PHRM828000: Dosage Form I (Subject to Change)

Fall 2014, MWF 12:30 pm 1:20 pm, MTHW

210 (Note)

Course Description and Objective

This course deals with the science of delivery of drugs to the body and the dosage
forms that enable the drug delivery. Material to be covered will include selected
properties of drug substances that have a critical impact on the delivery of drugs to the
human body, the dosage forms available for drug administration, and the therapeutic
effect with respect to physical and chemical properties of drug in the solution. This
material will provide the knowledge base upon which the pharmacist will depend to
make rational decisions about drug product therapy for patients as well as to
appropriately counsel patients.
The goals of this course include:
(1) to provide an understanding of the relationship between dosage forms and drug
delivery and the physicochemical properties and structures of drug molecules;
(2) to enable students to comprehend the underlying principles of drug product
development and be able to apply them to engage in critical thinking of drug stability,
formulation and delivery;
(3) to recognize the importance of physiological conditions on the design, selection, and
performance of dosage forms;
(4) to build up the knowledge in drug development and delivery and develop problemsolving skills.
(5) to build a solid foundation for understanding the role of formulations in drug therapy
that will be taught throughout your Pharm.D. training and long afterwards.

1.

Faculty
Greg Knipp, Ph.D., Course Coordinator
E-mail: gknipp@purdue.edu
Steve Byrn, Ph.D.
E-mail: sbyrn@purdue.edu
Keith Chadwick, Ph.D.
E-mail: chadwick@purdue.edu
Rodolfo Pinal, Ph.D.
E-mail: rpinal@purdue.edu
Lynne Taylor, Ph.D
E-mail: lstaylor@purdue.edu.

Elizabeth Topp, Ph.D.

E-mail: topp@purdue.edu

2.

Teaching Assistants
Nathan Wilson (wilso242@purdue.edu)
Iris Cho (cho118@purdue.edu)
Office Hours: To Be Determined

3.

Course Secretary
Mary Ellen Hurt
E-mail: mhurt@purdue.edu

4.

Prerequisite

You are required to have a good understanding of general and organic chemistry, and to
be competent in applying algebra and calculus to solve problems. It is expected that
everyone in PY1 should be able to meet the prerequisites.

5.

Textbooks and Supplies

The following Electronic Textbooks from Lippincott, which are available online through
Purdue (http://www.pharmacy.purdue.edu/students/hlaccess.php), are recommended
for the course

Ansels Pharmaceutical Dosage Forms, 9th Ed., Ansel, Allen and Popovich,
editors, Lippincott, Williams and Wilkins, Publishers (2011).

Martin's Physical Pharmacy and Pharmaceutical Sciences: Physical Chemical

and Biopharmaceutical Principles in the Pharmaceutical Sciences, 6th Ed., Sinko
and Singh, editors, Lippincott, Williams and Wilkins, Publishers (2011).

The following textbooks are not required, but may be useful for understanding the
course material:

Physicochemical Principles of Pharmacy, 5th Ed., Alexander T. Florence and

David Attwood, Pharmaceutical Press (2011).
Remington's Pharmaceutical Sciences, 21st or latest edition, Mack Publishing
Co., Easton, PA (2005).
Chemical Stability of Pharmaceuticals A Handbook for Pharmacists, Kenneth A.
Connors, Gordon L. Amidon, and Lloyd Kennon, John Wiley & Sons (1979)

Required calculator: Must be able to perform linear regression analysis

You are required to use your Blackboard account for accessing information of this
course. The address is http://www.itap.purdue.edu/learning/tools/blackboard. Note that
we are using Blackboard Learn, not Blackboard Vista, for our course. You may
download class handouts, take quizzes, and upload your term papers.

I strongly encourage you to make use of the facilities offered by the CIE
Department for studying. http://www.purdue.edu/cie/index.html

6.

Grading

7.1.

Examinations

There are three scheduled examinations and one final examination. The following table
contains the point value of each examination:
POINTS

COVERAGE

DATE

100

Will cover lectures up until

the 9/16 lecture

September 20, Held in class

Exam 2

100

Will cover ALL of the

lectures from Drs. Knipp
(some overlap from the first
exam) and Taylor

October 16, Held in class

Exam 3

100

Will cover lectures from Dr.

Topp

November 18, Held in class

150

Comprehensive (40%)
Solid Dosage Forms from
Dr. Byrn (60%)

TBD

Exam 1

Final
Exam

In some instances, more than one professor will be providing material for an
examination. The point value for such material on the examination will be split
according to the contents of lectures by each professor.
7.2.

Homework Assignments (100 Points)

POINTS

COVERAGE

Homework #1

20

Routes of Administration

Homework #2

20

Drug Product Performance

Homework #3

20

Solution Chemistry

Homework #4

20

Chemical Stability

Homework #5

20

Solid Dosage Forms

7.3.

Final Grade

Final grade in the course will be calculated on the number of points earned in lecture
examinations and homework assignments. Grades will be awarded on the following
scale:
Total Points
550

Exams
450

Homework
100

% Total Points
Final Grade

90% and above

A

80 to 89%
B

70 to 79%
C

60 to 69%
D

below 60%
F

7. Course Rules and Regulations

General policies on exam and quiz guidelines, teacher/course evaluations, personal
appearance standards, class attendance, cell/smart phone use in class, class
cancellations in severe weather, class and exam schedule changes, honor code and
senate procedures related to academic dishonesty will be followed as listed in the
student handbook. This material is also listed on web at:
http://www.pharmacy.purdue.edu/students/handbook.pdf
In addition, for this class, PHRM828000, the following should be added and/or
emphasized:
8.1. Professionalism: Professional behavior is expected at all times. Professionalism is
defined as treating the instructors, teaching assistants, and your fellow students in a
respectful and courteous manner; completing small group activities accurately and
efficiently; and leaving the classroom or work area in a clean and orderly manner.
As part of treating others with respect, students and faculty alike are required to place
cell telephones and pager devices in the non-audio mode so that students and faculty
will not be disturbed during class. In no case will a student or faculty member speak
on a cell telephone while in the classroom.
7.2.

Cheating and Plagiarism: Except in those instances where students are explicitly
instructed to submit work done as a group, students are expected to work and
submit materials individually. Cheating and plagiarism will not be tolerated and will
be prosecuted to the fullest extent possible. The student is directed to the "College
of Pharmacy Honor Code" for further explanation. All examinations are taken in
accordance with the Honor Code. It is a College of Pharmacy policy that it is up to
each student to ensure that their own behavior during an examination is such that
no doubt could possibly exist about their honesty and integrity.
The University policy on academic dishonesty states: Purdue prohibits
"dishonesty in connection with any University activity. Cheating, plagiarism, or
knowingly furnishing false information to the University are examples of
dishonesty." [Part 5, Section III-B-2-a, University Regulations] Furthermore, the
University Senate has stipulated that "the commitment of acts of cheating, lying,
and deceit in any of their diverse forms (such as the use of substitutes for taking
examinations, the use of illegal cribs, plagiarism, and copying during
examinations) is dishonest and must not be tolerated. Moreover, knowingly to aid
and abet, directly or indirectly, other parties in committing dishonest acts is in
itself dishonest." [University Senate Document 72-18, December 15, 1972]
Please refer to the Purdue's student guide for academic integrity
(http://www.purdue.edu/odos/aboutodos/academicintegrity.php )

The Universitys policy on plagiarism is:

Among the materials that may be protected by copyright law are the lectures,
notes, and other material presented in class or as part of the course. Always
assume the materials presented by an instructor are protected by copyright
unless the instructor has stated otherwise. Students enrolled in, and authorized
visitors to, Purdue University courses are permitted to take notes, which they
may use for individual/group study or for other non-commercial purposes
reasonably arising from enrollment in the course or the University generally.
Notes taken in class are, however, generally considered to be derivative works
of the instructors presentations and materials, and they are thus subject to the
instructors copyright in such presentations and materials. No individual is
permitted to sell or otherwise barter notes, either to other students or to any
commercial concern, for a course without the express written permission of the
course instructor. To obtain permission to sell or barter notes, the individual
wishing to sell or barter the notes must be registered in the course or must be an
approved visitor to the class. Course instructors may choose to grant or not grant
such permission at their own discretion, and may require a review of the notes
prior to their being sold or bartered. If they do grant such permission, they may
revoke it at any time, if they so choose.
8.3. Grading: Errors do occur in grading and students do have the right to have any
error corrected promptly. The student has 7 (seven) days after return of materials
to submit an examination for reconsideration, after which time, all grades become
final. In the event that a student wishes to have an examination re-graded, the full
examination paper and a written request are to be submitted to Dr. Knipp (either
directly in person or to the course secretary, Mrs. Hurt). The written request is to
identify the area of concern and to state reasons why the student believes there is
an error. The more clearly this request is written out, the more rapidly the faculty
member will be able to return the examination to the student. The right to re-grade
the entire examination upon resubmission is hereby reserved by the faculty.
Because a number of faculty members may be involved in the re-grading, the
process may take a seemingly long period of time. Patience is appreciated.
The final exam will not be returned. If you have questions regarding the final exam
and your performance, you may contact Dr. Knipp during the first two weeks of the
spring semester when you return from your winter break. No possible change of
your grade will be made after the two-week period.
8.4. Make-up Exam: A student may take a make-up exam if such a request can be
made before the regular exam and proper document and/or explanation can be
provided.
8.5. Laptop Use in Class: Using laptop in class to access course materials and work
on course assignments is permitted as the activities are pertinent to the lecture
being taught or directed by the instructor. Using laptop (or other types of mobile,
computing devices) for activities that share no direct learning purposes can pose a

significant distraction to the student and those nearby, and is therefore considered
unprofessional and strongly discouraged.
8.6. Attendance Policy: The faculty firmly believes that regular class attendance is
critical to success in the course. The faculty also believes that students are
professionals who are empowered to make their own decisions. Consequently,
class attendance will not be monitored. As indicated above, make-up quizzes will
not be administered.
The evening exams do involve some hardships on students and every effort will be
made to accommodate those individuals. Please contact Dr. Knipp early in the
semester if a re-scheduling of an examination is necessary for religious or medical
considerations. Examinations missed without notification of the faculty in advance
will be graded as a zero.
8.7. Late Arrival for Exam: A student who is late for an exam will have to meet the
same time frame of the exam. If a student arrives after someone already finishes
the exam and leaves the classroom, the student may not be allowed to take the
exam and needs to discuss with instructors about taking a make-up exam, whose
time frame is equivalent to what is left for the student for the regular exam.
8.8. Course Evaluation Policy: Regular course and instructor evaluations are required
by state, university, college and accreditation regulations. These evaluations are
essential for improving student learning by providing feedback to faculty about their
classroom presentations. Based on your feedback, important decisions are made
about courses and how they are taught. This process CANNOT work without your
input.
8.9. Emergency and Class Cancellation: In the event of a major campus emergency,
course requirements, deadlines and grading percentages are subject to changes
that may be necessitated by a revised semester calendar or other circumstances
beyond the instructors control. You may be informed through email or phone by the
University should such an event occur. Additionally please familiarize yourself with
the emergency response procedures that are posted in the classroom.
If the class is cancelled due to the instructors personal/medical reasons, you will be
informed by email as soon as possible. You are expected to read your
@purdue.edu email on a frequent basis as I will try to provide updates as
needed.
8.10 Students with Disabilities
If you have a disability that requires special academic accommodation, please
make an appointment to speak with me within the first four (4) weeks of the
semester in order to discuss any adjustments. It is important that we talk about this
at the beginning of the semester. It is the student's responsibility to notify the
Disability Resource Center (http://www.purdue.edu/drc) of an impairment/condition
that may require accommodations and/or classroom modifications.

THE SCHEDULE, POLICIES, AND ASSIGNMENTS IN THIS COURSE ARE SUBJECT

TO CHANGE IN THE EVENT OF EXTENUATING CIRCUMSTANCES OR BY MUTUAL
AGREEMENT BETWEEN THE INSTRUCTOR AND THE STUDENTS

8.

PHRM828000 Class Schedule (12:30-1:20 pm, Mon., Wed., Fri.)

Day
M
W

Dates
8/25
8/27

Instructor
Dr. Topp

8/29

Dr. Topp

M
W
F

9/1
9/3
9/5

Dr. Pinal
Dr. Topp

9/8

Dr. Taylor

9/10

Dr. Taylor

F
M
W
F
M
W
F
M
W
F
M
W
F
M
W
F
M
W
F
M
W
F
M

9/12
9/15
9/17
9/19
9/22
9/24
9/26
9/29
10/1
10/3
10/6
10/8
10/10
10/13
10/15
10/17
10/20
10/22
10/24
10/27
10/29
10/31
11/3

Dr. Chadwick
Dr. Chadwick
Dr. Chadwick
Dr. Chadwick
Dr. Knipp
Dr. Knipp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Topp
Dr. Knipp
Dr. Knipp
Dr. Knipp
Dr. Knipp
Guest/Dr.

Lecture Material
NO CLASS-Orientation
Introduction to Routes of Administration and Dosage
Forms
Introduction to Routes of Administration and Dosage
Forms
LABOR DAY HOLIDAY
Solubility and Techniques for Solubilization.
Introduction to Routes of Administration and Dosage
Forms
Fundamental concepts of Drugs in Solution: pH and
Solubility
Fundamental Concepts of Drugs in Solution: pH and
Partition
Solid State properties.
Solid State properties.
Solid State properties.
Solid State properties.
Introduction to Solid Dosage forms
Basic Principles of Pharmacokinetics
Exam 1
Chemical Stability of Drugs
Chemical Stability of Drugs
Chemical Stability of Drugs
Chemical Stability of Drugs
Chemical Stability of Drugs
Chemical Stability of Drugs
FALL BREAK
Chemical Stability of Drugs
Chemical Stability of Drugs
Chemical Stability of Drugs
Exam 2
Physiological Barriers to Drug Delivery
Physiological Barriers to Drug Delivery
Physiological Barriers to Drug Delivery
Physiological Barriers to Drug Delivery
Impact of Formulation and API properties on Dosage Form

11/5

Knipp
Guest

11/7

Dr. Knipp

M
W
F
M
W
F
M
W
F
M
W
F
M
W
F

11/10
11/12
11/14
11/17
11/19
11/21
11/24
11/26
11/28
12/1
12/3
12/5
12/8
12/10
12/12
TBD

Dr. Knipp
Dr. Byrn
Dr. Byrn
Dr. Byrn
Dr. Byrn
Dr. Byrn

Dr. Byrn
Dr. Byrn
Dr. Byrn
Dr. Byrn
Dr. Byrn
Dr. Byrn

Performance
Impact of Formulation and API properties on Dosage Form
Performance
Biopharmaceutics Classification System and Related
Systems
Pediatric Drug Delivery Considerations.
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
Exam 3
THANKSGIVING
THANKSGIVING
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
Solid Dosage Forms
FINAL EXAM