Bio pharmacy & Dosage Form Kinetics BIPH 4241

Course description:

Biopharmaceutical principles concerning the release from dosage forms, absorption, distribution, metabolism, and excretion of drugs, reaction kinetics (kinetics of drug degradation in vivo and in vitro), plasma concentration-time curves, multi-dosage principles, bioavailability, bioequivalence, in vitro/in vivo correlations. Pharmacokinetic basis for the development and testing of pharmaceutical products (pharmacokinetic models and parameters). Storage conditions and their effect on stability, methods of stability testing. Controlled-release vs. immediate-release preparations. The exercises during the tutorials include the analysis of drug degradation processes, in-vitro/in-vivo correlations, parameters derived from different compartmental kinetic models, parameters for drug absorption and bioavailability

Course Aims:

This course aims at informing the students of the main pharmacokinetics parameters regarding their importance, application, factors affecting them and how to calculate them. 
Accordingly, the student should know how to use blood and urine data following intravenous as well as extra- vascular administration to calculate pharmacokinetics parameters. 
The student should be also able to adjust a dosage regimen regarding initial dose, maintenance dose and dosing interval as well as intravenous infusion adjustment.
The student should also study about bioavailability and its parameters e.g. Cmax, AUC and tmax and how to calculate and apply them in evaluation and optimization of dosage forms.
A goal of this course is also to make the student aware of the biological as well as physicochemical factors affecting bioavailability of pharmaceutical dosage forms including the effect of dosage form manufacturing steps and excipients.The effect of food and co-administered drugs on bioavailability is also considered.

Course outcomes:

Upon successful completion of this course students will be able to:  
  • Recall the basics of pharmacokinetic parameters following intravenous and extra vascular administration of some drugs in one / multi-compartment model using blood and /or urine data and the basics of different orders of kinetics rather than the first order.  Identify the dosing types, regimens, pharmacokinetic, bioavailability parameters, and the physiological factors that affect the drug bioavailability and its proper use. 
  •  Recall the principles of pharmacokinetics & bioavailability with applications in therapeutic drug monitoring according to the sampling method obtained and with applications in dose modification according to the health condition of the patient. 
  • Define the principles of many body functions in health & some disease states on the drug bioavailability. 
  •  Identify methods of calculation of pharmacokinetic parameters and dose regimens of some drugs in one or / multi-compartment models using blood and/or urine data.