XRPD Stability Study with Different Types of Blisters
Packaging quality is an important component of the overall quality of a pharmaceutical drug
product when subjected to stability studies.
Solid dosage form packaging should provide; protection from moisture, gas, light and
temperature; microbiological integrity; pH stability and anti-counterfeit capabilities.
In this study we compared the state of the API in the two types of solid dosage forms after stability storage.
The oral dosage forms of a drug (COX-2 selective inhibitor) were subjected to a stability
test at 40°C/75% RH with two types of blisters.
The Alu-Alu-type blister belongs to the high-barrier film blisters group and the PVC-type
blister belongs to the low-barrier group.
Before and after six months of storage, an XRPD analysis was conducted on the dosage
forms stored in both types of blisters.
Based on analysis of XRPD patterns before and after storage, we found that the API form in the PVC-type blister converted to known hydrate form (Figure 1, red pattern).
The API within dosage forms stored in the Alu-Alu blisters exhibited no changes during the
Based on the results, the PVC-type blisters have been excluded from the possible options
for packaging of the drug products.
Figure 1. Comparison of XRPD patterns before and
after stability storage reveals the conversion of API to hydrate form in PVC-type blisters.