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

• Published in: Environmental research Vol. 187; p. 109642
• Main Authors: Gnananath, Kattamanchi, Nataraj, Kalakonda Sri, Rao, Battu Ganga, Kumar, Kolli Prabhanjan, Mahnashi, Mater H., Anwer, Md. Khalid, Umar, Ahmad, Iqbal, Zeenat, Mirza, Mohd Aamir
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.08.2020
• Subjects: Dietary supplement; Excipient compatibility; Excipient stability; Humic substances; Pharmaceutical excipient; Toxicity studies; Dietary supplement; Excipient compatibility; Excipient stability; Humic substances; Toxicity studies; Pharmaceutical excipient
• ISSN: 0013-9351; 1096-0953
• DOI: 10.1016/j.envres.2020.109642

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. [Display omitted] •This is the first report of peat derived fulvic acid as a functional excipient and its scope in co-crystal formation.•Herein focused mainly on its compatibility with other excipients commonly employed in solid dosage forms.•Acute, sub-acute toxicity studies and MTT assay of the fulvic acid using mammalian cell has been carried out.