XRPD Stability Study with Different Types of Blisters

Introduction

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.

Experiment

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.

Results

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 storage period.

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.