Evaluating the pharmacokinetic parameters of a single dose of oral disintegrating tablets in elderly patients with hypertension and hyperlipidemia

Abstract

Cardiovascular diseases (CVDs) are the leading cause of death worldwide, particularly in underprivileged areas such as Pakistan. Hypertension and hyperlipidemia are major risk factors for CVDs and often require medication for effective management. This study aimed to develop and validate a high-performance liquid chromatography (HPLC) method to assess the bioavailability of orally disintegrating tablets (ODTs) of atenolol and atorvastatin in elderly volunteers with high blood pressure and cholesterol levels by comparing the pharmacokinetic parameters of these ODTs with those of conventional tablet formulations. The study was conducted in Sargodha, Punjab Province, Pakistan, by recruiting 30 male and female elderly volunteers aged 45-65 years and weighing 60-90 kilograms. Each participant was administered a single dose of atenolol (25 mg), atorvastatin (10 mg), or an ODT containing both drugs. Blood samples were collected at specific intervals up to 48 hours postadministration. The concentrations of atenolol, atorvastatin, and the ODTs were measured using HPLC, and various pharmacokinetic parameters, including the area under the curve (AUC), maximum plasma concentration (Cmax), and elimination half-life (t½), were analyzed. The maximum concentration (Cmax) of 10 mg atorvastatin occurred at 4 hours (9.50 ng/mL), while for 25 mg atenolol, it peaked at 4 hours (150.00 ng/mL). The ODTs showed comparable pharmacokinetic profiles, with the Cmax values for atorvastatin and atenolol at 4 hours being 4.00 ng/mL and 165.00 ng/mL, respectively. The elimination half-life (t½) for the ODTs was 4.62 hours for atorvastatin and 4.95 hours for atenolol. The pharmacokinetic analysis indicated that the AUC and Cmax of the ODTs met the bioequivalence criteria, demonstrating absorption and elimination properties similar to those of conventional tablet formulations. The study concluded that the pharmacokinetic parameters of the ODT formulations atenolol and atorvastatin are comparable to those of conventional tablets. ODTs offer a viable and effective alternative for delivering these medications, particularly for patients who have difficulty swallowing pills, thereby potentially improving patient compliance.