Industrial Pharmacy and Laboratory of Pharmaceutical Technology
A.Y. 2024/2025
Learning objectives
The course aims to impart in-depth knowledge of the technical regulations concerning the manufacturing and marketing authorization of drug products and to provide a critical understanding of the rationale behind these requirements. The practical activities envisaged in the laboratory are aimed at consolidating the knowledge acquired in the previous courses through the preparation and control of magistral and officinal formulae and the drafting of the relative documentation in compliance with the current laws.
Expected learning outcomes
At the end of the course the student must be able to understand and apply, critically and independently, regulatory requirements concerning the production and marketing authorization of industrial medicinal products. He will also have gained practical skills in the compounding of magistral and officinal formulae and acquired knowledge on the dispensation of medicinal products in pharmacies.
Lesson period: First semester
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
First semester
Course syllabus
Course syllabus
- Integrated approach to drug development.
- Chemical-pharmaceutical, pharmaco-toxicological and clinical studies necessary for obtaining the Marketing Authorization (MA) for products containing new chemical entities.
- MA of medicines containing expired patent drugs.
- Production authorization (PA).
- Common Technical Document (CTD).
- Outlines of pharmaceutical patents, with particular regard to the aspects associated with the formulation and production of pharmaceutical forms.
- Structure and organization of a pharmaceutical plant.
- Personnel and Organization.
- Quality System and Compliance with Good Manufacturing Practices (NBF).
- Supplies of materials and services.
- Documentation.
- Risk management.
- Computerized systems.
- Premises, installations, equipment.
- Calibration, Qualification, Maintenance of the equipment.
- Validation of methods and processes.
- Production and Quality Control.
- Technology Transfer.
- Materials Management (storage and transport).
- Change Management.
- Management of deviations and non-conformities.
- Inspections and self-inspections.
Laboratory of Pharmaceutical Technology - Course syllabus
oral solid dosage forms: characterization of powders; preparation of mixtures; preparation and characterization of capsules; preparation and characterization of tablets
oral liquid dosage forms
preparation and characterization of solution intended for oral, cutaneous and nasal administration; formulation of suspension; preparation and characterization of syrups
rectal dosage forms: preparation of suppositories with different suppository bases
cutaneous dosage forms: preparation of lipophic and hydrophilic creams, gels, ointments and pastes.
- Integrated approach to drug development.
- Chemical-pharmaceutical, pharmaco-toxicological and clinical studies necessary for obtaining the Marketing Authorization (MA) for products containing new chemical entities.
- MA of medicines containing expired patent drugs.
- Production authorization (PA).
- Common Technical Document (CTD).
- Outlines of pharmaceutical patents, with particular regard to the aspects associated with the formulation and production of pharmaceutical forms.
- Structure and organization of a pharmaceutical plant.
- Personnel and Organization.
- Quality System and Compliance with Good Manufacturing Practices (NBF).
- Supplies of materials and services.
- Documentation.
- Risk management.
- Computerized systems.
- Premises, installations, equipment.
- Calibration, Qualification, Maintenance of the equipment.
- Validation of methods and processes.
- Production and Quality Control.
- Technology Transfer.
- Materials Management (storage and transport).
- Change Management.
- Management of deviations and non-conformities.
- Inspections and self-inspections.
Laboratory of Pharmaceutical Technology - Course syllabus
oral solid dosage forms: characterization of powders; preparation of mixtures; preparation and characterization of capsules; preparation and characterization of tablets
oral liquid dosage forms
preparation and characterization of solution intended for oral, cutaneous and nasal administration; formulation of suspension; preparation and characterization of syrups
rectal dosage forms: preparation of suppositories with different suppository bases
cutaneous dosage forms: preparation of lipophic and hydrophilic creams, gels, ointments and pastes.
Prerequisites for admission
To understand and elaborate the contents of the course, preliminary knowledge of pharmaceutical technology is recommended. In order to deal profitably and safely with laboratory exercises, a basic ability and knowledge of the risks associated with the handling of chemical substances are necessary. To attend the laboratory course, it is mandatory to have passed the exams and to have attended Laboratory courses, as indicated in the Study Manifesto.
Teaching methods
Regarding Fabbricazione Industriale dei Medicinali the course will be given in presence.
For the Pharmaceutical Technology Laboratory teaching unit there is a cycle of frontal lessons preparatory to practical laboratory activities, aimed at guiding students in identifying the dispensing regime, filling in the label and completing all the obligations required by the galenic preparations proposed in the laboratory exercises.
For the laboratory activities students are individually engaged for the preparation and control of a series of solid, liquid and semi-solid pharmaceutical forms.
At the end of the exercises it will be possible to upload the completed labels to the personal portfolio on the ARIEL website and they will be returned to class. To consolidate the learning of technical and regulatory knowledge, students, organized in small groups, will be asked to simulate the solution of "case studies" proposed by the teacher.
For the Pharmaceutical Technology Laboratory teaching unit there is a cycle of frontal lessons preparatory to practical laboratory activities, aimed at guiding students in identifying the dispensing regime, filling in the label and completing all the obligations required by the galenic preparations proposed in the laboratory exercises.
For the laboratory activities students are individually engaged for the preparation and control of a series of solid, liquid and semi-solid pharmaceutical forms.
At the end of the exercises it will be possible to upload the completed labels to the personal portfolio on the ARIEL website and they will be returned to class. To consolidate the learning of technical and regulatory knowledge, students, organized in small groups, will be asked to simulate the solution of "case studies" proposed by the teacher.
Teaching Resources
Learning supports will be provided by ARIEL website.
Assessment methods and Criteria
For the part of industrial manufacture, the exam consists of a written and an oral test. The written test concerns about 20 questions with open and closed answers lasting 90 min. To be admitted to the oral exam, the student must achieve a mark of at least 18/30. The oral test consists of a discussion and possible integration of the topics covered in the written test; the duration is about 20 minutes.
For the Pharmaceutical Technology Laboratory part there are an ongoing self-evaluation tests on the theoretical part of legislation, with open questions, to be taken before the laboratory activities. At the end of the laboratory, a simulation test of the compounding a recipe, in which the student, through a series of open and closed questions, will have to identify the dispensing regime required for the specific preparation, list the related formalisms, describe the preparation method and the quality controls required, as well as all legal obligations necessary for the correct management of the preparation activity in the pharmacy. The documentation necessary to carry out the test (e.g. safety data sheets, pharmacopoeia tables, national price list of medicines and list of substances whose use is considered doping) will be provided. The duration of the test is 1 hour and the grade corresponds to the score out of thirty obtained in the simulation test alone.
For the Pharmaceutical Technology Laboratory part there are an ongoing self-evaluation tests on the theoretical part of legislation, with open questions, to be taken before the laboratory activities. At the end of the laboratory, a simulation test of the compounding a recipe, in which the student, through a series of open and closed questions, will have to identify the dispensing regime required for the specific preparation, list the related formalisms, describe the preparation method and the quality controls required, as well as all legal obligations necessary for the correct management of the preparation activity in the pharmacy. The documentation necessary to carry out the test (e.g. safety data sheets, pharmacopoeia tables, national price list of medicines and list of substances whose use is considered doping) will be provided. The duration of the test is 1 hour and the grade corresponds to the score out of thirty obtained in the simulation test alone.
Industrial Pharmacy
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 40 hours
Professor:
Cerea Matteo
Laboratory of Pharmaceutical Technology
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Single bench laboratory practical: 48 hours
Shifts:
Turno 1
Professor:
Selmin FrancescaTurno 2
Professor:
Franze' SilviaEducational website(s)
Professor(s)
Reception:
by appointment
via G. Colombo 71
Reception:
by appointment
Dept. Pharmaceutica Sciences - via G. Colombo, 71