Patient-centered innovations in ambulatory care: developing a fixed-dose tablet to enhance adherence for patients with chronic diseases.

Abstract

Objective: To improve medication adherence in patients with chronic diseases by developing a tablet formulation containing a combination of metformin, atorvastatin, aspirin, and enalapril maleate. Significance: Effectively managing chronic diseases often requires multiple medications, which can result in low patient adherence and suboptimal therapeutic outcomes. Developing a combination tablet is an effective modality to address this issue.

Methods: To test the patient perception, an online survey was distributed patients with chronic diseases. Based on the survey results, combination tablets were prepared by direct compression using a multifunctional excipient (PROSOLV^® EASYtab). The compatibility between the drugs and excipients was studied using differential scanning calorimetry (DSC) and Fourier-transform infrared (FT-IR) spectroscopy. The tablets were evaluated for weight uniformity, friability, hardness, thickness, diameter, disintegration time, uniformity of drug content, and in vitro drug release.

Results: Most participants reported issues with non-adherence, but expressed a strong positive perception of combination tablets, particularly regarding their effectiveness in improving their condition. DSC and FT-IR studies confirmed the compatibility of the investigated drugs with each other and the used excipient. The tablets fulfilled the European Pharmacopeia 2014 specifications for the tested parameters. The release of all four drugs was fast and a cumulative percent drug release of approximately 50-85% was observed after 15 min.

Conclusions: These findings highlight the significant potential of the combination tablets as a single-dose delivery system, allowing the simultaneous administration of multiple medications for patients with chronic diseases, thereby enabling more effective and streamlined management.