Pharmaceutics is the science of compounding and pharmaceutical dosage form design. Its impact on the society is evident by the wide use of over the counter (OTC) products, prescription drugs, and chemotherapeutics. Recent advances in pharmaceutics research provided the very unique options of using once a day pills to liquid filled softgels.
Our research interest is in pharmaceutical manufacturing processes and process analytical technologies for both solid and liquid oral dosage forms and drug delivery systems. This interest coincides with FDA initiatives and the growing interest in novel technologies that could be used to predict potential failure of a given drug prior to clinical trials and reduce the expense and time required to deliver a drug product to the market.
Currently we are focused on two distinctive areas of research:
1. Chronotherapy and chronotherapeutics
Chronotherapeutics refers to a treatment method in which In Vivo drug availability is timed in relation to our bodies’ natural rhythms (circadian rhythm) to produce maximum health benefits. It is becoming increasingly evident that some medications may work better if their administration is coordinated with day-night patterns and biological rhythms. For example, researchers have reported that asthma is worst at 4 am when cortisol levels in the body are low and histamine concentrations are at their highest level.
As part of this initiative we are developing a predetermined gradient controlled release
dosage form for use in chronotherapy by modulating the fluid-bed manufacturing process.
A gradient release dosage forms are drug delivery systems with non-uniform drug distribution
that allow various drug release patterns. In addition to developing novel manufacturing
processes and formulation technologies we are interested in developing a remote PC
controlled unit and a simulation model. Our objective is to develop a fully automated
system by which we could predetermine the manufacturing process of the gradient controlled
release dosage forms. This automation will enable us to control the process to manufacture
pharmaceutical products with predetermined release patterns that mimic natural rhythms.
2. Lipid based drug delivery and real-time spectroscopic simulation of drug digestion and lipolysis
A major limitation that frequently confronts medical and pharmaceutical communities in developing therapeutics is the poor solubility and bioavailability of newly discovered drugs, especially those with critical social impact such as cancer and AIDS drugs. One of the most successful formulation strategies that overcome this barrier is the use of lipid based drug delivery systems, which are blends of natural and/or synthetic lipids. However, little is known about the criterion for developing optimum lipid based formulations and the mechanism by which they enhance oral bioavailability of drugs. As a result, there is a growing commercial and academic interest to simulate the gastrointestinal environment to predict digestion outcome.
Our research group is interested in designing optimal lipid based formulations (emulsions,
micro-emulsions, and self-emulsified drug delivery systems) and developing non-invasive
simulated In Vitro lipolysis (lipid digestion) model to predict digestion outcome
of lipid based drug delivery systems by real time fiber-optic spectroscopy. Our objective
is to develop a dynamic In Vitro lipolysis method for implementation in regulatory
guidelines and to establish the utility of spectroscopy and real-time fiber optics
to predict digestion, performance, and lipolysis of lipid formulations.
3. Gene Delivery
In addition to the traditional drug delivery and manufacturing technologies, which are the core interest of our group, we are pursuing research in gene delivery. Currently our focus is to utilize chitosan biopolymers to develop plasmid-nanoparticles for the management of prostate cancer. This research; however, is in its infancy. As we optimize our formulation techniques, we will also attempt to implement the layer-by-layer, or polyplexes, technology into our formulation work.
|Sami Mahoumd Nazzal, Ph.D.
Associate Professor of Pharmaceutics
Department of Basic Pharmaceutical Sciences
School of Pharmacy
University of Louisiana at Monroe
Monroe, LA 71209-0497