Hørsholm, Denmark: – Due to some disruption caused by the global coronavirus Covid-19 pandemic, Danish-based CRO Particle Analytical (PA) has managed to maintain its essential particle…
- By Particle Analytical ApS
- 1st May 2020
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Particle Analytical is a GMP contract laboratory that specialises in analysis of physical parameters of particles, powders or emulsions, using a range of advanced techniques.
The Danish-based company is one of the few laboratories in Europe to offer a complete range of services dedicated to analysis of powders, including particle size, and all physical chemical properties. These services are primarily focused on the pharmaceutical industry, where particle and powder analysis are essential in controlling compound properties during development, both with regard to production process and to behaviour in vivo.
Unique analysis services include determination of refraction index, fast compatibility screenings of excipients and determination of the percent crystallinity of samples.
Particle Analytical’s leading-edge capabilities include laser diffraction, XRD, thermal analysis, dynamic light scattering, microscopy, BET, dynamic vapour sorption, density measurement and air permeability. The laboratory is fully certificated as cGMP compliant by the Danish authorities and is also registered with the US Food & Drug Administration (FDA).
Particle Analytical services can either be used in routine analysis, separately to solve specific problems, or in parallel to larger drug development programs. Additionally, the laboratory can take on full responsibility for particle analysis.
The Particle Analytical laboratory provides the pharmaceutical industry with physical-chemical development services that include:
Particle Size Determination
Particle size is a critical parameter in the manufacture of many pharmaceutical products, directly influencing material properties such as reactivity or dissolution rate for catalysts or tablets, stability in suspension, efficacy of delivery, appearance of coatings, flowability and handling of granules, viscosity of sprays, packing density and porosity. Particle size thus needs to be known and controlled; both in order to protect patients and to avoid costly surprises during manufacture.
Measurement of particle size is not an exact technique and a “true” value does not exist. A range of analytical techniques is available. Since these all have particular strengths and weaknesses, Particle Analytical is expert in combining methods, such as laser diffraction, optical and electron microscopy in order to develop fully validated analyses within two weeks.
Examination of Physical Properties
Compound behaviour in solubility, dissolution rate, absorption, etc., is strongly dependent on physical form with regard to particle sizes and to crystallinity. Changes in these parameters might lead to changes in the plasma profile, which could be harmful for the patient – either caused by lack of efficiency or by toxicological effects.
Particle Analytical offer packages of analyses required to characterise the physical properties of solid APIs. These include crystal form (XRD), melting point (DSC), solvent content (TGA), morphology (microscopy) and hygroscopicity (DVS).
Full analysis of a compound is available within two weeks along with a report that can be used for regulatory purposes.
Polymorph Screening and Examination
The crystalline structures, or polymorphic forms, of solid materials confer differing physicochemical properties that impact on the intended use of the material. Further, the polymorphic form or crystalline structure synthesised during development is not necessarily a stable form, with risk of subsequent transformation.
This can happen suddenly during development, necessitating re-analysis for stability, dissolution and compatibility, or during clinical development, posing serious risks for patient safety. To minimize this risk, a polymorph screening should always be performed.
Particle Analytical offers a range of polymorph screening packages in order to find the stable crystalline structure.
Method Development and Validation
Particle Analytical possesses extensive expertise in developing and validating reliable methods that manufacturer and customer can use – and arrive at the same result.
Again, since no single “true” result exists, it is necessary to correlate several methods to justify results for accuracy in relation to the parameters specified in ICH and FDA guidelines, including accuracy, precision (repeatability and intermediate), specificity, detection and quantification limits, linearity, range, and robustness.
Particle Analytical’s broad range of instruments and technologies make it possible to use complementary techniques to obtain reliable results, as well as targeted analyses based on particular customers needs, such as determination of content of amorphous material in crystalline samples or content of hydrate versus anhydrate in a sample.
The laboratory can also produce reliable ID methods for “pure” drugs or for identification and quantification of active molecules in final product.