Generic Drug Makers Seeking “First-to-File” Status with the FDA can now Utilise Emerging Bioequivalence Technology

ChemImage, one of the world’s leading chemical and biological imaging technology solutions companies, is set to help generic drug makers become the first to achieve bioequivalence for nasal spray suspensions and inhalation products by providing a faster and more accurate way to determine drug particle size distribution in a drug product.

According to Thomas Voigt, Ph.D., Executive Vice President of ChemImage, generic companies are looking to improve their time-to-market, particularly through better technology. The payoff is a faster, more accurate and safe way to achieve generic drug approval and sales.

Utilizing ChemImage’s FALCON II™ Wide-Field Raman Chemical Imaging System, generic drug manufacturers can perform chemical imaging of particles in droplets to distinguish the chemical identity, particle size distribution of drug and other substances, aggregation, and the correlation about the location of the material in the formulation.

ChemImage’s laboratory services utilize the Falcon II system to enable generic drug developers to obtain drug particle sizing of nasal spray suspension, something drug makers have been unable to achieve in the past as part of bioequivalence testing.

In the near-term, ChemImage will work with generic drug manufacturers to lower their risk when going into clinical trials by providing them with additional bioequivalency data. Drug developers and formulators can utilize Raman Chemical Imaging technology and services to perform in vitro drug particle size distribution measurements, as well as understand the stability of the formulation by assessing aggregates.

The majority of the time and money for generic drug companies to achieve bioequivalence is involved in product development and clinical trials. This process begins many years before a product is released from patent because generic drug makers want to be ready the day it comes off patent.

“The long-term goal for ChemImage is to develop this method to measure the drug particle size distribution with sufficient accuracy and precision to demonstrate bioequivalence, enabling generic companies so that in vivo biostudies can be waived,” said Dr. Voigt, “which is why wide-field Raman Chemical Imaging technology will be so critical to companies interested in optimizing their market potential.”

Bioequivalence of nasal spray suspensions is achieved through a number of measurements including droplet size distribution, plume geometry, and spray pattern; clinical equivalence studies; and pharmacokinetic studies to demonstrate equivalence of systemic exposure, according to the U.S. Food & Drug Administration.

Innovative formulators can also utilize Raman chemical imaging technology to develop one-of-a-kind, hard to duplicate formulations. The value of the chemical image comes from the importance of knowing where drug particles are in relation to other materials and how they are distributed. This provides a wholesale opportunity for drug development and product advances that translates to real competitive advantages. What’s more, this technology can also be used as part of batch release testing.