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Using Raman Spectroscopy and LIBS for Automated Particle Identification

Authors & ContributorsDavid Exline July 01, 2015 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. Highlighted Topics

In-depth characterizations of OINDPs from R&D to regulatory submission

October 15, 2015 Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway analytical are pleased to present a webinar to provide a comprehensive

Challenges in Counting and Sizing Glass Lamellae using an Automated Method

Authors & ContributorsRebekah ByrneDavid ExlineNovember 18, 2015 Glass delamination is a phenomenon which can occur in parenteral drugs stored in glass containers.  By interaction of the drug product with the vial surface, the glass surface will sometimes break down, causing the layers to separate; ultimately this results in the presence of small glass flakes, known

Proactive vs. Reactive Testing for Glass Delamination in Pharmaceuticals

Authors & Contributors Emily Landsperger February 16, 2016 Glass delamination is a phenomenon which can occur when top layers of a glass surface separate and flake off or detach from the inner surface, typically in the microscopic range. Glass delamination is the result of several factors including the product formulation, the glass resistance and the

Case Studies in Foreign Particulate Analysis Using Manual Testing Methods

April 27, 2016 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Case Studies in Foreign Particulate Analysis will

Hair as a Pharmaceutical Contaminant: How It Is Identified, and How We Can Tell Where It Originated

Authors & ContributorsCara Plese July 27, 2016 Foreign particulate in drug products originate from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces. Typical contaminants include polymers, fibers, burnt material and metallic particulate. Hair is

Advancing Development of Generic OINDPs through In Vitro Testing

May 04, 2017 According to a 2007 report Measuring Trends in the Development of New Drugs: Time, Costs, Risks and Returns by J.A. DiMasi, companies spend an estimated $1.2-$1.3 billion on research and development for each approved drug due to the increasing complexity of the research and development process—particularly clinical trials. That’s a $500 million

Case Studies of Foreign Particulate Analysis

Authors & ContributorsDavid Exline January 23, 2019 Topics covered include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation also provides FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD