Presentation – Gateway Analytical

AAPS 2017 Development and Validation of a cGMP Compliant Particulate Characterization Database

admin — Wed, 16 Aug 2023 01:22:14 +0000

Reference databases catalog data and information for known materials, process and product related materials, and archived foreign particulate. In a simple process with few particulates and few reference materials, a hard copy catalog with pictures and spectra may suffice. However, for operations that generate numerous particulate with many lots and products, digital data storage is key to an efficient particulate characterization program. Reference databases can contain optical information, spectral files, chemical data and important information associated with non-conforming particles. This allows for mining of data, to aid in comparison to known materials, as well as to determine common lots, facilities, times, or any other information that may foster root cause analysis. Digital data management systems fall within the overall compliance strategy of the organization. Digital data is considered an electronic record and should be considered as such when collecting, analyzing, and using the information. The development and validation of a cGMP database will be discussed in this presentation, in addition to utility of the advanced data storage, comparison and mining capabilities

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RDD 2014: Chemically Specific Analysis of OINDPs: Differentiation of Drug Particle Agglomeration by Raman Chemical Imaging

admin — Tue, 10 Jan 2023 17:42:00 +0000

Proper characterization of pharmaceutical products with respect to particle size and distribution requires that the extent and size of drug particle agglomerates is determined, as well as the size and number of primary Active Pharmaceutical Ingredients (API) particles. Such characterization may also be necessary for assessing product quality, establishing Bioequivalence (BE), evaluating out-of-specification issues, batch-to-batch comparison studies and addressing stability of the product during scale-up, and long-term shipping/storage in varying environmental conditions. By providing chemically specific identification for each particle in addition to Particle Size Distribution (PSD), Raman Chemical Imaging (RCI) is an effective tool for identifying whether observed aggregates/agglomerates are combinations of multiple primary API particles, API-excipient particles or multiple excipient particles. In concert with other particle sizing techniques, RCI analysis of agglomerates can benefit developers of Orally Inhaled and Nasal Drug Products (OINDPs), containing multiple APIs and/or excipients such as nasal suspensions, dry powder inhalers and metered dose inhalers.

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PDA 2016 Annual Meeting: Proactive Versus Reactive Testing for Glass Delamination in Pharmaceuticals

admin — Wed, 28 Dec 2022 15:22:47 +0000

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 glass manufacturing process itself. The formation of glass lamellae has a significant impact on product and patient safety. USP details the testing requirements for assessing the durability of glass container surfaces. The purpose of this presentation is to recommend “approaches to predict the potential of a drug product to cause formation of glass particles and delamination and to detect their occurrence.” These methods are not only applicable to the common vials encountered, but also to syringes, ampules and other glass containers that house drug products. USP describes the various types of glass encountered, how molded/tubing glass containers are manufactured and glass surface chemistry. After discussing the variables that affect the durability of the inner surface of glass containers, both predictive and aggressive screening suggestions are outlined. A common question that often arises is when to utilize USP in its entirety versus other protocols to simply identify the presence or absence of glass lamellae. Suggested methodologies may differ when selecting appropriate vials by a drug manufacturer versus identifying the presence or absence of glass delamination in a final product.

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RDD 2015 Workshop: Assessing Aggregate Performance and the Presence of Foreign Particulate in OINDPs

admin — Fri, 04 Nov 2022 03:24:06 +0000

Establishing bioavailability and proving bioequivalence of inhaled combination therapies can be difficult without addressing two major concerns: accurate and precise particle size distribution data of the individual active pharmaceutical ingredient and source determination of the any existing foreign particulate matter. Raman spectroscopy and Raman chemical imaging have the potential to address the need to identify the presence and extent of aggregated drug particles as well as any foreign contaminants based on their unique spectroscopic properties.

During this workshop, Raman-based techniques were shown as a powerful characterization methodology for complex combinational therapeutics as it relates to product quality, safety and aerosolization performance during all stages of drug development.

Workshop Content

This workshop covers analytical techniques suitable for in-depth solid-state characterization of OINDPs. Methods will be presented on how to differentiate particles by their chemical make-up, acquire sizing information for each component, and evaluate the degree of drug-specific aggregates for all types of OINDPs, with an emphasis on complex combination inhalation products. Stability studies on the effect of the device on the de-agglomeration properties of the drug particles post actuations will be discussed in addition to presenting case study examples. Automated particle identification and contamination analysis examples will encompass manufacturing based and containment based source determination, including but not limited to sampling, packaging, repackaging, storage and transport.

Outcome for Participants

During the workshop, participants were shown validated methodologies for accurate, reproducible chemically specific particle sizing and aggregate classification, along with techniques for identifying foreign particulate. Understanding this comprehensive method for particulate analysis of drug products by spectroscopic techniques can benefit developers of OINDPs containing multiple APIs and/or Excipients. In addition, having knowledge of the conditions promoting foreign particulate drug particles adhesion in the final product can aid the understanding of OINDPs bioavailability, stability and efficacy. Helping manufactures adhere to FDA regulations related to undesired impurities of a chemical or microbiological nature in the drug products.

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Gateway Analytical to Present at 2012 MAAFS Meeting: The Introduction of Hyperspectral Imaging as an Additional Method of Examination for Tapes

admin — Sun, 04 Sep 2022 16:31:47 +0000

The Mid-Atlantic Association of Forensic Scientists (MAAFS) annual meeting is being held later this month from May 14^th through the 18^th. MAAFS is one of several regional/state forensic science associations in the United States. Regional meetings are great for scientists to attend because they usually require less travel than attending the national AAFS meeting, and they provide a more personal forum for presentations and also networking with scientists from that particular region. MAAFS is also a great forum for student presenters, as scholarships are awarded annually. I will be presenting on Thursday, May 17^thon the benefits of including fluorescence Hyperspectral Imaging (HSI) in the battery of analyses that are typically applied to tape examination. Fluorescence HSI adds value to tape examination, because it is a macroscopic analysis that provides both visual and spectral results, requires little samples preparation, is non destructive, and can allow for a quick elimination in a comparison of known and questioned tapes.

Presentation Abstract:

Current methods of tape examination include a wide variety of analytical techniques, however there is a void in the use of macroscopic fluorescence analysis. Hyperspectral Imaging (HSI) used in fluorescence mode has shown discrimination power in the analysis of tapes, and offers significant potential as a complimentary tool to the protocol of standard tape examination. Fluorescence HSI is a nondestructive method that can detect differences based on chemical composition of tape adhesive and backing. A variety of statistical evaluations are applicable to HSI data enabling the potential for a quantitative comparison of tape samples. This talk will discuss the application and an example of tape examination with the inclusion of fluorescence HSI in the tape examination protocol.

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2017 RDD Europe: Advancing the Determination of In Vitro Similarity in Tiotropium Formulations for Inhalation

admin — Mon, 04 Apr 2022 02:32:44 +0000

Three dry powder formulations of tiotropium bromide were manufactured for in vitro comparison to Spiriva® HandiHaler®. In this study, aerodynamic particle size distribution (APSD) characterization techniques that simulate patient conditions coupled with particle chemistry, morphology and size analysis were used to determine differences in the tiotropium bromide formulations. The objective of this study was to determine the comparability of the formulations using traditional and novel in vitro methods.

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AAFS 2013 Presentation: What Judges and Lawyers Need to Know about the Science Behind Trace Evidence

admin — Fri, 21 Jan 2022 01:36:16 +0000

Gateway Analytical scientists Cara Plese and Antonio Scatena recently presented at the 2013 AAFS Annual Meeting in Washington DC. The presentation titled: “What Judges and Lawyers Need to Know about the Science Behind Trace Evidence” is now available for download.

This presentation is specifically for attorneys and judges and gives a brief technical background on a variety of instruments used to analyze the wide array of samples that fall into the trace evidence category. Antonio and Cara discuss the strengths of trace evidence conclusions and how they can best be used in court. Also, discussed are case studies in which trace evidence was used successfully at trials.

If you have any questions on the presentation, please contact us.

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2018 PDA Annual Meeting: A Proactive Approach to the Particulate Management Lifecycle in Parenteral Drug Products

admin — Wed, 22 Dec 2021 03:27:57 +0000

The inspection, detection, characterization and source determination of foreign particulate matter in parenteral drug products is a critical aspect to the drug manufacturing process. Methodologies exist to address many of these phases. However, a cohesive program is vital to any parenteral drug manufacturer to manage the entire particulate management lifecycle.

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2014 ASSA International IWPCPS-16 Workshops: Spatially-Resolved Raman Imaging for Ingredient-Specific Characterization of Combination Dry Powder Inhalers

admin — Fri, 17 Dec 2021 02:21:18 +0000

Since the approval of Dry Powder Inhalers containing Fluticasone Propionate and Salmeterol Xinafoate in 1999, combination inhaled therapies have dominated the COPD market. However, due to the lack of specific guidance of the Office of Generic Drugs as to the abbreviated new drug application submission, there was very little attempts of generic manufactures to come up with bioequivalent DPI formulations until September 2013.

In this study, Raman Chemical Imaging (RCI) was shown to have a potential to address the need to accurately identify and size not only primary drug particles but also aggregates based on their unique spectroscopic properties. RCI method allows extraction of a Raman spectrum from every pixel in the image (spatial resolution approaching 350 nm can be achieved). Thus every image provides spectral and spatial information about any drug to drug or drug to excipient agglomerates that may form.

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2018 RDD Conference: Analysis of a Dry Powder Inhaler Active Pharmaceutical Ingredient Using Scanning Electron Microscopy

admin — Mon, 11 Oct 2021 02:56:30 +0000

Automated SEM-EDS has been evaluated as a potential tool for determining the API particle size distribution (PSD) and morphological characteristics, such as aspect ratio and roundness of particles, of a DPI. The only requirement for this technique is an elemental distinction, such as the presence of an inorganic element in the API, in comparison to the excipients. In this instance, the automated SEM-EDS technology has been applied to characterize a bromine- containing API in comparison to the carbon-rich lactose excipient of a DPI product.

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