Sometimes it's the smallest details that have the biggest Impact on pharmaceutical performance. That's certainly true when it comes down to the properties of particles and their impact on pharmaceutical performance. Subtle changes in particle size, shape and distribution can have a major impact on pharmaceutical solubility, stability and efficacy.
This is the baiss of an article by Chris Aiken, RSSL Physical Sciences Laboratory Manager for Outsouring Pharma.com. Here is an exract:
It's no surprise therefore that particle analysis often forms part of the basic characterisation of the physical, structural and behavioural attributes of Active Pharmaceutical Ingredients (APIs), excipients, and final drug products. Such analysis is often performed for QC release, pharmacopoeial testing, process development and troubleshooting. However, it is often worthwhile to further interrogate the physico-chemical properties of materials even if they are not reported as part of a manufacturer’s Certificate of Analysis (CoA). This is because this type of extended characterisation can help to identify the (potential) cause of variations in the behaviour of particles and finished product attributes during drug development and formulation. It's also useful in spotting potential problems when evaluating new suppliers, changing or adding manufacturing sites, or scaling up production.
Of course, the value and utility of data gleaned from such analyses will depend on the specific tests that are carried out. However, the bottom line is that spending some time on properly characterising materials before making potentially critical R&D, formulation or manufacturing decisions will more often than not save more time and money further down the line. For example, thorough particle characterisation can help to prevent API and final product wastage. It can even potentially prevent failure during clinical trials, preempt processing or manufacturing issues, and avoid repeated batch failure (OOS results) during production.
The article can be read here.
Posted by Dr. Tim Sandle
This is the baiss of an article by Chris Aiken, RSSL Physical Sciences Laboratory Manager for Outsouring Pharma.com. Here is an exract:
It's no surprise therefore that particle analysis often forms part of the basic characterisation of the physical, structural and behavioural attributes of Active Pharmaceutical Ingredients (APIs), excipients, and final drug products. Such analysis is often performed for QC release, pharmacopoeial testing, process development and troubleshooting. However, it is often worthwhile to further interrogate the physico-chemical properties of materials even if they are not reported as part of a manufacturer’s Certificate of Analysis (CoA). This is because this type of extended characterisation can help to identify the (potential) cause of variations in the behaviour of particles and finished product attributes during drug development and formulation. It's also useful in spotting potential problems when evaluating new suppliers, changing or adding manufacturing sites, or scaling up production.
Of course, the value and utility of data gleaned from such analyses will depend on the specific tests that are carried out. However, the bottom line is that spending some time on properly characterising materials before making potentially critical R&D, formulation or manufacturing decisions will more often than not save more time and money further down the line. For example, thorough particle characterisation can help to prevent API and final product wastage. It can even potentially prevent failure during clinical trials, preempt processing or manufacturing issues, and avoid repeated batch failure (OOS results) during production.
The article can be read here.
Posted by Dr. Tim Sandle
