UNIVERSITY OF SANTO TOMAS

Faculty of Pharmacy

An Outcomes-Based Teaching-Learning Program for Biopharmaceutics and Pharmacokinetics

1st 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, 1st 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)
Academic Excellence
Show expertise in the competencies necessary to
the practice of profession
Leadership and Teamwork
Demonstrate capacity for leadership and teamwork
including the ability to motivate others, to be
responsible and reliable
Critical Thinking, Research and Problem Solving
Skills
Initiate innovative ideas and methods through
research responsive to the changing needs of the
society
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
PROGRAM INTENDED LEARNING
OUTCOME
Demonstrate creative application of
concepts and methods of pharmacy
practice geared towards the
advancement of various fields of
Pharmacy.
Assume leadership roles as appropriate
to the work profession and society
effectively and harmoniously as
members of healthcare teams.
Demonstrate critical application of
principles, theories and processes in
pharmacy using logical and systematic
methods to provide practical solutions to
real-life professional situations.
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.
COURSE INTENDED
LEARNING OUTCOME
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
2.Lead the health care team as
a specialist in rationalizing
dosage forms and drug
delivery systems in clinical
settings
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.
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 Apply effective communication 6.Implement effective

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

Support the integration of
biopharmaceutics and
pharmacokinetcis in pharmacy
practice (CILO 1)
Activities
Unit I: INTRODUCTION
A. Biopharmaceutics and Lecture forum Summarizing
Pharmacokinetics Reflective lecturing
1. Definition of biopharmaceutics Assigned reading
and pharmacokinetics
2. Evolution of biopharmaceutics
and pharmacokinetics
Justify the application of
biopharmaceutics and
pharmacokinetics in both drug
and patient-oriented pharmacy
practice (CILO 2)
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)
Defend the biological and
pharmaceutical consideration
on drug product design and
manufacture (CILO 4)
B. Relevance of
biopharmaceutics and
pharmacokinetics
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
B. Biopharmaceutic
Consideration
1. Mechanism of drug absorption Lecture forum
2. Anatomy and physiology of
the gastrointestinal tract
3. Factors affecting drug
absorption
Lecture forum Directed paraphrasing
Reflective lecturing
Assigned reading
Lecture forum Whats the principle
Reflective lecturing Illustrating concepts and
Concept mapping principles
Work along Activities Categorizing grid
Problem solving learning Defining features matrix
Lecture forum Whats the principle
Reflective lecturing Illustrating concepts and
Concept mapping principles
Work along Activities Problem sets
Problem solving learning Problem recognition tasks
Whats the principle
Reflective lecturing Illustrating concepts and
Concept mapping 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)
Measure parameters that
influence drug product selection
and use (CILO 2, CILO 3,
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
B. Drug Product Selection
1. Bioequivalence
2. Pharmacologic effect or
clinical efficacy
3. Dosing regimen
Lecture forum Whats the Principle
Reflective lecturing Illustrating concepts and
Concept mapping principles
Work along Activities Categorizing grid
Problem solving learning Defining features matrix
Compare and contrast chart
Problem sets
Problem recognition tasks
Lecture forum Whats the principle
Reflective lecturing Illustrating concepts and
Work along Activities principles
Problem solving learning Categorizing grid
Assigned reading Defining features matrix
Concept mapping 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 7th 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