Formulation Development, Characterization, And Optimization Of Teneligliptin-Embedded Transdermal Patches For The Management Of Diabetes Mellitus

Abstract

Transdermal drug delivery transports active molecules across intact skin into the systemic circulation and can sidestep limitations of oral dosing and hypodermic injections. Teneligliptin hydrobromide hydrate, DPP-4 inhibitors, also known as "gliptins," are a class of oral medications used to treat type 2 diabetes was incorporated into polymeric films to explore a sustained-release patch. Hydroxypropyl methylcellulose (HPMC) and polyvinylpyrrolidone (PVP) were used as film formers; methanol as solvent; dibutyl phthalate as plasticizer; and dimethyl sulfoxide (DMSO) as a permeation enhancer. Among nine trial formulations (F1–F9), the HPMC-rich film F9 (400 mg HPMC; 0 mg PVP) showed uniform thickness (0.410 ± 0.003 mm), acceptable weight (90.2 ± 2.03 mg), and sustained release with 92.58% drug released at 7 h. Diffusion controlled release kinetics was attained as the best-fitting model to describe the release from SNEDDS.transport. Projected shelf-life Stability at Accelerated stability conditions of 40 degrees Celsius, allowing for a 2-degree variance, and 75% relative humidity, with a 5% tolerance. up to  3 months suggested preserved pH, drug content, and release profile with minor physical changes. Overall, F9 appears to be a promising transdermal platform for teneligliptin and may enable reduced dosing frequency and improved adherence in type 2 diabetes care.