Natoli Institute Brings Academic Focus to Industrial Pharmacy

Since it was established in September 2014, the Natoli Institute for Industrial Pharmacy Research and Development at Long Island University (LIU) has been providing students with the opportunity to learn about pharmaceutical compression science in an industrial pharmacy laboratory. Born out of a desire to bring additional academic focus to industrial pharmacy, the Institute allows students to work closely with Natoli scientists to study dosage formulation and engineering.

As a result of his continued work with the school, Dale Natoli, president of Natoli Engineering, was bestowed an Honorary Degree of Doctor of Science by LIU during the May, 2016 commencement ceremonies at the Arnold and Marie Schwartz College of Pharmacy and Health Sciences. The award recognized his dedication to encourage the advancement of the pharmaceutical industry’s body of knowledge through personal scholarship and academic partnerships to conduct meaningful research and create learning opportunities for pharmacy students. Pharmaceutical Technology sat down with Charles N. Kettler, PhD, director of Natoli Scientific, to discuss some of the research currently being done at the Natoli Institute.

PharmTech: When was the Natoli Institute for Industrial Pharmacy Research and Development at Long Island University established?

Kettler (Natoli): The discussions surrounding the Natoli Institute concept began in 2011. By 2012 there was an agreement and construction started in late 2012. The institute began working on projects in 2014.

PharmTech: What was the thought process behind the development of the Institute?

Kettler (Natoli): Dale Natoli believed there was an opportunity to bring additional focus in the academic world to encourage and promote advancements in industrial pharmacy. He wanted to make a contribution to this sector of pharmacy academic training and found that at LIU there was a sincere interest in rebuilding their industrial pharmacy program. In addition, there was an opportunity to partner with the Lachmann Institute to address industrial pharmacy problems from the unit operation and the drug product analysis domains.

PharmTech: What kind of research is currently being done at the Institute?

Kettler (Natoli): The projects being addressed at the Natoli Institute are diverse in nature. We work on proprietary problems for pharmaceutical companies, nutraceutical manufacturers, and legal representatives. These projects include formulation development, verification of unit operations for given formulations, evaluation of oral solid dose formulations from the compression and compaction standpoint, hot melt extrusion techniques for low solubility/low permeability API’s, confirmation of unit operation operating ranges for litigation support, and tablet sticking and picking problems.

PharmTech: What role do Natoli scientists play in the Institute? How involved are they with teaching students?

Kettler (Natoli): Robert Sedlock, Natoli’s director of technical training and development, spends a significant amount of time at the Natoli Institute training students how to evaluate the compressibility, tabletability, compactability, and strain sensitivity of formulations for Natoli Institute customers. In addition, he has instructed all the students in the proper way to install tools and start up the three different tablet presses at the Natoli Institute.

PharmTech: What role do students from LIU play in the Institute? Are they involved with research in the laboratory?

Kettler (Natoli): The students, most of whom are Doctor of Pharmacy students, are members of each project team and take on responsibilities such as: equipment qualification, execution of experiments under the direction of Rutesh Dave, PhD, analyze powder and tablet samples, write project progress and final reports, as well as maintaining the laboratory. For their service to the Natoli Institute the students are properly compensated.

PharmTech: What kind of technology and laboratory equipment is available at the Institute?

Kettler (Natoli): We have the following capabilities:

• Mendel roller compactor with mill

• GlobePharma Maxiblend V-blender

• Steer America Hot melt extruder

• Freund-Vector GMX high shear granulator

• Freund-Vector VFC-Lab fluid bed system

• Freund-Vector LDCS tablet coater

• Natoli RD10A Single Station Tablet Press

• Piccola Bench Top Press-8 station (instrumented)

• Manesty BetaPress-16 station (custom instrumentation)

For analytical needs we have:

• Particle sizing and imaging instruments

• Microbalance (microgram capable)

• Fourier Transform Infrared (FTIR)

• High-pressure liquid chromatography

• Dissolution

• All the tablet analysis tools needed

Analytical help can be obtained via the Lachman Laboratory.