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Overcoming Characterization Challenges in Drug Formulation – Q&A

19 October 2018 No Comment

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abstract-pill-medical-concept-in-capsule-523158464On October 2, 2018, we held a seminar entitled “Overcoming Characterization Challenges in Drug Formulation” in the Boston area.  It was a great opportunity to meet with many pharmaceutical scientists in the area and learn about their challenges and concerns.  The presentations addressed a number of topics of interest, from stability of formulations, trace phase and impurity detection, deformulation, root cause analysis, to optimizing small molecule candidate screening.  There were great questions from the audience, so we rounded up several questions and answers here to share.

How does the Mastersizer 3000 see high aspect ratio (needle-like) particles? Can it identify the diameter and length?

MS3000needlesIn some cases, the diameter and length are seen as distinct modes by the Mastersizer 3000, and the random orientation of the particles appears as a population between those 2 modes.  In this example, the diameter was approximately 15  microns, and length was 250 microns, which were confirmed with imaging.  The fines (1.0 – 4.0 microns) are caused by attrition to the delicate needles during dry dispersion.

Can I use the Morphologi 4-ID for Raman analysis on a subclass of particles of given shape and transparency?

Yes, the Morphologi 4-ID system is ideally suited to do so. First, a database of particle images is obtained by imaging the complex pharmaceutical product. Then, particles are classified according to any combination of size, shape and/or intensity parameters. Subsequently, particles in any given class are automatically targeted and analyzed with Raman spectroscopy, allowing for component-specific size and shape information to be obtained directly in complex mixtures.

What is the q range for the ScatterX78 stage for BioSAXS on the Empyrean diffraction platform? 943006072502

The ScatterX78 has a q range of 0.006 to 5.15 A-1.  Non-ambient experimental SAXS data on a liposome sample was shown – the publication from which it came can be accessed here.

Do you have a resource to learn more about Pair Distribution Function (PDF) analysis?

Analyzing powder diffraction data of nanocrystalline and amorphous materials using the atomic PDF method PDFprovides useful information about long- and short-range ordering of the atoms in the materials.  Data was presented at this seminar showing how PDF could be useful in evaluating stability of amorphous solid dispersions (ASD).  The Malvern Panalytical website has many on-demand webinars available, and the introductory PDF webinar can be viewed here.

Is X-ray Fluorescence (XRF) conducive to at-line analysis, for example, of catalyst residue?

Yes, a benchtop XRF is ideal for at-line analysis for several reasons: it does not require any special services such as chiller, compressed gases or vacuum; it is very sensitive Platinum Group Metals (PGMs) found in process catalyst; it is easy to operate; and it is nondestructive, so the sample can be returned to the process stream or sent on for another test.  You can read a recent blog about a customer experience using the Epsilon 1 XRF system for residual catalyst and counter ion analysis here.

How does the MicroCal PEAQ-DSC differ from a traditional pan DSC system?

These are very different systems. The PEAQ-DSC is designed specifically for biological solutions and measures aqueous or liquid samples. A pan type DSC is designed for solid samples and is not nearly sensitive enough to analyze dilute protein solutions.

This seminar will be repeated on the west coast in San Diego, CA on October 25, 2018 

 

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