Biotechnologies

TECNOLOGIE FARMACEUTICHE Definition of drug, substance, medicine. Classification of medicines according to administrative and normative aspects. Medicines prepared in pharmacy and industrial products. Medicine characteristics: quality, safety and efficacy. Routes of administration and associated pharmaceutical forms. Biopharmaceutic (mentions). Formulation and preparation problems: definition and classification of main excipients for pharmaceutical use. Drug-excipient interactions, with special attention to biotechnological drugs. Dosage forms. Divided and bulk solid preparations: powders. Size reduction methods and mixing. Powder technological properties: bulk volume, true volume, bulk density, porosity, packing geometry, powder flow. Methods of measuring angle of repose. Granules. Methods of granulation: dry and wet. Granules formulation example. Capsules. Tablets: tablet manifacturing, tablet presses and tablet coating (mentions). Technological controls accordino to Italian Pharmacopoeia (FU) XII ed. Disperse systems. Emulsions. Surface tension. Non ionic and ionic surfactants. Surfactant use: emulsion stabilization. Suspensions: problems of sedimentatio, caking. Stokes’ law. Hydrocolloids. Liquid dosage forms for oral administration (mentions). Parenteral dosage forms. Preparation of large and small volume parenterals. Excipients used for parenteral dosage forms. Vehicles: water and oils, FU controls. Iso-osmotic and isotonic solutions. Osmosis, osmotic pressure. Definition of osmole, osmolarity and osmolality. Example of a large volume parenteral and osmolarity determination. Differences between iso-osmotic and isotonic solutions. Iso-, ipo- and iper-osmotic solutions and their cell effects. Sterilization processes. Properties of a sterile product. Asepsis. Packaging. Material characteristics: glass and plastic materials. Freeze drying. Phase diagram for water. Stages of the freeze drying process: material preparation, freezing, sublimation stage, removal of residual moisture. Biotechnological products.

TECNOLOGIE FARMACEUTICHE The student must have: a) Good command of specific technical expression. b) Mastery of elementary algebra (properties of logarithms, operations with numbers in scientific notation, fractions and percentages) of elementary geometry and trigonometry c) In order to understand the contents of the lessons and to achieve the learning objectives, it is necessary that the student know the key competences related to General and Inorganic Chemistry, Organic Chemistry and Physics courses (unit of concentration, conversion operations of the main measurement units, definition and measurement units of the main physical quantities, physical state and phase transition processes, thermodynamics, colligative properties, pH effect and ionization, buffer systems, formulas and structures of organic substances, general aspects of organic reactions)

Farmacopea Italiana XII Ed. Farmacopea Europea P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale -Principi di Tecnologia Farmaceutica (II edizione) - Ed. CEA Casa Editrice Ambrosiana ... M. E. Aulton, K. M. Taylor - Aulton. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali – Edra – Milano Michele Amorosa, Principi di Tecnica Farmaceutica, PICCIN ISBN 978-88-299-3160-6, 2021.

The course provides lectures aimed to provide the main scientific and technological knowledge necessary for the design, development and control of dosage forms made of biotechnological and non biotechnological active pharmaceutical ingredients. During the lessons the teacher stimulates active participation of the student: at the end of each lesson the teacher asks questions to the students in order to have a feedback to verify the correct learning in order to modify the teaching activities in a more effective way, stimulating the self-directed learning. The active participation of the students in the lesson is completed by practical exercises. The introduction of a differentiated approach into the educational process helps to individualize the learning process of students, contributes to a more lasting and deeper acquiring of knowledge, the formation of positive motivation to learning, creation of a comfortable learning environment, building students’ self-esteem and making them more autonomous.

The lectures will be conducted face-to-face.

TECNOLOGIE FARMACEUTICHE The exam consists of an oral exam, in which the student have to demonstrate abilities in classifying conventional dosage forms and in evaluating the features of excipients. To obtain a final grade of 18/30 (minimum mark) student must demonstrate to possess basic knowledge and skills related to compounding and control of conventional dosage forms. To obtain a final grade of 30/30 cum laude, student must demonstrate to possess an excellent knowledge of the overall addressed arguments, with the ability to think critically in a logic and coherent way. The student must also demonstrate to have understood the key and characterizing elements to be able to spend this knowledge in different working environments.

The course provides lectures aimed to provide the main scientific and technological knowledge necessary for the design, development and control of dosage forms made of biotechnological and non biotechnological active pharmaceutical ingredients. During the lessons the teacher stimulates active participation of the student: at the end of each lesson the teacher asks questions to the students in order to have a feedback to verify the correct learning in order to modify the teaching activities in a more effective way, stimulating the self-directed learning. The active participation of the students in the lesson is completed by practical exercises. The introduction of a differentiated approach into the educational process helps to individualize the learning process of students, contributes to a more lasting and deeper acquiring of knowledge, the formation of positive motivation to learning, creation of a comfortable learning environment, building students’ self-esteem and making them more autonomous.