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Unformatted text preview: UNIVERSITY OF WYOMING School of Pharmacy COURSE SYLLABUS
PHCY 6100 – DOSE FORM DESIGN
Instructor: M. Glaucia Teixeira [Tesh-áir-ah], PhD - Assoc. Professor of Pharmaceutics
Phone: (307) 766-2690
E-mail: [email protected]
Office: Health Sciences Bldg., Pharmacy, Rm.390
Office Hours: M, T, W, TR, 10-11:00 AM. Other times, check if I am available, or
email/leave voice message for an appointment.
Prerequisites: CHEM 2420 and 2440.
Course Description: Extensively introduces various types of dosage forms, discusses
advantages and disadvantages of each and physicochemical principles involved in dose
form stability. Introduction to the principles and technologies applied in the preparation
of pharmaceutical dosage forms and drug delivery systems.
Disability Statement: Students who have a physical, learning, or psychological disability
and require accommodations, should let the instructor know as soon as possible.
Students also must register with, and provide documentation of disability to the
University Disability Support Services (UDSS), Rm. 330, Knight Hall, so accommodations
Through an integrated way, students will gain an understanding of the interrelationships
between physical pharmacy principles, biopharmaceutics and basic pharmacokinetics’
principles, dosage form design, product formulation, small- and large-scale product
manufacturing, and clinical application of pharmaceuticals in patient care. Learning will
also be integrated with and emphasized through laboratory exercises.
After completing this course, the student should demonstrate competency in the
1. Relationships between Drugs and Pharmacy
2. New Drug Development and Approval Processes (FDA)
3. Dosage Form Design: Biopharmaceutic and Pharmacokinetic considerations
emphasizing ADME processes, bioavailability and bioequivalence, routes of drug
administration and dosage regimen considerations.
4. Dosage Form Design: Formulation Considerations, Pharmaceutic Ingredients, and
Current Good Manufacturing and Compounding Practices.
5. Peroral Solids: Powders, Granules, Capsules, Tablets, and Modified-Release Dosage
Forms and Drug Delivery Systems
6. Oral Solutions, Syrups, and Elixirs; Topical solutions and Tinctures
7. Disperse Systems: Suspensions, Emulsions, Gels and Magmas
Syllabus-PHCY6100-Teixeira –2010 1 UNIVERSITY OF WYOMING School of Pharmacy 8. Aerosols, Inhalations, and Sprays
9. Parenteral Medications (SVP, LVP) and Sterile Fluids; pellets or implants; testing of
parenterals for sterility, particulate matter, pyrogens, content and stability.
10. Products of Biotechnology and Biologics
11. Ointments, Creams, Pastes, Gels, Lotions
12. Transdermal Drug Delivery Systems
13. Ophthalmic, Nasal, Otic, and Oral Preparations Applied Topically
14. Suppositories and Other Rectal, Vaginal, and Urethral Preparations
15. Novel Dosage Forms and Drug Delivery Technologies.
Text(s) and Readings
Pharmaceutical Dosage Forms and Drug Delivery Systems: Allen Jr., Popovich and Ansel,
9th Edition, 2010.
1. Web documents printable through http://mgt.uwyo.edu; click on CLASSES, fall
2010, PHCY 6100; log in: web_phcy (case sensitive, no spaces; web, underline,
phcy); password: dose-calc#10 (case sensitive, no spaces; dose, dash sign, calc,
pound sign, ten).
2. Articles selected by instructor (announced in class or sent through email).
3. Handouts distributed by instructor.
Course Requirements/Graded Assignments
Attendance will not be taken but enrolled students are expected to attend all classes.
Attendance to lectures is highly recommended and students are responsible for all
material covered and in-class announcements. Topics are covered as
preparation/complement to Dose Form Lab (PHCY 6101). Subjects scheduled to be
covered each week follow the textbook list of contents unless announced by the
instructor. Students are advised to read chapters simultaneously as they are presented
or in advance. Some topics may be added or deleted, semester progresses. Some
subjects may be supplemented with readings and articles posted in the website or sent
Exams: total of 3, non-cumulative, monthly based, covering the material up to previous
class unless otherwise announced by instructor. Exams include multiple-choice, truefalse, fill-in-the-blanks, matching, and short answers questions.
Final Exam: cumulative and multiple-choice (instructor may delete some subjectsannounced in advance).
% of grade
30 Syllabus-PHCY6100-Teixeira –2010 2 UNIVERSITY OF WYOMING School of Pharmacy GRADE DISTRIBUTION: (UW Regulation 6- 722, Rev.2, 2008)
Exceptional (≥ 90 %)
Very good (80 - 89.9 %)
Fair (70 - 79.9 %)
Poor (60 - 69.9 %)
Failure (≤ 59.9 %): may be assigned as
a grade for failure to attend, for academic dishonesty, or to
indicate failure to formally withdraw or terminate)
Incomplete (temporary mark pending course work
completion as agreed in a signed document)
*A grade of D or lower or course withdrawal in any required course constitutes failure to
progress towards the Doctor of Pharmacy degree and may result in termination from the
pharmacy program or inability to be placed in fourth professional year courses
Expectations and Course Policies: Attendance, Participation, Exams
It is expected that all students:
are on time for classes and remain for the entire period;
act constructively and not show disruptive and uncivil behavior in the classroom
or in the instructor’s office, especially in front of other members of the class or
the university community;
use words and actions that promote and encourage self-worth, respect, dignity,
ask questions or make comments related only to the subject presented/ discussed
in class, which may benefit the entire class. Mindless talking during lecture is
inconsiderate, immature behavior. Chit-chat must be left in the hallways where it
belongs. The instructor will ask the student(s) to leave the classroom if persistent
and disruptive talking happens. • • • • During classes and exams, cell phones, pagers, and all other technologies must be
turned off (or adjusted to silent mode) and placed away. If a cell phone
inadvertently, but continuously, rings during the class, the student may be asked by
the instructor to leave the class.
No make-up or early/late exam or final exam will be given for individual students
and/or for personal issues non-excusable by UW. For any missed and excusable work,
the student should provide as early as possible an excused absence and inform the
instructor (prior to the time the graded work would happen) through a phone call or
email. Students presenting multiple, repetitive, excused absences will be checked by
the instructor with the Dean of Students Office. Make-up of missed work will be at
the discretion of the instructor for format and date. Un-excused absence will count
Excused absence for missed work must be initiated by the student. Universitysponsored absences are cleared (justified) through the Dean of the Students Office,
Knight Hall, Room 128, (307)766-3296,Monday-Friday 8:00 am- 5:00pm;
http://www.uwyo.edu/DOS . Syllabus-PHCY6100-Teixeira –2010 3 UNIVERSITY OF WYOMING
• • • School of Pharmacy Students should check all dates for exams/graded assignments before making plans
for personal trips and buying air tickets. The instructor will neither consider requests
for changing exams’ dates nor make special arrangements based on personal trips,
engagements, or early purchase of air tickets scheduled at inappropriate academic
dates or times.
Graded exams will be discussed in class and collected back. No graded exams will be
given to the students.
Additional review of exams and grades may be requested by the students, at the
latest, after 5 working days of grades being discussed.
Grades are non-negotiable; whining is unproductive and annoying.
Any missing exam after discussion and/or review will automatically revert to a 0%
grade in that exam and an academic dishonesty process will be initiated by the
Partial exams may be reviewed before the final examination at a date and location
decided by the instructor.
During exams, all books, notebooks, notes, reading materials, backpacks and purses
should be closed and placed under the student’s desk or at a place designated by the
instructor. Additionally, hats must be removed or turned backwards; cell phones,
pagers, MP3s, iPods and palm-type of technologies will not be allowed in any mode
and must be turned off and kept away (not on the student’s desk).
Exams will be held during class meeting time (50 min.) and Final Exam held during
UW designated time and place.
Students must arrive on time for the examinations and nobody will be allowed to
take the exam after 10 minutes of its distribution.
Students who have a special need to leave the classroom for any reason (e.g. go to
the restroom) must do it prior to the beginning of all examinations. In extraordinary
circumstances, if a student is allowed by the instructor to leave the classroom during
an exam, it will be possible only before any student has turned the exam in.
Exams must be organized and in clear, legible handwriting, thus the instructor will
not be forced to guess the student’s ideas. The consequence may be no credit for the
Projects for other courses (including shadowing trips), student organizations’
activities and work schedules should be planned around meeting times for classes,
labs, and/or exams as no make-up or accommodations will be considered by the
instructor for these situations. How to study for this course:
Check the proposed schedule and announcements by instructor and read materials in
the textbook before lectures or immediately after.
Try to add supplemental information (from textbook, lectures, handouts, etc) to any
notes that may be provided at the instructors’ website and use the final document to
review material before exams.
Bring your questions to the class since they may benefit others.
This class will require studying at least 4 hours per week.
When getting “bored” with the book_ stop, clear your head by doing another activity,
then get back and finish the chapter.
Syllabus-PHCY6100-Teixeira –2010 4 UNIVERSITY OF WYOMING
• • School of Pharmacy Get immediate help from instructor, whenever you can’t follow a subject. Do not
leave it for the day before the exam.
Make sure you are prepared for exams and do not leave new material for the last
minute (the book will be overwhelming at that time).
Learn to organize your work, especially short answers questions in Exams. The
instructor may become irritated while trying to grade your writings and you may not
get all credit for your work.
Be positive and respectful of other students who are slower at understanding a
subject or have different learning styles than yours. How to be successful in this course:
Don’t procrastinate! Get a little work done every day.
Get help immediately if you can’t figure out a subject.
Come prepared for exams.
Don’t “study” from old exams. Use them to test your knowledge after studying.
Exams’ questions are freshly prepared every year.
Academic Honesty and Professional Conduct:
The University of Wyoming is built upon a strong foundation of integrity, respect and
trust. All members of the university community have a responsibility to be honest and
the right to expect honesty from others. Any form of academic dishonesty is
unacceptable to our community and will not be tolerated [UW General Bulletin].
Teachers and students should report suspected violations of standards of academic
honesty to the instructor, department head, or dean. Other University regulations can
be found at: http://uwadmnweb.uwyo.edu/legal/universityregulations.htm ).
If a student is caught in an act of academic dishonesty, a grade F will be assigned for
the course and the student will not be allowed to be in class for the rest of the
semester. The instructor may also decide to file an academic dishonesty case in
accordance to UW regulations.
Incivility in the classroom is defined as activities or behaviors that disrupt teaching and
learning. These include, but are not limited to, verbal obscenities, sound effects,
sleeping, reading newspaper or other materials unrelated to the class, shuffling papers,
books or notebooks, wearing a headset, ringing of pagers or cell phones, eating, chewing
tobacco or gum, talking, throwing objects, fighting, inappropriate dress (especially
during presentations), bringing your children to class or examinations and entering the
classroom late or leaving early. Incivilities will be initially addressed by the instructor,
privately, with the student(s) involved. Repetitive disruptive/uncivil behavior will be
reported to appropriate authorities and may lead to disastrous results.
Collaborations, unauthorized by the instructor, are considered academic dishonesty and
will follow the same sanctions mentioned above. Selected examples of unauthorized
collaborations are: arranging to have others take examinations or complete assignments
for oneself, questioning, collaborating, acquiring from or providing materials to other
student (s) on individual assignments, improperly obtaining copies of exams or
assignments before or after its administration and/or passing them over to students Syllabus-PHCY6100-Teixeira –2010 5 UNIVERSITY OF WYOMING School of Pharmacy enrolled in other sections of the same course, misrepresenting your attendance or the
attendance of others when mandatory attendance is in effect, etc.
Mon-Oct.25: Discussion of syllabus and class and course policies
Ch. 1 & 2 – Intro to Drugs and Pharmacy ; New Drug Development and
Ch.2 cont.– Drug Approval Process
Ch. 3 – CGMP & CGCP and Ch. 4 –Dosage Form Design- Part I
Ch. 4 –Dosage Form Design- Part I
Ch. 4 cont.–Dosage Form Design I
Ch. 4 –Dosage Form Design- Part I and Ch. 5 – Dosage Form Design –
Ch. 5 – Dosage Form Design – Part II
Labor Day – no classes EXAM 1 Advising Week for Spring 2011 (sign-up list for advising and class
schedule forms available at your advisor's office door during previous
EXAM 2 Syllabus-PHCY6100-Teixeira –2010 6 UNIVERSITY OF WYOMING Tues-Oct.26:
Thur-Dec.2: School of Pharmacy EXAM 3
Thanksgiving Break – no classes Final Exam – by UW Final Examination Schedule [Wed-Dec.8 (8-10 AM) OR Thur-Dec.9
*This syllabus is only a projection of activities that may take place over the course. The
instructor reserves the right to modify it to fit unforeseen circumstances or to
maximize learning. Scheduling is flexible and subjects may be added or dropped. This
syllabus may be replaced by updated policies, if needed. Any changes are discussed with
the students, clearly announced in class and posted on instructor’s website. Syllabus-PHCY6100-Teixeira –2010 7 ...
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This note was uploaded on 10/15/2010 for the course PHCY 6100 taught by Professor Teixeira during the Fall '10 term at Univeristy of Wyoming- Laramie.
- Fall '10