In Vitro Biopharmaceutical Quality Control of Risperidone (2 mg) Tablets and Their Impact on Public Health

Abstract

Introduction: Innovative and similar branded medications are expensive and are not accessible in the poorest sectors of Peru, hence the importance of having bioequivalent generic medications. This study aims to evaluate the in vitro biopharmaceutical quality of risperidone 2-mg tablets and their impact on public health. Methods: Four brands of risperidone from the local market were studied (two generic [G1T, G2A], one similar [M1], and one reference [R1]). An analytical and experimental study was conducted using a spectrophotometric method for the dissolution profile in a United States Pharmacopeia (USP) apparatus 2 at 50 rpm with 500 mL of dissolution medium at pH 1.2, 4.5, and 6.8, at 37 ± 0.5 °C. Weight, hardness, and friability were also evaluated. Similarity factor (f2), dissolution efficiency, and mean dissolution time were used as statistical indicators of biopharmaceutical quality control. Results: At pH 1.2 and 4.5, the generic (G1T, G2A) and similar (M1) products did not release more than 85% of the drug within 15-30 min. API release at pH 1.2 was 73.53–74.99% and 75.82–76.64% at 15 and 30 min, respectively. At pH 4.5, API release was 54.92–66.25% and 57.50–75.25% at 15 and 30 min, respectively. In the basic dissolution medium (pH 6.8), the dissolution percentages were 81.99–105.43% at 15 min and 88.32–107.24% at 30 min. When compared to the reference brand, the f2 values in pH 1.2, 4.5, and 6.8 were 55.42, 47.21, and 58.75 for G1T, respectively; 47.51, 28.63, and 24.33 for G2A; and 47.16, 31.51, and 27.68 for M1. The dissolution profiles for G2A and M1 presented differences of 15% at pH 1.2 and more than 20% at pH 6.8. Dissolution efficiency at pH 1.2 and 6.8 was greater than 77%, and mean dissolution time was less than less than 25.29 min. All formulations met the quality control attributes of the biopharmaceutical phase (weight, hardness, and friability). Conclusion: Only one of three generic medicines (G1T) was considered biopharmaceutically equivalent to the reference brand in vitro in both acidic and basic dissolution medium.