Nivedita Shetty works for the Small Molecule Pharmaceutical Sciences Department of Genentech, Inc., in South San Francisco, CA responsible for formulation development of inhaled and oral drugs to support phase I clinical studies.

Prior to joining Genentech, she completed her PhD in Pharmaceutics at Purdue University with a focus in particle engineering for inhalation. During her PhD she was awarded the Outstanding Student Research Award from National Institute for Pharmaceutical Technology & Education (NIPTE); Excipient Graduate Student Scholarship by International Pharmaceutical Excipients Council (IPEC); McKeehan Graduate Fellowship and Ronald W. Dollens Graduate Scholarship from Purdue University. She holds undergraduate Pharmacy degree from Bombay College of Pharmacy, India and Master’s degrees in Pharmaceutics from Northeastern University, Boston.

She served as co-chair for New Devices and Emerging Therapies networking group at International Society for Aerosol in Medicine (ISAM) and current secretary of Inhalation and Nasal Community of American Association of Pharmaceutical Scientists (AAPS). She serves as an expert reviewer on numerous journals including AAPS PharmSciTech, Molecular Pharmaceutics and Pharmaceutics (MDPI).

Her current research interests are particle engineering for high drug load inhaled formulation and mechanistic understanding of the role of material properties on aerosol performance.

Project summary

For locally acting dry powder inhaler formulations deposition of drug particles in the lung followed by its dissolution in lung mucosal fluid is very complex. In recent years, inhaled drug molecules seem to be poorly soluble and high doses of drugs need to be delivered to the lungs to exert local therapeutic effect. Such scenarios where the drug dose is high and solubility is low could result in dose number >>1 thereby resulting in deposition of insoluble particles in the lung which could have toxicity implications.

Our current research aims to work with one such poorly soluble model internal compound to better understand the difference in in-vitro deposition and dissolution performance between jet milled and spray dried high dose formulation for inhalation. Jet milling is a well-established cost-effective technology for inhaled formulation development. Spray drying has also been used for producing inhaled formulations but could be more cost and time consuming. Jet milled particles are crystalline whereas solution-based spray dried particles tend to be amorphous. We aim to evaluate and compare the in-vitro deposition and dissolution advantage of spray dried to jet milled formulations for inhalation. We will also characterize the formulations for its flow and solid-state property.

The outcome of this research aims to help early formulation feasibility decisions for high dose drugs with poor solubility. As per the Inhalation Ad Hoc Advisory Panel for the USP Performance Tests of Inhalation Dosage Forms dissolution testing is not a requirement for inhaled products. Through this research we might be able to provide a scenario where in-vitro dissolution of inhaled DP is critical during early formulation screening (high target lung dose with poor solubility).

Career Development Award Proposal

1. Through this research I hope to get a better understanding on the importance of in-vitro dissolution testing for inhaled drug products.
2. Internally, we do not have the capability to run analytical testing’s such as NGI and dissolution. Hoping to collaborate with a university to execute these analytical testings
and mentor a PhD student in the process.
3. Looking to get a Publication upon completion of this project.