Development of a topical suspension containing three active ingredients

Area of Science:

• Pharmaceutical Sciences
• Formulation Development
• Drug Stability

Background:

• Developing stable multi-drug topical suspensions presents challenges due to varying physicochemical properties.
• Sarafloxacin hydrochloride, triamcinolone acetonide, and clotrimazole require careful formulation for topical application.

Purpose of the Study:

• To develop a stable room-temperature topical suspension containing sarafloxacin hydrochloride, triamcinolone acetonide, and clotrimazole.
• To address challenges in formulating a stable multi-active topical suspension.

Main Methods:

• Utilized Arrhenius equation to predict drug stability in various buffer solutions under accelerated conditions.
• Employed a 3^2 factorial design to optimize suspending agent (carboxymethylcellulose) and sodium chloride concentrations.
• Assessed drug stability and viscosity changes at different storage temperatures (25°C and 40°C).

Main Results:

• Identified a 0.02 M phosphate buffer (pH 7.0) with polysorbate 20, NaCl, and EDTA as a suitable medium.
• Initial use of high-viscosity carboxymethylcellulose (HV-CMC) showed drug stability but viscosity issues.
• Optimized formulation with medium-viscosity carboxymethylcellulose (MV-CMC) and 1% sodium chloride demonstrated improved viscosity stability.

Conclusions:

• A stable topical suspension formulation containing sarafloxacin hydrochloride, triamcinolone acetonide, and clotrimazole was successfully developed.
• Medium-viscosity carboxymethylcellulose (MV-CMC) is a superior suspending agent for enhancing viscosity stability in this multi-drug formulation.
• The optimized formulation is suitable for clinical studies due to its improved storage stability.