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ABSTRACT:
The nanoemulsion formulation containing clobetasol propionate (CP) was prepared by spontaneous emulsification method. For the formulation of nanoemulsion Tea tree oil, Tween 80, transcutol P, and distilled water were used. Drug was incorporated in oil phase in 0.05% w/v. The lipohilic nature of drug leads to O/W nanoemulsion formulation. These were characterized by droplet size, pH, viscosity, conductivity and refractive index. Stability studies were performed as per ICH guideline for a period of 3-months. Shelf-life of nanoemulsion formulation was also determined after performing the accelerated stability testing. It was found that the droplet size, conductivity and refractive index were slightly increased while viscosity and pH, slightly decreased at refrigerator (4°C), room temperature (25°C) and 400C during 3 months of storage period. However, the changes in these parameters were not statistically significant (p>0.05). The degradation (%) of optimized nanoemulsion of CP were determined and the shelf-life was found to be 13.28 months at room temperature. These results indicated that the physical and chemical stability of CP were maintained in nanoemulsion formulation.
KEYWORDS: Nanoemulsion, clobetasol propionate (CP), shelf- life, Stability, ICH.
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INTRODUCTION
Aim of present study was to proof how the quality of drug product changes with time under the influence of some environmental factors like temperature, humidity and light that leads to change the shelf-life of pharmaceutical product. Nanoemulsions are isotropic, thermodynamically stable transparent (or translucent) systems of oil, water, and surfactants with a droplet size usually in the range of 10-200 nm [1, 2]. It may become unstable due to environmental factor and long period storage [3-5]. The degree and speed of destabilization vary from system to system. So, it is important for a formulator to carry out studies on the stability of the system.
Nanoemulsions in general can be destabilized by the following mechanisms: creaming, flocculation [6], coalescence [7] and Ostwald ripening [8].
Creaming is the separation of emulsion phases based on their marked density difference between the dispersed phase and the dispersion medium. Creaming is an undesirable process; however, it is a reversible process when it will shake properly. To prevent creaming, the density different of dispersed phase and the dispersion medium should not be too much high. The other factors which govern creaming according...