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Stability of clozapine tablets repackaged in dose administration aids using repackaging machines
Marion Emonet1, Antony Citterio-Quentin2, Sandrine Bourgeois3
1Pharmacy Department, The Vinatier Hospital, Bron, France.
Repackaged clozapine tablets remained chemically stable for 84 days, meeting mass uniformity standards. However, physical tests revealed cracking and reduced hardness, leading to an 84-day shelf life.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Formulation Development
Background:
- Repackaging medications for automated dispensing may affect drug stability.
- Manufacturer's original packaging is the standard for stability assessment.
Purpose of the Study:
- To evaluate the physical and chemical stability of repackaged clozapine tablets.
- To determine a suitable shelf life for repackaged clozapine in hospital pharmacy settings.
Main Methods:
- Clozapine 100 mg tablets were repackaged and stored under various conditions for 84 days.
- Physical tests (appearance, mass uniformity, friability, hardness) and chemical stability (UHPLC-MS/MS) were performed.
- Results were compared to control tablets in original packaging.
Main Results:
- No significant chemical degradation or N-desmethyl-clozapine formation was observed.
- Mass uniformity was maintained, but tablets showed cracking in friability tests and decreased hardness.
- Visual changes occurred only under UV light exposure.
Conclusions:
- Repackaged clozapine tablets exhibit good chemical stability for 84 days.
- Physical integrity, specifically tablet hardness and friability, is compromised post-repackaging.
- An 84-day shelf life was established for repackaged clozapine tablets based on these findings.
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