A novel once monthly injectable formulation of semaglutide demonstrated promising results in preclinical studies. The formulation, named AdoGel-semaglutide, aimed to provide sustained release over a 1-month period using an innovative hydrogel platform.
AdoGel consists of cross-linked degradable polymers that can be injected using a 25-gauge needle. The hydrogel properties are tailored to entrap semaglutide, limit initial burst release, and allow for controlled release through hydrogel degradation without generating toxic molecules.
The lead AdoGel-semaglutide product is injected with a 25-gauge needle, with gelation starting within minutes of mixing. In vitro drug release assessments showed extended and constant release rates, with the release duration tailored through optimization of the hydrogel properties and loading.
In a rat study (N = 6), the AdoGel-semaglutide formulation was administered subcutaneously. Pharmacokinetic analysis, performed using LC-MS/MS with organic precipitation, showed limited burst release and regular release over a 1-month period. The product was well-tolerated, with no inflammatory reactions observed during the treatment period.
The researchers utilized two innovative polymers to create the unique in situ forming semaglutide-loaded hydrogel. The injectability, gel formation kinetics, and mechanical properties were adjusted by varying the molecular weight and ratio of the polymers. In vitro and in vivo studies were conducted to investigate drug release rate, duration of action, and overall correlation, guiding the selection of the optimal formulation.
The study results were presented at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting.