| Adrian Possumato of Multisorb Technologies calculates successful packaging formulations in the search for the right approach to optimising pharmaceutical protection
Pharmaceuticals are subject to a variety of degradation pathways that compromise drug safety and shelf-life. By far the greatest degradation is caused by hydrolysis and oxidation. However, other mechanisms include racemisation, photodegradation, elimination and complexation. There are a number of active packaging components available to help maintain pharmaceutical integrity. Determining the optimal solution requires a calculated analysis that combines both the expertise of packaging engineers and pharmaceutical formulation chemists.
Sorbents represent a class of active packaging components that can be used to guard against the effects of degradation, ensuring the integrity of packaged pharmaceuticals. These sorbents are considered ‘active’ because they respond to changes in the headspace of packaging relative to outside conditions. Packaged sorbents are manufactured from silica gel, molecular sieve and oxygen-absorbing compounds. Active sorbents have high adsorbing capacity, take up little space, and when incorporated successfully into packaging, they can significantly reduce the rate of degradation, resulting in an improvement in pharmaceutical quality, safety, shelf-life, stability and usability.
Sorbents come in different delivery formats, including canisters and packets, as well as a new compressed density format. Determining the correct active formula requires manufacturers to consider a variety of factors.
PSEUDO-EMPIRICAL MODELLING
When evaluating the moisture management requirements for drugs, pharmaceutical manufacturers often collaborate with sorbent providers to find the optimal moisture management and packaging solutions. Sorbent providers help customers determine the precise amount of sorbent required to combat chemical and physical degradation of sensitive drug formulations in commercial and bulk (in-process) packaging presentations.
This service is termed as ‘pseudo-empirical modelling’ because technical engineers first define the adsorption properties of a particular drug product formulation, and then simulate the effect of it when combined with a selected packaging presentation with varying amounts and types of desiccants. This unique analytical approach takes into account the conditions during all stages of drug processing – from pharmaceutical formulation to the packaging environment and throughout the distribution chain. After running this analysis, technical engineers provide clients with specifications and recommendations for the ideal drug product and packaging combinations. |
