NGHIÊN CỨU BÀO CHẾ VÀ ĐÁNH GIÁ SẢN PHẨM GEL TROXERUTIN 2%

Abstract

Troxerutin is an active compound with vasoprotective and anti-edematous effects, widely used in the treatment of chronic venous insufficiency and hemorrhoids. However, it is currently mainly administered via the oral route, while topical formulations such as gels remain underexplored. Therefore, the study entitled “Formulation Development and Evaluation of troxerutin 2% gel” was conducted to develop an effective and safe topical dosage form that acts directly on the affected area, thereby enhancing therapeutic efficacy and minimizing systemic adverse effects. The objectives of this study were to develop an optimal formulation, establish a manufacturing process, prepare pilot batches, and evaluate physicochemical properties as well as the reproducibility of the process at laboratory scale. A Box-Behnken design was employed to investigate the effects of key excipients (carbopol 940, cremophor RH40, and triethanolamine) on viscosity and drug release. The results identified the maximum absorption wavelength of troxerutin at 352 nm, with a calibration curve showing excellent linearity with R² = 0.9998. The optimized formulation consisted of troxerutin 2%, carbopol 940 1.173%, cremophor RH40 1.47%, triethanolamine 0.79%, along with other excipients. The preparation process was carried out using the dissolution method with critical stirring speeds of 900 rpm (polymer phase), 350 rpm (drug phase), and 500 rpm (final mixing). The prepared gel met all quality criteria, including appearance, pH (5.0-7.0), viscosity, and spreadability. Notably, the drug release reached 75.53% after 6 hours. The manufacturing process demonstrated good reproducibility and high stability, as confirmed by ANOVA statistical analysis.