Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
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Department of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi 110062, India
2
Department of Pharmaceutics, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi 110017, India
3
Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, Taif 21944, Saudi Arabia
*
Authors to whom correspondence should be addressed.
Academic Editor: Valentina Onnis
Sci. Pharm. 2022, 90(2), 33; https://doi.org/10.3390/scipharm90020033
Received: 9 April 2022
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Revised: 6 May 2022
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Accepted: 11 May 2022
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Published: 19 May 2022
The present work aimed to re-assess the bioavailability enhancement potential of fulvic acid (FA). Carbamazepine (CBZ) and peat were used as a model drug and FA source, respectively. Our group has already evaluated the bioavailability enhancement potential of a less commercially viable source of FA, i.e., shilajit. In the present work, the phase solubility of CBZ was analyzed with varying concentrations of peat-sourced FA (2–12% w/v). The prepared complex (CBZ-FA) was characterized by X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), and differential scanning calorimetry (DSC). Dissolution, pharmacokinetic, and pharmacodynamic studies were also carried out. The results showed the presence of an interaction between the drug and FA within the complex, which led to 98.99 ± 2.0% enhancement in drug solubility. The results also showed 79.23 ± 2.1% dissolution of the complexed drug over 60 min and 69.32 ± 2.2% permeation from the intestinal gut sac over 90 min, which led to a significant enhancement of bioavailability and a reduction in the duration of epileptic seizures. Thus, this study re-authenticates our earlier results and suggests switching the FA source (shilajit to peat) for commercial product development.
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Keywords:
carbamazepine; fulvic acid; bioavailability; complexation; humic substances; pharmacokinetic; pharmacodynamic
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MDPI and ACS Style
Khan, R.; Jain, P.; Zakir, F.; Aqil, M.; Alshehri, S.; Mirza, M.A.; Iqbal, Z. Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study. Sci. Pharm. 2022, 90, 33. https://doi.org/10.3390/scipharm90020033
AMA Style
Khan R, Jain P, Zakir F, Aqil M, Alshehri S, Mirza MA, Iqbal Z. Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study. Scientia Pharmaceutica. 2022; 90(2):33. https://doi.org/10.3390/scipharm90020033
Chicago/Turabian StyleKhan, Rahmuddin, Pooja Jain, Foziyah Zakir, Mohd Aqil, Sameer Alshehri, Mohd A. Mirza, and Zeenat Iqbal. 2022. "Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study" Scientia Pharmaceutica 90, no. 2: 33. https://doi.org/10.3390/scipharm90020033
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