Eplerenone sublingual dissolving film: preparation and evaluation

Abstract

Eplerenone is a medication used to manage hypertension and chronic heart failure by inhibiting aldosterone receptors. This study's objective is to prepare sublingual dissolving films containing Eplerenone, to enhance patient adherence, avoid first-pass metabolism, and minimize the need for repeated dosing. To achieve this goal, eight different formulations were prepared using a solvent-casting method. The study examined how various formulation factors influenced the physical and mechanical characteristics of the films, as well as their drug-release behavior. Notably, the results showed that the Eplerenone oral film, which included a combination of hydroxypropyl methylcellulose (HPMC E5) and polyvinyl alcohol (PVA), exhibited the fastest disintegration time, dissolving within just 27 seconds. Furthermore, formula F3, containing 25 mg of HPMC E5, 25 mg of PVA, and 30% glycerin, demonstrated a remarkable drug release rate of 72.4% within a 2-minute period with satisfactory mechanical properties. To summarize, this investigation successfully developed sublingual dissolving films for Eplerenone to improve patient adherence and decrease the necessity for frequent dosing. These films disintegrate rapidly and provide effective drug release, offering a patient-friendly alternative for managing conditions such as hypertension and chronic heart failure.