Formulation development and accelerated stability testing of a novel sunscreen cream for ultraviolet radiation protection in high altitude areas

Abstract

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, in vitro 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+ in vitro 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.

Keywords:

• International Conference on Harmonization guidelines
• oil-in-water emulsion
• stability
• sunscreen cream
• UV filters

Acknowledgements

The authors extend their immense gratitude to Prof. Tarun Kumar Maji, Department of Chemical Sciences, Tezpur University, Tezpur, Assam, India and Mr. Amlanjyoti Puzari, Research Scholar, Department of Chemistry, Dibrugarh University, Assam for their assistance in Differential Scanning Calorimetry experiments. The authors are also grateful to the Defence Research and Development Organization, Ministry of Defence, Government of India for providing the necessary facilities, financial aid and support to execute the research work.

Nilutpal Sharma Bora specifically acknowledges Defence Research and Development Organization, Ministry of Defence, Govt. of India for providing assistance in the form of a research fellowship (Letter no. DRL/1206/TC/03) and Dibrugarh University, Dibrugarh, Assam, India for necessary support to carry out doctoral research work.

Disclosure statement

No potential conflict of interest was reported by the authors.