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

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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.

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For more information on Gateway Analytical’s pharmaceutical services, contact Tracey Safran, Senior Account Manager at safrant@gatewayanalytical.com.

About Gateway Analytical

Based in Gibsonia, Pa., Gateway Analytical, LLC partners with companies in need of high-quality laboratory analysis that do not have the time, resources or capabilities for specialized, comprehensive testing. Through conventional and innovative testing methods, the company provides expert laboratory services and analytical solutions for the pharmaceutical, forensic and materials science industries.

Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.

About ChemImage

ChemImage Corporation, a leader in hyperspectral and Raman chemical imaging technology provides innovative instrumentation, analysis software, contract services and expert consulting to government, industrial and academic organizations. The company’s proprietary, state-of-the-art imaging technology has many applications, including defense, security, pharmaceuticals, forensics and biomedical diagnostic research, which can reveal critical chemical and biological information from a variety of material systems.

ChemImage’s headquarters are located in Pittsburgh, PA, where it pioneers research and development, as well as providing engineering and manufacturing which develops innovative products for the global marketplace.

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

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