Industrial Pharmacy and Laboratory of Pharmaceutical Technology
A.Y. 2022/2023
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 cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
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 attende 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 teaching unit of Laboratory of Pharmaceutical Technology, instructions to compoudng and to assess the quality of several dosage forms, that students will have to prepare individually, will be provided. Students will also be guided to the identification of the dispensation regimen, to the filling of labels, product files and all documentations required in the actual legal framework. Students will be invited to upload the labels filled on the personal Porfolio on the ARIEL site and a correction will be made in class.
To consolidate the body of knowledge, students, divided in small groups, will be required to simulate all decisions and steps that a pharmacy have to take in consideration upon treceipt of a medical prescription. Some case studies will be proposed by the instructor.
For the teaching unit of Laboratory of Pharmaceutical Technology, instructions to compoudng and to assess the quality of several dosage forms, that students will have to prepare individually, will be provided. Students will also be guided to the identification of the dispensation regimen, to the filling of labels, product files and all documentations required in the actual legal framework. Students will be invited to upload the labels filled on the personal Porfolio on the ARIEL site and a correction will be made in class.
To consolidate the body of knowledge, students, divided in small groups, will be required to simulate all decisions and steps that a pharmacy have to take in consideration upon treceipt of a medical prescription. Some case studies will be proposed by the instructor.
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 2 hours is concerned. 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; duration, about 20 minutes.
For the part of Laboratory of Pharmaceutical Technology, the exam consists of a written and an oral test. The written test, lasting 1 hour, deals with the simulation of the dispensing a pharmacy preparation.. To pass the written test, the student must correctly identify prescription required, enlist its formal requirements, describe the method of preparation of the dosage form along with the quality controls, fill the product file and the documentations as defined by the actual legal framework. All Legal and informational documents (i.e., safety data sheets, Pharmacopoeia tables, national tariff for medicinal products and WADA list) will be provided. The oral exam, which is accessed having obtained at least 18/30 mark in the written test, is a brief interview on the technical and legislative topics covered during laboratory activities and allows the student to change the partial vote to a maximum of 4 points.
For the part of Laboratory of Pharmaceutical Technology, the exam consists of a written and an oral test. The written test, lasting 1 hour, deals with the simulation of the dispensing a pharmacy preparation.. To pass the written test, the student must correctly identify prescription required, enlist its formal requirements, describe the method of preparation of the dosage form along with the quality controls, fill the product file and the documentations as defined by the actual legal framework. All Legal and informational documents (i.e., safety data sheets, Pharmacopoeia tables, national tariff for medicinal products and WADA list) will be provided. The oral exam, which is accessed having obtained at least 18/30 mark in the written test, is a brief interview on the technical and legislative topics covered during laboratory activities and allows the student to change the partial vote to a maximum of 4 points.
Industrial Pharmacy
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Cerea Matteo
Laboratory of Pharmaceutical Technology
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Single bench laboratory practical: 64 hours
Shifts:
Turno 2
Professor:
Foppoli Anastasia AnnaTurno 3
Professor:
Cerea MatteoEducational website(s)
Professor(s)
Reception:
by appointment
via G. Colombo 71
Reception:
by appointment
Dept. Pharmaceutica Sciences - via G. Colombo, 71