BIOPHARMACEUTICS
Academic year and teacher
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- Versione italiana
- Academic year
- 2022/2023
- Teacher
- ALESSANDRO DALPIAZ
- Credits
- 9
- Didactic period
- Primo Semestre
- SSD
- CHIM/09
Training objectives
- The main objective of the course is to provide the basis of kinetic studies of drugs related with the administration of pharmaceutical formulations (pharmacokinetics) and the determination of their expiration date. Polymers used in the pharmaceutical field will be also described in order to provide the basis for the preparation of micro and nanoparticles characterized by release and smart targeting properties.
The main knowledge gained will be:
• pharmacokinetic parameters obtained from the study of the kinetics of absorption and elimination of drugs and their bioavailability
• chemical and kinetic models of drug degradation;
• the Arrhenius equation for accelerated stability studies of drugs;
• pharmacodynamics basis ;
• synthesis and chemical-physical properties of polymers used in the pharmaceutical field;
• formulation of polymeric micro and nanoparticles.
At the end of the course the students will be able
• to plan the procedures in order to obtain the main pharmacokinetic parameters of administerd pharmaceutical formulations, ie the absorption and elimination half-lives, the distribution volume, the clearance, the absolute bioavailability;
• to use the pharmacokinetic parameters in order to produce therapeutic protocols appropriate for the health condition and therapeutic needs of the patients;
• to plan the procedures in order to determine the expiry date of pharmaceutical formulations;
• to understand and evaluate the innovative potentialities and criticisms of micro and nanoparticulate pharmaceutical formulations with respect to conventional formulations. Prerequisites
- The following concepts and knowledges are mandatory:
• derivatives and integrals;
• inorganic chemistry;
• organic chemistry;
• physical chemistry. Course programme
- The course includes 72 hours of lessons during which the following topics will be addressed.
Pharmacokinetics (30 hours)
Cellular basis of pharmacokinetics; principles of first -order kinetics; pharmacokinetic analysis of blood and urine data for drug elimination; pharmacokinetic analysis of blood data for drug absorption; bioavailability and bioequivalence; multiple dosing-regimens.
Oral administrations: the factors influencing the drug bioavailability (9 hours)
Getting the drug to its site of absorption; factors affecting the rate of dissolution; gastrointestinal membrane transport: physical chemistry, physiological and formulation variables
Chemical kinetics and drug stability (7 hours)
Modes of pharmaceutical degradation; quantitation of rate of degradation; environmental factors that affect reaction rates; the Arrhenius equation and accelerated stability testing to determine the expiration date of drugs.
Drug-protein interactions (4 hours)
Evaluation of drug affinities for endogenous proteins; intrinsic activity.
Use of the polymers in the pharmaceutical field (22 hours)
Natural and synthetic polymers as drugs or drug delivery systems: synthesis methods and physical-chemistry properties of polymers; pharmaceutical application of polymers; polymeric microparticles: preparation and pharmaceutical use; polymeric nanoparticles: preparation, administration modes and pharmaceutical use; micro and nanoparticles for the brain targeting of drugs; the liposomes as an example of non-polymeric micro and nanoparticles: physical chemistry properties, preparation and pharmaceutical use. Didactic methods
- The course includes 72 hours of lectures in the classroom.The teaching method is based on lectures in the classroom, as an indispensable tool for synthesis and development of the formative objectives: relies on slides projected, diagrams and mathematical demonstrations that facilitate the study of the subject shown on the board to guide the training course. The lectures are set to an interactive dialogue student-teacher.
Learning assessment procedures
- The aim of the examination is to test the level of achievement of learning objectives previously indicated. An oral examination will investigate on the knowledge of the students, in particular they will be stimulate to connect and compare different aspects covered during the course in order to explain how to optimize the pharmaceutical formulations and their administration on the basis of the therapeutic needs of patients. To pass the exam, students must acquire a minimum overall score of 18/30.
Reference texts
- A.T. Florence, D.Attwod - Physicochemical Principles of Pharmacy - The Mac Milan Press.
R. Notari- Biofarmaceutica e Farmacocinetica - Piccin Ed.
Modern Pharmaceutics - Ed. G.S. Banker, C.T. Rhodes, Marcel Dekker, Inc.
