Pharmacy Compounding Research & Education Laboratory
Pending approval from the Board of Trustees
What is it:
Mission: The Pharmacy Compounding Research and Education Laboratory (PCREL) is dedicated to advancing the science and practice of pharmacy compounding by producing research and providing education to fulfill the need for safe, effective, and innovative compounded pharmaceuticals.
As the focus on personalized medicine intensifies and the demand for safe and effective personalized medications grows, there is a need for a corresponding advance in the research base, technology, and practice of pharmacy compounding. Pharmacy compounding involves designing, formulating, and preparing a non-commercially available medication specific to the needs of an individual patient.
The Pharmacy Compounding Research and Education Laboratory (PCREL) at Roseman University in South Jordan, Utah educates students to meet this need by providing advanced pharmaceutical compounding education. Additionally, the PCREL is dedicated to advancing the art and science of pharmacy compounding by conducting cutting edge research, consulting on the formulation of complex dosage forms and drugs on shortage, and offering quality testing of compounded preparations to regional pharmacies and health care institutions.
Compounding pharmacies are required to abide by guidelines issued by the United States Pharmacopeial Convention (USP) for the quality assessment of their compounded preparations. Testing of compounded preparations is a required component of all quality assurance programs, according to USP Chapter 1163. Currently, many compounding pharmacies seek out quality testing of end products from contract laboratories to demonstrate their commitment to safety and accuracy for both patients and providers, and in anticipation of future regulation.
In addition, patient safety concerns spurred the passing of the Compounding Quality Act in November 2013. This act has led to increased scrutiny of compounding pharmacies by the FDA. In a regulatory environment that is rapidly evolving, an academic center to advance the science and practice of pharmacy compounding through quality testing of compounded pharmaceuticals is needed. In short, the PCREL elevates the quality of pharmacy compounding and thereby improves patient health and outcomes.
What it offers:
- Quality Testing of Compounded Preparations
- Beyond-Use Dating (BUD) – Stability
- Endotoxins and Pyrogen Testing
- Microbiological Detection and Sterility Testing
- Pre-formulation and Formulation Services
- Analytical method development and validation
- Drug compatibility with excipients
- Solubility profile, Dissociation constant (PKa), and Log P evaluation
- Dissolution profile in simulated biological fluids
- Particle Size and Surface Charge
- Oral permeability studies using Caco-2 cell monolayer and isolated tissue Using chamber models
- Transdermal permeability studies using Franz diffusion cell system
- Freeze-drying process optimization
- Characterization of drugs by differential scanning calorimetry (DSC), Fourier transform infrared (FTIR) spectroscopy and particle morphology by optical microscopy
Casey L. Sayre, PharmD, PhD
Director, Pharmacy Compounding Research & Education Laboratory (PCREL)
Office: 801-878-1126 | firstname.lastname@example.org
Pharmacy Compounding Research & Education Laboratory (PCREL)
Roseman University of Health Sciences
10920 S. River Front Parkway, South Jordan, UT 84095