Micromeritics Pharmaceutical Services Brochure
Micromeritics Pharmaceutical Services is a FDA-registered, DEA-licensed, cGMP/GLP-compliant contract lab service organisation backed by Micromeritics’ 50 years of experience analysing the surface properties of materials and particulates.
Chemical analysis has long been at the heart of the pharmaceutical sciences and the systematic approach to development that is called Quality by Design (QbD), which emphasises predefined objectives and a scientific approach to process and product understanding. However, as part of the drive for even greater lot-to-lot consistency within the industry there has also been a greater consideration of the physical/material properties of preparations.
Micromeritics Pharmaceutical Services have now brought together the services and equipment they offer with respect to this growth area of pharmaceutical material characterisation within a new informative brochure. Here they outline their expertise in analysing the many important particle attributes, such as shape and morphology, particle size distribution, surface area, surface energy, porosity, vapour sorption, flow properties and thermal analysis, and relate this to how such measures become predictive tools for manufacturing efficiency.
In particular, the early identification of what has been designated as the Critical Quality Attributes (CQA), of both the active pharmaceutical components and the inactive substances formulated alongside, has been identified as a way that material characterisation, as offered by Micromeritics Pharmaceutical Services, can contribute to QbD.
This is applicable at preformulation stage, where the evaluation of particle size and shape, water vapour sorption, porosity, bulk powder flow, BET surface area, surface energy, and density, help establish initial physical and mechanical properties. Later when it comes to the formulation stage, this data can then be applied to assess the compatibility of formulation components and applicability for final process design and pilot scale up.
To carry out these crucial measurements MPS offers a number of sophisticated instruments utilising many different approaches. The Particle Insight Dynamic Image Particle Shape Analyser, with unique high resolution, high-frame rate optics, allows greater processing control by providing information about total particle shape not just diameter measurements.
The easy to use Nanoplus utilises electrophoretic light scattering techniques and photon correlation spectroscopy to determine both particle size and zeta potential. The Saturn DigiSiser II is a laser particle size analyser for high-resolution measurements of articulations in scattering patterns.
The Elzone II employs electrical sensing zone technology to provide the highest resolution available for complicated samples containing both organic and inorganic materials. The Sedigraph III plus uses the x-ray absorption technique to measure mass concentration and Stoke’s Law, and thus obtain particle size measurements.
The AccuPyc II uses the reliable helium pycnometry approach to produce density determinations and volume measurements of powders, solids, and slurries. The Geopyc calculates envelope volume and density of monolithic samples and the bulk volume and density of powdered materials using a quasi-fluid displacement medium. The AutoPore IV series is a safe application of mercury intrusion and extrusion used to calculate pore volumes and pore size distribution, percent porosity, density, compression/compaction and fluid transport properties.
MPS offers two automated three-station instruments for the measurement of surface area and porosity: the 3Flex and the TriStaR ii. For surface energy, yield strength of powders and material segregation measurements, inverse gas chromatography is used in the Surface Energy Analyser and spectroscopic technology in the SPECTester. The SSSpin Tester uses centrifugal force to measure the yield strength of fine powders. The DVS Intrinsic measures water vapour sorption using a high performance balance.
With this arsenal of sophisticated technology at their disposal Micromeritics Pharmaceutical Services can provide the products and services to help streamline your pharmaceutical development and thereby reduce the costs caused by batch rejection, reprocessing, or testing failures.
Date added: 2015-05-25 12:24:29