Summary
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 while maintaining microbiological integrity, pH stability and anti-counterfeit capabilities.
In this study we compared the state of the API in two types of solid dosage forms after stability storage at 40°C/75% RH for six months.
Methods & Experimental Design
Stability Testing Conditions
Study Parameters
- Drug productCOX-2 selective inhibitor (oral dosage form)
- Stability conditions40°C/75% RH for 6 months
- Blister types comparedPVC (low-barrier) vs. Alu/Alu (high-barrier)
- AnalysisXRPD before and after storage
XRPD Measurement
Instrument Parameters
- X-ray sourceCu Kα
- InstrumentLaboratory XRPD at DANNALAB
- Angular Range0-40 deg 2θ
- AnalysisXRPD pattern comparison before and after 6-month storage
Results
Critical Finding: PVC Blisters Failed, Aluminum Protected
Based on analysis of XRPD patterns before and after 6-month storage at 40°C/75% RH:
- PVC-type blister: API converted to known hydrate form — significant transformation detected in XRPD pattern
- Alu/Alu blister: API exhibited NO changes during storage period — anhydrous form maintained
Figure 1. Comparison of XRPD patterns before and after 6-month stability storage at 40°C/75% RH. API in PVC-type blister (red pattern) converted to hydrate form. API in Alu/Alu blister remained in original anhydrous form (no pattern change).
Decision & Impact
Based on results: PVC-type blisters were excluded from packaging options for this drug product. Aluminum/aluminum cold-formed blisters were selected for commercial packaging to ensure product stability throughout shelf life.
Conclusion
Packaging quality is an important component of the overall quality of a pharmaceutical drug product when subjected to stability studies. This study demonstrated that proper blister selection is critical for maintaining API stability during storage, preventing costly product failures and regulatory issues.
Related Application Notes
Related Patents
WO2024184529A1 — X-ray Diffraction Apparatus and Method for Analysing Packaged Samples
Inventors: Vladimir Kogan, Detlef Beckers | Granted 2024
Download Patent (PDF)