TY - JOUR AU - Bhagat, Babasaheb Vasantrao PY - 2023/03/15 Y2 - 2024/03/28 TI - Stability and In vitro Comparative Study of Optimized Non-Aqueous Nano Emulsion of Naproxen with Marketed Formulations JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 17 IS - 1 SE - ORIGINAL ARTICLES DO - 10.22377/ajp.v17i1.4728 UR - https://asiapharmaceutics.info/index.php/ajp/article/view/4728 SP - AB - <p>Aim: The current study’s objective was to evaluate stability study and compare and analyze the improved nonaqueous<br>nanoemulsion (NANE) of naproxen with marketed gel formulations (M1 and M2). Methods: Utilizing<br>a low energy emulsification technique, an optimized NANE of naproxen was prepared. The comparison research<br>was assessed for general appearance, pH, viscosity, drug content, and in vitro drug release against marketed<br>formulations. Six months of stability investigations were carried out as per ICH Q1A R2 guideline. During<br>stability study, phase separation, creaming, cracking, phase inversion, color, pH, viscosity, and drug content<br>were evaluated. Results: In comparative study, pH of NANE and marketed formulations M1 and M2 was found<br>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<br>found that optimized NANE showed lower viscosity (54.40 ± 1.25 mPa.S) than marketed formulations (M1-<br>78.20 ± 0.76 mPa.S, M2-80.56 ± 0.28 mPa.S). Drug content of NANE of naproxen and marketed formulations<br>was found to be 95 ± 0.46, 98 ± 0.16, and 97 ± 0.38, respectively. From the in vitro drug release study, we found<br>that optimized NANEs of naproxen showed highest percentage of drug release (96.24 ± 1.96) as compared to<br>marketed formulation M1 (90.58 ± 1.31) and M2 (89.15 ± 1.33), respectively. No phase separation, creaming,<br>cracking and phase inversion was seen after agitation, centrifugation, and freeze-thaw cycles. This demonstrated<br>the NANE excellent stability in the presence of gravity. pH and drug content of NANE was stable within 6 months<br>of stability study. Viscosity of optimized NANEs decreased from 55.80 ± 0.48 mPa.S to 51.20 ± 1.06 mPa.S within<br>6 months in accelerated stability study and stable in intermediate stability study. Conclusion: It was discovered<br>following a stability assessment that there was no indication of instability.</p> ER -