TECNOLOGIA FARMACEUTICA

The aim of the course is to provide basic theoretical knowledge regarding the design, production and quality control of the main dosage forms of biotechnological medicines. As part of the course, the student will acquire knowledge on the role of the different components of a formulation, with particular attention to formulation approaches and production processes of greatest interest for biological medicines.

EXPECTED LEARNING RESULTS

At the end of the course the student will be able to understand the role of each component within the different dosage forms for each specific route of administration. At the end of the course the student will be able to:

- acquire knowledge on biopharmaceuticals, on the fundamental principles underlying the design of a biotechnological medicine, on the release of drugs, on the technological development of pharmaceutical forms;

- understand the properties and correct methods of use of excipients in the production of pharmaceutical forms with biotechnological medicines;

- apply the current legislation for the verification of the quality controls to be carried out on the various pharmaceutical forms of greatest interest for biological medicines;

- recognize the properties of the vehicles used in the preparation of pharmaceutical forms and their influence in the production of biotechnological medicines;

- verify the therapeutic efficacy of a medicine by studying the composition of the raw materials used in the formulations,

- applying the basic notions and modern pharmaceutical technology.

The course includes 42 hours of shared and cooperative lectures (6 CFU), during which students will be invited to participate in feedback evaluation activities. Each lesson ends with a short discussion in the classroom as a verification of learning. Lessons include question time.

If the teaching is given in mixed or remote mode, the necessary changes may be introduced with respect to what was previously stated, in order to comply with the program provided and reported in the Syllabus.

Definition and classification of medicines: Generic, Biological Drug, Biosimilars, Biobetter, ATMPs. Outline of Biopharmaceuticals.

Fundamental operations in pharmaceutical technology: dissolution, filtration, concentration, drying, freeze-drying, sterilization.

Pharmacokinetic aspects in the design of pharmaceutical forms. Preformulation and formulation development of biotechnological drugs.

Definition of the different pharmaceutical forms, with reference to the pharmaceutical products on the market and the different routes of drug administration:

- Liquid pharmaceutical forms (solutions, suspensions, emulsions): definition, characterization, assays and controls.

- Solid pharmaceutical forms (powders, granules, tablets, capsules): definition, classification, routes of administration, chemical-physical and biological requirements and controls.

- Ophthalmic pharmaceutical forms: definition, classification, chemical-physical and biological requirements and controls.

- Parenteral pharmaceutical forms: definition, classification, routes of administration, chemical-physical and biological requirements and controls.

- Nasal and Pulmonary pharmaceutical forms: definition, routes of administration, requirements and controls.

• Principi di Tecnologia farmaceutica, P. Colombo et al., Casa Editrice Ambrosiana, 2015
• Compendio di biotecnologie farmaceutiche, M.L. Calabrò, EDISES.
• Farmaci Biotecnologici - Aspetti farmacologici e clinici, Elisabetta Vegeto, Adriana Maggi, Paola Minghetti, Zanichelli, 2020.