ID:
501325
Duration (hours):
88
CFU:
9
SSD:
FARMACEUTICO TECNOLOGICO APPLICATIVO
Year:
2025
Overview
Date/time interval
Secondo Semestre (02/03/2026 - 19/06/2026)
Syllabus
Course Objectives
Educational objectives – To provide the theoretical and practical bases of conventional pharmaceutical technology, useful for the student to understand and use the concepts and operations necessary for the formulation of pharmaceutical products.
To provide the student with the keys to understanding the complex legislative apparatus, both national and supranational, that regulates pharmaceutical activities in Italy; in particular, let the student know, from a regulatory stand point, the types of medicines and the related regulations for dispensing them to the public.
Learning outcomes - At the end of the course the student will be able to: consult the European regulations relating to the pharmaceutical product, discriminating; conduct formulation studies for the preparation of galenic preparations; conduct technological checks on pharmaceutical companies; select suitable excipients for a given formulation in relation to the route of administration and the characteristics of the active ingredient; send a masterful galenic recipe and not...
In summary, the student will have acquired: the basic skills to move within the European regulatory apparatus relating to medicines; the basic skills to formulate a medicine.
To provide the student with the keys to understanding the complex legislative apparatus, both national and supranational, that regulates pharmaceutical activities in Italy; in particular, let the student know, from a regulatory stand point, the types of medicines and the related regulations for dispensing them to the public.
Learning outcomes - At the end of the course the student will be able to: consult the European regulations relating to the pharmaceutical product, discriminating; conduct formulation studies for the preparation of galenic preparations; conduct technological checks on pharmaceutical companies; select suitable excipients for a given formulation in relation to the route of administration and the characteristics of the active ingredient; send a masterful galenic recipe and not...
In summary, the student will have acquired: the basic skills to move within the European regulatory apparatus relating to medicines; the basic skills to formulate a medicine.
Course Prerequisites
Basic knowledge of Chemistry (General Chemistry, Organic Chemistry) and physiology.
Teaching Methods
Lectures, discussion of topics, laboratory exercises. The single-seater exercises are mandatory and concern the preparation of pharmaceutical forms and their checks with particular regard to the technological controls of the Official Pharmacopoeia. Pricing of galenic preparations.
Each student is engaged for 32 hours.
The exercises end with the final test which is awarded a score equal to a maximum of 3 points which are added to the exam grade, if the latter reaches a passing grade.
The topics developed in the laboratory exercises are the subject of the practical evaluation test of the qualifying degree.
Each student is engaged for 32 hours.
The exercises end with the final test which is awarded a score equal to a maximum of 3 points which are added to the exam grade, if the latter reaches a passing grade.
The topics developed in the laboratory exercises are the subject of the practical evaluation test of the qualifying degree.
Assessment Methods
VERIFICA FINALE: a final test is scheduled at the end of the lessons on all the topics covered in the course, with the goal to help the student in evaluating their acquired knowledge/skills. The final test will be a multiple-choice questionnaire: 28 questions/60 minutes (1 point for each correct answer, -1 for each incorrect answer, -0.5 points for non-answer).
FINAL EXAM: the final exam will be an oral exam. The student will be asked topics of pharmaceutical technology, pharmaceutical legislation both about community pharmacy and sanitary service in Italy, and European and italian regulatory science referred to industrial medicines.
Typically, the exam will be composed of 3 questions, the answer to each one can get a maximum score 9. 3 additional points might be achieved from the laboratory final test. The evaluation criteria include: ability to present and connect topics, evaluation of knowledge and skills. Laude is acquired by those students that get maximum scores both in the oral exam and laboratory final test.
FINAL EXAM: the final exam will be an oral exam. The student will be asked topics of pharmaceutical technology, pharmaceutical legislation both about community pharmacy and sanitary service in Italy, and European and italian regulatory science referred to industrial medicines.
Typically, the exam will be composed of 3 questions, the answer to each one can get a maximum score 9. 3 additional points might be achieved from the laboratory final test. The evaluation criteria include: ability to present and connect topics, evaluation of knowledge and skills. Laude is acquired by those students that get maximum scores both in the oral exam and laboratory final test.
Texts
P. Colombo et al: “Principi di tecnologie farmaceutiche” Ed. Ambrosiana 2004;
Martin “Physical Pharmacy” Ed. Lea and Fabiger - Philadelphia 2015;
Florence -Atwood “Physicochemical Principles of Pharmacy” Ed. Macmillan 2000;
P. Minghetti “Legislazione Farmaceutica” Casa Editrice Ambrosiana 2021.
Principi di Calcolo farmaceutico. G.Colombo, 2017, Ed Edra.
For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available for fruitful independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, and by dedicated meetings, including online, with time flexibility depending on needs.
Martin “Physical Pharmacy” Ed. Lea and Fabiger - Philadelphia 2015;
Florence -Atwood “Physicochemical Principles of Pharmacy” Ed. Macmillan 2000;
P. Minghetti “Legislazione Farmaceutica” Casa Editrice Ambrosiana 2021.
Principi di Calcolo farmaceutico. G.Colombo, 2017, Ed Edra.
For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available for fruitful independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, and by dedicated meetings, including online, with time flexibility depending on needs.
Contents
Definition of the different pharmaceutical dosage forms and the different routes of drug administration. Biopharmaceutics – Aspects: pharmacokinetics in the design of dosage forms. Bioavailability and bioequivalence. Biopharmaceutical classification system.
Pharmaceutical Technology. Excipients, functions and characteristics. Theory and formulation aspects of dosage forms: liquids, solutions, dispersed systems (suspensions and emulsions). Theory and formulation aspects of dosage forms: solid (granules, tablets, capsules rigid and soft); powders and properties of powders. Injectable preparations: formulation characteristics, preparation and production requirements. Sterilization; Freeze-dried products.
Preparations for cutaneous administration.
Technological controls of pharmaceutical forms and requirements required by the different pharmacopoeias.
Pharmaceutical Legislation - Notes on legislation regarding the production and marketing of products pharmaceuticals. Regulatory bodies. Elements of public law. Notes on the historical evolution of pharmaceutical legislation in Italy. Italian state health organization. European Union bodies and community regulatory acts. Classification administration of medicines. Official Italian Pharmacopoeia and European Pharmacopoeia. Dispensing discipline to public of medicines. Regulations regarding the narcotics sector. Criminal and civil liability of the pharmacist.
Professional associations and notes on healthcare ethics. Pricing of galenic preparations.
Pharmaceutical Technology. Excipients, functions and characteristics. Theory and formulation aspects of dosage forms: liquids, solutions, dispersed systems (suspensions and emulsions). Theory and formulation aspects of dosage forms: solid (granules, tablets, capsules rigid and soft); powders and properties of powders. Injectable preparations: formulation characteristics, preparation and production requirements. Sterilization; Freeze-dried products.
Preparations for cutaneous administration.
Technological controls of pharmaceutical forms and requirements required by the different pharmacopoeias.
Pharmaceutical Legislation - Notes on legislation regarding the production and marketing of products pharmaceuticals. Regulatory bodies. Elements of public law. Notes on the historical evolution of pharmaceutical legislation in Italy. Italian state health organization. European Union bodies and community regulatory acts. Classification administration of medicines. Official Italian Pharmacopoeia and European Pharmacopoeia. Dispensing discipline to public of medicines. Regulations regarding the narcotics sector. Criminal and civil liability of the pharmacist.
Professional associations and notes on healthcare ethics. Pricing of galenic preparations.
Course Language
Italian
More information
During the course, group activities will be proposed to develop transversal skills. These activities do not lead to the acquisition of a score and are carried out at the discretion of the students.
Degrees
Degrees
MEDICINAL CHEMISTRY AND PHARMACEUTICAL TECHNOLOGY
Single-cycle Master’s Degree
5 years
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People
People
Professore Ordinario
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