TECNOLOGIA FARMACEUTICA - LABORATORIO GALENICO - TECNOLOGIA COSMETICA CON ESERCITAZIONI A - LModule LABORATORIO GALENICO
Academic Year 2026/2027 - Teacher: CLAUDIA CARBONEExpected Learning Outcomes
Knowledge and Understanding
The primary objective of the course is to provide students with the fundamental knowledge required for dispensing galenic formulations and to deepen their understanding of magistral and officinal preparations, core pharmaceutical operations, and current legislation.
The course comprises formal lectures and laboratory practicals, conducted both individually and in groups, incorporating active learning practices.
The course comprises formal lectures and laboratory practicals, conducted both individually and in groups, incorporating active learning practices.
During laboratory practicals, students will undergo ongoing evaluations (formative feedback assessments) focused on dispensing compounding prescriptions, and more broadly, on the preparation and quality control of extemporaneous dosage forms, thereby facilitating the overall learning process.
Applying Knowledge and Understanding
EXPECTED LEARNING OUTCOMES
By the end of the course, students will be able to:
- Develop a clear awareness of the pharmacist's responsibilities within a galenic laboratory;
- Understand the correct procedures for completing the required documentation associated with dispensing galenic medications;
- Apply current regulations for the accurate pricing of galenic preparations;
- Recognize the mandatory formal requirements of a galenic prescription for its valid dispensing;
- Evaluate the quality controls to be performed during the dispensing phase of magistral and officinal preparations;
- Prepare the main solid, liquid, and semi-solid galenic dosage forms;
- Verify the quality of galenic preparations through specific pharmaceutical quality controls;
- Organize workflows within the galenic laboratory in full compliance with NBP - Norme di Buona Preparazione.
Course Structure
The GALENIC LABORATORY A-L course comprises formal, participatory, and cooperative lectures (1 CFU), during which students will be encouraged to take part in formative feedback evaluation activities. The course includes individual laboratory practicals (3 CFU) and group laboratory sessions dedicated to quality control procedures (2 CFU).
Course attendance is compulsory and is officially recorded upon attending at least 70% of the laboratory practical sessions.
Attendance at the FIRST LABORATORY PRACTICAL SESSION is MANDATORY, as students will receive essential training and safety briefings regarding safety procedures within the Compounding Laboratory. At the end of this first session, a written test will be administered to verify the acquisition of these safety competences.
Laboratory practical sessions will take place on a weekly basis from October to January. The complete schedule of these sessions will be presented in class. The exact start date of the practical exercises will be announced by the professor (both in the classroom and via an online notice on the Pharmacy / DSFS website). Given the limited number of available laboratory workstations, and to ensure proper workflow organization, it is mandatory for each student to register on the Studium platform for the Compounding Pharmacy Laboratory module, alongside simultaneous online booking for the practical sessions.
At the end of the course, students are required to take the final theoretical-practical examination. The specific date will be announced to students at the beginning of the course. No absences are permitted.
Should the course be delivered via blended learning, necessary adjustments to the aforementioned structure may be introduced to ensure full compliance with the planned program outlined in this syllabus.
Required Prerequisites
Basic knowledge of:
- Mathematic, Statistic and Informatic;
-General and Analitical Chemistry;
- Anatomy;
- Microbiology, Pharmacology and Physiology;
- Basic knowdledge of excipients for pharmaceutical use.
Attendance of Lessons
Course attendance is compulsory and is officially validated by attending at least 70% of the laboratory practical sessions.
Attendance at the FIRST LABORATORY PRACTICAL SESSION is MANDATORY (scheduled for mid-October), during which students will receive essential training and briefings regarding safety procedures within the Compounding Laboratory.
Attendance is strictly mandatory for the final practical examination held at the end of the course.
The complete schedule and the start date of the laboratory practical sessions (which will take place from October to January) will be announced by the professor both in class and via an online notice on the Pharmacy/DSFS website.
Given the limited number of available laboratory workstations, and to ensure proper workflow organization, students must reserve their laboratory placement. Booking procedures will be outlined by the professor via an official notice on the DSFS website starting from September 15th.
Detailed Course Content
Dispensing a galenic prescription: galenic vs. industrial medicinal products. Magistral and officinal preparations. Norme di Buona Preparazione (NBP). Current National Pharmaceutical Tariff (Tariffa Nazionale dei Medicinali). In-depth study of the current Italian Official Pharmacopoeia (F.U.I.) Tables, including updates and amendments. Customized packaging (deblistering).
Individual laboratory practicals with ongoing formative feedback assessments on dispensing a galenic prescription: preparation techniques for the most common galenic dosage forms, regulatory and formal checks on the prescription and final preparation, and required documentation.
Group practicals will be dedicated to quality control procedures.
During the first individual practical session, a mandatory written test will be administered following the safety and training briefing provided by the professor. This test aims to verify the acquisition of knowledge regarding laboratory codes of conduct, safety regulations, and occupational health and safety standards.
Textbook Information
1. Farmacopea Ufficiale Italiana in vigore e relativi supplementi e aggiornamenti.
2. Decreto Ministero della Sanità del 22 settembre 2017 (Tariffa Nazionale dei Medicinali),
Allegati A e B, secondo aggiornamento del 30.01.2018
3. Farmacopea Europea in vigore.
4. P. Caliceti. Tecnologia Farmaceutica - prima edizione – Casa Editrice Ambrosiana, 2025.
5. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015.
6. Enrico Ragazzi “Galenica Pratica” Formulazione e Tecnologia. – Ed. 2006 – Libreria
Internazionale Cortina Padova.
7. Minghetti Paola. Legislazione Farmaceutica, Casa Editrice Ambrosiana. Ed. 2018.
8. Francesca Baratta, Irene De Pellegrini, Maria Beatrice Iozzino, Paola Brusa. Manuale di
galenica a uso umano e veterinario. Casa Editrice Ambrosiana (Ed. 2019).
Support material will be shared online on the teacher's Studium page during the year.
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Norme di Buona Preparazione (NBP) | |
| 2 | Shipping of medicinal prescriptions and National Medicines Tariff |
Learning Assessment
Learning Assessment Procedures
Assessment Methods
Ongoing evaluation through formative feedback will be provided both in the classroom and during laboratory practicals.
Written Test: A mandatory written test will be administered at the end of the first laboratory practical session. This test evaluates the acquisition of knowledge regarding laboratory codes of conduct, safety regulations, and occupational health and safety standards within the compounding laboratory.
To acquire the 6 ECTS (CFU): A theoretical-practical assessment on dispensing a galenic prescription will be held in January. This consists of a written exam featuring multiple-choice and/or open-ended questions.
Specifically, the final assessment will cover the following topics:
- Prepared dosage form (quality, quantity, quality control tests);
- Final laboratory report (content, precision of technical terminology, and overall communication skills);
- Pricing (application of current regulations from the National Pharmaceutical Tariff);
- Worksheet and label (content, terminology precision, application of current regulations);
- Compounded vs. industrial medicinal products;
- Magistral and officinal preparations;
- Current Italian and European Pharmacopoeias;
- Norme di Buona Preparazione (NBP);
- Quality control tests for pharmaceutical dosage forms.
Information for Students with Disabilities and/or Specific Learning Disabilities (SLD/DSA)
To guarantee equal opportunities and in compliance with current legislation, interested students may request a personal interview to arrange potential compensatory and/or dispensatory measures based on educational objectives and specific needs.
Students may contact Prof. Santina Chiechio, the departmental CInAP liaison (Center for Active and Participatory Integration - Services for Disabilities and/or SLD/DSA) at the Department of Drug and Health Sciences.
Students may contact Prof. Santina Chiechio, the departmental CInAP liaison (Center for Active and Participatory Integration - Services for Disabilities and/or SLD/DSA) at the Department of Drug and Health Sciences.
EVALUATION CRITERIA
The final examination will be assessed based on the following equally weighted indicators, consistent with the expected learning outcomes (Dublin Descriptors):
- capacity for personal elaboration and operational initiative;
- ability to consult and utilize bibliographical material;
- presentation and communication skills;
- scientific understanding of the subject matter.
Therefore, the final grade takes into account the various factors listed below.
Quality of knowledge, skills, and competences possessed and/or demonstrated:
a) appropriateness, accuracy, and consistency of knowledge
b) appropriateness, accuracy, and consistency of skills
c) appropriateness, accuracy, and consistency of competences
b) appropriateness, accuracy, and consistency of skills
c) appropriateness, accuracy, and consistency of competences
Presentation modality:
a) Expressive capacity;
b) Appropriate use of subject-specific terminology;
c) Logical reasoning and consequentiality in connecting content;
e) Ability to link different topics, identifying common points and establishing a coherent overall framework, namely by managing the structure, organization, and logical connections of the discourse;
f) Synthesis skills, also through the use of subject-specific symbolism and the graphical representation of notions and concepts (e.g., in the form of formulas, diagrams, and equations).
b) Appropriate use of subject-specific terminology;
c) Logical reasoning and consequentiality in connecting content;
e) Ability to link different topics, identifying common points and establishing a coherent overall framework, namely by managing the structure, organization, and logical connections of the discourse;
f) Synthesis skills, also through the use of subject-specific symbolism and the graphical representation of notions and concepts (e.g., in the form of formulas, diagrams, and equations).
Relational qualities:
Willingness to engage and interact with the examiner during the interview.
Personal qualities:
a) critical thinking;
b) self-assessment skills;
c) problem-solving skills;
d) decision-making capacity.
b) self-assessment skills;
c) problem-solving skills;
d) decision-making capacity.
Based on the above criteria, the final evaluation is graded as follows:
a) Sufficient (18 to 20/30)
The candidate demonstrates few acquired notions, a superficial level of understanding, and numerous gaps. Expressive capacity is modest but sufficient to maintain a coherent dialogue; logical skills and consequentiality in linking arguments are at an elementary level; poor synthesis skills and rather limited graphical expression; scarce interaction with the examiner during the interview.
b) Fair / Pass (21 to 23/30)
The candidate demonstrates a fair acquisition of notions but limited depth, with few gaps; expressive capacity is more than sufficient to maintain a coherent dialogue; acceptable mastery of scientific language; logical skills and consequentiality in linking arguments of moderate complexity; more than sufficient synthesis skills and acceptable graphical expression.
c) Good (24 to 26/30)
The candidate demonstrates a rather broad range of notions, moderate depth, with minor gaps; satisfactory expressive capacity and significant mastery of scientific language; dialogue skills and critical thinking are clearly identifiable; good synthesis skills and a more than acceptable capacity for graphical expression.
d) Very Good (27 to 29/30)
The candidate demonstrates a very extensive, well-deepened range of notions, with marginal gaps; remarkable expressive capacity and high mastery of scientific language; remarkable dialogue skills, strong competence, and significant aptitude for logical synthesis; high synthesis skills and excellent capacity for graphical expression.
e) Excellent (30/30)
The candidate demonstrates a very extensive and in-depth range of notions, with any gaps being negligible; high expressive capacity and high mastery of scientific language; optimal dialogue skills, strong aptitude for linking different topics; excellent synthesis skills and great proficiency in graphical expression.
Honours (Cum Laude) is awarded to candidates who are distinctly above average, and whose potential informational, expressive, conceptual, or logical limitations are overall completely negligible.
Examples of frequently asked questions and / or exercises
Exam Examples
The examination will focus on dispensing a compounding prescription, as shown in the examples below:
Example 1:
A) Dispensing 30 g of lidocaine-based gel.
B) Lyophilization: describe the stages of the process.
C) Milling and comminution mechanisms (meccanismi di polverizzazione).
Example 2:
A) Dispensing 50 g of codeine-containing syrup.
B) Dry heat sterilization.
C) Purified water: characteristics and production methods.
Example 3:
A) Dispensing 20 senna capsules.
B) Main drying techniques.
C) Water for injections (WFI): characteristics and production methods.