AI as a supportive tool for study and personal re-elaboration, in compliance with current legislation and according to point 5.1 of the University guidelines.

If the course is delivered in blended or remote mode, appropriate adjustments may be made to the above, in order to ensure consistency with the syllabus.

Knowledge of the fundamental concepts of General Chemistry is considered indispensable.
Lecture attendance is compulsory, according to the rules established by the educational regulations of the Degree Course in SFA.

Attendance is mandatory, as established by the academic regulations of the Degree Programme.

Students may be absent for no more than 30% of the total teaching hours, taking into account all forms of course delivery, in accordance with the academic regulations of the Degree Programme.

1. The herbal drug (crude drug); initial treatments:
   1a) Extraction preparation techniques;
   1b) Mother tinctures and calculation of residual water content.
2. Powdering techniques.
3. Capsules, powders and granules.
4. Preparation techniques by distillation.
5. Concentration, drying, freeze-drying and spray drying.
6. Aqueous and hydroalcoholic solutions (definition of alcoholic strength; density).
7. Syrups, elixirs, etc.
8. Techniques for the preparation of ointments.
9. Quality of phytogalenic products; titration and standardization.
10. Stability and stabilization of products.
11. Product storage and preservation; basic concepts of packaging materials.
12. Overview of Good Preparation Practices (GPP).
13. Laboratory conduct and safety.

Laboratory Activities

• Preparation of a syrup
• Preparation of an ointment
• Preparation of capsules

DETAILED COURSE PROGRAM

According to the RDA, Art. 12 - University Educational Credits (CFU). Within the standard workload of 25 hours of total student commitment, corresponding to one credit, the following may be included:

• a) 7 hours dedicated to face-to-face lectures or equivalent teaching activities and the remaining hours to individual study;
• b) at least 12 hours dedicated to classroom exercises or equivalent assisted activities (laboratories) and the remaining hours to study and personal re-elaboration.

1) Principi di Tecnologia Farmaceutica; Colombo ed Altri; CEA edizione 2015

2) Il Laboratorio di Chimica, M. Consiglio, V. Frenna e S. Orecchio ed Edises 2001

3) Manuale delle preparazioni erboristiche; Franco Bettiol, Franco Francesco Vincieri. Tecniche nuove 2012.

4) Principi di Tecnica Farmaceutica, Michele Amorosa, Sesta edizione, Piccin.

- Many topics should be studied from the lecture notes. The textbooks listed above may be useful for further study and in-depth examination of specific topics.

1. Teaching Methods

Lectures and supervised laboratory exercises.

2. Assessment Methods

Learning outcomes are assessed through an oral examination, aimed at verifying the achievement of the expected learning outcomes, with reference to theoretical knowledge, application skills, and the ability to integrate and apply the knowledge acquired.

The oral examination is designed to assess, in particular, the student’s knowledge and understanding of the course content, ability to use the technical and scientific terminology of the discipline correctly, ability to establish connections among different topics, and ability to apply the acquired knowledge to problem-solving.

The assessment may also be conducted remotely, should circumstances require it.

Assessment Criteria

The final grade, expressed on a scale of thirty, will be determined on the basis of the following criteria, considered in a balanced manner and consistently with the expected learning outcomes and the Dublin Descriptors:

Quality of knowledge, skills and competences

• appropriateness, accuracy and completeness of knowledge;
• ability to correctly apply the knowledge acquired;
• ability to analyse and solve problems;
• ability to integrate knowledge relating to different topics within the discipline;
• degree of autonomy in applying the knowledge and skills acquired.

Communication and presentation skills

• clarity and effectiveness of expression;
• appropriate use of the specific technical and scientific terminology of the discipline;
• logical reasoning and coherence in presenting and connecting concepts;
• ability to establish connections among different topics, identifying common elements and constructing a coherent overall framework;
• ability to structure and organise the presentation in a logical and coherent manner;
• ability to summarise concepts, including through the use of the specific symbols and graphical representations of the discipline, such as formulae, diagrams and equations, where appropriate.

Interpersonal skills

• willingness to engage in discussion and interaction with the examiner during the oral examination;
• ability to discuss and elaborate on the topics covered in the course.

Personal skills

• critical thinking;
• self-assessment skills;
• problem-solving skills;
• ability to make decisions based on the knowledge acquired.

Criteria for the Final Grade

Fail: The student does not demonstrate the minimum knowledge required of the fundamental contents of the course, has inadequate command of the specific terminology of the discipline, and is unable to apply the acquired knowledge independently.

18–21: The student demonstrates a minimum knowledge of the learning objectives and fundamental contents of the course. The ability to integrate and analyse the situations presented and to apply the acquired knowledge is limited. The student presents the topics with sufficient clarity, although command of the specific terminology and autonomy in elaborating the contents are limited.

22–25: The student demonstrates a satisfactory knowledge of the learning objectives and main contents of the course. The student is able to integrate and analyse the situations presented, although not always in a fully coherent and autonomous manner. The topics are presented with adequate clarity and the student demonstrates a satisfactory command of the specific terminology of the discipline.

26–28: The student demonstrates a good knowledge of the learning objectives and contents of the course. The student is able to integrate and critically and coherently analyse the situations presented, applying the acquired knowledge with a good degree of autonomy. The student demonstrates good problem-solving skills, including in dealing with complex problems, and presents the topics clearly, using appropriate technical and scientific terminology.

29–30 and honours (cum laude): The student demonstrates an in-depth and comprehensive knowledge of the learning objectives and contents of the course. The student is able to independently integrate and critically analyse the situations presented, applying the acquired knowledge accurately and effectively, including when solving highly complex problems. The student demonstrates excellent communication skills, full command of the technical and scientific terminology, and outstanding abilities in summarising, connecting and critically re-elaborating the course content.

Information for Students with Disabilities and/or Specific Learning Disorders (SLD)

To ensure equal opportunities and in compliance with current legislation, students concerned may request an individual meeting to plan any appropriate compensatory and/or exemption measures, taking into account the learning objectives of the course and their specific individual needs.

Students may contact Prof. Santina Chiechio (santina.chiechio@unict.it), also in her capacity as the CInAP contact person (Centro per l’Inclusione Attiva e Partecipata – Services for Students with Disabilities and/or Specific Learning Disorders) of the Department of Drug and Health Sciences.

Examination Schedule

Examination dates are published on the website of the Degree Programme:

https://www.dsf.unict.it/it/corsi/l-29_sfa/calendario-esami

The oral examination lasts approximately 15–20 minutes and generally consists of three main questions:

• One question focusing on extraction techniques.
• One specific question focusing on the laboratory experiences and preparations directly carried out by the student, such as syrups, ointments and capsules.
• One question focusing on regulatory aspects (Good Preparation Practices – NBP), stability, pharmaceutical technology calculations (e.g., alcohol content), or packaging.