Course Details

Pharmaceutical Technology and Legislation II

FA0033

Course
Pharmaceutical Technology and Legislation II
Code
FA0033
Academic Year
2025/2026
Curriculum Year
2022/2023
Degree Programme
PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
Curriculum
000 - CORSO GENERICO
Course coordinator
Credits
10
Lecture Hours
56
Scientific Disciplinary Sector (SSD)
CHIM/09 - Applied Technological Pharmaceutics
Course Type
Single-subject learning activity
Course Delivery
OBB - Obbligatoria
Year
4
Teaching period
Annuale
Campus
NOVARA
Teaching language
Italian
Course Contents
• Dispersed systems: colloids, emulsions, and suspensions.
• Semi-solid preparations: dermatological formulations.
• Production of semi-solid preparations.
• Nasal and pulmonary dosage forms.
• Suppositories.
• Formulation of biological/biotechnological drugs.
• Medical devices.
• Pharmaceutical legislation: Italian and supranational laws. Classification of pharmacies and medicines. Dispensation of medicinal products in local pharmacies. General characteristics of cosmetic and homeopathic products. Authorization for marketing of medicinal products. Protection of intellectual activity.
• Preparatory lessons and practical laboratory exercises: preparation, price composition, labeling, and quality control of magistral and officinal galenic formulations. Preparation of the most common cosmetic products. Use of software for the management of professional activity.
Reference Texts
• Aulton ME et al. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali. E. Edra. • Caliceti P. Tecnologia Farmaceutica. Ed. Ambrosiana. • Colombo P et al. Principi di tecnologie farmaceutiche. Ed. Ambrosiana. • Amorosa M. Principi di tecnica farmaceutica. Sesta edizione, Ed. Piccin. • Minghetti P, Marchetti M. Legislazione farmaceutica. Ed. Ambrosiana. • Farmacopea Ufficiale Italiana, edizione vigente. • Farmacopea Europea, edizione vigente. • Buone pratiche di laboratorio - Linee guida AFI - Volume XVII. Ed. Tecniche nuove. • Fabris L, Rigamonti S. La fabbricazione industriale dei medicinali. Ed. Esculapio, Bologna. • Bettiol F. Manuale delle preparazioni galeniche. Ed. Tecniche nuove. • Frongia M, Casettari L. Il galenista e il laboratorio. E. Edra. • Baratta et al. Manuale di galenica a uso umano e veterinario. Zanichelli. • Bettiol F et al. Manuale delle preparazioni veterinarie. Ed. Tecniche nuove. • Bettiol F, Cecchi M. Manuale delle preparazioni cosmetiche e dermatologiche. Ed. Tecniche nuove. • D’Agostinis G, Elio Mignini E. Manuale del cosmetologo. Ed. Tecniche nuove. • Aracri R et al. Il diritto nella cosmesi. Ed. Tecniche nuove. • Ansel HC et al. Principi di calcolo farmaceutico. Quindicesima edizione. E. Edra. • Loliscio N. La farmacia: un campo minato. 2025. Ed. Esculapio.
Learning Outcomes
The objective of the first part of the course is to provide the student with the theoretical notions of pharmaceutical dosage forms not explained in Tecnologia e Legislazione Farmaceutiche I: semi-solid preparations, nasal and pulmonary dosage forms, and suppositories. In particular, the physico-chemical characteristics of excipients used to prepare these dosage forms are explained, together with the technological and biopharmaceutical properties of final forms, the preparation methods in pharmacy and the production in industrial laboratories, and the correlated quality controls. Moreover, the course provides basic notions of pharmaceutical legislation, national and supranational, regulating industrial activities and the production and marketing of various medicinal products, their classification, and related dispensing discipline in local pharmacies.
The second part of the course aims to provide the students with theoretical and practical information about preparation methods, price determination, labeling, and quality control of magistral and officinal galenic preparations, according to the pharmacopeia requirements. Particular attention is dedicated to describing the technological characteristics of the immediate-release dosage forms usually prepared in pharmacies and the pharmaceutical industry.
Prerequisites
Fundamentals of pharmaceutical chemistry, pharmacology, and pharmaceutical technology.
Teaching Methods
The frontal lessons (7CFU) and the exercises concerning the expedition of a medical recipe are supported by multimedia tools for the exposition of the didactic materials. As a method of innovative teaching, the use of Kahoot is being experimented in the classroom. Kahoot is an app that allows students to participate in a fun competition by answering 10-40 multiple-choice questions within a predetermined time, at the end of each topic. The use of Kahoot enables students to consolidate their understanding of the explained concepts, especially the more complex ones, grasp the relationships among various concepts, and comprehend the connections between different parts of the study material. For the teacher, the use of Kahoot stimulates active student interaction, facilitates the assessment of learning progress over time, and helps identify any topics that require review or further integration during the lessons.
The mandatory practical exercises are carried out individually in the laboratory. Some information is provided about using specific informatics media to manage the pharmacist’s professional activity, and the correlated individual exercises are carried out in the informatics laboratory. 3 CFU are dedicated to all laboratory exercises.
Additional Information
The frequency of the lessons – both frontal and preparatory to the laboratory – and the practical laboratory exercises are mandatory and certified by the teachers.
It is not allowed to record, video record, or photograph the lessons—both frontal and preparatory to the laboratory.
Students with physical disabilities, Learning Disabilities, or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.
Assessment Methods
The written exam concerns the theoretical and practical basis for the formulation, preparation, and control of immediate-release pharmaceutical dosage forms and the basic concepts of pharmaceutical legislation. It consists of questions intended to test the knowledge and ability to apply in an independent way the knowledge acquired. Moreover, the student’s communication skills are evaluated, particularly the use of specific language for the pharmaceutical and technological discipline. The evaluation considers the student’s learning skills, particularly the capability to face the professional responsibilities of a pharmacist and a pharmaceutical technologist. The capability to update the health field and consult pharmaceutical-technological databases is also considered. The exam takes place during the official dates, and the grade is expressed in thirtieths. Practical laboratory exercises are preceded by an itinere written test on the main notions covered during the lessons preparatory to the laboratory. The student can perform the practical part of the laboratory only in case of sufficient results (≥ 18/30). Otherwise, the student can perform the practical part of the laboratory only after putting right the theoretical gaps. During the practical laboratory, the ability to apply the knowledge acquired is evaluated, considering the accurate presentation of the pharmaceutical preparation, the correct expedition of a medical recipe, and the composition of the technical report about the quality control of the officinal products student prepare. Interim evaluations are considered valid for the exam if the grade, expressed in thirtieths, is greater than/equal to eighteen. The overall grade, expressed in thirtieths, is calculated from the average, weighed on the number of CFU, of the grades obtained in the written and itinere written tests, and the practical exercises.
Detailed Syllabus
• Dispersed systems: colloids: classification, properties, pharmaceutical applications. Nanosystems for the delivery of drugs. Suspensions: definition and properties: wettability (contact angle), sedimentation (Stokes’ Law), zeta potential; stability: flocculation, de-flocculation, caking; pharmaceutical suspensions, routes of administration, requirements, quality assurance tests. Emulsions: definition; tests for identification of emulsion type, emulsifying agents; stability: sedimentation, creaming, coalescence, phase inversion; manufacture methods; quality assurance tests.
• Semi-solid preparations: principles of rheology; classification of semi-solid preparations: definitions, excipients, manufacture methods; dermatological formulations: trans-epidermal penetration; physicochemical and biological factors affecting penetration, percutaneous permeation, and absorption. Transdermal therapeutic systems. Liquid crystals.
• Equipments for the production of semi-solid preparations.
• Nasal and pulmonary dosage forms: classification, characteristics, devices.
• Suppositories: definitions and classification; suppository specific excipients; manufacture procedure (melting and compression methods); substitution factor; examples of suppository formulations; specific technological tests; rectal drug delivery systems.
• Biological/biotechnological drugs: routes of administration of protein drugs, biopharmaceutical and pharmacokinetic considerations. Antigenicity and immunogenicity. Preformulation studies, formulation, and stability aspects of biotechnological products. The PEGylation of peptides and proteins.
• Secondary packaging.
• Medical devices: definitions, requirements, classification, examples, CE mark.
• Pharmaceutical legislation: Italian government; sources of law; penal and civil code. Supranational laws. Italian health organization: Ministero della Salute, Servizio Sanitario Nazionale (SSN). Italian Pharmacopoeia, European Pharmacopoeia and United States Pharmacopoeia. Management of health waste. Type of pharmacy, organic plan, health professions, ethical code. Classification of medicines. Medical prescription: type of prescription, formalisms, validity. Toxic substances: definition, supplying, storage, prescription, dispensation. Narcotic and mood-altering substances: Table 7 of Italian Pharmacopoeia, supplying, storage, documentation, dispensation. Cosmetic products: definition and general characteristics. Homeopathic products: definition and general characteristics. Authorization for marketing of medicinal products. Protection of intellectual activity.
• Propaedeutic lectures and practical laboratory exercises. Galenic preparations: preparation of magistral galenic formulations (suppositories, ovules, syrups, solutions, emulsions, suspensions, creams, ointments, gels, pastes). Composition of the price according to the National Price List of drugs, labeling, and control of the preparation. Production of officinal galenic preparations: semi-solid preparations for cutaneous application. Perfusion solutions of the pharmaceutical factories and Hospital Pharmacy. Preparation of isosmotic and isotonic solutions. Quality control tests: control of the dosage forms (in particular solid dosage forms such as capsules and tablets and semi-solid preparations) according to Pharmacopoeia requirements. Composition of the certificate of analysis. Small-scale production of the most common cosmetics. Use of software for the management of professional activity.
Expected Learning Outcomes
The student must be able to apply the theoretical knowledge acquired in Pharmaceutical Technology and Legislation courses and transfer them in a critical way to technological-pharmaceutical problems. In particular, he/she will have to demonstrate to know and expose with adequate scientific language the chemical-physical and technological properties of the excipients and the dosage forms intended for the different routes of administration. In addition, the knowledge related to the plants for the industrial production of pharmaceutical forms will have to be acquired. The student must also have learned the regulatory skills required for the preparation and dispensing in pharmacies of galenic preparations and for the production, quality control and marketing of industrial medicines.
Last update:09-09-2026 00:14:31