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Unformatted text preview: UNIVERSITY OF WYOMING School of Pharmacy COURSE SYLLABUS PHCY 6101 – PRACTICAL ASPECTS OF DOSAGE 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: MATH 2100; concurrent enrollment in PHCY 6100. Course Description: Preparation and evaluation of dosage forms is main thrust of course. This course deals with the application of physical, chemical, and mathematical principles to the formulation, preparation and evaluation of pharmaceutical dosage forms. Laboratory emphasizes manipulative and mathematical skills, prescription formats, packaging and storage, and current good compounding practices, as they apply to pharmaceuticals. 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: Learn and practice pharmaceutical compounding techniques in an integrated format with lectures. • Upon successful completion of this course, the student should be able to: 1. Understand various aspects of dosage form preparation, characteristics of components of 2. 3. 4. 5. each dosage type, methods of manufacture and/or compounding of representative formulations and the effects of these on the stability and bioavailability of a given drug. Calculate the quantity of medication to be compounded or dispensed, reduce and enlarge formulation quantities and calculate the quantity of ingredients needed to compound the proper amount of the preparation. Identify and use equipment necessary to prepare and extemporaneously compound medications. Identify the appropriate packaging, storage, handling and disposal of medications. Be able to do proper labeling of formulated products. Use a critical-thinking process and apply knowledge of skills and techniques upon which pharmaceutical and biopharmaceutical processes are dependent to permit the dispensing and recommendation of safe and effective medications. Syllabus-PHCY6101-Teixeira –2010 1 UNIVERSITY OF WYOMING School of Pharmacy 6. Understand the importance of accuracy, neatness and cleanliness accompanied by the maintenance of a professional attitude in the performance of all operations pertaining to pharmacy. Text(s) and Readings: • Lab packet or individual lab exercises: available through; click on CLASSES, fall 2010, PHCY 6101; 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). • Pharmaceutical Dosage Forms and Drug Delivery Systems: Allen Jr., Popovich and Ansel, 9th Edition, 2010. • Pharmaceutical Calculations: Zatz J.L. and Teixeira M.G., 4th Edition, 2005. • Articles selected by instructor (announced in class, posted on website, or emailed). • Handouts distributed by instructor. Required materials needed during all labs: • Lab exercises in print • Lab coat or jacket • Eye protection (goggles or else). Students who wear prescription glasses do not need additional eye protection per UW Safety rules. • Calculator , any kind (same used for PharmCalc course is OK) • To be kept in each student’s locker: one fine ballpoint pen, one sharpie fine point, and wite out. Pencil and felt /gel pens are not adequate to prepare labels of compounded products as they cannot be read or leach/smudge on labels. • During first lab all students must bring $40.00 (cash only; $5, $10 or $20 denominations only) as a deposit with the instructor to be kept for replacement of broken glassware, loss of magnet or other lab materials and/or for replacement of locker key. This deposit/ portion of it will be returned to the students at the end of the semester (check-out day).Eye protection (goggles or else, including prescription glasses) Course Policies: 1. Labs will start at 2:20 PM sharp to allow students enough time to walk/drive from the ANS-MOLB complex. 2. Lab attendance is mandatory. Early/late labs will not be considered and lab make-up is allowed only with official excused absences. i. For any missed work the student should obtain as early as possible an excused absence and inform the instructor before the lab meeting time through a phone call or email. University sponsored absences are cleared through the Dean of the Students Office, Knight Hall, Room 128 ~ (307) 766-3296 ~ ~ Monday-Friday 8:00 am- 5:00pm. ii. Excused absence for missed lab should be initiated by the student. iii. Missed laboratory exercises (with excused absence) will be re-scheduled by the instructor after consultation with the student. 3. Un-excused absence will count as 0% for each type of lab graded activity. 4. Prior to the laboratory session, there will be a “pre-lab” lecture in which we will discuss theories and methods related to the laboratory exercises. Syllabus-PHCY6101-Teixeira –2010 2 UNIVERSITY OF WYOMING School of Pharmacy 5. All labs are done individually and students work at their own pace. However, students are expected to finish all lab preps by 6 PM at the latest. In few occasions, the instructor will assign students to work in pairs or in small groups. 6. No weighing “in advance” (prior to lab meeting time) of drugs and chemicals will be allowed. 7. Cleaning of lab bench and assigned balance will be considered for lab grade. 8. It is strongly recommended to read each lab exercise before the class. This will allow for appropriate selection of supplies, correct technique, and calculations required for preparation of each prescription. 9. Thinking up the labels and auxiliary labels required for all preps prior to the lab is highly recommended. 10. Searching/proposing a technique to prepare a given lab prep is mandatory when assigned by the instructor and may be collected for bonus grading at the end of the lab. 11. Students are expected to actively contribute in class and groups. Discuss with classmates, ask questions, but understand and turn in your own work. Questions, comments and discussions are always welcome and encouraged. 12. Laboratory sections are not interchangeable and even ONE extra student added to a lab section will be a burden for everyone in that section. 13. If a student cannot come to his/her registered lab section, arrangements may be made in advance with another classmate in another section to swap labs. The instructor must be notified before the lab. 14. Students are expected to practice good manners in the laboratory at all times and maintain an attitude of professional concern in the performance of all operations. Materials and equipment are often limited and must be shared. Return of all stock bottles, chemicals, special equipment, and books, to their proper locations when through with them is also expected. Cleanliness of lab bench and assigned balance will be considered for lab grade. 15. Students are advised to not taste any of the chemicals, products, or preparations. Most chemicals are for laboratory use only but in few occasions the instructor may allow students to take the final product home at their own risk. 16. Eating and drinking are strictly prohibited in the lab. The pre-lab area is OK. 17. Quizzes cover material discussed/presented/practiced in class. If a student is more than 10 minutes late for a quiz, he/she will not be allowed to take it and will be assigned a zero grade for that quiz. The same policy applies to the Final Exam. 18. During quizzes and final exam, 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). If a calculator is needed, it should be removed from the student’s backpack before initiating the exam. 19. Students are not allowed to leave and go to the restroom during quizzes/final exam (unless an emergency- let instructor know before the quiz or exam). No student will be allowed to resume working on the quiz/exam if he/she leaves the class/lab for whatever reason after anyone has turned the quiz/exam in. 20. Quizzes must be organized and in clear and legible handwriting, thus the instructor will not be forced to guess the student’s answers. If a calculation is required, all calculations must be shown. Failure to follow these may lead to no credit for a question. 21. Grades for laboratory exercises, quizzes and assignments are non-negotiable. The student should see the instructor within the next 5 business days if there is a grading mistake. No review will be considered by the instructor after this time. Syllabus-PHCY6101-Teixeira –2010 3 UNIVERSITY OF WYOMING School of Pharmacy 22. The instructor will neither consider requests for changing dates of quizzes/final exam nor make special arrangements based on personal trips or early purchase of air tickets for inappropriate dates/times. 23. Incivilities and academic dishonesty will not be tolerated and may lead to several disciplinary sanctions. If a student is caught in an act of academic dishonesty, a grade of F will be assigned for the course and the student will not be allowed to be in class for the rest of the semester. An academic dishonesty case will be filed with the school’s student affairs committee. 24. Projects for other courses (including shadowing trips) and work schedules should be planned around the laboratory meeting times. No special accommodations are made for students who “need” to leave early and no make-up will be considered by the instructor for these situations. 25. During all classes, cell phones and pagers must be turned off (or adjusted to silent modenot manner mode) and placed away. If a cell phone inadvertently, but continuously, rings during the class, the student shall be asked by the instructor to leave the class/lab. 26. Mindless talking during pre-lab lecture and lab is inconsiderate, immature behavior. Students are expected to ask questions or make comments related to the subject presented/discussed in class, which may benefit the entire class. Chit-chat must be left in the hallways where it belongs. The instructor shall ask the student(s) to leave the class/lab if persistent and disruptive talking happens. Grading GRADING SYSTEM Activity A. Labs B. Quizzes C. Final Exam % of grade 40 30 30 A. LABS are worth 40% of the grade, distributed as follows: Balance cleaning: 5 points (each student is responsible for cleaning one balance at designated dates which are posted on the wall of lab and pre-lab room) Timekeeping: 5 points (students must finish every lab by 6 PM, at the latest; One point will be subtracted of each lab graded activity for every additional 5 minutes beyond 6:00 PM within the lab area. Students may go to the pre-lab area to finish calculations, assignments, labels, etc, without consequences to their grade. Good Lab Practices (GLP): 30 points, distributed as follows: 20 points: Each student is observed during product preparation and is graded by the instructor. Grading is based mainly on attitude and performance. • 10 points: Attention during instructor’s explanations, interest in learning (not only finish the assignment and "leave early") and good compounding practices (including bench and personal cleanliness, that of the environment and waste disposal). • Laboratory Exercises (also called Preps): 60 points per lab; include correctly compounded product(s), packaging, amount dispensed and label(s). Bonus points: 5 points (may include lists of problems, literature review, or short writing assignments done in class or due by the following lab, as announced). Syllabus-PHCY6101-Teixeira –2010 4 UNIVERSITY OF WYOMING School of Pharmacy B. Quizzes are worth 30% of the grade and are scheduled as follows: Sept. 28, 29, 30 Oct. 19, 20, 21 Nov. 16, 17, 18 C. Final Exam is worth 30% of the grade and will happen during the first 60 minutes of the last lab section. Nov. 30, Dec. 1, 2 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. (School of Pharmacy regulation, fall 2004) 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. 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. Syllabus-PHCY6101-Teixeira –2010 5 UNIVERSITY OF WYOMING School of Pharmacy 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, 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 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: Aug. 24, 25, 26 LAB 1: Intro to Lab & Check in Aug.31, Sept. 1, 2 LAB 2: Pharmaceutical measurements Sept. 7, 8, 9 LAB 3: Powders & Granules Sept. 14, 15, 16 LAB 4: Capsules & Tablet testing (USP) Sept. 21, 22, 23 LAB 5: Ointments & sticks Sept. 28, 29, 30 LAB 6: Creams & Pastes; QUIZ 1 Oct. 5, 6, 7 LAB 7: Gels, Lozenges Oct. 12, 13, 14 LAB 8: Suppositories Oct. 19, 20, 21 LAB 9: Solutions; QUIZ 2 Oct.25-29: Advising Week for Spring 2011 (sign-up list for advising and class schedule forms available at your advisor's office door during previous week) Oct. 26, 27, 28 LAB 10: Syrups Nov. 2, 3, 4 LAB 11: Elixirs & Tinctures Nov. 9,10, 11 LAB 12: Suspensions Nov. 16,17, 18 LAB 13: Emulsions; QUIZ 3 Nov.24-26: Nov.30, Dec. 1,2 Thanksgiving Break – no classes LAB 14: FINAL EXAM & lab check-out *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. 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-PHCY6101-Teixeira –2010 6 ...
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