Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study

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,...

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Main Authors: Rahmuddin Khan, Pooja Jain, Foziyah Zakir, Mohd Aqil, Sameer Alshehri, Mohd Aamir Mirza, Zeenat Iqbal
Format: Article
Language:English
Published: MDPI AG 2022-05-01
Series:Scientia Pharmaceutica
Subjects:
Online Access:https://www.mdpi.com/2218-0532/90/2/33
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author Rahmuddin Khan
Pooja Jain
Foziyah Zakir
Mohd Aqil
Sameer Alshehri
Mohd Aamir Mirza
Zeenat Iqbal
author_facet Rahmuddin Khan
Pooja Jain
Foziyah Zakir
Mohd Aqil
Sameer Alshehri
Mohd Aamir Mirza
Zeenat Iqbal
author_sort Rahmuddin Khan
collection DOAJ
description 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% <i>w</i>/<i>v</i>). 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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spelling doaj.art-104b310d0e41494f91c221c1d41811b82023-11-23T18:51:12ZengMDPI AGScientia Pharmaceutica0036-87092218-05322022-05-019023310.3390/scipharm90020033Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation StudyRahmuddin Khan0Pooja Jain1Foziyah Zakir2Mohd Aqil3Sameer Alshehri4Mohd Aamir Mirza5Zeenat Iqbal6Department of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi 110062, IndiaDepartment of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi 110062, IndiaDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi 110017, IndiaDepartment of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi 110062, IndiaDepartment of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, Taif 21944, Saudi ArabiaDepartment of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi 110062, IndiaDepartment of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi 110062, IndiaThe 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% <i>w</i>/<i>v</i>). 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.https://www.mdpi.com/2218-0532/90/2/33carbamazepinefulvic acidbioavailabilitycomplexationhumic substancespharmacokinetic
spellingShingle Rahmuddin Khan
Pooja Jain
Foziyah Zakir
Mohd Aqil
Sameer Alshehri
Mohd Aamir Mirza
Zeenat Iqbal
Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
Scientia Pharmaceutica
carbamazepine
fulvic acid
bioavailability
complexation
humic substances
pharmacokinetic
title Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
title_full Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
title_fullStr Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
title_full_unstemmed Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
title_short Quality and In Vivo Assessment of a Fulvic Acid Complex: A Validation Study
title_sort quality and in vivo assessment of a fulvic acid complex a validation study
topic carbamazepine
fulvic acid
bioavailability
complexation
humic substances
pharmacokinetic
url https://www.mdpi.com/2218-0532/90/2/33
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