Medical products are developing rapidly, and different pharmaceutical and nutraceutical products have different requirements for storage.
Some products are extremely sensitive to moisture content. If the moisture content is too high or too low, the product will lose effectiveness. Thus, if the manufacturers simply use a desiccant to absorb moisture, it may affect the moisture content in the product itself. To solve such problem, a professional solution is required.
Some of our clients encountered the same problem. While they were creating pharmaceutical or nutraceutical products that needed stable moisture content, they chose to use a regular desiccant. However, after storing the finished product for a period of time, they found that the moisture inside the product was also absorbed, which made the product invalid. To solve this problem, the customers came to WiseSorbent® R&D center and requested a solution.
Here is one of the cases:
The pill bottle used by the customer is a screw-sealed glass bottle with aluminum foil gasket seal. The volume of the pill bottle is 25ml. Weight of the pills is 2.5g, water activity is 0.349, moisture content is 2.5%. Water vapor transmission rate is 0.1mg/bottle.24h. Shelf life of the pills is 24 months.
The customer’s requirement is: RH of the air in the bottle should be kept in the range of 25°C, RH30~40%, and ensure that the moisture content of the pills are kept stable.
For such products which requires a stable moisture content, our R&D team suggested using humidity control packet. It absorbs moisture when the RH in the package is too high, and releases moisture when RH in the package is too low, which effectively keeps the humidity rate in the package stable. Thus, it is able to keep the medicine effective and extends the shelf life of the medicine.
Based on the customer’s requirement, we suggestd using silica gel humidity control packet. Silica gel is non-toxic, non-corrosive, non-contaminate, and tasteless. We also recommend using Tyvek printed with water-based ink to be used as packaging material for silica gel. The raw material and packaging material both comply with US FDA 21cfr 177.1520 test standard, which is safely come in direct contact with food, pharmaceutical and nutraceutical products.
After confirming the raw material and the packaging material, R&D team calculated the tests respectively.
Based on the humidity control packet dosage calculation model:
The result is, under test condition, necessary humidity control usage amount is 1.008g for 24 months. Therefore, our suggested amount was 1g.
An actual test is necessary to verify the theoretical quantity.
To keep the moisture content stable, during test process, the sample pills are kept and sealed together with humidity control packet and button temperature and humidity recorder, and placed in a constant temperature and humidity chamber which was set to 25°C, RH90%. Sample was taken out 6 months later to test the water activity and moisture content and to read the records of the button temperature and humidity recorder.
|wdt_ID||storage||Water Activity||Moisture Content|
(Result of water activity and moisture content of the pills before and after storage)
During the actual validation test, at 25℃ condition, humidity control packet is able to keep the humidity rate in the pills stable at around 35%. And even under high humidity condition (25°C，RH90%), the water activity and moisture content does not change.
We did drug aging test after using humidity control pack. Moisture damage to the medicine or excessive moisture absorption caused by desiccant did not occur anymore.
After the customer used our moisture control solution and released the product to the market, moisture damage or excessive moisture absorption to the medication did not occur again during the shelf-life with long term monitoring and tracking, which improves the customer’s brand awareness and reputation. The customer was satisfied with our professional solution and evaluated us highly and now have a long term relationship with us.