TY - JOUR
T1 - Stability of zoledronate gel emulsion in virgin coconut oil
AU - Gayatri, Prima Abigail
AU - Krisnawati,
AU - Sahlan, Muhamad
AU - Pratami, Diah Kartika
AU - Widayati, Retno
N1 - Funding Information:
The authors would like to thank Universitas Indonesia PITTA Grant (International Indexed Publication for UI Student’s Final) 2018 committee for providing financial support for our research. In addition, we would like to thank Laboratory of Pharmaceutical Formulation and Development Universitas Indonesia and RCBE for providing the testing machines and facilities.
Publisher Copyright:
© 2019 The Authors.
PY - 2019/4/1
Y1 - 2019/4/1
N2 - Objective: This study aimed to analyze the physical stability and drug content of zoledronate (ZOL) gel emulsion in virgin coconut oil (VCO) as a new pharmaceutical 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% sodium benzoate, and 0.009% antioxidant butylated hydroxytoluene, and distilled water. Samples of this gel emulsion were stored for 1 month at 25°C and 40°C, and the parameters used for stability tests were pH, viscosity, spreadability, and adhesive strength. The drug content was also evaluated with a spectrophotometer. 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 days of 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 spreadability value (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 physical stability and drug content can be maintained.
AB - Objective: This study aimed to analyze the physical stability and drug content of zoledronate (ZOL) gel emulsion in virgin coconut oil (VCO) as a new pharmaceutical 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% sodium benzoate, and 0.009% antioxidant butylated hydroxytoluene, and distilled water. Samples of this gel emulsion were stored for 1 month at 25°C and 40°C, and the parameters used for stability tests were pH, viscosity, spreadability, and adhesive strength. The drug content was also evaluated with a spectrophotometer. 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 days of 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 spreadability value (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 physical stability and drug content can be maintained.
KW - Drug stability
KW - Orthodontic tooth movement
KW - Virgin coconut oil
KW - Zoledronate
UR - http://www.scopus.com/inward/record.url?scp=85067918419&partnerID=8YFLogxK
U2 - 10.22159/ijap.2019.v11s1.18204
DO - 10.22159/ijap.2019.v11s1.18204
M3 - Article
AN - SCOPUS:85067918419
SN - 0975-7058
VL - 11
SP - 201
EP - 206
JO - International Journal of Applied Pharmaceutics
JF - International Journal of Applied Pharmaceutics
ER -