OVERVIEW

Pharmaceutical Technology deals with the preparation of the various pharmaceutical dosage forms used to deliver active ingredients through specific routes of administration. Pharmaceutical Legislation focuses on the regulatory framework governing medicinal products, from their marketing authorization to the procedures for their supply to the public, as well as on the organization of the Pharmaceutical Service, including its relationship with the National Health Service.

AIMS AND CONTENT

LEARNING OUTCOMES

The course is aimed at providing students with the fundamental knowledge concerning the preparation and quality control of the various pharmaceutical dosage forms and, with regard to the legislative component, the regulatory framework governing the Italian healthcare system and the professional practice of pharmacy.

The Pharmaceutical Technology Laboratory is designed to provide students with the physicochemical and regulatory foundations underlying the preparation and quality control of the main magistral and officinal preparations. In particular, through individual practical sessions, students will learn how to prepare solid, semi-solid, and liquid dosage forms for both internal and external use, in accordance with the Good Preparation Practices for Medicinal Products, either following a medical prescription or an officinal formula described in a Pharmacopoeia of the European Union.

AIMS AND LEARNING OUTCOMES

The Pharmaceutical Technology component of the course covers the main basic pharmaceutical technological operations and subsequently focuses on the study of the different pharmaceutical dosage forms. Students are expected to be able to identify and understand oral dosage forms (tablets, capsules, granules, and syrups), solutions, ophthalmic preparations, parenteral preparations, biphasic systems (emulsions, suspensions, and colloids), topical formulations, and suppositories. These dosage forms are presented through the study of the excipients they contain, their structural characteristics, and the properties that make them suitable for the development of specific formulations. For each dosage form, the relevant manufacturing equipment and technologies are also examined. Particular attention is devoted to the physicochemical principles underlying the main pharmaceutical processes. The quality control tests prescribed by the Pharmacopoeia complete the study of each formulation. During laboratory sessions, students are expected to be able to independently prepare the dosage forms covered in the theoretical part of the course.

Through the Pharmaceutical Legislation component, students acquire knowledge of the fundamental aspects of the healthcare system and pharmaceutical services, with particular emphasis on the administrative classification of pharmacies and the territorial distribution system. The supply of medicinal products for human use, including the different types of prescriptions, is addressed in accordance with Legislative Decree No. 219/2006. Regulations concerning medicinal products containing narcotic and psychotropic substances, as provided by Presidential Decree No. 309/1990, are also examined, including procurement and prescribing procedures, as well as the mandatory legal requirements for prescribing physicians and dispensing pharmacists.

The Compounding Pharmacy Laboratory consists of a series of individual practical sessions dedicated to the preparation of classical officinal and magistral pharmaceutical preparations. The laboratory is designed to enable students to acquire the following competencies:

• understand the responsibilities of the pharmacist within a compounding laboratory;
• correctly complete the documentation required for the dispensing of compounded preparations;
• apply current regulations governing the pricing of compounded medicines;
• identify the mandatory elements of a magistral prescription;
• perform the required checks for the dispensing of magistral and officinal preparations;
• prepare the principal solid, liquid, and semi-solid pharmaceutical dosage forms;
• assess the quality of compounded preparations through appropriate pharmaceutical quality control procedures;
• organize and manage compounding laboratory activities in compliance with the Good Preparation Practices (GPP).

During the laboratory sessions, students will undertake two formative assessments: one focused on the dispensing of a magistral prescription and the other on the preparation of extemporaneous pharmaceutical dosage forms and the corresponding quality control procedures. These assessments are intended to support the learning process and provide progressive evaluation of the competencies acquired throughout the course.

PREREQUISITES

Students enrolling in the course Pharmaceutical Technology I and Pharmacy Legislation (with Laboratory) are expected to have:

• a sound knowledge of General Chemistry, Mathematics, and Physics, which are core subjects taught during the early years of the degree programme;
• a thorough knowledge of Medicinal Chemistry.

These subjects are listed in the Pharmacy Degree Programme Curriculum as prerequisite courses for enrollment in this course.

TEACHING METHODS

The course consists of lectures and individual laboratory practical sessions conducted in person.

Lectures cover the topics included in the course syllabus and involve the use of slide presentations, written demonstrations, and class discussions.

The laboratory component consists of a series of individual hands-on practical sessions focused on the preparation of the pharmaceutical dosage forms covered in the theoretical part of the course.

Students holding valid certification for Specific Learning Disorders (SLD), disabilities, or other officially recognized special educational needs are encouraged to contact both the course instructor and the School/Department Disability Coordinator (Prof. Luca Raiteri, Luca.Raiteri@unige.it) at the beginning of the course in order to discuss any appropriate teaching arrangements. Such arrangements will be designed to accommodate individual learning needs while ensuring that the learning objectives of the course are fully achieved.

Important: Requests for examination accommodations must be submitted at least 10 working days before the scheduled examination date, following the instructions provided on the University of Genoa webpage dedicated to disability and SLD services: https://unige.it/disabilita-dsa/comunicazioni

SYLLABUS/CONTENT

Pharmaceutical Technology

• Incompatibilities: physical, chemical, and therapeutic incompatibilities. Clinical risk and risk management strategies aimed at reducing medication errors.
• Pharmaceutical operations: drying, size reduction (comminution), sieving, mixing, dissolution, filtration, lyophilization, sterilization, granulation, and tableting.
• Micromeritics: study of the fundamental properties of powders (particle size distribution, particle diameter, surface area) and derived properties (density, porosity, wettability, flowability, hygroscopicity, and polymorphism).
• Solutions: solubility and its fundamental aspects (Noyes–Whitney equation, precipitation pH, cosolvents); buffer solutions (Henderson–Hasselbalch equation, Van Slyke equation); biological buffer systems; isotonicity.
• Biphasic systems: electrical properties at interfaces (zeta potential), surface tension, and interfacial tension.

Preparation and quality control, in accordance with the current Pharmacopoeia, of the following pharmaceutical dosage forms:

• Powders for internal and external use.
• Granules, effervescent granules, and pellets.
• Conventional tablets, coated tablets (sugar-coated and film-coated), and special tablets (sublingual, buccal, vaginal, implantable, and effervescent tablets).
• Hard gelatin capsules and soft gelatin capsules.
• Solutions (syrups, infusions, decoctions, and oral drops).
• Ophthalmic preparations (eye drops, eye lotions, and ophthalmic ointments).
• Parenteral preparations (injectables, infusion fluids including hypodermoclysis and intravenous infusions, large volume parenterals, concentrated solutions, powders [lyophilized products] for injectable preparations, and implants).
• Emulsions, suspensions, and colloidal systems.
• Semi-solid preparations (creams, ointments, gels, and pastes).
• Suppositories and vaginal pessaries (ovules).
• Otic, nasal, and throat preparations.
• Pharmaceutical preparations derived from medicinal plants (powders, tinctures, fluid extracts, and soft extracts).

Pharmaceutical Legislation

• National and supranational pharmaceutical legislation.
• Central and local organization of public administrative services.
• The Official Pharmacopoeia of the Italian Republic and the European Pharmacopoeia.
• Good Preparation Practices (GPP).
• Pharmacy ownership, direct management by the owner, and related responsibilities.
• Corporate management of pharmacies.
• Administrative classification of pharmacies and the territorial distribution system.
• Hospital pharmacies and territorial pharmaceutical services.
• Public pharmacies.
• Medical prescriptions and the supply of medicinal products for human use.
• Pharmacy inspections.
• Possession and sale of poisonous substances.
• Regulations concerning narcotic and psychotropic substances: Presidential Decree No. 309/1990 and subsequent amendments, including requirements for procurement, storage, and dispensing.
• Officinal and magistral compounded preparations.
• Direct distribution and distribution on behalf of the National Health Service (DPC).
• The professional order of pharmacists and the Code of Professional Ethics.

Compounding Pharmacy Laboratory

The laboratory component includes a series of practical sessions devoted to the preparation of magistral and officinal compounded medicines. The activities are designed to develop competencies related to prescription management, evaluation of prescriptions and pharmaceutical compatibilities, dosage calculations, selection of raw materials and containers, packaging and labeling procedures, completion of laboratory documentation and pricing, performance of quality control tests, and application of the Good Preparation Practices (GPP).

The following dosage forms are prepared during the laboratory sessions:

• Powders for sachets and capsules;
• Aqueous and non-aqueous solutions;
• Infusions and decoctions;
• Syrups;
• Emulsions and suspensions;
• Creams, ointments, pastes, and gels;
• Suppositories and ovules;
• Infusion preparations and ophthalmic solutions (eye drops).

RECOMMENDED READING/BIBLIOGRAPHY

G. Barberini, L. Casettari, Legislazione farmaceutica nella pratica professionale, Ed. Piccin

P. Minghetti, Legislazione farmaceutica, Ed. CEA M.

P. Caliceti, Tecnologia farmaceutica, Ed. Casa Editrice Ambrosiana

Amorosa, Principi di Tecnica Farmaceutica, Ed. Piccin

H.C. Ansel, S. J. Stockton, Principi di calcolo farmaceutico, Ed. Edra 

Farmacopea Ufficiale Italiana e Farmacopea Europea 

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

Classes are held during the first semester, in accordance with the Degree Programme Regulations (Manifesto degli Studi).

CLASS SCHEDULE

The timetable for this course is available through the EasyAcademy Portal.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

Assessment consists of an oral examination conducted in person before a panel of two examiners, one of whom is always the course coordinator/instructor. The examination covers all topics included in the course syllabus and addressed during the lectures.

ASSESSMENT METHODS

For the laboratory component of the course, students are assessed through an intermediate practical test and a final practical test. These assessments require students to prepare a pharmaceutical formulation and submit a written report describing the procedures followed, the preparation of the product label, and the calculation of the applicable dispensing fee.

Successful completion of both practical assessments is required in order to be admitted to the final oral examination.

FURTHER INFORMATION

For any further information not included in this course description, students are invited to contact the course lecturer directly at eleonora.russo@unige.it