a Division of Pharmaceutical Technology, Defence Research Laboratory , Defence Research and Development Organization, Ministry of Defence, Government of India , Tezpur , India.
b Department of Pharmaceutical Sciences , Dibrugarh University , Dibrugarh , India.
Drug Dev Ind Pharm. 2019 Aug;45(8):1332-1341. doi: 10.1080/03639045.2019.1616750. Epub 2019 May 22.
The present study is aimed at the development of a sunscreen cream for use in high altitude areas which have been found to possess superior sun protection factor (SPF) along with remarkable antioxidant activity. The topical formulation is a standard oil-in-water emulsion of a combination of United States Food and Drug Administration (US FDA) approved ultraviolet filters; along with melatonin and pumpkin seed oil. The in-silico optimized formulation was characterized using established methods and the stability study was carried out as per International Conference on Harmonization guidelines. The formulation was prepared after requisite pre-formulation analysis by Fourier-transform infrared spectroscopy, differential scanning calorimetric and thermogravimetric analyses; followed by characterization based on color, odor, phase separation, spreadability, specific gravity, homogeneicity, centrifugation and sensitivity. For the stability study, a total of three samples from three batches of the finished product were subjected to the stability study. The samples were analyzed for content uniformity, pH, SPF, rheology, zeta potential, droplet diameter and microbial analysis of the 0th day and also the the end of the storage period. Results obtained from the stability study indicated that the formulation possesses 50+ SPF value and remained stable for 6 months and 12 months under storage at 40 ± 2 °C and 75 ± 5% relative humidity; and -20 °C ± 5 °C respectively.
本研究旨在开发一种适用于高海拔地区的防晒霜，这些地区已被发现具有优越的防晒因子（SPF）和显著的抗氧化活性。该局部制剂是一种标准的油包水乳液，含有美国食品和药物管理局（US FDA）批准的紫外线滤光剂；以及褪黑素和南瓜籽油。通过建立的方法对优化后的配方进行了特征描述，并按照国际协调会议（ICH）指南进行了稳定性研究。在进行必要的预配方分析（傅里叶变换红外光谱、差示扫描量热法和热重分析）后，通过颜色、气味、相分离、铺展性、比重、均一性、离心和敏感性等特性对制剂进行了制备。为了进行稳定性研究，共从三个批次的成品中抽取了三个样品进行稳定性研究。对样品的含量均匀度、pH 值、SPF、流变学、zeta 电位、粒径和微生物分析进行了分析，分析时间分别为第 0 天和储存期结束时。稳定性研究结果表明，该配方具有 50+的 SPF 值，在 40±2°C 和 75±5%相对湿度下储存 6 个月和 12 个月，以及在-20°C±5°C 下分别保持稳定。
