SEPA Training Modules

The Art of Drug Design and Synthesis- Unsolved Solutions

Faculty Instructor: Dr. Patrice Jackson-Ayotunde

Objectives: 1) Explain the purpose and steps for liquid-liquid extraction techniques, 2) Identify the active pharmaceutical ingredient in an over-the-counter medication using gas chromatography and mass spectrometry (GC/MS).

Method: The focus of the training is design, synthesis and structure-activity relationship of anticonvulsant agent to treat drug resistant epilepsy. Drug synthesis (medicinal chemistry), involves several steps to obtaining the desired compound. One of those steps is separating out the anticipated compound from the reaction mixture hat contains different components using liquid-liquid extraction. Next is the analysis of the organic phase from the extraction to determine the present of the desired compound. Structurally identification of compounds that will move to in vitro and in vivo studies is a very important step in drug design and discovery of anticonvulsant agents. In the interactive lab session, students will be introduced to the area of medicinal chemistry through hands-on experience in the lab that involve separation techniques. The students will be divided into groups of our. They will be given a packet containing information about liquid-liquid extraction and the pharmaceutical ingredients with different molecular weights. The groups will be given a solution containing an unknown pharmaceutical ingredient from an over-the counter drug (e.g. Tylenol). Each group will work together to complete the liquid-liquid extraction of the unknown solution. They will obtain two phases, an organic phase and an aqueous phase. The groups will be instructed to collect and save the organic phase for analysis on the GC/MS. Based on the results from the GC/MS the students will need to match the data with the correct active pharmaceutical ingredient present in their unknown solution based on the molecular weight found on the worksheet. The groups will wrap-up the session with a brief decision explaining their findings and what they learned.

Biomarkers: What are they?

Faculty Instructor: Dr. Bi-dar Wang

Objectives: Biomarker also referred as molecular markers, is defined as a biological molecule found in blood, other body fluids, or tissues that can serve as index for a normal or abnormal process in diseases. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Prostate cancer is the most commonly diagnosed and second leading cause of cancer death among American men. Prostate specific antigen (PSA) is the most widely used biomarker in prostate cancer diagnosis and monitoring. Due to the limitation of this currently clinical biomarker, novel precision biomarkers with higher specificity are needed for early detection of the PSA risk and monitoring of disease recurrence.

Method: This unit will offer the attending high-school students an opportunity to explore/learn the basic science of biomarker in disease diagnosis. The faculty will provide interactive learning activities (hands-on experiments, video demonstration etc.) for delivering the concept of biomarker, and the student will also learn basic molecular biology skills on how to use biomarker for detecting cancer diseases.

Show your Compounding Skills: The Making of Salicylic Acid Capsules

Faculty Instructors: Drs. Adel Karara and Anjan Nan

Objectives: 1) Describe the advantages and limitations of capsules as dosage forms, 2) Describe official USP tests required for capsules iii) Prepare and dispense hard gelatin capsules.

Method: Capsules are a common form of dosage for oral administration of pharmaceutical and nutraceutical products. Capsules are gelatin shells filled with the ingredients that make up an individual dose. Dry powders, semi-solids and liquids that do not interact or dissolve gelatin may be compounded into capsules. Capsules account for about 20% of all prescriptions dispensed. The proposed exercise will be a compounding exercise involving labeling and dispensing a prescription of extemporaneously compounded salicylic acid capsules. The students will individually work to do all necessary calculations, weigh all ingredients, mix ingredients in mortar and pestle and perform the compounding. This will be followed by quality control testing of the finished capsules.
Content uniformity will test the accuracy of the mixing operation by UV analysis of the dissolved salicylic acid capsules and analysis of weight variation to test whether the prepared capsules meet compendial requirements. Students will present their data at the end of the session which will be discussed collectively for the whole class.

A Physician’s Perspective on Opioids Abuse Prevention

Faculty Instructor: Dr. Khaled Hasan

Objectives: 1) Define opioids abuse and addiction, 2) Discuss misconceptions and facts about opioids, 3) Analyze the abuse of opioids and suggest factors responsible for the progression from misuse to physical dependency, 4) Explain the science behind authentic stories of prescription opioid misuse and heroin use

Method: This interactive method provides slide-by-slide details, which allows the educator to be prepared to engage the students, explain, discuss, and effectively facilitate the content in the presentation. During the activity, students will learn that opioids are drugs that are derived from the opium poppy plant or are synthetic equivalents, such as methadone and fentanyl. Heroin is an illegal opioid, but many opioids are legal. Opioids are commonly prescribed in forms of medications that relieve pain and reduce the intensity of pain signals reaching the brain.
Prescription opioid misuse is the use of a medication without a prescription. This may mean taking more than prescribed or for the feeling of being high. Prescription medications that are examples of opioids include hydrocodone (e.g., Vicodin®), oxycodone (e.g., OxyContin®, Percocet®), morphine (e.g., Kadian®, Avinza®), and codeine. Opioids act by attaching to specific opioid receptors. Endorphins are naturally produced in our bodies to help manage pain. When opioid drugs attach to these receptors, they also reduce the awareness of pain. After considering several facts vs. misconceptions, students will examine the adverse effects of opioids on the nervous system. They will learn that opioids act upon the opioid receptors in our nervous system, and many
parts of our nervous system are affected by opioid misuse. Different messages are communicated through our bodies using neurotransmitters. They take the messages across the synaptic gap to the next neuron. When they are released, the body receives a message that inhibits pain messages – we basically do not get the pain messages with as much strength because the endorphins block pain signals. A person’s experiences when misusing a drug match to a specific neurotransmitter whose activity it disrupts. Students will begin to uncover that, with all these changes in the human nervous system, drug misuse is no longer a choice. When opioids are misused for pleasure, they can lead to physical and chemical changes in our bodies. These changes can prevent us from controlling the impulse to continue misusing opioids. The initial decision is typically voluntary but can lead to tolerance and dependence. Students then will apply what they learned by reviewing different case studies and explaining the science behind some of the signs and symptoms of opioid misuse.

The NEST – Community Pharmacy Operations

Faculty Instructor: Dr. Tosin David

Objectives: 1) Identify key areas in a community pharmacy, 2) Determine over the counter medications used to treat common conditions, 3) Describe the pharmacist’s role in medication safety and preventive health

Method: The University’s Next-level Educational Simulation Training (NEST) center is a simulated mock pharmacy area where participants can see the interworking of a community pharmacy. The participants will practice filling placebo pills for fictitious patients and complete the workflow process for a prescription. The participants will also select appropriate over the counter medications for common conditions. To emphasize the importance of medication safety participants will also participate in a game where they will have to recognize real medication formulations from candy. Participants will also gain exposure on how pharmacists aid in preventive health. Each student will have an opportunity to complete a pre-diabetes questionnaire and have their blood pressure assessed by a student pharmacist.

Computer Aided Drug Design (CADD): 3-D Printing of Dosage Forms

Faculty Instructor: Dr. Richard Debenedetto

Objectives: 1) Apply creativity and critical thinking skills to solve a problem, 2) Design a 3 dimensional model to assist with nasal medication administration, 3) Discuss the pros and cons to different administration devices

Method: Students will explore medication administration devices through a critical thinking exercise developing a solution to an existing medication administration problem. Intranasal administration is a methodology for administering medications to patients by bypassing the oral swallowing process and avoiding needles. It allow for administration to an individual who is not conscious without first achieving intravenous access. In this activity students will work in groups of 2-3 along with a pharmacy student assistant. They will be presented with a liquid dosage unit in a luer-lock syringe and be tasked with creating a device to help administer the medication. As students are brainstorming ideas for device attachment and styles, several pieces of information regarding
important considerations for nasal administration will be provided. After brainstorming, a draft diagram of the device will be produced in order to clearly define the idea. Finally, students will, with assistance of the trained pharmacy student, use design software to create a 3-D image of the device. Conclusion of the activity will have the class gather as a whole to discuss challenges, solutions, devices created and best practices. During this debrief period, 3-D products will be printed from the images designed and demonstration of the device functionality will provide an exciting end of the class.

Promoting Healthy Behaviors and Disease Prevention: Healthy Eating, Optimizing Activity, Obesity and Overweight, Heart Health, and Diabetes

Faculty Instructor: Dr. Dana Fasanella

Objectives: 1) Define carbohydrate, fat, and protein, 2) Correctly interpret food labels to identify the serving size, calories, carbohydrates, and fats, 3) Discuss the health implications of overconsumption of calories, carbohydrates, proteins, and fats, 4) Identify the impact of physical activity on weight, cardiovascular health, and overall wellness, 5) Educate peers regarding the impact of diet and physical activity on weight, cardiovascular health, and overall wellness.

Method: This module will introduce and discuss the health risks associated with overweight and obesity, hypertension, hyperlipidemia, and elevated blood sugar. Nutritional Activity (~ 50 minutes): Step 1: First we will discuss the importance of diet in disease prevention as well as recommendations regarding healthy eating from American Heart Association and American College of Cardiology (AHA/ACC) guideline on therapeutic lifestyle modifications, the USDA dietary recommendations for Americans, and other sources. The students will use standard cooking measuring cups and spoons to do these activity. They will also be allowed to keep these measuring devices to use at home later. After discussing healthy eating guidelines we will measure out the amount of carbohydrates (sugar), fat (Crisco), and salt recommended to be consumed in on day onto a plate. Step 2: Students will be given photos and nutrition facts for different meals from popular local restaurants and homemade alternatives. In each pair one student will measure out the sugar, fat (Crisco), and salt found in one restaurant and one healthier homemade alternative onto a paper plate. For example, one student may have a fast food hamburger and French fry to measure while the other measures put a homemade hamburger and baked potato. After measuring out the nutrient content of the meals on the plates we will compare as a group the visual difference in sugar, fat, and salt between the different meals and the daily recommended intake measured in the first part of the activity. We will then discuss how visuals like this can be used to help people realize the unhealthy contents of their diet. Often providing this kind of visual can help better motivate people toward dietary change rather than just discussing differences in foods. Step 3: For drinks we will compare popular soft drinks, sports drinks, and juice in terms of sugar content. Students will measure into cups the amount of sugar and sodium found in 4 ounces, 8 ounces, 12 ounces, and 16 ounces of different drinks and compare this to recommendations for daily intake. Physical Activity (~40 minutes): Step 1: First we will discuss the importance of physical activity in disease prevention and recommendations regarding regular physical activity from AHA/ACC and other sources. Students will be instructed on how to take a radial pulse. Definitions for moderate and vigorous exercise will be reviewed. Step 2: Students will be split into two groups and asked to stand on either side of the room with a table or chairs used as the dividing line. Balloons will be placed on the floor on either side of the room. Students will be directed to pick up the balloons once music is started. For the duration of the music they will pick up the balloons and toss them to the other side of the room. Balloons can only be picked up directly from the floor. This exercise shows how everyday items can be used to increase physical activity. Step 3: Basic chair and standing exercises. We will perform some basic sitting and standing exercises such as marching in place, triceps and bicep curls, and wall squats. A handout will also be provided for these exercises. Education material creation (~40 minutes): The final portion of the session will be creation of an education handout. The students will be split into small groups and they will design a handout aiming at promoting healthy lifestyle to their peers. We will provide paper, colored pencils, markers, and glue for this portion of the session. Students will be given some example handouts but encouraged to use their creativity in their own designs. Each pair of students will also have a laptop they can use to create posters or handouts which can later be printed or posted to social media. Debrief and sharing of education materials (~50 minutes): Each group will share the education material they created and discuss methods for encouraging healthy lifestyle and teaching about disease prevention.



Hospital Pharmacy Operations: Site Visit to Peninsula Regional Medical Center (PRMC)

Faculty Instructor: Dr. Dennis Killian

Objectives: 1) Identify how pharmacists are part of a multi-disciplinary health care team in the hospital, 2) List various technologies that can be utilized to improve medication safety and efficiency.

Method: Students will have an interactive experience with an IP128 Automated Packaging System from Pearson Medical Technologies. This device is used to repackage medications from a bulk container to a unit-of-use format, which allows nurses to barcode scan at the patient’s bedside during administration. Students will simulate medication repackaging by operating the device to package M&M’s®.

Animal Behavior

Faculty Instructor: Dr. Mark Simmons

Objectives: Use the principals of classical and operant conditioning to guide animal behavior

Method: The software includes a training session, where the students will train a rat to press a bar to obtain mood. They will then progress to more complex studies of behavior. The software includes a series of “Mind Windows” that illustrate how Sniffy the Virtual Rat’s experiences in the experiment produce psychological changes. The activity will consist of the following sections.
Introduction to the principles of behavior (15 min): It is expected that the teachers will have introduced the concepts of learning prior to the exercise. We will review these principles and discuss the difference between Pavlovian (classical) and Skinnerian (operant) learning. We will discuss how reward and reinforcement influence behavior. Introduction to the software (15 min): Each student will have access to a computer with the software so they can run it on their own. We will go through a step by step introduction to working with the virtual rat. Define an experiment (30 min): We will show the students how to train the rat. Different schedules of reinforcement will be reviewed. Do the experiment (1 hr): We will give the students a specific hypothesis to test related to acquisition, extinction, or stimulus properties. They will then measure the rat’s behavior in the specific paradigm. Presentation of results (30 min): The students will discuss and compare their results. This will allow the students to see how different conditions lead to different behaviors. Summary and discussion (30 min): We will summarize and reinforce these concepts. This will also open the door for a discussion of how environment and reward influence human behavior.


Characterization of Drug Effects on Viral Neuronal Infection

Faculty Instructor: Dr. Victor Hsia

Objectives: To understand the principles and perform basic experiments cell/molecular biology.

Method: The experiment is designed for students to infect neuronal cells with herpes simplex virus type 1 (HSV-1) in the presence or absence of several compounds to test the potential inhibitory effects. A brief introduction will be presented to the students with handouts. Students will be assisted by graduate students in cell culture, infection, fluorescent microscopy, RNA isolation, and quantitative RTPCR to analyze the gene expression of virus understand drug influences. Students will collected raw data followed by analyses and interpretation and orally present their data.

Going after Prostate Cancer Cells

Faculty Instructor:Dr. Miguel Martin

Objectives: Introduce students to the concept of cell morphology and differentiation: 1) Understand changes in cell morphology resulting from cytokine-induced differentiation of prostate cancer cells, 2) Discuss the role of cytokine-induced differentiation in the progression of prostate cancer.

Method: Students will received hands-on experience on cell culture of LNCaP prostate cancer cells and assess changes in cell morphology resulting from cytokine-induced differentiation. LNCaP cells are currently the main model used to study the transformation of prostate cancer cells. This cell line is derived from a prostate cancer that metastasized to the lymph nodes. Neuroendocrine differentiation (NED) has been associated with the progression of prostate cancer into an androgen-refractory phenotype, which develops as an adaptive response to anti-androgen therapies. We are trying to understand the cellular and molecular mechanisms by which the cytokine IL-6 promotes NED of prostate cancer cells in order to develop novel therapies against advanced prostate carcinomas. The proposed module will be designed to show students the effect on IL-6 on prostate cancer cells, especially changes in cell morphology. First, students will learn how to culture LNCaP cells under sterile conditions. Second, students will be able to assess some of the morphological changes associated with NED that occur in LNCaP cells treated with IL-6, including changes in cell body shape and extension of long neurite processes. Students will assess how induction of NED evokes changes in morphology and increased expression of the neuronal marker tubulin IIIbeta. Culture of LNCaP cells will be performed on a biosafety cabinet. Changes in cell morphology will be assessed with a Nikon Eclipse Ti microscope and a 20X inverted objective using a Photometrics Coolsnap camera. Upon completion of this exercise students will be able to understand the role of NED on the transformation of prostate cancer cells and its clinical relevance in the formation of androgen-refractory prostate tumors.

Going After Breast Cancer

Faculty Instructor: Dr. Sean Vasaitis

Objectives: 1) To introduce students to key concepts in breast cancer treatment mechanisms, 2) To utilize a receptor competitor assay system to examine the ability of receptor antagonists to bind with the estrogen receptor.

Method: Hormone responsive breast cancer cell proliferation is increased with exposure to estrogens. Receptor antagonists are utilized clinically to reduce hormone driven cancer growth. The PolarScreen™ ER (Estrogen Receptor) Alpha Competitor Assay Kit will be used to analyze the ability of test compounds and the estrogen receptor antagonist ICI 182,780 (fulvestrant) to compete for binding to the estrogen receptor. For student projects the faculty will premix the reagents and add them to demonstration plates in advance, so that students will be able to obtain and analyze results within the class time. The kit reagents will be added in assay plate wells according to the manufacturer’s directions. The assay plate will be mixed, covered, and incubated at room temperature for two hours. The fluorescence will be measured on a fluorescence plate reader and competitive binding will be evaluated. During the incubation period, we will walk through and discuss a simplified case study featuring a simulated breast cancer patient on anti-estrogen therapy. This will connect the lab activity to real-life scenarios and generate interest in the experimental results. At the end of this module, the student will be able to 1) discuss how estrogen fuels breast cancer growth, and 2) explain the mechanism by which common antiestrogen therapies work.

Determination of Caffeine in Beverages by High Performance Liquid Chromatography (HPLC)

Faculty Instructor: Dr. Adel Karara

Objectives: 1) Apply concepts of basic chromatography and separation science, 2) Measure the concentration of caffeine in a beverage using HPLC with UV detection and estimate the total amount of caffeine, 3) Compare the amount of caffeine in different beverages and discuss some of the potential risks of high energy drink consumption

Method: Dr. Karara was a Lab Head of bioanalytics at Novartis Pharmaceuticals for 9 years. He has experience in HPLC method development and validation. Students will explore through hands-on lab exercise the use of HPLC as an analytical tool to separate the measure caffeine concentrations as in ingredient in different beverages. Students working in groups of 2-3 along with a pharmacy student will prepare samples, learn about stationary phase on an HPLC column, liquid mobile phase, set chromatographic conditions for the HPLC, caffeine standards and Beer’s plot. Students will be able to explore how the chromatographic parameters of solvent polarity selection, solvent flow rate, temperature can be used to optimize the separation of mixture of compounds. Students will run samples in the HPLC, observe chromatographic peaks at caffeine retention time, record peak areas and determine the concentration & amount of caffeine in the different beverages. Conclusion of the activity will have the students discuss the chromatographic data, compare results and reflect on the some of the dangers of consuming drinks with high amounts of caffeine.

Kinesiology and Health-Related Components of Physical Fitness

Faculty Instructor: Dr. Margarita Treuth

Objectives: 1) Gain knowledge of the physiologic basis of the major components of physical fitness: flexibility, cardiovascular fitness, muscular strength, muscular endurance, and body composition, 2) Measure and categorize the results for muscular strength, 3) Measure and categorize the results for flexibility

Method: The student will gain an understanding of two of the health-related components of physical fitness, in particular muscular strength and flexibility. The health-related components of physical fitness have a strong relationship with overall health and are an indication of an individual’s ability to perform activities of daily living. These components are also associated with a lower prevalence of chronic disease and health conditions and their related risk factors. During this module, there will an interactive learning session with anatomical models of the arm and leg. The muscles will be located on the models, in addition to paper diagrams. There will be a discussion on basic kinesiology concepts, including topics related to strength (muscle physiology, force, isometric strength) and flexibility (joint range of motion, joint capsule, warm-up, muscle viscosity). The students will be divided into groups, in which one student will test the strength and flexibility of the other. The groups will then compile their data and devise a graph to compare the individual and group values to the norms. A discussion will follow as to ways to improve muscular strength and flexibility in youth.

Drug Delivery: Nanotechnology for Targeted Drug Delivery

Faculty Instructor: Dr. Anjan Nan

Objectives: 1) Identify drug delivery challenges that exist for small and macromolecules, 2) Learn the state of the art methods of nanoscale drug delivery systems characterization, 3)Understand the effects of physicochemical properties of nanomaterials on their biological disposition.

Method: How can we create nano-structures that are 10,000 times smaller than the diameter of a human hair? How can we “see” at the nano-scale? Through instruction and lab demonstrations, in this course students will obtain a rich understanding of the capabilities of nanotechnology tools, and how to use this equipment for nanoscale characterization. Recent advances in nanotechnology has enabled applications in biomedicine due to the advantage of their size, nanoparticles have been shown to be robust drug delivery systems and may be useful for encapsulating drugs and enabling more precise targeting with a controlled release. Students will be provided with nanoparticles that are synthesized prior in the lab by graduate students. They will use a Malvern Zetasizer Pro equipment to measure the hydrodynamic size and surface charge of the nanoparticles. These will provide valuable insight and hands-on training on understanding the relationship between physicochemical characteristics of nanoparticles and their impact on potential biological effects in vivo such as efficacy, toxicity, stability etc.

Killing of Bugs and the Discovery of Potent Antibiotics

Faculty Instructor: Dr. Madan Kharel

Objectives: Educate high school students about the relevance of infectious diseases and the importance of antibiotic research at their early learning stage. The students will learn the concept of antimicrobial drug therapy, antibiotic resistance, and approach of antibiotic discovery. Growing incidences of multi-antibiotics resistant bacteria have become a major health threat all over the world. The rate of emergence of antibiotic resistance has outpaced the discovery and development of new antibiotics. The sluggish progress in new antibiotic development eclipsed with the widespread misuse/inappropriate use of antibiotics. Both the lack of sufficient public education/awareness about antibiotic misuse, and declining interests in antibiotic research in big pharmaceutical companies are to blame for this crisis.

Method: First, students will use Bio-safety cabinet to initiate a new bacterial culture on an agar plate or in a 96-well plate and observe pre-formed bacterial colonies on agar plates. Second, students will use a 96-well plate reader to collect data on dose-dependent inhibition of growth of test microorganisms using colorimetric detections and pre-developed assay culture. Third, students will measure bacterial growth inhibition zones using pre-developed growth inhibition assay agar plates. This will provide students with visual evidences to relate optical density data obtained from 96-well plate reader with the inhibition zones on the agar plates and help them formulate the concept of minimum inhibitory concentration (MIC) of an antibiotic.

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