Pharmaceutical Technology and Legislation with Laboratory of Galenic Preparations
A.Y. 2025/2026
Learning objectives
To present the principles underlying the formulation, manufacturing and quality control of the most common immediate-release dosage forms. To give the students essential knowledge for understanding the existing connections among technological, biopharmaceutical and pharmacokinetic properties of drug products. In addition, the legislative aspects involved by the professional practice will be introduced. Practical laboratory activities will be aimed at developing skills in the production and quality control of galenic preparations, both magistral and officinal, according to the standards of good pharmacy practice.
Expected learning outcomes
The students will gain fundamental skills on formulation, manufacturing and quality controls of the most common immediate release dosage forms. As a result, they will acquire the competences required to link the formulation characteristics of different immediate-release dosage forms with the relevant biopharmaceutical properties, and to critically evaluate how to fine-tune the latter through appropriate technological actions. Moreover, the students will be able to understand and apply the regulations regarding the professional practice.
Lesson period: year
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Linea Unica
Responsible
Lesson period
year
Course syllabus
1 ] Biopharmaceutics: Classification of pharmaceutical dosage forms; conventional and non-conventional dosage forms; definition of bioavailability. L.A.D.M.E. related to different routes of administration.
2] Pharmaceutical dosage forms for oral administration.
3] Parenteral dosage forms.
4] Eye drops.
5] Pharmaceutical dosage forms intended for application to the skin.
6] Inhalation dosage forms.
7] Suppositories.
8] Overview of drug product stability.
9] Principles of pharmacy practice .
2] Pharmaceutical dosage forms for oral administration.
3] Parenteral dosage forms.
4] Eye drops.
5] Pharmaceutical dosage forms intended for application to the skin.
6] Inhalation dosage forms.
7] Suppositories.
8] Overview of drug product stability.
9] Principles of pharmacy practice .
Prerequisites for admission
Due to the multi-disciplinarily of the course, the students, are required to be familiar with the concepts acquired in the courses of Fundamentals of pharmaceutical pre-formulation and formulation and General Pharmacology.
Teaching methods
The course is delivered by in-person lectures supported by informal assessments of students' understanding of core concepts through the use of the Wooclap platform. To reinforce the theoretical content and enhance comprehension of key pharmaceutical operations, students are required to participate in mandatory individual laboratory sessions. These practical sessions involve the preparation and technological characterization of selected pharmaceutical dosage forms. Additionally, students will be introduced to the use of spreadsheet software (Excel) for the elaboration of experimental data. Th e work will be organized in collaborative working groups, where students will analyze their results and present their findings in class. This activity is designed to foster peer-to-peer learning and develop both scientific communication and teamwork skills.
Teaching Resources
1. Principi di tecnologie farmaceutiche. P Colombo, F Alhaique, C Caramella, B Conti, A Gazzaniga, E Vidale. C.E.A. Casa Editrice Ambrosiana Ed. 2015.
2. Aulton's Pharmaceutics, The Design and Manufacture of Medicines, 5th Edition, edited by . ME Aulton, KMG Taylor. Elsevier.
3. Legislazione Farmaceutica. P Minghetti, M Marchetti, C.E.A. Casa Editrice Ambrosiana.
Handouts of slides and other supplementary materials will be available on the ARIEL website at the end of the course.
2. Aulton's Pharmaceutics, The Design and Manufacture of Medicines, 5th Edition, edited by . ME Aulton, KMG Taylor. Elsevier.
3. Legislazione Farmaceutica. P Minghetti, M Marchetti, C.E.A. Casa Editrice Ambrosiana.
Handouts of slides and other supplementary materials will be available on the ARIEL website at the end of the course.
Assessment methods and Criteria
The course exam consists of an written and oral test. The former is based on quiz and open-ended questions. The passing of the written test is subject to the achievement of a grade of at least 18/33.
The oral exam is articulated in at least one questions regarding pharmaceutical technology and one on pharmacy practice. The candidate has to achieve a grade of 18/30 in each answer.
The oral exam is articulated in at least one questions regarding pharmaceutical technology and one on pharmacy practice. The candidate has to achieve a grade of 18/30 in each answer.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 12
Single bench laboratory practical: 32 hours
Lessons: 80 hours
Lessons: 80 hours
Shifts:
Professor:
Cilurzo Francesco
Turno 1
Professor:
Palugan LucaTurno 2
Professor:
Cilurzo FrancescoTurno 3
Professor:
Moutaharrik SalihaTurno 4
Professor:
Moutaharrik SalihaProfessor(s)
Reception:
by appointment
Via G. Colombo 71