Drug Delivery Systems III

Drug Delivery Systems III PHAR 2223 Spring/ P1 03/3/2016 5/06/2016 Syllabus Team Members: Nishil N. Desai, Ph.D. (Team Leader) Email: nishil.desai@ttuhsc.edu Office: TTUHSC SOP # 2605 (Abilene) Phone: 325-696-0442 Office hours: by appointment Fakhrul Ahsan, Ph.D. ( Campus Coordinator) Email: fakhrul.ahsan@ttuhsc.edu Office: TTUHSC SOP # 214 () Phone: 806-414-9235 Office hours: by appointment Chair Liaison: Tom Abbruscato, Ph.D. Email: tom.abbruscato@ttuhsc.edu Office: TTUHSC SOP # 314 () Phone: 806-414-9234 Office hours: by appointment

COURSE PREREQUISITES: Completion of PHAR 2322, Drug Delivery Systems II with good standing as a P1. COURSE CATALOGUE DESCRIPTION: Continuation of PHAR 1321 and 2322 COURSE MISSION: The pharmacological action of a drug depends on the dosage form, additives present in the formulation, the manufacturing process and overall release characteristics of the drug from a dosage form. To be able to dispense a dosage form and advice patient on the use of a given dosage form, pharmacists must have the knowledge of various dosage forms, excipients present in a dosage form, their methods of preparation and quality assurance processes. A thorough understanding of the dosage forms can help understand the factors that may influence the bioavailability, routes of administration and therapeutic efficacy of a drug. Further, the understanding of the science of dosage form is doubly important for understanding the factors involved in the release of a drug from modified release dosage forms, a modern drug delivery system, in which formulations with predetermined release profile can be obtained. PHARM 2223 is the last course of drug delivery system course series, and is designed to introduce the fundamental concepts of solid dosage forms, modified release dosage forms, particulate delivery systems and non-invasive routes of administration. Course Delivery Facilities Instructional All lectures will be held in room and 2100 for and Abilene campuses, respectively. All major examinations will be conducted either in the scheduled classroom or in any other classrooms as determined by the instructor. Classes will be held on Mondays, Tuesdays, Wednesdays and Thursdays at 10.30-11.20 am. TEXTBOOK/COURSE MATERIALS: There is no required textbook for this class. However, students are encouraged to use the following book as a reference: Pharmaceutical Dosage Forms and Drug Delivery Systems, by Loyd V. Allen, Nicholas G. Popovich and Howard C. Ansel; 9th edition, Williams & Wilkins, 2011. Teaching methods Course material is presented in interactive lectures (questions encouraged at all times!), problem solving in groups, reading assignments and homework problems. Questions arising out of lectures, reading material or exercises should be addressed to the Course Team. However, students are also encouraged to email or visit/call faculty at their offices. Course Objectives: Course Mapping to the Curriculum and ACPE Standards Mapped to Appendix B and to Techs top 10 terminal outcomes:

At the end of the course, Doctoral Candidates are expected to: Know about drug delivery systems by invasive (parenteral) and non-invasive routes of administration (Ability number 7, 8) Know the principles and practices of parenteral drug delivery systems and incompatibilities encountered in large volume parenterals (Ability number 22) Describe different types of solid dosage forms and their characteristics (Ability numbers 20, 22, 23) Describe the methods of tablet preparation (Ability number 23) Learn about different types of tablet coatings and their common defects (Ability numbers 7 and 8) Understand the role and types of inert additives used in solid dosage forms (Ability numbers 7 and 8) Define bioavailability, bioequivalence and related terms (Ability numbers 13 and 14) Understand the factors that affect bioavailability of drugs (Ability numbers 13 and 14 Explain the benefits of rate-controlled drug delivery systems in pharmaceutical care (Ability numbers 22, 23). Evaluate release profiles from rate-controlled delivery systems and predict therapeutic efficacy for the patient (Ability number 20). Describe the methods used to control the delivery of drugs to specific organs advanced drug delivery systems (Ability number 23). Know about particulate drug delivery systems (Ability number 20) Course Expectations Attendance Students are encouraged to attend classes. The team will take attendance and give practice quizzes in each class. Students who attend classes and take practice quizzes regularly will receive extra points that can be traded with a bad quiz grade as described below. Work and travel plans do not constitute valid reasons for missing course activities. Under no circumstances, will credit be given for a missed class. Similarly, no arrangements will be made for missed practice quizzes. No excuses (including computer problems, delay in booting computer and forget to take quizzes and miss the password) will be acceptable. Missed Exam Policy: http://www.ttuhsc.edu/sop/administration/policies/documents/77p.34_missed_exam- Absences_For_Major_Course_Assessments.pdf Although it is not required to inform the instructor if a student has to miss a class, it is recommended that the student contact the faculty member in case of an extreme emergency. A student s course grade will not be affected if he/she does not attend classes or take daily practice quizzes. However, if a student decides not to attend classes or take practice quizzes, he/she will not be eligible for dropping any quiz grades.

COURSE GRADING: There will be two major assessments: Exam I (midterm) and Exam II (final) and four quizzes: Exam schedule and grade distribution for the course is as follows: Item Covered Material Big Quiz I Lectures 1-8 Big Quiz II Midterm Exam Big Quiz III Big Quiz IV Final Exam or Cumulative final Attendance & Practice Quizzes Lectures 10-16 Lectures 1-16 Lectures 18-24 Lectures 26-32 Lectures 19-32 Current Lecture Examination methods/type Percent counted to final grade Date Time Location 7.5% Mar 17, 2015 10.30-11.20 AM 7.5% Apr 07, 2015 10.30-11.20 AM 35% Apr 11, 2015 3.30-4:50 PM (Exam Block) 7.5% Apr 21, 2015 10.30-11.20 AM 7.5% May 05, 2015 10.30-11.20 AM 35% May 9, 2015 7.5% (used in exchang e for lowest big quiz grade)* During regular class time 10.30AM - 12.20 PM 10.30-11.20 AM *applies to students fulfilling the requirements for points exchange described in the syllabus

COURSE EXAM AND GRADING POLICIES Students will be reminded of the date, time and place of exams two to three days before the exams. The assessment dates are set and will NOT be changed. There will be no comprehensive final exam for this course. However, the team may require a student to take a final comprehensive exam if he/she fails to attend three or more classes during the semester. In addition to two major assessments, there will be daily practice quizzes and announced big quizzes and required homework. Students who are tardy to an assessment will only have the remaining time in the exam period to complete the assessment. Only EXTREME emergencies such as the death of an immediate family member, an accident or serious illness will be considered as an excuse for missing an exam. Schedule for any make up exam will be made at the convenience of the faculty. In principle, no arrangements will be made for make-up quizzes, regardless of the nature of excuse for missing a quiz. However, students are advised to contact the instructor in the event of an extreme emergency and the instructor will make the final determination on a case by case basis. The final grade of the course will be calculated using the average of actual grades received in quizzes and exams. There will be no curving or magical changes in the final course grade. Since there will be numerous quizzes and exams during the semester, students are asked to keep track of their grades. Students should verify that the grade posted online matches the actual grade received. In case of any discrepancy between the posted grade and actual grade received, students should contact the team leader and confirm their actual grades and/or grade calculation method within one business day following posting of a grade. If an error is found in calculation of the grade, the student will always receive the accurate grade, regardless whether the erroneously posted grade was higher or lower than the true grade. Students will be allowed to trade their accumulated points (after conversion to a scale of 100) for practice quizzes and attendances with the grades of one announced big quiz. However, a student can only exchange accumulated points of practice and attendance quizzes with one big quiz grade if he/she has not missed more than three classes or practice quizzes. In other words, if a student misses more than three classes or practice quizzes, or modules he/she will not be eligible for dropping any big quiz grades. General policies on course examinations, academic misconduct and candidate disabilities are found in the student handbook. The handbook can be found here: (http://www.ttuhsc.edu/studentservices/documents/final_hsc_2011-2012_hndbk_for_website.pdf) o Any student who, because of a disability, may require some special arrangements in order to meet course requirements should contact the course team leader as soon as possible to request reasonable accommodations. Students should present appropriate verification from the Office of Student Services. No requirement exists that

accommodations be made prior to completion of this approved university process. o Second Chance Policy Second Chance: The second chance exam policy shall be consistent with SOP OP: 77.P.15 SECOND CHANCE EXAM POLICY, adopted by Faculty December 15, 2008. Policy Statement: The Second Chance Policy applies to all courses except case studies and clerkships. A doctor of pharmacy student, if eligible, may take a single comprehensive examination to demonstrate competency in that course providing that: The student has passed 50% or more of the major assessments in that course; The student has earned a final grade of 66-69% in the course, and; The student has not exceeded the number of second chance attempts as outlined below. A student may invoke the Second Chance Policy in a maximum of two courses per semester, and no more than four times total in his/her career at the School. No student may invoke the second chance exam for the same course twice. The second chance assessment shall occur in a timely fashion, the timing at the discretion of the course team. Grading for Second Chance: An individual who passes the Second Chance exam will receive a grade of 70% for their final grade. If the Second Chance exam is not passed, the candidate will receive the original course grade. CANDIDATE INQUIRIES Questions or comments regarding the course should be directed to the applicable team member or the team leader. Office hours vary for each faculty member. If students wish to meet with an individual faculty member, they are encouraged to contact the faculty via e-mail to set up an appointment. Students are encouraged to utilize online discussion forum for questions regarding lecture or discussion material in order to facilitate communication with the entire class. Students can expect to receive a response to an email inquiry within 24-48 hours during the typical workday. Questions posed late before an exam may not receive a response from the faculty member in time for the exam. Weekend and holiday questions will be addressed as though they were posted the morning of the following business day. Lecture Schedule with Description: # Date Topic Faculty Origination 1 Mar. 03 (Th) Course Overview and Ahsan Respiratory Drug Delivery Systems-Principle 2 Mar 07 (M) Respiratory Drug Delivery Systems-Principle Ahsan

3 Mar 08 (T) Drug Delivery Systems- Ahsan Aerosol 4 Mar 09 (W) Drug Delivery Systems- Ahsan Nebulizers 5 Mar 10 (Th) Drug Delivery Systems-pMDI Ahsan and DPI 6 Mar 14 (M) Nasal Drug Delivery Ahsan 7 Mar 15 (T) Dissolution and Diffusion Ahsan 8 Mar 16 (W) Dissolution and Diffusion Ahsan 9 Mar 17 (Th) BIG QUIZ I Ahsan/Desai /Abilene 10 Mar 21 (M) Tablet and Tablet Types Ahsan 11 Mar 22 (T) Tablet Composition Ahsan 12 Mar 23 (W) Tablet Manufacturing Ahsan 13 Mar 24 (Th) Tablet Coating Ahsan Mar 28-Apr 1 Spring Break 14 Apr 04 (M) Tablet Quality Control Ahsan 15 Apr 05 (T) Modified Release Dosage Forms 16 Apr 06 (W) Particulate Drug Delivery Systems Ahsan Ahsan 17 Apr 07 (Th) BIG QUIZ II Ahsan/Desai /Abilene Apr 11 (M) EXAM I 3.30-4:50 PM Ahsan/Desai /Abilene 18 Apr 11 (M) Particulate Drug Delivery Systems Ahsan 19 Apr 12 (T) Drug Targeting Ahsan 20 Apr 13 (W) Biopharmaceutics Ahsan 21 Apr 14 (Th) Biopharmaceutics Ahsan 22 Apr 18 (M) Parenteral Drug Delivery Desai Abilene 23 Apr 19 (T) Parenteral Drug Delivery Desai Abilene

24 Apr 20 (W) Parenteral Drug Delivery Desai Abilene 25 Apr 21 (Th) BIG QUIZ III Ahsan/Desai /Abilene 26 Apr 25 (M) Parenteral Drug Delivery Desai Abilene 27 Apr 26 (T) Implants Desai Abilene 28 Apr 27 (W) Transdermal Drug Delivery Desai Abilene Systems 29 Apr 28 (Th) Transdermal Drug Delivery Desai Abilene Systems 30 May 02 (M) Bioequivalence Desai Abilene 31 May 03 (T) Biopharmaceuticals Desai Abilene 32 May 04 (W) Biopharmaceuticals Desai Abilene 33 May 05 (Th) BIG QUIZ IV Ahsan/Desai /Abilene May 09 (M) Final Exam 10.30AM-12.20 PM Ahsan/Desai /Abilene DISCLAIMER: This document is a general guideline on how the course will be conducted. This guideline of the course cannot be used as a legal contract between the students and instructors. The team can make minor changes in the schedule, grade distribution and content of the course if there is any need.