Unit

PRINCIPLES OF PHARMACEUTICAL TECHNOLOGY

Code	A005294
CFU	6
Teacher	Cinzia Pagano
Teachers	Cinzia Pagano
Hours	42 ore - Cinzia Pagano
Learning activities	Affine/integrativa
Area	Attività formative affini o integrative
Sector	CHIM/09
Type of study-unit	Opzionale (Optional)
Language of instruction	Italian
Contents	Contents: basic principles of pharmaceutical dosage forms and their industrial manufacturing methods, including equipment and production facilities.
Reference texts	P. Caliceti et al., Tecnologia Farmaceutica Casa Editrice Ambrosiana, 2025 M.E. Aulton, K.M.G. Taylor, Tecnologie farmaceutiche, Progettazione e allestimento dei medicinali, eds Aulton, Edra LSWR, 2015
Educational objectives	This course is the first Pharmaceutical Technology module and aims to provide the theoretical foundations of pharmaceutical dosage forms. Students will acquire fundamental knowledge of pharmaceutical dosage forms, with particular emphasis on conventional formulations, including powders, granules, tablets, capsules, solutions, suspensions, emulsions, semisolid preparations, injectables, and rectal, vaginal, ophthalmic, dosage forms. In addition, students will gain basic knowledge of manufacturing methods and pharmaceutical production equipment.
Prerequisites	To understand and follow most of the topics covered in this course and to successfully pass the examination, students are required to have previously passed the examinations in Chimica organica e bio-organica Anatomia umana e Fisiologia cellulare, Fondamenti di fisica.
Teaching methods	The course is delivered through classroom lectures.
Learning verification modality	Oral examination aimed at assessing students’ theoretical knowledge of the technological and formulation aspects of conventional pharmaceutical dosage forms, as well as manufacturing methods and the operation of production equipment. The examination consists of an oral interview lasting approximately 30 minutes (depending on the progress of the assessment). Its purpose is to evaluate the student’s level of knowledge of the topics covered, command of scientific terminology, communication skills, ability to synthesize information, and capacity to establish connections among the different subjects addressed in the course.Oral exam will consist in an interview 30 minutes long (but it depends on the performance of the test itself) aiming to verify the knowledge level and the understanding capability acquired by the student on theoretical and methodological contents as indicated on the program. The exam has the aim to evaluate the student communication skills and his autonomy in the organization and presentation of the topics of the course. For information on support services for students with disabilities and/or Specific Learning Disorders (SLD), please visit: http://www.unipg.it/disabilita-e-dsa.
Extended program	1. The Pharmacopoeia: the current Italian Pharmacopoeia, the European Pharmacopoeia, and other national pharmacopoeias. General Notices, General Chapters, and Monographs. 2. LADME and the factors, including formulation-related variables, that influence the bioavailability of active ingredients contained in pharmaceutical dosage forms. 3. Excipients: definition and classification. Medicines and drugs: definitions and main regulatory aspects. Classification of pharmaceutical dosage forms. 4. General operations common to various pharmaceutical dosage forms: milling, mixing, filtration, drying, lyophilization, sterility and sterilization, and the related equipment and facilities. 5. Solid dosage forms, manufacturing techniques, and production equipment for powders, granules, pellets, tablets, and capsules. 6. Liquid dosage forms, manufacturing processes, and production equipment for solutions, suspensions, and emulsions. Overview of the stability of suspensions and emulsions. 7. Semisolid preparations. Methods and production equipment for the manufacture of ointments, creams, gels, emulgels, and pastes. 8. Requirements, properties, preparation methods, and manufacturing equipment for rectal and vaginal, injectable, ophthalmic.
Obiettivi Agenda 2030 per lo sviluppo sostenibile	Objective 3. Health and wellness Problem of microplastics in pharmaceutical field and their impact on both environment and human health. Valorization of natural sources (including wastes from food industry) as source of active ingredients and raw materials to be used as excipients.

SCIENCE AND TECHNOLOGY OF MATERIALS

Code	50145902
CFU	6
Teacher	Debora Puglia
Teachers	Debora Puglia
Hours	42 ore - Debora Puglia
Learning activities	Affine/integrativa
Area	Attività formative affini o integrative
Sector	ING-IND/22
Type of study-unit	Opzionale (Optional)
Language of instruction	Italian
Contents	The course aims to provide an integrated and interdisciplinary perspective that combines materials science, the design of pharmaceutical dosage forms (formulations) and the development of packaging systems. Students will learn how the chemical and physical properties of materials influence the stability, safety and efficacy of the drug, with an in-depth focus on drug-container interactions, regulatory requirements and industrial technological challenges.
Reference texts	- William F. Smith : “SCIENZA E TECNOLOGIA DEI MATERIALI” Ed. McGraw Hill, 2004 - Paolo Caliceti, Tecnologia farmaceutica. Ed. CEA, 2025
Educational objectives	By the end of the course, students will be able to: - Classify packaging materials (glass, polymers, metals) according to their structural and barrier properties. - Link the chemical and physical characteristics of the formulation to the choice of primary packaging. - Apply the regulations of the Pharmacopoeias (EP, USP) and GMP/ICH guidelines to packaging quality control.
Prerequisites	A basic understanding of chemistry, physics and mathematics
Teaching methods	The course consists of lectures supported by PowerPoint presentations
Learning verification modality	Oral exam
Extended program	- Classification and structure of materials; an introduction to materials in the pharmaceutical sector. - Fundamental barrier properties: permeability to oxygen, carbon dioxide, water vapour and UV-visible radiation. - Advanced materials and biomaterials; biodegradable and biocompatible biopolymers. - ‘Smart’ and active packaging systems (time-temperature indicators, oxygen scavengers). - Advanced drug delivery systems (liposomes, nanoparticles). - Degradation kinetics, degradation mechanisms of formulations (hydrolysis, oxidation, photolysis). - Pharmaceutical packaging technology: thermoforming vs cold forming, closure systems and elastomers, secondary and tertiary packaging, and logistics - Packaging sterilisation methods: moist heat (autoclave), ethylene oxide (EO), beta/gamma rays. - Green packaging in the pharmaceutical sector, environmental sustainability, the circular economy, and regulatory barriers to the recycling of primary contact materials.