1) provide the theoretical and methodological competences related to the development of biotechnological products; 2) provide an overview of medical devices; 3) provide an overview of the medicinal products for veterinary use considering the need to develop species-specific dosage forms, in the light of anatomical and physiological differences that may affect the bioavailability of drugs in different species. Through the course, the student will acquire theoretical and practical skills that will allow him to face the exercise of the profession with complete mastery of the subject.
Course Prerequisites
Pass the exam of Pharmaceutical Technology and Legislation (Prerequisites of the Teaching Regulations) and Pharmaceutical Technology and Medicines Regulation. Basic knowledge of pharmaceutical technology, especially for solid and liquid pharmaceutical forms. Knowledge of the basic concepts of biopharmaceuticals is required, the routes of administration, the factors that influence the absorption of drugs and the influence of the pharmaceutical form on the biological effect.
Teaching Methods
Lectures and seminars led by external experts whose attendance is strongly recommended. The teaching materials presented during the seminars, as well as those presented during the teacher’s lectures, will be assessed during the exam For students with specific needs, who cannot attend in person the teaching activities and who have applied for Inclusive Teaching Methods, the professor will provide teaching material suitable for independent study. If requested, self-learning can be supported by supplementary teaching activities and dedicated meetings, also online, with flexible hours depending on the needs.
Assessment Methods
The weight of the individual questions in the overall assessment is variable and is detailed in each test. The duration of the test is 2 hours. The results of the tests will be made known through esse3. Appropriate exam modalities are provided for students falling within the categories of Specific Learning Disorders (SLD) and Special Educational Needs (SEN).
Texts
Tecnologia Farmaceutica, P. Caliceti. Casa Editrice Ambrosiana. Principi di Tecnica Farmaceutica, M. Amorosa. Piccin Editore. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali, M.E. Aulton, K.M.G. Taylor. EDRA LSWR Editore. Principi di calcolo farmaceutico, H.C. Ansel, S.J. Stockton. EDRA Editore. Biotecnologie farmaceutiche, D.J. Crommelin, R.D. Sindelar. Zanichelli Editore. Compendio di Biotecnologie Farmaceutiche, M.L. Calabrò. EdiSES Editore. Manuale delle preparazioni veterinarie, F. Bettiol. Tecniche Nuove Editore. Farmaci biotecnologici. Aspetti farmacologici e clinici, E. Vegeto, A. Maggi, P. Minghetti. Zanichelli Editore.
Contents
The stability of drugs and products. Methods for the evaluation of stability. Stabilization and storage of products. Biotechnological drugs, biosimilar drugs. Routes of administration of biotechnological drugs, biopharmaceutical and pharmacokinetic aspects. Antigenicity and immunogenicity of proteins. Preformulation studies, formulation and stability of biotechnological products. Micro and nanoparticulate systems for the delivery of synthetic and biotechnological drugs. Outline of Advanced Therapy Medicinal Products. Characteristics of medical devices, examples, classification criteria. Legislation to the production, dispensing and monitoring of medical devices. Types of veterinary medicines. Species-specificity of the veterinary medicinal product. Major pharmaceutical forms for veterinary use: conventional forms for oral use, intraruminal modified-release systems, injectables conventional and modified release, preparations for intramammary use, transdermal preparations.
Course Language
Italian
More information
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