Gateway Analytical Collaborates with the FDA to Present their Latest Findings on Temperature-mediated Drug Agglomerates

March 11, 2014

PITTSBURGH, March, 11th, 2014 — Gateway Analytical announced today that they have collaborated with researchers from the Division of Pharmaceutical Analysis at the Food and Drug Administration’s Drug Evaluation and Research Center (FDA/CDER) to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products (OINDP’s) at the upcoming Respiratory Drug Delivery (RDD) conference in Fajardo, Puerto Rico, May 4-8, 2014.

The study was performed in order to address aqueous nasal spray suspensions stability during long-term shipping or storage conditions. During the study, suspension formulations were subjected to temperatures that may possibly be reached inside shipping containers during the hottest and coldest months in St. Louis, Missouri.

During the initial part of the study, optical microscopy showed that the extent of aggregation differed across the suspensions treated at various temperatures. Moreover, observed aggregates vary by morphological parameters such as shape and size. “Using chemically-specific imaging (Raman Chemical Imaging) coupled with optical microscopy we were able to identify whether observed aggregate/agglomerates are combinations of multiple primary API particles, API-excipient particles or multiple excipient particles,” said Oksana Olkhovyk, Ph.D., Senior Scientist at Gateway Analytical who worked directly with scientists at the FDA/CDER.

Any increase in the quantity of drug-drug aggregates can significantly affect dissolution rate of the drug. Also, an increase in API-excipient agglomeration may reduce effectiveness of aerosolized formulations since the targeted therapeutics may not be able to reach the intended site of action in the respiratory tract since the agglomerate particle size may be larger than that required for the drug particles. Both types of agglomeration, however, can manifest a larger drug PSD and ultimately affect product bioavailability, stability and efficacy.

Knowledge of the environmental conditions promoting the adhesion of drug particles to each other or to excipients may benefit developers of formulations containing multiple APIs and/or excipients such as nasal suspensions, dry powder inhalers and metered dose inhalers.

Gateway Analytical is a full service, FDA registered and inspected laboratory with specialized expertise in techniques for chemically specific particle sizing and particulate contamination identification. The lab is cGMP compliant, following 21 CFR parts 210 & 211, 21 CFR part 820, and ICH Q7.  Accreditations include ISO 9001:2008, ISO 17025:2005, and ASCLD/LAB-International.