Extemporaneously compounded liquid formulations of clofazimine
R Taneja1, M C Nahata2, J Scarim3
1Global Alliance for TB drug Development (TB Alliance), New York, NY, USA.
Summary
Stable, extemporaneous liquid formulations of clofazimine (CFZ) were developed for leprosy and TB patients who struggle with swallowing capsules. These field-friendly CFZ preparations offer practical dosing solutions for vulnerable populations.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Medicinal Chemistry
Background:
- Clofazimine (CFZ) is a vital medication for leprosy and tuberculosis (TB).
- Current commercial formulations (soft gelatin capsules, solid dosage forms) present challenges for patients with dysphagia.
- A need exists for alternative, easily administered CFZ formulations for improved patient compliance.
Purpose of the Study:
- To develop stable, extemporaneous liquid formulations of clofazimine (CFZ).
- To ensure these formulations are suitable for storage at room temperature for extended periods.
- To provide practical dosing options for patients unable to swallow standard CFZ dosage forms.
Main Methods:
- Two liquid formulations (syrup and sugar-free vehicles) were prepared using standard clofazimine tablets.
- The extemporaneous preparations were stored at room temperature and 30°C for 30 days.
- Formulations were assessed for appearance, pH, potency, and microbial contamination at regular intervals.
Main Results:
- Both liquid formulations maintained stable appearance throughout the 30-day storage period.
- Potency remained within acceptable limits (90-110%) for 30 days in the syrup and 15 days in the sugar-free formulation.
- Microbial counts adhered to United States Pharmacopeia standards, with no specific organisms detected.
Conclusions:
- A simple, pharmacy-adaptable method for preparing stable clofazimine liquid formulations was successfully established.
- These extemporaneous formulations offer a viable solution for administering clofazimine to pediatric and adult patients with swallowing difficulties.
- The developed liquid CFZ preparations enhance treatment accessibility and adherence in field settings.
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