STABILITY OF ZOLEDRONATE GEL EMULSION IN VIRGIN COCONUT OIL

Objective: This study aimed to analyze the physical stability and drug content of zoledronate (ZOL) gel emulsion in virgin coconut oil (VCO) as a newpharmaceutical product at 25°C as room temperature and 40°C as an accelerated temperature for a stability physics test.Methods: The ZOL gel emulsion comprises the following ingredients: 0.16% ZOL powder, 2% carboxymethyl cellulose, 5% VCO, 0.44% sodiumbenzoate, and 0.009% antioxidant butylated hydroxytoluene, and distilled water. Samples of this gel emulsion were stored for 1 month at 25°C and40°C, and the parameters used for stability tests were pH, viscosity, spreadability, and adhesive strength. The drug content was also evaluated with aspectrophotometer. The ZOL gel emulsion was evaluated against these metrics on days 1, 7, 14, and 28.Results: The results showed that ZOL pH, viscosity, spreadability, adhesive strength, and drug content gel emulsion were clinically stable over 28 daysof storage at 25°C, whereas it was not stable when stored at 40°C for the same duration. pH value of ZOL gel emulsion significantly decreased at 28 days(p<0.05). Also for viscosity, adhesive strength, and drug content of ZOL gel emulsion showed statistically significant (p<0.05), except for spreadabilityvalue (p>0.05). The spreadability value between ZOL gel emulsion that stored at 25°C and at 40°C showed no significant result at 7 and 14 days (p>0.05).Conclusion: ZOL gel emulsion was stable at 25°C when stored for 28 days, suggesting that this is a suitable storage temperature at which its physicalstability and drug content can be maintained