From concept to counter, many complex steps are involved in identifying, developing and integrating a new active pharmaceutical ingredient (API) into a suitable dosage form (mixture with excipients). This must then be thoroughly tested for patient usage. Certain physical characteristics of API’s determine their applicable properties. Particle size is arguably the most important of these variables.
Changes in particle size might alter the correlated properties, i.e. shape, surface area, and porosity. This, in turn, can affect bulk properties, product performance, processability, stability and appearance of the end product. The APIs being developed are increasingly more intricate, smaller particle sizes are typically required in the pharmaceutical industry. Therefore monitoring particle size is paramount to the entire development and manufacturing process.
Particle shape and particle size distribution, particle surface characteristics also influence the performance and appropriateness of a drug formulation. The link between particle size and product performance is well documented with regards to dissolution, absorption rates, and content uniformity. Reducing particle size can aid in the process of hygroscopicity. Particle size analysis is an integral component of the effort to formulate and manufacture many pharmaceutical dosage forms.
Delft Solids Solutions has broad expertise in the area of powder and particle testing and possesses a wide range of analytical instruments and methodologies providing support for product development and insights into mechanistic aspects of particle processes.
The particle size and morphological distribution of powders
It is important to describe the effectiveness of physical end chemical processes and the quality of semi-finished products and final products. Modern techniques cover a size range from nanometers up to millimeters.
- Laser Diffraction or static light scattering for particle size analyses of dry powders or powders suspended in aqueous or organic liquids
- Droplet size distributions of sprays, nebulizers, inhalers, etc.
- Image Analysis – “Seeing is Believing”.
- Nanoparticle assessment by photon correlation spectroscopy
- Zeta potential
- Gravitational Sedimentation
- Electrical Sensing Zone, highest resolution for narrow size distributions – applicable for cleanliness investigations of liquids and particle concentrations of dispersions.
- Sieve Analysis, mechanical, dry, wet, and sonic.
- Morphology (surface and size) by scanning electron microscopy (SEM) coupled to elemental analysis with Energy dispersive X-ray (EDX)
Matching realistic conditions
Investigations and analyses are performed in close consultation with the customer and – as far as possible – executed under conditions that closely match the practical situation and the targeted application of the product or actual problem.
This is feasible due to the broad array of instruments and specially-designed and built set-ups, accessories, and dedicated sample holders. Access to a modern workshop enables the design of custom-made accessories.Find out more about Delft Solids SolutionsClick here for related articles and news
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Delft Solids Solutions is a privately-held contract research organization working on research and characterization of solid materials. Topics include, but are not limited to, primary physical properties as porosity, pore volume, pore size, surface area, particle size, density of powders and granules. We also investigate related characteristics such ...