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Stability of dithranol in creams
E W Wuis1, D M Burger, M Beelen
1Department of Clinical Pharmacy, University Hospital Nijmegen St Radboud, The Netherlands.
Pharmacy World & Science : PWS
|February 5, 2000
Summary
Dithranol stability in creams was assessed. Low concentrations (0.1-0.5%) in aluminum tubes remained stable for 12 months at 4°C, indicating suitability for advance preparation and refrigeration. Polypropylene tubes are not recommended.
Area of Science:
- Dermatology
- Pharmaceutical Sciences
- Formulation Chemistry
Background:
- Dithranol is a key anthraquinone derivative used in topical treatments.
- Ensuring the stability of dithranol in cream formulations is crucial for therapeutic efficacy.
- Previous studies have indicated potential degradation issues with dithranol in certain formulations.
Purpose of the Study:
- To evaluate the long-term stability of dithranol in cream formulations.
- To determine the optimal storage conditions and packaging for dithranol creams.
- To assess the impact of different concentrations and container materials on dithranol stability.
Main Methods:
- Dithranol cream formulations at 0.1%, 0.3%, and 0.5% concentrations were prepared.
- Creams were stored in aluminum-coated and polypropylene tubes.
- Samples were stored at controlled temperatures (4°C and 20°C).
- Drug concentration was quantified using high-performance liquid chromatography (HPLC) at various time points (0, 3, 6, 12 months).
Main Results:
- All tested concentrations of dithranol (0.1%, 0.3%, 0.5%) demonstrated stability for 12 months when stored at 4°C in aluminum-coated tubes.
- Dithranol cream stored in polypropylene tubes showed instability, indicating material incompatibility.
- The stability was maintained across all tested concentrations under refrigerated conditions in appropriate packaging.
Conclusions:
- Low concentrations of dithranol in cream formulations are stable for at least 12 months when stored refrigerated (4°C) in aluminum-coated tubes.
- Aluminum-coated tubes are suitable packaging for long-term storage of dithranol creams.
- Polypropylene tubes are unsuitable for storing dithranol cream formulations due to potential degradation.