The use of pharmaceutical bottle packaging is a tried and trusted way of protecting pills and tablets against moisture-damage during storage and transportation. In 2012, it was reported that 67% of medication shortages were due to quality issues in the US,1 so it’s important that we get this right. In addition to reduced efficacy, humidity can also significantly reduce the shelf-life of your product.
Plastic bottles, such as those made from HDPE or PP can protect against liquid moisture ingress. However, to ensure that your product is also protected against in-pack humidity, you will need an in-pack desiccant. This can take the form of a sachet or canister, or the desiccant can even be incorporated into the bottle’s screw-cap. Also, these desiccants adsorb moisture that is sealed-in with your product at the time of manufacturing (i.e. the headspace at the top of the bottle), preventing damage from gradual moisture ingress; through the bottle’s seal, during storage.
They also protect your products from the more severe type of ingress that occurs when the patient opens the bottle, to take-out a pill. For example; in a bottle of 500 pills, where there’s a dose of 2 pills per day, you will have 250 pill bottle openings and headspace replacements, if the patient takes 2 pills per time. This will increase to 500 openings and headspace flushes, if the client takes 2 pills per day, but at two different times. Consider also that, when a 500-pill bottle is 50% empty, or 90% empty, the headspace volume itself (and its potential to contain humidity) has also increased significantly!
Desiccant Options for Pharmaceutical Bottle Packaging
For automated bottling lines, Desiccant Sachets can be dropped into the bottle itself, via a dispenser machine such as the PRONTOPACKER™. Furthermore, desiccants can also be physically integrated into the bottle’s screw-cap, which is useful, as it eliminates the risk of desiccant ingestion by the end-user. These integrated products are called Desiccant Caps and Stoppers.
“To ensure that your product is also protected against in-pack humidity, you will also need an in-pack desiccant”
Which Option is Best?
Choosing the right desiccant option depends on your specific needs. If you are designing your first automated line, which runs at low speeds, then Desiccant Sachets are advisable, as they require minimal re-validation work / stability testing. This is because you can use the same 1g or 2g desiccant sachets that were used by your hand-fill staff, but now on a continuous strip desiccant sachet reel, that feeds a Desiccant Dispenser, that in-turn cuts and drops sachets into your bottles.
By contrast, if you are moving from a low speed automation to a high-speed line, it’s advisable to use Desiccant Canisters. They can achieve higher production rates, compared to desiccant sachets – because their rigidity and dimensional regularity enables them to be quickly incorporated into the product packaging through feed hoppers and multi-lane delivery systems. This means that you can fill multiple bottles at the same time (in parallel).
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Citations:
1: S. Shukar, F. Zahoor, K. Hayat, A. Saeed, A. H. Gillani, S. Omer, S. Hu, Z.-U.-D. Babar, Y. Fang, and C. Yang, “Drug shortage: Causes, impact, and Mitigation Strategies,” Frontiers in pharmacology, 09-Jul-2021. [Online]. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299364. [Accessed: 31-Mar-2023]
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