Development of Bilayer Tablet Formulation for Co-Delivery of Metformin Hydrochloride & Metoprolol Tartrate for Enhanced Therapeutic Impact

Abstract

Introduction: Diabetes mellitus often accompanies serious complications like hypertension, heart issues, and stroke, particularly affecting older adults. Metformin hydrochloride is the standard medication for type 2 diabetes, Metoprolol tartrate is commonly used to manage hypertension in diabetic individuals. The need arises for a comprehensive treatment approach to address these complications effectively.

Objectives: Aim was to develop a bilayer tablet formulation capable of releasing metformin gradually and metoprolol immediately, facilitating once-daily dosing. This formulation would target both diabetes and hypertension concurrently, potentially offering improved therapeutic benefits compared to conventional treatments.

Methods: To achieve objectives, we meticulously formulated various bilayer tablet formulations (F1 to F7), employing specific release-retarding agents for sustained metformin release and super disintegrants for immediate metoprolol release. These formulations subjected to rigorous testing, evaluating their flow properties and various tests such as weight variation, hardness, thickness, swelling index, and in vitro drug release.

Results: The bilayer tablets containing metformin and metoprolol showed rapid release of the drugs within just 40 minutes. While Formulations F1 and F2 used different super disintegrants, Cross povidone and sodium starch glycolate (SSG) respectively, Formulations F3 to F7 experimented with varying ratios of these super disintegrants. Among these, Formulation F7 stood out as the most effective for sustaining the release of metformin hydrochloride, while the composition of super disintegrants in the metoprolol layer also led to optimal immediate-release outcomes.

Conclusions: The developed bilayer tablet formulation shows promise in offering enhanced therapeutic efficacy compared to traditional dosage forms. These results underscore the importance of carefully selecting polymer combinations and adjusting super disintegrant ratios to fine-tune drug release patterns and enhance formulation performance. By simplifying the dosing regimen to once daily and addressing both diabetes and hypertension simultaneously, has the potential to improve patient compliance and treatment.