Development of a transdermal gel containing modified metformin: a more effective approach to the treatment of type II Diabetes Mellitus (T2DM)

Abstract

Pharmacotherapy for type II diabetes mellitus (T2DM) aims to reduce blood glucose levels, with metformin, a widely administered oral hypoglycemic agent. However, its oral efficacy can be compromised due to drug interactions. Micronized metformin hydrochloride encapsulated in liposomes emerges as an optimized form of conventional metformin, with ionized nanoparticle technology allowing its topical use. This form of the drug is available in higher plasma levels, significantly increasing its efficacy. Thus, it is essential to incorporate this drug into a topical galenic base, improving the therapeutic regimen of polymedicated patients with T2DM who do not respond adequately to oral administration. Therefore, this work aimed to develop a transdermal gel containing micronized metformin encapsulated in liposomes as a more effective alternative in the treatment of T2DM. Micronized metformin encapsulated in liposomes (50 mg/dose) was incorporated into a transdermal gel base (q.s.). A preliminary stability study was conducted over 30 days (T0, T7, T15, T30) under different conditions, evaluating organoleptic and physicochemical aspects, with samples subjected to thermal and mechanical stress. A homogeneous white transdermal gel was obtained. Preliminary stability showed that the evaluated parameters remained constant in two environments (refrigerator and room temperature). In addition to the formulation, it is crucial to establish quality control parameters that ensure compliance. Thus, this work enabled the development of a transdermal gel containing modified metformin and its preliminary stability study, promoting a more effective therapeutic response in the treatment of T2DM.