Ateneo - UPO

The Pharmaceutical technology course aims to illustrate the principles, strategies, and technologies underlying the design and production of liquid, solid, and semi-solid dosage forms used in therapeutic contexts, with a particular focus on industrially manufactured medicinal products. During the course, the structure and characteristics of various pharmaceutical dosage forms are described, along with the properties of the raw materials that compose them and their functions in the product, as well as the operations and processes used in pharmacies and on an industrial scale for their production and quality control.

The reference texts for the course are as follows: - Caliceti P. et al. Tecnologia farmaceutica. Nuova edizione (2025), Ed. Ambrosiana. - Aulton ME et al. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali. Ed. Edra. - 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. - Ansel HC et al. Principi di calcolo farmaceutico. Quindicesima edizione. Ed. Edra. Some of the recommended texts are available for free as e-books at: https://upo.studenti33.it/indexupo.php or can be found in the university libraries (see the catalog at: https://upo.sebina.it/opac/.do). The lecture slides and teaching materials are provided free of charge to students on the course’s DIR page.

In line with the educational objectives of the degree program, the course aims to provide students with a solid theoretical and methodological foundation in the design and production of solid, liquid, and semi-solid dosage forms, deepening their understanding of formulation, excipients, production techniques, and controls according to Pharmacopoeia specifications. The course also seeks to develop the ability to understand the physicochemical properties of active ingredients and excipients, recognize their technological functions, and relate these elements to the choice of pharmaceutical dosage form and production process, both in industrial and galenic (compounding) settings. Alongside the theoretical dimension, the course intends to enhance practical and critical skills, enabling students to autonomously address issues related to drug delivery in a suitable pharmaceutical dosage form according to the administration route and therapeutic goals. Finally, the course aims to strengthen transversal skills, such as analysis, synthesis, and integration of knowledge, as well as effective communication by correctly using the technical and scientific terminology of the discipline, fostering the ability to interact with industry professionals and clearly and structurally present complex content.

A good knowledge of the content from previous years’ courses is required.

Lessons are held in a traditional classroom setting, utilizing a frontal mode, supported by multimedia tools for projecting teaching materials. Alongside conventional teaching, the course employs innovative teaching methods designed to foster active learning and critical participation among students. In particular, the flipped classroom approach is experimented with, where students autonomously review teaching materials (slides, scientific articles, short videos) before the lesson, allowing classroom time to be devoted to analysis, discussion, and solving practical problems. This approach stimulates reasoning skills, encourages independent study, and facilitates the consolidation of knowledge through direct interaction with the instructor and classmates. As an additional interaction tool, the Kahoot platform is used, allowing students to participate in a fun competition by answering 5–10 multiple-choice questions within a set time at the end of each topic. Using Kahoot helps students consolidate their understanding of concepts, especially the more complex ones, understand the relationships between different concepts, and grasp connections across various parts of the teaching material. For the instructor, Kahoot encourages active student participation, helps evaluate learning progress over time, and more quickly identifies topics needing review or integration. These integrated methodologies – frontal lecture, flipped classroom, and gamification via Kahoot – help make the learning experience dynamic, stimulating, and oriented toward developing transversal skills as well as understanding disciplinary content.

Attendance of at least 75% of lessons is mandatory and certified by the instructor. Students with disabilities, Specific Learning Disorders (SLD), or Special Educational Needs (SEN) can request dedicated services and tools by contacting the Career Development and Student Services Staff, or by consulting the University’s page: https://uniupo.it/it/servizi/servizi-studenti-disabili-e-dsa. After contacting University staff, such students can reach out to the course instructor regarding exam modalities and teaching-related aspects.

The exam is oral and covers all topics of the program. It aims to assess: (a) the level of theoretical knowledge acquired, (b) the ability to autonomously apply the acquired knowledge to practical problems typical of pharmaceutical dosage form design and production, and (c) communication skills, with particular attention to clarity, structure of discourse, and correct use of technical-scientific terminology. For an excellent grade, the ability to establish connections between concepts, integrate knowledge from different areas, and develop a critical approach regarding professional practice needs is also considered. Exams are held in scheduled sessions, and grades are awarded out of 30. In detail, the evaluation criteria are the following: (a) pass (18–23/30): student shows essential knowledge of fundamental concepts, generally understandable exposition (though not always complete), and acceptable use of technical-scientific language; (b) good (24–27/30): student demonstrates complete and confident knowledge of content, correctly applies knowledge to standard cases, and presents clearly and structurally with appropriate terminology; (c) excellent (28–30 cum laude): beyond thorough and integrated knowledge, the student proposes solutions to complex problems, integrates concepts from different areas, develops interdisciplinary connections, and expresses critical judgments on technological and production implications. The presentation is clear, rigorous, and complete, with a mastery of specialist vocabulary and an awareness of the application context.

INTRODUCTION TO PHARMACEUTICAL TECHNOLOGY. Definition of active ingredient, excipient, pharmaceutical dosage form, and medicinal product. Formulation rationale and classification of pharmaceutical dosage forms by physical state, administration route, and release modalities. Roles and competencies of professionals involved in the design, production, and control of medicinal products. – DISPERSED SYSTEMS, INTERFACIAL PHENOMENA, AND SURFACTANTS. Description of dispersed systems and interfaces, focusing on surface tension, wettability, and adsorption phenomena. Surfactants: classification, technological functions, and HLB system. – RHEOLOGY OF DISPERSED SYSTEMS. Differences between Newtonian and non-Newtonian fluids, concepts of thixotropy and antithixotropy. Viscosity measurement methods using capillary, falling, and rotational viscometers. – PHARMACEUTICAL SOLUTIONS. Classification, requirements, and advantages. Dissolution theory, factors influencing solubility and dissolution rate. Colligative properties and solubilization strategies. Preparation, excipients, and quality control of pharmaceutical solutions. – COLLOIDAL DISPERSIONS. Characteristics and classification of colloids, properties, and stability according to DLVO theory. Coagulation, flocculation, coacervation, and salting-out phenomena. – NANOPARTICULATE SYSTEMS. Introduction to nanoparticles for drug delivery, targeting strategies, and PEGylation. Classification into bio-inspired, synthetic, and inorganic nanosystems, with preparation methods. – PHARMACEUTICAL SUSPENSIONS. Classification, advantages, and stability issues. Mechanisms of flocculation and deflocculation, role of wetting agents and thickeners. Preparation and quality controls. – PHARMACEUTICAL EMULSIONS. Characteristics, stability, and stability issues (creaming, coalescence, phase inversion). Selection of emulsifiers via HLB, formulation, and preparation methods. – FILTRATION. Filtration mechanisms and factors influencing filtration speed. Filter types and pharmaceutical applications. – POWDERS, GRINDING, AND MIXING. Physical and technological powder characteristics, as well as granulometric analysis methods. Principles and equipment for grinding and mixing powders. – GRANULES AND GRANULATION. Purpose of granulation, advantages, and disadvantages. Dry, wet, and fusion granulation processes with related equipment. – TABLETS AND COMPRESSION. Types of tablets, compression processes, and factors influencing product quality. Compression methods and role of excipients. – CAPSULES. Characteristics of hard and soft capsules, materials, production, and filling methods. – COATING OF SOLID PHARMACEUTICAL DOSAGE FORMS. Rationale and coating techniques (sugar coating, film coating, dry coating), composition of coatings, and machinery used. – PREPARATIONS FOR ORAL AND BUCCAL USE. Characteristics of buccal and oral preparations, absorption factors, and formulation types. – PREPARATIONS FOR DERMATOLOGICAL USE. Skin structure, active ingredient absorption mechanisms. Dermatological preparations (solid, liquid, semi-solid) and quality controls. – PREPARATIONS FOR RECTAL AND VAGINAL USE. Advantages and limitations of these administration routes, suppository and ovule formulation, calculation of substitution factor, and preparation methods. – PREPARATIONS FOR NASAL AND INHALATION USE. Mechanisms of inhaled particle deposition, influence of particle properties. Nasal and pulmonary formulations with related delivery devices. – PREPARATIONS FOR PARENTERAL AND OPHTHALMIC USE. Requirements, quality controls, and types of parenteral and ocular preparations. – STERILITY AND STERILIZATION. Concepts of PNSU, SAL, process validation, and sterilization methods (heat, filtration, radiation, gas). Aseptic preparations and environment classification. – DRYING. Principles of drying, evaporation and sublimation techniques, equipment, and processes. – FORMULATION OF BIOLOGICAL/BIOTECHNOLOGICAL DRUGS. Stability of protein drugs, degradation mechanisms, and stabilization strategies. Immunogenicity, PEGylation, and bioconjugation approaches. – QUALITY AND QUALITY BY DESIGN. Evolution of quality systems and principles of Quality by Design. – TECHNOLOGICAL CONTROLS OF PHARMACEUTICAL DOSAGE FORMS. Pharmacopoeial assays for the treated pharmaceutical dosage forms.

Upon passing the course, students will have a solid understanding of the theoretical foundations of pharmaceutical technology, particularly in the design, formulation, and control of liquid, solid, and semi-solid pharmaceutical dosage forms. They understand the physicochemical properties of active ingredients and excipients, recognize their technological functions, and are familiar with the production processes and equipment used in both industrial and pharmacy settings. Students will also be able to independently apply their skills to solve concrete problems in drug production, proposing appropriate solutions for delivering active ingredients via different administration routes and critically selecting excipients, pharmaceutical dosage forms, and production processes based on therapeutic goals and the properties of the active ingredient. They even develop analytical and critical evaluation skills of different formulation approaches, considering advantages, limitations, and technological implications, and can integrate knowledge to solve complex problems, forming independent judgments in pharmaceutical dosage form design and production. Finally, students demonstrate practical communication skills, master the technical and scientific terminology of the discipline, can interact with pharmaceutical professionals, and present complex content clearly and structurally, showing synthesis skills, linking concepts, and awareness of the application context.