Selection of excipients for the development of an oral powder containing dimethylaminoethanol and sodium succinate

Abstract

Dimethylaminoethanol (DMAE) and sodium succinate are promising active compounds with demonstrated nootropic and metabolic potential, making their combination a candidate for the development of a novel drug aimed at improving cognitive function and supporting neurometabolic processes. Oral powders in sachet form represent a technologically rational choice for such a formulation, offering precise dosing, stability, and ease of use. However, the development of a high-quality sachet powder requires careful selection of excipients that are fully compatible with the active substances and capable of ensuring optimal physicochemical and organoleptic characteristics of the final product. The aim of the study is to scientifically substantiate and select optimal excipients for an oral powder form containing dimethylaminoethanol and sodium succinate, based on a comprehensive assessment of pharmacotechnological indicators. Materials and methods. Nine powder dosage forms were evaluated using a three-factor Greco-Latin square. Each series containing equal amounts of both active ingredients – dimethylaminoethanol and sodium succinate – in a 1 : 1 ratio. Three levels were studied for each factor: fillers (mannitol, lactose, sucrose), disintegrants/anti-caking agents (croscarmellose sodium, potato starch, magnesium carbonate basic), and solubilizers (PEG 4000, PVP K17, PVP K90). Pharmaco-technological parameters were assessed in duplicate; statistical significance was determined by ANOVA. Results. The optimal formulation – comprising sucrose (86%), magnesium carbonate basic (2%), and polyethylene glycol 4000 (2%) alongside 5% each of the two active substances – demonstrated the best combination of technological performance and consumer acceptability. Conclusions. A rational excipient composition for an oral powder sachet containing dimethylaminoethanol and sodium succinate was established through systematic three-factor experimental design and ANOVA.