Pharmaceutical Engineering BIOE 425/625
Spring 2007
1:00 –2:20
Instructor: Carolyn Nichol, Ph.D.
Email: cnichol@rice.edu
Phone 713 348 3059 (office)
713 818 0857 (cell)
Office Ryon 111
Office hours: Tues/Thurs 12-1
TA: Vittal Raman Srinivas vrs4929@rice.edu
Course description: The purpose of this course is to learn how pharmaceutically active agents behave in the body and how they are delivered to the body. Topics to be covered include the study of how drugs are absorbed and distributed in organs and tissues; what chemical alterations a drug may undergo in the body; and how drugs are stored in the body and eliminated from it. The kinetics of drug absorption and tissue distribution will be mathematically modeled to better understand how drugs are processed in vivo. How the physical and chemical properties of the active agent relate to the absorption, distribution, metabolism, and elimination will also be probed. The time course of drug and metabolite levels in different fluids, tissues, and excreta of the body, and of the mathematical relationships required to interpret such data will be discussed.
In addition, the delivery of bioactive agents from pharmaceutical dosage forms will be evaluated. Pharmaceutical formulation will be studied including the engineering aspects of liquid, solid and aerosol dosage form design with emphasis on controlled drug delivery. The course will examine the transport phenomena involved in controlled release dosage form design and along with other novel delivery systems to administer drugs. Mathematical modeling of drug diffusion and analytical testing methods will be discussed. In addition, industrial processing and regulatory issues will be covered.
The purpose of this course is:
Course prerequisites: Differential equations, Numerical methods and/or Transport phenomena
Textbook: Principles
of Clinical Pharmacology, 2nd edition Atkinson, Abernethy,
Daniels, Dedrick, Markey (on 2 hr hold at Fondren)
Other resources
RM301.5 .K96 2002 (Online) 2002
Handbook of essential
pharmacokinetics, pharmacodynamics and drug
metabolism for industrial scientists [electronic resource] and hardback on 2 hour
hold at library
Kwon, Younggil
http://www.boomer.org/c/p1/ course notes from UOK
RM301.25 .P75 2002
(Online)
Principles
and practice of pharmaceutical medicine [electronic resource] / Andrew J.
Fletcher ... [et al., editors]
Fletcher,
Andrew J.\
Y 10.2:P 49
Research
and development in the pharmaceutical industry [electronic resource]
Transport Processes in Pharmaceutical Systems
Drugs and the
Pharmaceutical Sciences ; V. 102
by Amidon, Gordon L.
M. Dekker
RS201 .S57 P64 1999 (Online)
Polymorphism
in pharmaceutical solids [electronic resource] / edited by Harry G. Brittain
Brittain, H. G.
RM301.13
.P475 2002 (Online)
Pharmacology
[electronic resource] : PreTest
self-assessment and review / Arnold Stern ; student reviewers, Christopher A.
Heck, Junda C. Woo
Stern,
Arnold.
http://www.youtube.com/watch?v=N5vm4ZoCmUA
Suggested reading
The
Billion-Dollar Molecule,
Homework: There
will be 7 homework assignments. These will be mostly problem solving
assignments. The problems will require
knowledge of analytical differential equations and numerical methods. Students are not allowed to consult previous year’s
homework sets when working on the assignments. These homework sets take at least 8 hours,
based on student comments, so do not
wait until the night before to start!
The tentative homework assignment dates are on the BIOE 425/625 lecture
schedule. LATE assignment will have
10pts/day deducted, including weekends.
For example, if homework due on Thursday is turned in to the professor
or the TA on Monday, 40 points will automatically be deducted.
Graduate students enrolled in BIOE 625 will be required to solve more challenging homework problems than students enrolled in BIOE 425. In addition, BIOE 625 students will be assigned write critical evaluations of current peer reviewed journal articles on biopharmaceuticals.
Class participation, case studies: In class problem sets will be assigned for individual and group discussions. This will be part of class participation grade. In addition, class participation grade will be based on your evaluation (and attendance) of your peer’s research project.
Exams: There will be One take-home final exam. The exams will have a 3-5 hour time limit. Students will be asked to sign an honor code statement for each exam. Last year’s final will be posted for students to review.
Research Project and presentation: The student will chose a drug to characterize in a research paper (10 – 15 pages including graphics and bibliography). The topic must be approved by Dr. Nichol. Students should pick their topic and the date for their presentation by January 27, 2007. Papers will be due on April 13, 2007. Copies of students papers will be distributed to students and round table discussion groups of the papers will be held on April 27 and April 29.
The purpose of the project is to understand how, why, and when the drug is administered by delving into its pharmacokinetics and pharmaceutical properties. The paper should include a complete discussion of the properties of the active agent. Issues such as physico-chemical properties, biological activity, biological half life, targeted organs, metabolism, drug interactions, adverse effects, formulation, routes of delivery, pharmaceutical processing and side effects of the drugs should be covered in the paper. More detailed guidelines for the research project will be given in class.
Group
Design/Development Project
Students will form a group of 2-5 and design a new pharmaceutical product based on either a new chemical entity or an improvement in a currently marketed drug. First the group must choose a drug candidate. Examples of new chemical entities include novel molecules, new targets or the application of known drugs to new diseases or diseases with poor therapeutic outcomes. Examples of improvements in a currently marketed product should address some drawback, weakness or negative aspect of the drug. This could include improvements in the delivery system, lowering toxicity, addressing drug or food interactions, more specific drug targeting, improving physical properties, lowering cost, etc . The group must draft a 2-3 page proposal for the new product design to be turned in on the due date present (5-10 minutes) their proposal to the class on the due date. All groups will present on this date (4/17) and the professor rank the proposals and will decide who’s project will be funded (there will be a prize involved).
Homework 35%
Case studies/participation 10%
Research Paper and discussion 10%
Group Design/Development Project 10%
Final Exam 35%
Honor code
Students
are encouraged ask questions and discuss problems with other students, the
teaching assistant, or the instructor about homework assignments or the
research project. Students are not allowed
to copy answers from one another.
Students may not consult previous years’ homework sets or tests. If the internet or textbook sources are used,
they must be cited. The final exam will
be open book and open notes, but Internet searching during the exam or any
communication about the exam at any time is not allowed.
There will be a help session at a time to be determined.
|
Any student with a disability
requiring accommodations in this class is encouraged to contact the instructor
after class or during office hours. Additionally, students should contact the
Coordinator for Disabled Student Services in the RMC Cloisters. |