Are you seeking a career in pharmaceutical tech or medicinal development? It’s essential you learn the ins and outs of particle size distribution curve. This is one of the most necessary components of creating viable drugs for the population, involving everything from BET surface area analysis to particle size analysis to hone potential products to a razor fine edge. The field of analytical method development is a rapidly growing one and is all the better served by those who are eager to give multiple industries across the country their very best effort.
What Is The Function Of Particle Size?
It helps to know exactly whyparticle size distribution curve analysis is so essential. Drugs are frequently created in either powder or liquid form, created from the ground up to work as quickly and as efficiently as possible. Although modern technology has made it easier to achieve the previously thought impossible, laser diffraction testing and analytical method validation guidelines are still a necessary resource to reduce margins for error.
How Has Technology Changed?
There have been multiple long-term adjustments to previous methods of sieving, distribution and standard testing. The last twenty years has seen laser diffraction largely replacing traditional methods of particle size analysis, including but not limited to sieving and sedimentation. Laser diffraction is easily the most commonly used particle sizing method now, particularly for those that range from 0.5 to 1,000 microns — it works by having a beam of light (or a laser) scattered by a group of particles. The angle of said light is in direct proportion to particle size, with the smaller the size the larger the angle.
What Is Sieving And Sedimentation?
Generally, particle size analysis by either sieving or laser diffraction methods includes a handful of steps. The first is the sampling of bulk powders. The second is sub-sampling of bulk samples for a given specimen, with the third following close behind for specimen preparation or dispersion. The fourth sets up the instrument and verifies the fifth step’s measurements. The sixth involves data analysis and interpretation by multiple parties and the last, of course, reports the size results and confirms them for the final product.
What Other Guidelines Are There?
For each drug substance the International Conference on Harmonization (shortened to the ICH) provides regular guidance on which particle size specification should be considered at a time. A particle size specification is required if the particle of the drug is absolutely specific to its performance — the terms used for determining these qualities are dissolution, solubility, bioavailability, content uniformity and stability. Research has shown that inadequate dispersion is one of the greatest sources of measurement error for particles with a diameter of 20 um or less. Knowing is half the battle and particle size distribution curve is only going to get more advanced from here on out.
