In the pursuit and attainment of excellence, the USF Health Taneja College of Pharmacy (TCOP) is guided by the mission to revolutionize health as it becomes the pacesetter for pharmacy education in an ever-changing healthcare field. Personalized medicine is a key part of the future of healthcare, and that’s where pharmaceutical compounding plays a role.

USF TCOP has a non-sterile compounding lab that provides the setting for the education and training to current and future pharmacists and pharmacy technicians through an in-depth, hands-on continuing education (CE) program. “We are the only college in Florida and one of the few across the Nation that provides a CE program in compounding,” Vijaykumar Sutariya, MPharm, PhD, RPh, associate professor in the Department of Pharmaceutical Sciences at USF TCOP, said. “The open lab has all the equipment required, from the laminar flow hood for sterile preparations, mortars and pestles, balances, mixers, ultraviolet (UV) spectroscopy, dissolution testers, disintegration testers and density testers.”

Trainees also benefit from regular collaboration with the USF Clinical Investigational Research Pharmacy (CIRP) and their sterile clean room located on the sixth floor of the Morsani Center for Advanced Healthcare. The primary function of CIRP is to conduct double blinded studies and appropriate procurement, storage, documentation, control, sterile preparation, distribution and disposal of investigational products for clinical trial patients.

Currently, the non-sterile lab is located on the University of South Florida’s Tampa Campus, but it will soon be moving downtown to Water Street Tampa and into the new USF Health Morsani College of Medicine, Taneja College of Pharmacy and Heart Institute. The new space will provide room for a modern, state-of-the-art pharmaceutical compounding lab with mobile workstations.

The U.S. Pharmacopeia Convention (USP) formally defines compounding as, “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice.”

Traditionally, patients are prescribed manufactured or mass-produced drug products approved by the Food and Drug Administration (FDA) in order to treat their illnesses. According to the American Pharmacists Association (APhA), pharmaceutical compounding comes in when patients have special needs that prevents them from being able to take medications already on the commercial market. A few examples of customized medications include changing the strength or dosage; adding flavor to make the drug more appealing to a child or pet; reformulating the drug to exclude an unwanted, nonessential ingredient, such as lactose, gluten, or a dye to which a patient is allergic; changing the form of the drug, such as from oral to suppository for a patient who has difficulty swallowing; and providing access to a drug that was discontinued from the commercial market. The practice of compounding is regulated by state boards of pharmacy and does not include making copies of commercially available drug products, as this is not allowed by law. There are currently 7,500 pharmacies in the United States that specialize in compounding services. USF Health Pharmacy Plus on the first floor of the Morsani Center offers compounding services for medications that can be customized in a non-sterile environment such as topical pain creams for a USF athlete or an Orthopedic and Sports Medicine patient.

In addition to a brand-new lab, USF TCOP is developing a unique certificate program in pharmaceutical compounding. “The certificate program will be great for undergraduate students who are interested in going into pharmacy, so they can see what compounding is before they make the decision to come to the pharmacy program,” Dr. Sutariya said. USF TCOP PharmD students can also pursue the certificate for more exposure into the practice of compounding beyond the three courses already built into the PharmD program. “If a student would like to open their own compounding pharmacy or work for one, the USF Health Taneja College of Pharmacy is the best place to start their career.”

Tampa, FL (June 24, 2013) – The University of South Florida College of Pharmacy received a $195,000 grant  from CoreRx, Inc., a research-based drug development firm, and the Florida High Tech Corridor to bolster the training needed to prepare students for innovation and technology in the pharmaceutical industry.

USF’s existing partnership with CoreRx  offers the university’s Doctor of Pharmacy (PharmD) students some internships with hands-on training and teaching by CoreRX scientists. The new funds from CoreRx (including in-kind contributions) and the Florida High Tech Corridor will allow additional qualified USF students across disciplines — from doctoral and graduate to undergraduate levels — to learn firsthand about the industry’s drug-making and delivery process.

L to R: USF College of Pharmacy’s Dr. Srinivas Tipparaju, principal investigator for the Florida High Tech Corridor grant; with co-investigator Dr. Yashwant Pathak; Dr. Todd Daviau, president and CEO of CoreRx; and Dr. Kevin Sneed, dean of the USF College of Pharmacy.

The academic-industry alliance helps address the state’s need for a more highly skilled workforce prepared for STEM (science, technology, engineering, math) jobs, said Srinivas Tipparaju, PhD, MPharm, assistant professor of pharmaceutical sciences at USF Health.  

Dr. Tipparaju is principal investigator for the Florida High Tech Corridor grant, and Yashwant Pathak, PhD, MPharm, associate dean in the USF College of Pharmacy, is co-investigator. They are working with the CoreRx team led by Todd R. Daviau, president and CEO of CoreRx.

“There is a shortage of home-grown talent to meet the workforce demands of the technology-driven, multibillion-dollar pharmaceutical sector,” Dr. Tipparaju said.  “We want to create that talent right here in the Tampa Bay area, so that our graduates can take leading roles managing and delivering advanced pharmaceutical care in tomorrow’s patient-centered practice, as well as help drive pharmaceutical research and development.”

“We’re thrilled to expand our affiliation with USF and to continue to find ways to offer students hands-on learning experiences in industrial pharmaceutics,” Dr. Daviau said. “We are excited that CoreRx will play a role in furthering the development of more students through this opportunity.”

Brian McMillan, MSPharm, vice president of formulations for CoreRx, helped lead first-year USF pharmacy students on a tour of the company’s laboratories earlier this year.

McMillan, far right, demonstrates the tablet press, a mechanical device that compresses powder into drug tablets of uniform size and weight.

Among the key concepts students will learn will be early-stage development of pharmaceuticals, how liquid medicine, tablets and capsules are made (with hands-on instruction), the functionality of additional ingredients found in modern-day drugs, and  hands-on processes used to manufacture a wide range of pharmaceutical dosage forms.  In addition, the training will help educate students about biopharmaceutical techniques, quality control and assurance, and the U.S. Food and Drug Administration’s regulatory standards for prescription drugs.

USF’s newest college, the College of Pharmacy, admitted it first class less than two years ago and continues to advance on a fast track. The program, awarded candidate accreditation status by the Accreditation Council for Pharmacy Education, attracted nearly 800 applicants for 100 spots in the class entering August 2013.

-About USF Health-

USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a global research university ranked 50^th in the nation by the National Science Foundation for both federal and total research expenditures among all U.S. universities. For more information, visit www.health.usf.edu

About CoreRx, Inc.

CoreRx is a contract research organization providing customized pre-formulation services, formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. CoreRx’s unique corporate structure creates project teams that work intensively with each client, bringing an extension of its own organization into the CoreRx lab.

Keep on top of new developments at CoreRx and throughout the drug development industry by following www.twitter.com/CoreRx  and for more detailed information about the company, visit www.corerxpharma.com

Media contacts:
Anne DeLotto Baier, USF Health Communications, (813) 974-3303 or abaier@health.usf.edu
Jenna Leitao, CoreRX Inc.,   (727) 259-6950 or  jenna.leitao@corerxpharma.com

USF pharmacy students stand next to a V-blender used to mix active pharmaceutical ingredients with pharmacologically inactive substances. The are gowned to comply with current Good Manufacturing Practices, the FDA’s regulations to ensure the quality of drug products.

Photos by Jenna Leitao, CoreRx Inc.

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