UNIVERSITY OF SANTO TOMAS

Faculty of Pharmacy

An Outcomes-Based Teaching-Learning Program for Biopharmaceutics and Pharmacokinetics
1
st
Semester, A.Y. 2013-2014



Course Title: Biopharmaceutics and Pharmacokinetics
Course Number: PHBS 1

Credit Units: 3 units lecture

Contact Hours: 3 lecture hours per week, 18 weeks per semester


Course Placement: 3rd year, 1
st
semester


Pre requisites: BIOSCI 3, PH-BIOCHEM, PHAR 3
Co requisites:
Course Facilitator: Assoc. Prof. Jovencio G. Apostol, Ph.D., RPh;
Gavino Ivan N. Tanodra, MD, RPh, DPCOM

Course Description: This course deals with the study of the intrinsic, formulation, physiologic, and pathologic factors affecting
bioavailability of drugs from drug products. It focuses on drug absorption, distribution, metabolism and excretion and how these
processes are modified by the different factors affecting the presence and action of the drug in the biologic system. Students are
expected to be able to rationalize the design of drug delivery systems in relation to dose, dosage form and clinical efficacy. They are
also expected to explain the construction of a dosing regimen in relation to optimizing therapeutic outcomes.
Approved by: Assoc. Prof. Ma. Elena J. Manansala, MSc.
Dean

Date of Approval: June 5, 2013
INSTITUTIONAL INTENDED LEARNING OUTCOME
(GRADUATE ATTRIBUTES)
PROGRAM INTENDED LEARNING
OUTCOME
COURSE INTENDED
LEARNING OUTCOME
Academic Excellence
Show expertise in the competencies necessary to
the practice of profession

Demonstrate creative application of
concepts and methods of pharmacy
practice geared towards the
advancement of various fields of
Pharmacy.
1.Demonstrate mastery of drug
absorption, distribution,
metabolism and excretion; drug
product design and how these
factors influence drug action
and apply this in patients drug
therapy

Leadership and Teamwork
Demonstrate capacity for leadership and teamwork
including the ability to motivate others, to be
responsible and reliable
Assume leadership roles as appropriate
to the work profession and society
effectively and harmoniously as
members of healthcare teams.
2.Lead the health care team as
a specialist in rationalizing
dosage forms and drug
delivery systems in clinical
settings

Critical Thinking, Research and Problem Solving
Skills
Initiate innovative ideas and methods through
research responsive to the changing needs of the
society

Demonstrate critical application of
principles, theories and processes in
pharmacy using logical and systematic
methods to provide practical solutions to
real-life professional situations.
3. Analyze drug absorption,
distribution, metabolism and
excretion through physiologic
and mathematical models.
Appraise factors that influence
drug product design and justify
the criteria for drug product
selection in clinical practice.

Productivity and Accountability
Develop new knowledge and understanding that
will contribute to nation-building and sustainable
development through the processes of inquiry,
research and innovation





Generate insights and new knowledge in
pharmacy that will contribute to nation-
building and sustainable development
through drug designs and development
for the prevention, diagnosis, mitigation
and treatment of diseases of man and
animals.
4. Design a drug product that is
safe and effective; optimize
patient therapy through
appropriate drug product
selection and customizing
disease treatment based on
drug pharmacokinetics


Social and Ethical Responsibility
Uphold Catholic values and moral principles
reflective of a competent, committed and
compassionate Thomasian in the formation of
humanely progressive and healthy society
Exhibit Catholic values and moral
principles reflective of the Thomasian
identity as health care professionals in
the formation of humanely progressive
and healthy society.
5. Integrate Catholic values
and moral principles in drug
selection and use that
strengthen the therapeutic
relationship of patient and
pharmacist.

Communication and Relational Skills
Develop effective communication competencies
through interpersonal skills and utilize information
technology responsibly as an effective tool in
exploring and expressing ideas.

Apply effective communication
competencies through interpersonal
skills and utilize information technology
responsibly as an effective tool in
exploring and expressing ideas
individually and collaboratively, and in
maintaining therapeutic relationships by
providing drug and health related
information


6.Implement effective
communication and
interpersonal skills concerning
drug pharmacokinetics that
highlight the role of the
pharmacist in the health care
team and encourage patient
trust and confidence in the
pharmacist
Intended Learning Outcomes Content Teaching-Learning
Activities
Assessment Tasks

Support the integration of
biopharmaceutics and
pharmacokinetcis in pharmacy
practice (CILO 1)
Unit I: INTRODUCTION

A. Biopharmaceutics and
Pharmacokinetics
1. Definition of biopharmaceutics
and pharmacokinetics
2. Evolution of biopharmaceutics
and pharmacokinetics



Lecture forum
Reflective lecturing
Assigned reading





Summarizing


Justify the application of
biopharmaceutics and
pharmacokinetics in both drug
and patient-oriented pharmacy
practice (CILO 2)
B. Relevance of
biopharmaceutics and
pharmacokinetics
Lecture forum
Reflective lecturing
Assigned reading

Directed paraphrasing








Explain the complex systems
and events or sequences of
events and pathways for drug
disposition (CILO 3)


Analyze the LADMERT system
using applicable physiologic
and mathematical models
(CILO 3)

Unit II: Pharmacokinetic
Parameters and
Biopharmaceutic
Consideration

A. Pharmacokinetic
parameters
1. Drug absorption, distribution,
metabolism and excretion




2. Pharmacokinetic Modelling
a. Mathematical models
b. Physiologic models










Lecture forum
Reflective lecturing
Concept mapping
Work along Activities
Problem solving learning

Lecture forum
Reflective lecturing
Concept mapping
Work along Activities
Problem solving learning









Whats the principle
Illustrating concepts and
principles
Categorizing grid
Defining features matrix

Whats the principle
Illustrating concepts and
principles
Problem sets
Problem recognition tasks



Defend the biological and
pharmaceutical consideration
on drug product design and
manufacture (CILO 4)

B. Biopharmaceutic
Consideration
1. Mechanism of drug absorption
2. Anatomy and physiology of
the gastrointestinal tract
3. Factors affecting drug
absorption




Lecture forum
Reflective lecturing
Concept mapping



Whats the principle
Illustrating concepts and
principles
Categorizing grid
Defining features matrix
Compare and contrast chart







Compare the factors to be
considered in bioavailability
testing and drug product
selection (CILO 4)


Unit III: Drug Design and
Bioavailability
A. Drug Product Design
1. Effect of drug product design
and manufacture on drug
availability
2. Drug delivery systems
3. Bioavailability




Lecture forum
Reflective lecturing
Concept mapping
Work along Activities
Problem solving learning






Whats the Principle
Illustrating concepts and
principles
Categorizing grid
Defining features matrix
Compare and contrast chart
Problem sets
Problem recognition tasks



Measure parameters that
influence drug product selection
and use (CILO 2, CILO 3,
CILO 4)

B. Drug Product Selection
1. Bioequivalence
2. Pharmacologic effect or
clinical efficacy
3. Dosing regimen


Lecture forum
Reflective lecturing
Work along Activities
Problem solving learning
Assigned reading
Concept mapping


Whats the principle
Illustrating concepts and
principles
Categorizing grid
Defining features matrix
Compare and contrast chart
Problem sets
Problem recognition tasks
Documented problem solution
Paper or project prospective







REFERENCES:
Basic Readings
Boroujerdi, Mehdi. Pharmacokinetics: Principles and Applications. New York: McGraw-Hill, 2002.
Cadwallader, Donald E. Biopharmaceutics and Drug Interaction. USA. Raven Press 1983.
Ritschel, W. A. Handbook of Basic Pharmacokinetics: Including Clinical Applications 7
th
ed. Singapore: Info Access &
Distribution Pte Ltd, 2009.
Rowland, Malcolm. Clinical Pharmacokinetics: Concepts and Application. Baltimore: Williams and Wilkins, 1995.
Shargel, Leon. Applied Biopharmaceutics & Pharmacokinetics. Stanford, CT: Appleton and Lange, 2012.
Extended Readings
Allen, Ansel, Popovich. Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lipincott, 2010
Web Researches

GRADING SYSTEM:
Monthly Grading (33.33%) Preliminary Grading (33.33%) Final Grading (33.33%)
Quizzes, seatworks, assignments - 40% Quizzes, seatworks, assignments - 40% Quizzes, seatworks, assignments - 40%
Monthly Examination - 60% Prelim Examination - 60% Final Examination - 60%





TENTATIVE COURSE CALENDAR:
WEEK CONTENT
1 Definition and evolution of biopharmaceutics, relevance of biopharmaceutics & pharmacokinetics
2 Drug absorption, distribution, metabolism & excretion
3 Drug absorption, distribution, metabolism & excretion
4 Mathematical models
5 Mathematical models, physiologic models
6 MOTHLY EXAMINATION
7 Mechanisms of drug absorption
8 Mechanisms of drug absorption
9 Anatomy and physiology of the gastrointestinal tract
10 Factors affecting drug absorption
11 Factors affecting drug absorption
12 PRELIMINARY EXAMINATION
13 Effect of drug product design and manufacture on drug availability
14 Effect of drug product design and manufacture on drug availability, drug delivery systems
15 Bioavailability, bioequivalence
16 Pharmacologic effect or clinical efficacy
17 Dosing regimen
18 FINAL EXAMINATION