Too often, the reason for carrying out a particle size distribution analysis is stated as “for QA”, or “I need the numbers”, or “because my boss says so”, or “for characterization”. Often, we can proceed deep into a project, having acquired huge amounts of data, with no real clarity about what is driving the measurement.
This webinar explores the scientific reasons for performing a particle size distribution measurement, investigates bulk and dispersed particle sizes, and relates these to Critical Quality Attributes (CQAs) and Product Performance Indicators (PPIs).

A product flowability or rheology issue is not solved by aggressive dispersion conditions that cannot be mimicked in the plant, as these flow properties are related to the bulk – not dispersed – particle size distribution. Likewise, relating dissolution and bioavailability is best done on a dispersed sample, as most of the surface area will be available to the external continuous phase. Understanding the reasons for making such a measurement leads to the setting of reasonable and achievable product specifications that are in line with the required product performance.

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Who should attend?
All who would like to understand or have their knowledge refreshed on the holistic reasons for making a size measurement – particularly those who are interested in investigating and understanding the links to product performance. This includes those who need to formulate reasonable and achievable specifications and targets for statistical quality control.

What will you learn?
An overall guide to the reasons for performing a particle size distribution measurement, and some of the many factors that are controlled or influenced by particle size and particle size distribution.

In traditional DLS experiments, the scattered light is detected at a single angle and then auto-correlated to determine the diffusion rate of the particles, and ultimately the particle size distribution. Since the direction and the number of photons scattered depends on the size of the particles, for mixed particle sizes a single angle result may misrepresent the true particle size population. Multi-angle dynamic light scattering (MADLS) overcomes many of these drawbacks by automatically combining correlograms from multiple measurement angles to give a robust, angular independent result, with improved resolution, which is suitable for comparison with data from orthogonal techniques. In this webinar we will explain the basic principles behind the MADLS measurement on the Zetasizer Ultra and provide measurement examples.

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Who should attend?
Anyone who is a user of DLS, is interested in DLS, or who faces challenges in particle size characterization across technologies.

What will you learn?
Attendees will learn that multi-angle dynamic light scattering is a new capability that delivers robust, angular-independent, size determination of their sample with the ability to discover previously hidden size populations.

Oral Solid Dose (OSD) formulations remain the dominant delivery method for pharmaceutical products, representing over 60% of global pharmaceutical sales. As such, they remain an important target for generic product developers. The process of deformulation and subsequent in vitro bioequivalence assessment is often viewed as being simpler for these products than other complex dosage forms. However, many of the targets for generic development relate to drug substances which have low solubility or a narrow therapeutic window. Successful product development therefore depends upon understanding and controlling the critical material attributes of both the APIs and excipients. Here, physicochemical analysis has a key role to play, not only in confirming the API form, but also in understanding its interaction with functional excipients within the formulation.

In this webinar, we will consider the typical workflow associated with OSD product deformulation and how this is enabled through the application of physicochemical characterization techniques. We will then present case studies which confirm how developing understanding of the API and excipients within a formulation can enable more rapid product development, reducing the time to market for new generic products.

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– Who should attend?
Anyone interested in the development of generic versions of oral solid dose drug products. Those generally interested in deformulation and establishing bioequivalence, and understanding how improved physicochemical analysis methods and techniques can help accelerate these processes.
– What will you learn?
We will take an in-depth look at the workflow associated with the deformulation of oral solid dose products in order to establish when and how various physicochemical characterization tools are applied in order to speed the development of safe and effective drug products.

When daily operations require elemental analysis of a wide range of inorganic/geological samples, it is often cumbersome, or not possible to setup and maintain a large number of dedicated calibrations to handle such range. In these cases, a widely applicable, but accurate solution is highly desirable. In this webinar we demonstrate Malvern Panalyticals unique solution WROXI in combination with Epsilon 4, which is capable to handle a wide range of sample types.

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Who should attend?

Anyone interested in elemental analysis by XRF on a variety of materials in particular geological samples

Why attend?

Learn about a versatile calibration strategy for a wide range of elements, and how it can now be applied to the Epsilon 4 benchtop XRF system

What will you learn?

Overview of the WROXI calibration methodology, and examples of standards run against this calibration on the E4 for validation.

For complex generic pharmaceutical products such as locally-acting nasal sprays, US FDA guidance outlines methods for determining the equivalence of physicochemical properties between the reference listed drug product (RLD) and the test product as a key step on the route to determining bioequivalence in vitro. These include the measurement of critical quality attributes such as drug particle size and shape, formulation rheological profile and spray droplet or aerosolized particle size distributions. Characterizing the RLD according to these requirements during the early deformulation stage of a development workflow will ensure full understanding of the properties of the drug and will help accelerate product development by ensuring the appropriate tools are available for test products to be routinely compared to the reference, so any potential problems can be identified and addressed early on. Critically, this minimizes the risk of failure when comes to performing in vitro bioequivalence studies.

This webinar will provide an overview of Malvern Panalytical’s set of analytical techniques designed to accelerate the deformulation of orally inhaled and nasal drug products (OINDPs), along with example case studies for nasal sprays and a discussion of how this workflow could be successfully implemented for dry powder inhaler products.

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Who should attend?

Those involved in the development and manufacture of generic orally inhaled and nasal drug products (OINDPs). Anyone interested in complex drug deformulation and development, and in the possibilities of and requirements for establishing bioequivalence in vitro.

What will you learn?

How physicochemical measurement techniques can be applied to speed the deformulation of complex drug products such as orally inhaled and nasal drug products. Also, how these technologies are used to help establish Q3 bioequivalence for nasal sprays, and how they may be applied to other OINDPs such as dry powder inhalers (DPIs) in the future.

Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules. In parallel with these technological advances, the regulatory agencies have shown increased interest in more in-depth characterization of therapeutic products. Careful interpretation of data and deeper understanding of the method limitations is of utmost importance when using complementary methods to characterize particle profiles of therapeutic products for regulatory submissions. This presentation demonstrates how multiple particle techniques can be used to adequately characterize therapeutic products and their particle populations.

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Who should attend?
Those working in the following areas:
Research and Development
Formulation and Stability
Analytical Development
Quality Control
Regulatory

What will you learn?
Attendees willl gain an understanding of which technologies are available for particle characterization in pharmaceutical products, and how to choose the right combination of technologies to characterize a product’s particle profile.