Desiccants are products which remove moisture from inside of the bottle
In real life, when you are sick or when you want to enhance your immunity, you often go to hospitals or pharmacies to purchase specific medications or nutraceutical products, while most of these products are stored in plastic bottles. When you open the bottles, aside from the pills, you find a small silica gel desiccant packet. Silica gel desiccant packs remove water vapor (absorb moisture) inside the bottle, which protects the pills from moisture damage.
However, how to select the most appropriate and safe desiccant silica gel from various desiccant products in the market, and how to decide the right amount of desiccant and the right method of desiccant insertion to ensure the safety of the pills during transportation and storage, are the problematic issues that many pharmaceutical producers encounter. Thus, professional solutions are needed.
Some of our customers met the same challenge: utilizing an inappropriate desiccant for the medication they produce. After a period of time, their medication was damaged by moisture, and the product’s weight increased. To solve this problem, customers came to WiseSorbent® R&D center to ask for a solution. One of the cases are as following:
Case Study: pharmaceutical pill bottle
The pill bottle this customer used was:
- Composed with PP
- The volume was 25ml
- Water vapor transmission rate was 45.0 mg/24h.L (25℃，RH90%)
- The weight of the medication was 2.5g, and its moisture content was 3%
Their requirements are:
- after long term test (24 months, 25℃, RH60%±10%)
- Accelerated test (6 months, 40℃, RH75%±5%)
- The weight increase of the medication should not exceed 3%.
When R&D people received this request, they suggested to use silica gel desiccant. Silica gel is a type of highly active absorption material, which is non-toxic, non-corrosive, non-contaminate, and tasteless. It complies with US FDA 21cfr 177.1520 test standard, and is safe to get in direct contact with food, drugs, and nutraceutical products.
Tyvek: The packaging material
Inside the pill bottles, the packaging material of the desiccant comes in direct contact with the pills. Thus, it’s suggested that Tyvek printed with water-based ink should be used as packaging material for silica gel desiccant packets. Tyvek is made of PE. It is non-toxic and odorless, while also having strong chemical stability, and it complies with US FDA 21cfr 177.1520 test standard. It is a type of environmental-friendly packaging material that is safe to come in direct contact with food.
After determining the absorbent material and packaging material, our R&D team calculated for both long-term tests and accelerated tests.
1. long-term test
2. accelerated test
The conclusion is, under long – term test, silica gel desiccant calculated demand is 0.7g, and under the accelerated test, silica gel desiccant calculated demand is 1g. We recommend to use the method with larger demand, which is using silica gel desiccant for 1g. After confirming the absorbent material and packaging material, our R&D team calculated for the long-term test dosage and the accelerated test dosage respectively.
To ensure the accurate result, we still set up lab tests to verify the conclusion. To prevent the pills from moisture damage, we controlled the environment in bottles under 25℃,RH50% in the long-term test, and 40℃，RH20% in accelerated test. R&D team set up lab environment based on the above standard for tests.
After lab test, we learned the result: after a 24 -month long term test, the moisture content in the pills increased from 3.1% to 3.4%; after a 6 months long accelerated test, moisture content in the pills increased from 3.1% to 4.0%, which both met the customer’s requirement. The final solution is to use silica gel desiccant packaged with Tyvek printed with water-based ink.
Moisture damage was no longer an issue!
After inserted the silica gel desiccant into the pill bottles, we also had drug aging test. Moisture damage didn’t occur any more. After the customer launched the product into the market, moisture damage to the medication never happened again with long term monitoring and tracking. The customer was satisfied and evaluated us highly, and now has a long-term relationship with us.