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Comparative stability of repackaged metoprolol tartrate tablets
Yongsheng Yang1, Abhay Gupta, Alan S Carlin
1Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
International Journal of Pharmaceutics
|November 3, 2009
Summary
Metoprolol tartrate tablets repackaged in unit-dose blister packs showed increased moisture uptake and decreased hardness under accelerated conditions. This stability issue highlights potential impacts on bioavailability, even with USP Class A materials.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability Studies
- Packaging Science
Background:
- Metoprolol tartrate is a widely prescribed beta-blocker.
- Ensuring drug product stability during storage and repackaging is crucial for patient safety and therapeutic efficacy.
- High-density polyethylene (HDPE) containers are common for pharmaceutical packaging.
Purpose of the Study:
- To investigate the stability of metoprolol tartrate tablets packaged in original HDPE containers versus USP Class A unit-dose blister packs.
- To assess the impact of different packaging materials on key quality attributes under various environmental conditions.
Main Methods:
- Stability studies conducted at 25°C/60% RH for 52 weeks and 40°C/75% RH for 13 weeks.
- Analysis of potency, dissolution, water content, loss on drying, and tablet hardness.
- Near-infrared (NIR) chemical imaging used to monitor moisture uptake non-invasively.
Main Results:
- No significant stability differences observed between packaging types at 25°C/60% RH.
- Potency remained within USP specifications for both packaging types under all conditions.
- Repackaged tablets in blister packs showed significant weight gain, decreased hardness, and increased dissolution rates at 40°C/75% RH due to moisture uptake.
Conclusions:
- Unit-dose blister packs may offer less protection against moisture compared to original HDPE containers for metoprolol tartrate tablets under humid, accelerated conditions.
- Product quality and potential bioavailability can be negatively affected by moisture uptake in repackaged drugs, even when using high-quality materials.
- Careful consideration of packaging materials is essential to maintain drug product integrity, especially for moisture-sensitive formulations.
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