Maintaining and preserving the drug presentation, integrity and performance should be a manufacturer’s highest priority. Moisture management plays a critical role in any pharmaceutical process. In this article, we will analyze the significance of moisture content while packaging moisture-sensitive drugs.
Any exposure of moisture into the pharmaceutical products can subsequently affect the stability of the product. It can influence the chemical stability, crystal structure, powder flow, compaction lubricity, dissolution rate, and lead to the growth of microorganisms as well. Packaging scientists have to be mindful of their product quality right from the manufacturing till packaging. And not just it, they should also consider the fact that the moisture uptake of a product varies considerably during its lifetime, i.e. bulk packing process, storage, primary packing process, storage in consumer container to regular usage by the consumer.
Oxygen absorbers are an essential component of pharmaceutical packaging, particularly for products that are sensitive to oxygen exposure. These absorbers are designed to reduce the level of oxygen in a sealed package, which can significantly extend the shelf life of the product.Oxygen absorbers work by removing oxygen from the package and creating a low-oxygen environment. The absorbers contain iron powder, salt, and other components that react with oxygen to create iron oxide. This process effectively removes the oxygen from the package, reducing the risk of oxidation and degradation of the product.
The key role of moisture-sensitive packaging in the pharmaceutical industry is to limit exposure to moisture. Maintaining a low relative humidity level for better protection of humidity-sensitive drugs is crucial. Reports suggest that almost 65% of moisture content in the drugs is caused during the packaging process. Knowing the Equilibrium relative humidity or ERH of a pharmaceutical formulation or product is always beneficial in controlling the packing environment. ERH is the percentage relative humidity (%RH) at which equilibrium is achieved. By ERH value, one can predict if the material is likely to absorb or lose moisture at a given %RH.
The use of desiccants is a great option for humidity management in moisture sensitive packaging of drugs. Silica Gel Pouches, Molecular Sieve Pouches, Clay Desiccant sachet, and Activated Carbon Sachet are some of the commonly used desiccants in the pharmaceutical industry. To choose the right desiccant, it is important to know how much water vapor can be absorbed by the desiccant at various relative humidity.