Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Stability testing of beclomethasone dipropionate nanoemulsion

Mohammad Sarfaraz Alam, Mohammad Sajid Ali , Mohammad Intakhab Alam, Tarique Anwer, Mohammed Mohsen A Safhi

College of Pharmacy, Jazan University, Jazan, Saudi Arabia;

For correspondence:- Mohammad Ali Email: mdsajidaali@gmail.com Tel:+966591668359

Received: 23 February 2014 Revised: 15 November 2014 Published: 30 January 2015

Citation: Alam MS, Ali MS, Alam MI, Anwer T, Safhi MM. Stability testing of beclomethasone dipropionate nanoemulsion. Trop J Pharm Res 2015; 14(1):15-20 doi: 10.4314/tjpr.v14i1.3

© 2015 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To perform stability studies on a nanoemulsion formulation containing beclomethasone dipropionate (BD) and prepared by spontaneous emulsification method.

Method: A nanoemulsion (o/w) containing BD was prepared using eucalyptus oil, Tween-40, ethanol and distilled water. The nanoemulsions were characterized by droplet size, pH, viscosity, conductivity and refractive index. Stability studies were performed according to International Council on Harmonization (ICH) guidelines over a period of 3 months. Droplet size, pH, viscosity, conductivity and refractive index were determined monthly for 3 months. The shelf-life of the nanoemulsion formulation was determined by accelerated stability testing.

Results: The droplet size, conductivity, viscosity, pH and refractive index of the optimized formulations did not change significantly (p ≥ 0.05) after 3 months of storage at room temperature (25 ºC). The shelf life was 1.83 years at room temperature.

Conclusion: The study demonstrates that the physical and chemical stability of BD is enhanced when it is formulated as a nanoemulsion.

Keywords: Nanoemulsion, Beclomethasone dipropionate, Shelf-life, Accelerated stability, Viscosity, Conductivity, Refractive index