LECOM School of Pharmacy

Bradenton Campus
Traditional Pathway
Pharmaceutics II W/lab (PCC1019 PH1 BP1)
Spring 2017
COURSE INFORMATION:
Credits:

4 Semester hours

Time and Location:

Lectures:
Thursday: 10:00 to 10:50 AM (LH 211)
Friday: 10:30 AM to 12:20 PM (LH 212)
Enrichment Sessions:
Monday: 5:00 to 5:30 PM (LH 212)
Wednesday: 2:00 to 2:30 PM (LH 211)
Lab Recitation:
Wednesday: 12:00 noon to 12:50 PM (LH 211)
Laboratories: (All Labs will be in MP1)
Group I: Wednesday: 2:30 to 4:30 PM
Group II: Thursday: 1:30 to 3:30 PM
Group III: Friday: 8:00 10:00 AM
Group IV: Friday: 2:00 to 4:00 PM

CONTACT INFORMATION:
Instructor

Office

Sunil Jambhekar, M.S.,

Ph.D.
Professor,
Pharmaceutical Sciences

272

Phone
E-mail
Course Coordinator
941-782-5692

sjambhekar@lecom.edu
(preferred contact)

Office Hours

By Appointment

Course Instructors
Nina Pavuluri, Ph.D.
Associate Professor &
Assistant Dean
Ningning Yang, Ph.D.
Assistant Professor

121

941-782-5698

npavuluri@lecom.edu

By Appointment

281

941-782-5994

nyang@lecom.edu

By Appointment

COURSE DESCRIPTION:
This second course of the two course sequence is optimally designed for first year
pharmacy students to teach basic concepts and applications of physical-chemical properties of
therapeutics agents and their importance and utility in the development of safe and effective
pharmaceutical dosage forms. This course, therefore, will integrate important concepts from
pharmaceutics I to illustrate design and development of conventional drug delivery systems as
well as novel drug delivery systems used currently in pharmacy practice. Additionally, this
course will integrate physical chemical principles in the design, development, manufacture of
stable, safe, and effective dosage forms and finished drug products. Specific topics will focus on
the formulation of safe, effective, and stable liquid dosage forms like solution, disperse systems
like and suspension and emulsion, conventional solid dosage forms like powder, tablet and
capsule, semi-solid dosage forms like creams, ointments, lotions, gels, and suppository, and
novel drug delivery systems like modified release dosage forms, transdermal patches, and
aerosols.
This second course in this series provides students with a qualitative and quantitative
overview of drug disposition and the processes important to disposition, namely, absorption,
distribution, metabolism and excretion. Sterile dosage forms will also be introduced teaching the
organization and administration of an admixture program and admixture techniques. The proper
utilization of parenteral products, as well as parenteral drug compatibility literature is also
considered. Several laboratory sessions will be devoted to sterile dosage forms.
RATIONALE FOR COURSE:
The course seeks to illustrate the application of scientific principles of chemistry, physics,
and kinetics as they apply and relate to the design, preparation, physical chemical stability,
and In Vitro and In Vivo performance of various pharmaceutical dosage forms and drug
delivery systems. The lectures will serve to present the basic fundamentals of dosage forms
design and the principles utilized in the design, production, and the performance evaluation
of dosage forms. The laboratory series will serve to develop and strengthen the
understanding of the principles presented in the lectures as well communications skills that
will be necessary later in clinical experience as well as real professional world.
Additionally, the laboratory will provide opportunities to develop verbal communications
skills with group presentations of the results of weekly laboratory experiments.
EDUCATIONAL OUTCOMES:
Toward the development of the LECOM School of Pharmacy Curricular Outcomes, this
course will help students become the following:
Learners: Develop, integrate, and apply knowledge from the foundational sciences (i.e.,
pharmaceutical, social/behavioral/administrative, and clinical sciences) to evaluate the
scientific literature, explain drug action, solve therapeutic problems, and advance
population health and patient-centered care.

Caregivers: Provide patient-centered care as the medication expert (collect and interpret
evidence, prioritize, formulate assessments and recommendations, implement, monitor and
adjust plans, and document activities).
Promoters of health and wellness: Design prevention, intervention, and educational strategies
for individuals and communities to manage chronic disease and improve health and
wellness.
Problem Solvers: Identify problems; explore and prioritize potential strategies; design,
implement, and evaluate a viable solution.
Inter-professional collaborators: Actively participate and engage as a healthcare team
member by demonstrating mutual respect, understanding, and values to meet patient care
needs.
Communicators: Effectively communicate verbally and nonverbally when interacting with an
individual, group, or organization.
COURSE SPECIFIC OUTCOMES:
At the successful completion of this course, the students must be able to understand,
discuss, and apply all of the below in various pharmacy practice set ups.
1. Develop, integrate, and apply knowledge from the foundational sciences (i.e.,
pharmaceutical, social/behavioral/administrative, and clinical sciences) to evaluate the
scientific literature, explain drug action, solve therapeutic problems, and advance
population health and patient- centered care.
2.

Understand the nomenclature and role of excipients in common dosage forms and drug
delivery systems.

Understand the biopharmaceutical implications and expectations of relevant dosage

forms and the bioavailability of drug from the dosage form.

Understand the biopharmaceutical implications and expectations of relevant dosage

forms and the bioavailability of drug from the dosage form.

Understand the role of excipients in the formulation of drug dosage forms and how they
may affect the in vitro and in vivo performance of drug from the dosage form.

6.

Collect accurate and comprehensive information from appropriate sources to be used in

monitoring therapeutics outcomes.

7.

Describe the role of the pharmacist in impacting the safety and efficacy of each component
of a typical medication use system (i.e., procurement, storage, dispensing, and
administration).

Apply standards, guidelines, best practices, and established processes related to safe and
effective medication use.

Recognize any special packaging and storage requirements for a given dosage forms

10 Evaluate and determine the suitability of a container for a given drug dosage form based
upon the physical chemical properties and stability studies of drugs.
11 Select the appropriate drug delivery systems and the route of drug administration that will
provide optimum therapeutics benefit to an individual patient.
12 Assess and interpret the physical chemical stability data and determine the expiration date
for a dosage form
13. Determine the appropriate drug delivery system for a patient based upon individual patient
needs
14 Evaluate the suitability of an extemporaneously compounded prescription formulation for
the administration of a desired drug.
15 Determine if the product is packaged in compliance with legal requirements and bears no
signs of tampering
16 Recommend the storage conditions for a particular product to the patients.
REQUIRED/SUGGESTED TEXTBOOK(S) AND MATERIAL(S):
Suggested Textbook: Ansels Pharmaceutical Dosage Forms and Drug Delivery Systems
By Loyd V. Allen, Jr., Nicholas G. Popovich, and Howard C. Ansel
Eighth Edition; Lippincott Williams and Wilkins Publishing Company
(ISBN: 0 -7817- 4612- 4)
EXAMINATIONS:
All examinations will be administered in Lecture Hall 212 during the examination block (From
2:00 to 3:50 PM)
Examination I:
Examination II:
Examination III:
Final Examination:

Monday, February 13, 2017

Monday, April 10, 2017
Monday, May 1, 2017
Monday, May 15, 2017 (1:00 to 3:50 PM; LH 211)

Exam 1
Exam 2
Exam 3
Lab Grade
Final Exam
Total

20%
20%
20%
10%
30%
100%

Material Covered on Examinations:

All material in the handouts, reading assignments, lectures and, laboratory is included for
all examinations. Each examination will be scheduled at an approximate time interval of four
weeks. The final examination will be held in the finals week. All material covered up to that
point of the exam will be included. The final examination will, of course, be in the finals week.
Each examination, to some extent, will be cumulative in nature. The final examination will be
comprehensive, cumulative and integrated.
Dr. Pavuluri: The format of examinations will be multiple choice questions on ExamSoft.
Absolutely NO partial credit will be given. Grades will be posted on the learning management
portal, Jenzabar.
Dr. Yang: The format of examinations will be multiple choice and true/false questions on
ExamSoft. Absolutely NO partial credit will be given. Grades will be posted on Jenzabar.
Dr. Jambhekar: The format of examinations will be multiple choice questions and definitions
on ExamSoft. Profile questions, if and when applicable, are asked on paper copies of the profile
section of the examination. Following the administration of the examination, I start correcting
one question of the examination at a time for all students. For example, I may start correcting the
profile questions first followed by definition question. Please note that at this stage I am only
correcting profile question (i.e. no scores are given). Only after I finish correcting all profiles of
all students, I will start giving scores and add all points. While assigning the points, I am
reviewing your papers to make sure that I have not marked something incorrectly.
Method of Evaluation:
1.

There will be three examinations (20% each; total 60%) and the final examination (30%).
The remaining 10% of the grade is for the laboratory portion of the course. This will
include 1% for the kick off examination, 5% for the laboratory quizzes, and 4% for the
laboratory attendance and participation. The final examination will be comprehensive,
cumulative, and integrated. The overall passing grade is 70%. Of that 70%, the didactic
portion should represent minimum of 63%.

2.

The first few minutes of the laboratory recitation component will include
calculations/problems, prescriptions, and quizzes each week.

3.

Style and format of all examinations will include multiple choice questions, definitions,
true/false statements and calculations (when applicable) and profile questions (a general
profile illustrating relationship between two variables; dependent and independent).

4.

Since the nature of the course is a bit mathematical, as one would expect, there will be
calculation and profile type questions; nonetheless, all questions will require clear
conceptual understanding of equations (when applicable) and other material.

5.

Equations will not be provided for any examination. It is expected that students should
have clear conceptual understanding of all equations.

6.

It is the students responsibility to learn to overcome the phobia for managing equations
that employ simple mathematical principles (ratio; proportion, multiplication, and
fraction; and exponential equations like e-Kt, etc.)

7.

Laboratory series will be evaluated based on the students competency in the laboratory
exercises that include maintaining a clean laboratory, completing the necessary
calculations, labeling as well as following guidelines laid down by the course
coordinator.

Examination Reminders:
Students are required and permitted to bring the following items for each examination:
1. Personal computer with the examination downloaded prior to the examination time.
2. Texas Instruments TI-30X IIS 2-Line Scientific Calculator as specified in the Student
handbook.
3. Ruler: 6 or 12 inches
4. Pen, pencils, and eraser
5. Graph paper will be provided, if required
6. Examination Decorum: In accordance with LECOM School of Pharmacy Student
Handbook, students will be allowed to bring only the above mentioned items into the
examination room. Students must leave all personal items including bags, cell phones,
and other sophisticated electronic gadgets outside the lecture halls, in their vehicles or
lockers.
7. Online quizzes will be given using Jenzabar during the first 10 minutes of recitation
session. The students are expected to follow online examination decorum. During the
online quiz, students are expected to be present in the lecture hall and are strictly
not allowed to open any other browser window on his/her computer.
8. Students must follow pre-assigned seating for recitation sessions and exams.
9. Following the completion of your test and exiting the room, please go as far away as
possible from the lecture hall (Ideally, parking lot or students lounge) and discuss
your examination as loudly as you wish
Exam Review:

We will go over the important aspects of each examination in the classroom and/or during
review sessions once grading is completed and students had a chance to review their
examination. Any discrepancies (for example, error in addition or a question is marked
incorrectly) related to a particular examination must be resolved within a week after the students
have had a chance to review the examinations.
None of the examinations including the final will be given back to the students. However
a 45 minute time will be reserved for exam review after the course coordinator records the
grades. The students will be allowed to look at their examination during the exam review. They
will be able to look at a copy of their performance report on ExamSoft and will be informed of
their performance on each question. Students can schedule individual appointments with the
course coordinator and review their exam with the coordinator for discrepancies (if any).
Missing an Exam:
Attendance is mandatory (Refer to LECOM Student Handbook). Only students with legitimate
excuses, as defined in the Student Handbook, will be allowed to take the exam at a time/day other than
the time/day designated.
The make-up examination, in addition to being different, will include short essay type questions,
definition question, and K type question. Additionally, the numerical value questions of the makeup
examination will not be in a multiple choice format; instead, you will be asked to provide the numerical
value answer, for each question, in the space provided.

ACADEMIC HONESTY POLICY:

I shall adhere to the Academic Honesty Policy in accordance with the LECOM Student
Handbook.
COURSE GRADING:
Grading scale:

A = 90-100
B = 80-89
C = 70-79
F = Below 70

The coordinator has the discretion to decrease student final grades by a maximum of 5% to
reflect professionalism, diligence, and participation. Students are expected to be present and
on time for lectures, quizzes, and exams. Emails should be written professionally and
interactions with faculty, staff, and other students should be appropriate and respectful.
Final course grades will be given according to the LECOM School of Pharmacy Student
Handbook in the section titled Grading and Credit Hours.
SPECIFIC COURSE AND INSTRUCTOR POLICIES:
The LECOM School of Pharmacy Academic Catalog and Student Handbook provide a
detailed description of classroom policies. Particular emphasis is placed on the following:
Students are expected to be prepared prior to each class, including completion of assigned
readings and any other specific assignments.
Attendance and punctuality will be monitored and will be reflected in course grading.
Cell phones are to be turned off and kept stored during all class sessions and exams.
7

Computers may only be used to take notes.

Student(s) causing any disruption during class may be asked to leave for the remainder of
that class session.
Emails should be written professionally and interactions with faculty, staff, and other
students should be professional, appropriate, and respectful.

COMMUNICATION WITH INSTRUCTOR AND COURSE COORDINATOR:

The instructors will be available through email, scheduled question/answer sessions, the
scheduled office hours and, appointments.
Students are advised NOT to ask/expect an email explanation to a problem; such
methods of communication carry the dangerous risk of un-clarity causing further
confusion. Alternately, students are encouraged to attend the question/answer
sessions (three times a week), an open door office hour sessions or email the
instructor in advance, to schedule a time to discuss any issues with particular
problems or concepts. It is advised that the students bring all relevant materials
(textbooks, homework, notes, etc.) to such meetings in order to facilitate a
meaningful and successful outcome.
COURSE AND INSTRUCTOR EVALUATIONS:
At the completion of the course, students will be required to complete a course and
instructor evaluation. It is expected that any written comments will be provided as professional
constructive criticism.
AVAILABILITY OF COURSE MATERIALS:
Power point (power point slides) presentations for all lectures and other course material
will be made available prior to the lecture via the LECOM Bradenton Jenzbar. Additionally, the
textbook is available for reference within the LECOM school library.
SPECIAL CIRCUMSTANCES:
LECOM will take all reasonable steps to accommodate any qualified student with special
circumstance, which a student feels may affect his/her performance in this course. A request for
special accommodation must be brought to the attention of the Director of Student Affairs, in
writing, during the first full week of the semester. Student Affairs will require documentation of
special circumstances.
Last minute accommodation requests may not be met. Even if you have received
accommodations from a professor in a previous class, you are responsible for establishing new
guidelines at the start of each semester.
SCHEDULE OF CLASSROOM TOPICS (Specific Quarter/Semester):
Date/Week
January 26
January 27
through Feb.3
February 3
through 10

Topic
Introduction to various dosage forms
Suppository as a dosage form

Instructor
Dr. Jambhekar
Dr. Yang

Solutions as dosage form

Dr. Yang

Hours
1
4
4

February 16
February 17
February 17
through February
23
February 24
March 2 through
March 10
March 10 through
March 17
March 17 through
April 6
April 7 through 13

Aerosol as a dosage form

Dr. Yang

Transdermal Drug Delivery system

Dr. Yang

Powders as a dosage form

Tablets as a dosage form

Dr. Jambhekar
Dr. Jambhekar

2
5

Hard and soft gelatin capsules as a dosage

form
Modified Release dosage form

Dr. Jambhekar

Dr. Jambhekar

Introduction to disperse system

Dr. Pavuluri

April 14 through
21
April 21 May 4
May 5

Suspension as a dosage form

Dr. Pavuluri

Emulsion as a dosage form

Radiopharmaceuticals

Dr. Pavuluri
Dr. Yang

4
2

All students are expected to read the syllabus, understand its implications, and abide by it. The
course coordinator has the right to make changes to the syllabus as needed.
For all topics not covered in this syllabus, please refer to the most recent version of the student
handbook.

All students are expected to read the syllabus, understand its implications, and abide by it.

List of Reference Books

1. Modern Pharmaceutics: Volume1, Basic principles and Systems by Alexander T. Florence

and Juergen Siepmann, Informa Healthcare; ISBN-10: 1420065661, ISBN-13:
9781420065664.
2. Pharmaceutical Preformulation and Formulation, A Practical Guide from Candidate Drug
Selection to Commercial Dosage Form, by Mark Gibson, Informa Healthcare; ISBN-10:
142007317-6, ISBN-13: 978142007317-1
3. Gibaldis Drug Delivery Systems in Pharmaceutical Care by Archana Desai and Mary
Lee, American Society of Health-System Pharmacists, ISBN-13: 9781-58528-136-7.
4. Physical Pharmacy: Physical Chemical Principles in the Pharmaceutical Sciences by
Alfred N. Martin, Pilar Bustamante, A. H. C. Chun, Lippincott Williams & Wilkins;
ISBN-10: 0812114388, ISBN-13: 978-0812114386
5. Pharmaceutical Dosage Forms (Pharmaceutical Dosage Forms-Disperse) by Herbert
Lieberman, Informa HealthCare; ISBN-10: 0824798422, ISBN-13: 978-0824798420
6. Physicochemical Principles of Pharmacy, 4th Edition by A. T. Florence , David Attwood ,
Pharmaceutical Press; ISBN-10: 085369608X, ISBN-13: 978-0853696087
7. Advanced Pharmaceutics: Physicochemical Principles by Cherng-ju Kim, CRC; ISBN10: 0849317290, ISBN-13: 978-0849317293
8. Theory and Practice of Contemporary Pharmaceutics by Tapash K. Ghosh , Bhaskara R.
Jasti, CRC; ISBN-10: 0415288630, ISBN-13: 978-0415288637
9. Pharmaceutics: The Science of Dosage Form Design by Michael E. Aulton ; ISBN-10:
0443055173 ;ISBN-13: 978-0443055171
10. Pharmaceutical Dosage Forms and Drug Delivery by Ram Mahato and Ajit Narang,
Second Edition, CRC Press; ISBN 978-1-4398-4918-7
Pharmaceutics II Laboratory Component (Spring Semester 2017)
The following laboratory syllabus comprises of twelve laboratory exercises illustrating
the general principles involved in the preparation of solution, suspension, emulsion, suppository,
ointments, creams, and lotions.
Prior to each laboratory, the students will receive a handout outlining the objectives,
methodology, and the likely results and observations from the experiments performed in the
laboratory.
Laboratory I (Two weeks)
Preparation of cocoa butter suppository
Calibration of the mold and the density factor
Preparation of gelatin suppository
Preparation of PEG suppository
Laboratory II (One week)
Preparation of simple solutions
Preparation of solutions by dilution method and chemical method
Preparation of aromatic water

10

Preparation of simple syrup (by mixing and by heat)

Preparation of Potassium Iodide Solution
Laboratory III (One week)
Preparation of isotonic solution
Preparation of osmolar solution
Measurement of osmolarity
Laboratory IV (One week)
Preparation of lotions
Preparation of bentonite magma
Preparation of Calamine lotion and white lotion
Preparation of cream (vanishing cream)
Preparation of Zinc oxide paste
Preparation of oleaginous ointment bases
Laboratory V (Two weeks)
Preparation of PEG base
Use of levigating agent
Preparation of sulfur ointment
Preparation of a coal tar ointment
Preparation of salicylic acid cream
Laboratory VI (One week)
Preparation of powders and powder paper
Trituration & mixing techniques
Principles of geometric dilutions
Use of aliquot method
Use of sieves and selection of capsule size
Preparation of eutectic mixtures
Preparation of eutectic powder mixtures
Observation of the differences in two mixtures
Laboratory VII (One week)
Capsule filling using Jansun capsule filling machine
Laboratory VIII (One week)
Evaluation of tablets
Weight variation test
Disintegration tests

11

Conventional and enteric coated tablets

Dissolution test
Laboratory IX (One week)
Preparation of suspensions without suspending agent
Preparation of suspension with suspending agents
Observation of the differences in two suspensions
Observation of sedimentation and re-dispersibility of suspension
Laboratory X (Two weeks)
Emulsion as a dosage form
Preparing mixture of oil and water
Observe the meniscus of two different liquids
Observe the inter-phase of two immiscible liquids
Preparation of mineral oil emulsion using dry and wet gum methods
Preparation of emulsion by using different surface active agents
Preparation of Cold Cream
Use of HLB value and alligation method in the preparation of emulsions

12