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Unformatted text preview: UNIVERSITY OF WYOMING School of Pharmacy COURSE SYLLABUS PHCY 6100 – DOSE FORM DESIGN Fall 2010 Instructor Information: Instructor: M. Glaucia Teixeira [Tesh-áir-ah], PhD - Assoc. Professor of Pharmaceutics Phone: (307) 766-2690 E-mail: [email protected] Website: 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 are planned. Objectives/Outcomes/Standards 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 following subjects: 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 Required text: Pharmaceutical Dosage Forms and Drug Delivery Systems: Allen Jr., Popovich and Ansel, 9th Edition, 2010. Support materials: 1. Web documents printable through; 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 through email. 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). Grading Standards GRADING SYSTEM Activity % of grade Exams 70 Final Exam 30 Syllabus-PHCY6100-Teixeira –2010 2 UNIVERSITY OF WYOMING School of Pharmacy GRADE DISTRIBUTION: (UW Regulation 6- 722, Rev.2, 2008) Grade Points Definition A 4 Exceptional (≥ 90 %) B 3 Very good (80 - 89.9 %) C 2 Fair (70 - 79.9 %) D 1 Poor (60 - 69.9 %) F 0 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) I 0 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 (rotations). 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, and professionalism; • 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 as 0%. 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; . 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 instructor. 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 question. 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: ). • 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. Course Outline: Mon-Aug.23: Tue-Aug.24: Wed-Aug.25: Thur-Aug.26: Mon-Aug.30: Tues-Aug.31: Wed-Sept.1: Thur-Sept.2: Mon-Sept.6: Tues-Sept.7: Wed-Sept.8: Thur-Sept.9: Mon-Sept.13: Tues-Sept.14: Wed-Sept.15: Thur-Sept.16: Mon-Sept.20: Tues-Sept.21: Wed-Sept. 22: Thur-Sept.23: Mon-Sept. 27: Tue-Sept. 28: Wed-Sept.29: Thur-Sept.30: Mon-Oct.4: Tues-Oct.5: Wed-Oct.6: Thurs-Oct.7: Mon-Oct.11: Tues-Oct.12: Wed-Oct.13: Thurs-Oct.14: Mon-Oct.18: Tues-Oct.19: Wed-Oct.20: Thur-Oct.21: Oct.25-Oct.29: Mon-Oct.25: Discussion of syllabus and class and course policies Ch. 1 & 2 – Intro to Drugs and Pharmacy ; New Drug Development and approval process 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 – Part II 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 week) EXAM 2 Syllabus-PHCY6100-Teixeira –2010 6 UNIVERSITY OF WYOMING Tues-Oct.26: Wed-Oct.27: Thur-Oct.28: Mon-Nov.1: Tues-Nov.2: Wed-Nov. 3: Thur-Nov.4: Mon-Nov. 8: Tues-Nov.19: Wed-Nov. 10: Thur-Nov.11: Mon-Nov. 15: Tues-Nov.16: Wed-Nov.17: Thur-Nov. 18: Mon-Nov.22: Tues-Nov.23: Nov.24-26: Mon- Nov.29: Tues-Nov. 30: Wed-Dec.1: 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 (10:15-12:15 PM)] *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.

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