Stability and In vitro Comparative Study of Optimized Non-Aqueous Nano Emulsion of Naproxen with Marketed Formulations
Main Article Content
Aim: The current study’s objective was to evaluate stability study and compare and analyze the improved nonaqueous
nanoemulsion (NANE) of naproxen with marketed gel formulations (M1 and M2). Methods: Utilizing
a low energy emulsification technique, an optimized NANE of naproxen was prepared. The comparison research
was assessed for general appearance, pH, viscosity, drug content, and in vitro drug release against marketed
formulations. Six months of stability investigations were carried out as per ICH Q1A R2 guideline. During
stability study, phase separation, creaming, cracking, phase inversion, color, pH, viscosity, and drug content
were evaluated. Results: In comparative study, pH of NANE and marketed formulations M1 and M2 was found
to be 5.5 ± 0.36, 5.8 ± 0.80, and 5.6 ± 0.08, respectively. Viscosity is a crucial characteristic of NANE; it was
found that optimized NANE showed lower viscosity (54.40 ± 1.25 mPa.S) than marketed formulations (M1-
78.20 ± 0.76 mPa.S, M2-80.56 ± 0.28 mPa.S). Drug content of NANE of naproxen and marketed formulations
was found to be 95 ± 0.46, 98 ± 0.16, and 97 ± 0.38, respectively. From the in vitro drug release study, we found
that optimized NANEs of naproxen showed highest percentage of drug release (96.24 ± 1.96) as compared to
marketed formulation M1 (90.58 ± 1.31) and M2 (89.15 ± 1.33), respectively. No phase separation, creaming,
cracking and phase inversion was seen after agitation, centrifugation, and freeze-thaw cycles. This demonstrated
the NANE excellent stability in the presence of gravity. pH and drug content of NANE was stable within 6 months
of stability study. Viscosity of optimized NANEs decreased from 55.80 ± 0.48 mPa.S to 51.20 ± 1.06 mPa.S within
6 months in accelerated stability study and stable in intermediate stability study. Conclusion: It was discovered
following a stability assessment that there was no indication of instability.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
This is an Open Access article distributed under the terms of the Attribution-Noncommercial 4.0 International License [CC BY-NC 4.0], which requires that reusers give credit to the creator. It allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only.