Ateneo - UPO

This course provides an in-depth exploration of the fundamental principles underlying the design and development of medicinal products. The primary objective is to equip students with the theoretical and practical knowledge required to understand how the physicochemical properties of active pharmaceutical ingredients (APIs), in conjunction with excipients, influence pharmaceutical formulation, drug bioavailability, and the overall pharmacokinetic behavior of medicinal compounds within the human body.The course begins by examining the classification of pharmaceutical dosage forms according to their physical characteristics, routes of administration, and release mechanisms. It then delves into preformulation studies, a critical phase that focuses on evaluating the stability, solubility, and intrinsic properties of the API, which inform rational formulation choices. Core topics include drug diffusion and dissolution processes, with a special emphasis on the Noyes–Whitney equation, which models the dissolution rate. A substantial component of the course is dedicated to biopharmaceutics and pharmacokinetics, particularly the LADME system, which outlines the absorption, distribution, metabolism, and elimination pathways of drugs. Key concepts such as bioavailability and bioequivalence are thoroughly discussed, highlighting their significance in determining therapeutic efficacy and regulatory interchangeability. Finally, students will study advanced drug release mechanisms from conventional and non-conventional solid dosage forms, including reservoir, matrix, and osmotic systems. These technologies exemplify contemporary challenges and innovations in controlled drug delivery. By the end of the course, students will gain a comprehensive understanding of the scientific and technological factors that shape effective drug design, laying the foundation for informed decision-making in formulation development.

Paolo Caliceti, Tecnologia farmaceutica, 2025, CEA Casa Editrice Ambrosiana. Aulton ME, Taylor K.M.G. Tecnologie farmaceutiche, 2015 EDRA LSWR. Ansel, HC et al. Principi di calcolo farmaceutico. Quindicesima edizione. 2017 Ed. Edra. Farmacopea Ufficiale Italiana edizione vigente. Farmacopea Europea edizione vigente. Lachman L, Lieberman H, Kanig J. The theory and practice of industrial pharmacy. Ed. Lea & Febiger, USA. Fabris L, Rigamonti S. La fabbricazione industriale dei medicinali. Ed. Esculapio, Bologna.

🎓 Knowledge and Understanding By the end of the course, students will have gained solid knowledge of the fundamental principles of biopharmaceutics and preformulation. They will be able to clearly distinguish between drug, medicine, and excipient, and to classify the main pharmaceutical dosage forms based on structure, route of administration, and release mechanism. They will understand the theoretical foundations of drug design and development, with specific focus on the phases of preformulation and stability assessment, and they will be familiar with the phenomena of diffusion, solubility, and dissolution, including the use of the Noyes–Whitney equation to estimate dissolution rate. 🔍 Applying Knowledge and Understanding Participants will be able to apply their acquired knowledge to correlate the physicochemical properties of an active pharmaceutical ingredient with the choice of the most appropriate dosage form. They will analyze the influence of formulation and technological factors on drug release from conventional solid dosage forms and effectively explain release mechanisms from non-conventional systems such as reservoir, matrix, and osmotic technologies. 🧠 Making Judgements The course will support the development of critical thinking in evaluating the processes involved in drug formulation and optimization. Students will be able to make informed judgments regarding the potential efficacy and safety of a medicinal product based on its biopharmaceutical properties and technological profile. 🗣️ Communication Skills Students will be capable of clearly and accurately presenting key concepts in biopharmaceutics and preformulation, employing appropriate scientific terminology. This includes the ability to describe the LADME process and explain the concepts of bioavailability, bioequivalence, and the Biopharmaceutics Classification System (BCS) in academic and professional contexts. 📚 Learning Skills The course provides a solid foundation for approaching more advanced content in pharmaceutical technology and drug development. Learners will cultivate a mindset oriented toward research and continuous professional development within the field of pharmaceutical sciences.

To enroll in the course, the student must be familiar with the content covered in the first-year courses. Access to the final exam is subject to meeting the prerequisite requirements specified in the Academic Regulations (completion of all first-year exams)

The course will be delivered primarily through lectures. Several seminars will be held by professionals working in the pharmaceutical industry, who will illustrate the practical application of the theoretical concepts presented. On certain occasions, students will be invited to respond collectively to questions on previously covered topics and to retrieve supplementary educational material from the official websites of AIFA, EMA, and FDA.

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.

The exam will be held in written and/or oral form. To obtain a grade, students must demonstrate that they have understood and are able to apply the fundamental concepts of each topic. The evaluation, expressed on a scale of thirty, will be based on the following criteria: Knowledge and theoretical/applicative understanding of the subjects studied; Independent judgment and ability to make connections between topics; Communication skills and appropriateness in the use of technical language; Learning ability.

Drugs, medicines, excipients, and pharmaceutical dosage forms. Criteria for the classification of dosage forms: physical form, route of administration, and release modality. Design and development of medicines: formulation, preformulation, and stability. General principles of diffusion, solubility, and dissolution; dissolution rate and the Noyes-Whitney equation. Biopharmaceutics and pharmacokinetics: The LADME system; bioavailability and bioequivalence; the biopharmaceutical classification system of drugs. Release of drugs from conventional solid dosage forms: effect of formulation and technological factors. Drug release mechanisms from unconventional solid dosage forms: reservoir, matrix, and osmotic systems.

🎓 Knowledge and Understanding By the end of the course, students will have gained in-depth knowledge of the various types of pharmaceutical dosage forms and the criteria used for their classification. They will understand the essential principles of preformulation and formulation that underpin the development of new medicinal products. Learners will also be familiar with the phenomena of drug diffusion, solubility, and dissolution, and will have acquired the key concepts of biopharmaceutics and pharmacokinetics, including LADME, bioavailability, and bioequivalence. 🛠️ Applying Knowledge and Understanding Students will be able to relate the physicochemical properties of an active pharmaceutical ingredient to the choice of the most appropriate dosage form. They will be capable of predicting how formulation variables and technological factors affect drug release, and of distinguishing between different release mechanisms from both conventional and non-conventional dosage forms, such as reservoir, matrix, and osmotic systems. 🧠 Making Judgements The course will promote the development of independent critical thinking in assessing the challenges involved in drug design and development. Students will learn to formulate sound judgments regarding the potential efficacy and safety of a medicinal product based on its biopharmaceutical characteristics. 🗣️ Communication Skills Students will develop the ability to clearly and accurately express the key concepts of biopharmaceutics and preformulation, using appropriate scientific terminology in both academic and professional contexts. 📚 Learning Skills The course provides a solid foundation for future study in the field of pharmaceutical technology. It will encourage the development of a research-driven mindset and a commitment to lifelong learning in pharmaceutical science and innovation.