FORMULATION AND RELEASE OF BIOTECHNOLOGICAL DRUGS
Learning outcomes of the course unit
The purpose of this course is to provide a general knowledge of the role of the formulation on stability, release and bioavailability pf active compounds , with a particular attention to biotech drugs. A further aim of the course is to provide the students the tools for the elaboration of the information given so as to integrate them into their knowledge. In particular at the end of the course the student shall:
-have aquired a general knowledge on pharmaceutical formulations for biotech drugs
-be able to highlight, for every formulation/administration route, potentialities, limits and impact on patient therapy
-ba able to present (orally or in writing) the topics studied in a clear way and using a correct technical language
Basic knowledge of anatomy, physiology and chemistry are required
Course contents summary
The first lecture of the course presents the impact that the formulation can have on the release of the active compound and on its bioavailability, with a particular attention to the biotech drugs. Then the conventional formulations (solutions, emulsions, suspantions, solid forms) will be illustrated as well as the innovativce approaches to increase drug bioavailability
The program is the following:
General topics: BIOAVAILABILITY, BIOPHARMACY, POLYMERS, DIFFUSION
Conventional formulations: SOLUTIONS, EMULSIONS, SUSPENSION, COLLOIDAL DISPERSIONS. LIQUIDS FOR ORAL AND PARENTERAL ROUTES, SEMISOLID FORMULATIONS, POWDERS, TABLETS, CAPSULES
INNOVATIVE FORMULATIONS and CONTROLLED RELEASE: RESERVOIR and MATRICES, OSMOTIC SYSTEMS, GASTRORETENTIVE SYSTEMS, COLON DELIVERY, MUCOADHESION, MICROPARTICLES, NANOPARTICLES, LIPOSOMES, HYDROGELS, ORAL ADMINISTRATION OF BIOTECH DRUGS
Alternative administration route: TRANSDERMAL , BUCCAL, NASAL, PULMONAR DRUG DELIVERY, ORAL ADMINISTRATION OF PEPTIDE AND PROTEINS
Textbook: Principi di tecnologie farmaceutiche, P. Colombo, P.L. Catellani, A. Gazzaniga, E. Menegatti, E. Vidale, Casa Editrice Ambrosiana Ed. 2004
Since some topics are not present in the book, specific texts (availabe at the library of the Food and Drug Department ) will be suggested.
The teacher makes available copies of the slides on Elly portal.
Lessons (hybrid learning) will be held in the classroom and will also be delivered at distance, synchronously, on Microsoft Teams.
The first lecture presents the rationale of the pharmaceutical formulations and highlight the background needed to deal with this course. Then, general topics such as bioavailability and bioequivalence, dissolution, diffusion, polymers, are presented. Finally, the different pharmaceutical formulations (conventional and innovative) and alternative delivery routes are explained in detail.
Assessment methods and criteria
The final examination is an oral examination that will be held either at distance or both at distance and in presence, depending on the COVID situation.
The exam is organized to evaluate:
-the knowledges of the topic treated during the course
-the ability to understand and elaborate information
-the ability of applying general concepts to specific subjects
-the ability to relate the different topic studied with the knowledge aquired in the previous courses
-the pertinence of the written language (in terms of clarity and accuracy)