Corsi di studio in
Farmacia - Chimica e tecnologia farmaceutiche

The aim of the course, together to TNF I is to give to the students theoretic and practical bases about the preparation and the quality assurance of the pharmaceutical forms. Fundamental knowledge of pharmaceutical legislation about the pharmacist's responsibility in the medicinal products delivery and his social role in the territory. The course comprehends individual practical exercises about the preparation of galenics, quality assurance and delivery of the more common pharmaceutical forms prepared in the laboratory of the pharmacy in agreement with the law in force, moreover the more common medical devices are shown and discussed. Classroom exercises regarding several theoretic arguments of interest are also comprehended in the course.

Knowledge and understanding

By the end of the course, students should know the characteristics and specificities of solid dosage forms for oral, rectal and vaginal use and the technologies related to their preparation and characterization. They should have learnt the physico-chemical characteristics of powders and the technologies for their transformation and processing for pharmaceutical applications. They must know the requirements, the types and methods of control and sterilization of injectable and ophthalmic preparations. They must also have an in-depth knowledge of the broad panorama of the most innovative drug delivery systems.

The knowledge in the regulatory field will complete the preparation acquired by the students in the course of Pharmaceutical Technology and Legislation I with particular emphasis on the relationships that the pharmacy has with the territorial authorities that govern the exercise of the profession. Students should therefore have developed an up-to-date and exhaustive knowledge of the Italian regulatory panorama in the pharmaceutical sector.

Ability to apply knowledge and understanding

To be able to highlight the interconnection among the various regulatory topics so as to move fluently among them and be able to recognize their role in the carrying out of professional activity.

To be able to identify the rationale behind the various regulatory acts to have a complete and

Be aware that the contents learned in this course integrate and complete those acquired in the Pharmaceutical Technology and Legislation I course

Autonomy in intellectual production and critical judgment

To be able to answer uncoded questions that go beyond purely mnemonic study and that involve cross-cutting reasoning involving both technology and regulatory issues and that cannot be separated from the content acquired in the teaching of Pharmaceutical Technology and Legislation I.

Soft skills

Communicate with clarity and fluency, using appropriate terminology to explain even complex concepts.

Maintain concentration and control of the topics studied even in the event of stressful conditions due to expectations of success during the examination.

Pharmaceutical technology 

• Powders: definition, physico-chemical and technological characteristics for the determination. Milling, powdering, micronization, mixing, drying.
• Freeze-drying.
• Description of the most used excipients in solid pharmaceutical forms: diluents, adsorbents, lubricants, etc.
• Tablets: definition and classification. Alternative and rotary press tablet machines. Compression theory. Coating.
• Hard and soft capsules, charcteristics and productin technologies.
• Granulates: definition, typologies and granulation techniques. Pellets: definition, mechanism of growth, methods of preparation.  
• Description of the principal assays of quality and assurance control.
• Rectal and vaginal dosage forms.
• Sterility: microbial degradation kinetics; chemical and physical methods of sterilization. Pyrogens and bacterial endotoxins.
• Parenteral formulations: description, administration routes, physico-chemical and biological requirements; infusion solutions, TPN.
• Ophthalmic dosage forms: definition, physico-chemical and biological characteristics.  Transdermal therapeutic systems.
• Supramolecular systems: micro/nano particles, microemulsions, liposomes, cyclodextrins. Preparation methods of the most used galenics.
• Counseling and prescription of medical devices (advanced medication forms) and of non conventional release medicines.

Pharmaceutical legislation 

• NHS. Local Health Agency.
• LEA.
• Pharmaceutical spending.
• Medicine pricing.
• ADR Monitoring. Use of the medicinal products in clinical trial. Prescription of off label medicines.
• Healthcare advertising (Dlgs 219/06).
• Administrative classification of community pharmacies.
• Hospital pharmacy. Regulated distribution of the pharmacies on the Italian territory 
• Inspections in pharmacies. Inspection reports.
• Mandatory documents.
• Pharmacist profession: legislation pertinent to the ownership. L124/17.
• Privacy (GDPR, 2018).
• Pharmacoeconomics and pharmaceutical socioeconomics: notices and definition.
• Competitive exam for the assignment of a new pharmacy. Official State exam.
• National Federation of Orders of Pharmacists.
• Professional Ethics Codex.
• Disciplinary power.
• National Authority for Pharmacist Welfare.
• Owners Association: Federfarma. Pharmacist’s network. Not owners Pharmacist Association.
• Scientific Soceties.
• Intermediate Suppliers.
• Marketing in pharmacy.
• Web in pharmacy.

ESERCITAZIONI DI LABORATORIO - Comprendonoesercitazioni inerenti a:

• allestimento di formule magistrali ed officinali operando in autonomia la scelta degli eccipienti, con modalità di preparazione manuali e meccaniche;
• controllo della qualità delle principali forme farmaceutiche secondo FU;
• elaborazione di etichette per formule magistrali ed officinali.

ESERCITAZIONI IN AULA - Comprendono esercitazioni inerenti a:

• proiezioni di video inerenti ad apparecchiature per la produzione e il controllo di forme farmaceutiche
• simulazione di quiz inerente a concorso per assegnazione di sedi farmaceutiche
• criteri di indagine sul territorio attraverso l’uso di questionari
• uso di piattaforme informatiche legate alla professione del farmacista
• simulazione di colloquio di lavoro
• presentazione dei principali dispositivi medici presenti in farmacia
• interazione tra farmacisti e vittime di violenza
• rischi professionali del farmacista

PRACTICAL EXERCISE IN THE LABORATORY - They are organized in:

• individual practical exercises about quality control protocols for the most used pharmaceutical forms according to FU
• preparation of galenics - magistral and officinal - by both manual and automatic methods, making independent choices of excipients
• elaboaration of labels for galenics

Students are required, as an integral part of laboratory exercises, to produce a written report about quality control experiments.

PRACTICAL EXERCISE IN THE CLASSROOM - They are organized in:

• videos of equipments for the production and quality control of dosage forms
• simulation of the pharmacies contest exam
• sampling strategy to collect data in territorial survey
• use of IT platforms related to the profession of pharmacist
• job interview simulation
• presentation of the principal medical devices remboursed by NHS.
•  professional risks of the pharmacist profession

Lectures will be conducted in presence according to the class schedule.

The teaching material presented idurin the  lectures, any technological and regulatory updates, all preliminary material for the lab and supplementary material with links to websites will be available on the Moodle platform.

Laboratory exercises will be conducted on an individual basis. Students will be divided into several lab shiftsdepending on the capacity of the laboratory where the exercises will be carried out.

Off-site students will decide with their teachers the most convenient lab shifts in which to be placed.

Oral examination after receiving signature of attendance at the laboratory and compulsory lectures.

The oral examination consists of technology and regulatory questions and covers all the topics in the syllabus and addressed in the lectures and laboratory.

Technology and legislation are given equal weight in the evaluation of the candidate. Thus, generally, at least three technology questions and at least three regulatory questions are asked, but the teachers reserve the right to increase the number of questions to focus on specific topics when necessary for a correct evaluation of the candidate, who will also have to demonstrate that he/she has also acquired the ability to have an overview of the subject.

The number of questions may also increase if the candidate demonstrates excellent preparation that could lead to the attainment of the “lode”.

During the oral examination, in addition to the knowledge of the topics discussed in the course, the individual language clarity and appropriateness to communicate the learned assumptions will be evaluated as well.