Ateneo - UPO

This course provides an in-depth exploration of the fundamental principles underlying the design and development of medicinal products. The principal aim 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 drugs 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 the evaluation of the stability, solubility, and intrinsic properties of the API, which influence 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 dosage forms. 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.

The course provides a solid foundation in biopharmaceutics and preformulation concepts. Students will learn to distinguish among drug substances (APIs), medicinal products, and excipients, and to classify dosage forms based on their structure, route of administration, and release mechanism. Furthermore, they will understand the stages of drug development and stability, deepening their knowledge of diffusion, solubility, and dissolution phenomena.
From a practical standpoint, by the end of the course, students will be able to correlate the physicochemical properties of an active ingredient with the most suitable dosage form, analyzing the impact of formulation on drug release in both conventional dosage forms and novel drug delivery systems.
The course fosters independent judgment, enabling students to critically evaluate the efficacy and safety of a medicinal product. They will also develop strong communication skills, learning to express themselves with appropriate scientific rigor when illustrating the LADME process, bioavailability, bioequivalence, and the Biopharmaceutics Classification System (BCS). Finally, the course ensures a high learning capacity, providing the necessary skills to face advanced courses in pharmaceutical technology and innovative dosage forms.

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.

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.

The course provides an in-depth understanding of dosage forms, their classification criteria, and the essential principles of formulation and preformulation for drug development. Students will grasp the phenomena of diffusion, solubility, and dissolution, while deepening their knowledge of key biopharmaceutics and pharmacokinetics concepts, with a particular focus on the LADME model, bioavailability, and bioequivalence.
From a practical perspective, participants will learn to correlate the physicochemical properties of an active ingredient with the most appropriate dosage form. They will also be able to evaluate the impact of technological factors on drug release, critically distinguishing between different release mechanisms in both conventional and non-conventional delivery systems.
The course fosters independent judgment, enabling students to critically evaluate the efficacy and safety of a drug based on its biopharmaceutical characteristics. Furthermore, they will develop strong communication skills, learning to express the concepts acquired with proper scientific and terminological rigor. Finally, the course ensures a solid learning capacity, providing the necessary methodological foundations to face subsequent technological courses and promoting continuous professional development in the pharmaceutical field.