Ternary System of Bacogenins with Fulvic Acid and Hydrogenated Soy Lecithin: Preparation, Characterization and, In vivo Studies.

AIMS: The aim of this study was to simultaneously enhance the solubility and stability of bacogenins hydrolyzed bacoside rich extract by a ternary system comprised of hydrogenated soy lecithin and a third auxiliary substance, fulvic acid. METHODS: Both ternary and binary complexes were prepared using the solvent evaporation method were characterized by Fourier transform infrared technique, differential scanning calorimeter and scanning electron microscope. The entrapment efficacy in both binary and ternary system was calculated and the effect on the solubility, dissolution and stability of bacogenins was found out. Furthermore, the prepared complexes were subjected to behavioural pharmacological studies. RESULTS: FTIR, DSC, and SEM studies in totality confirmed the formation of binary and ternary complexes. Enhancement in solubility was observed, and the order of release characteristics was found to be BHFS> BHSL>BHF> BH when the dissolution studies were carried out in 40% aqueous solution of ethanol. A significant improvement in the memory and antioxidant capacity was noticed in both binary, ternary complexes and fulvic acid treatment groups. CONCLUSION: The results revealed that the ternary complex could be a promising drug delivery system to improve the oral bioavailability of the bacogenins.

Exploration of fulvic acid as a functional excipient in line with the regulatory requirement.

Fulvic acid, a humic substance often considered as a geopolymer, extracted from different natural resources like Shilajit, Peat, dissolved organic matters, etc. There are several reports of its pharmacological properties and its potential as pharmaceutical excipients. So, we have devised a project to strengthen its claim as a functional excipient. For the given project, lyophilized sample of a dietary supplement product (an aqueous solution of peat derived Fulvic acid) was used. The selected studies were typical for an excipient development like physicochemical properties, flow properties, compatibility with other excipient and stability studies, non-clinical safety studies (acute toxicity in mice whereas sub-acute toxicity in rats) and some functionality tests. We also suggest its ability to form co-crystal with natural phytochemicals. Our group has already reported its ability to enhance solubility and or bioavailability of different BCS class II drugs. Henceforth, we can propose that Fulvic acid appears a good candidate to be further explored as a functional excipient and should be evaluated as per the remaining recommendations of IPEC, USFDA, and USP.