NJIT's Davé is Tapped for a Top Award in Pharmaceutical Engineering

Rajesh Davé, a problem-driven inventor whose groundbreaking methods for re-engineering tiny particles have fueled advances in drug formulations, delivery systems and manufacturing processes, is the 2022 winner of the prestigious Pharmaceutical Development, Discovery and Manufacturing Forum (PD2M) Award from the American Institute of Chemical Engineers (AIChE).

Davé, a distinguished professor of chemical and materials engineering at NJIT, was honored for his contributions to what is known as QbD: engineering approaches that enable drug design based on a deep understanding of the dozen constituents that form a tablet or drug product, as well as the processes used to achieve desired functionalities. By contrast, empirical approaches rely on experience-based educated guesses, followed by numerous trials.

“These approaches allow us to achieve high quality results without excessive experimentation, and thus to both design and manufacture products at a lower cost and with higher reliability,” said Davé said. “Our research, for example, also facilitates making smaller tablets with the same efficacy and therapeutic effect, enhancing patient tolerance and compliance.”

Drawing on physics, chemistry and engineering, Davé’s research into the behavior of particles is fundamental and his methods for adapting them, widely applicable. For example, by shaking granular or particulate materials along with nanomaterials, which form a thin coating around them, he is able to optimize their flow, among other processing improvements.

Most recently, he has been re-engineering drug particles to enhance the effectiveness of medications in a variety of ways: by increasing the absorption rates of drugs with poor water solubility, delaying the release of medications that degrade in the acidic environment of the stomach and masking the bitter tastes of drugs to make them more palatable for children as well as for adult patients who have difficulty swallowing.

Swallowing a pill is simple. Developing one the body will absorb into the bloodstream and deliver to the precise location, at the right concentration and in the optimal sequence is complex. The vast majority of pills are composed of powders, materials with properties of both solids and liquids, and they are tricky to design and manufacture because of their sometimes unpredictable behaviors.

“Drugmakers face a number of fundamental problems,” says Davé. “Most drug molecules in the pipeline – about 80% – are poorly soluble, for example, making it difficult for the body to incorporate and distribute them effectively. The experimentation needed to bring them to market is lengthy and expensive. Quality, affordability and accessibility remain challenges.”

More than a dozen pharmaceutical companies and equipment manufacturers have turned to Davé and Calvin Sun, a collaborator at the University of Minnesota who specializes in particle and crystal engineering, to help them tackle shared hurdles in research and development. These include acquiring a better understanding of various powder properties and the ability to predict their behaviors, while exploiting that knowledge to develop ways to design new drugs digitally and simpler methods to manufacture them.

Their Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP), a National Science Foundation-designated and funded Industry-University Cooperative Research Center, will investigate drug particles at the molecular and particulate scale to see how they behave when blended with other powders and in the various steps of manufacturing, among other settings. The companies, along with the Lawrence Livermore National Laboratory, directly fund their research and provide mentorship to each of the projects they collectively chose. They will share all of the intellectual property developed.

At an initial brainstorming session in the summer of 2019, potential industry partners spoke bluntly about the pressures they face to develop new drugs swiftly and cost-effectively.

“They said it used to take them 10 to 12 years to develop a new drug at a cost of over a $1 billion, but that they no longer have the luxury of that amount of time or expense,” Davé recalled. “Our goal is to help them come up with good formulations in a quarter of that time and a tenth of the material cost.”