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Phospholipid complex-loaded self-assembled phytosomal soft nanoparticles: evidence of enhanced solubility, dissolution rate, ex vivo permeability, oral bioavailability, and antioxidant potential of mangiferin

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Abstract

In this study, self-assembled phytosomal soft nanoparticles encapsulated with phospholipid complex (MPLC SNPs) using a combination of solvent evaporation and nanoprecipitation method were developed to enhance the biopharmaceutical and antioxidant potential of MGN. The mangiferin-Phospholipon® 90H complex (MPLC) was produced by the solvent evaporation method and optimized using central composite design (CCD). The optimized MPLC was converted into MPLC SNPs using the nanoprecipitation method. The physicochemical and functional characterization of MPLC and MPLC SNPs was carried out by differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Fourier-transform infrared spectroscopy (FT-IR), powder X-ray diffractometer (PXRD), proton nuclear magnetic resonance (1H-NMR), solubility, in vitro dissolution, oral bioavailability, and in vivo antioxidant studies. A CCD formed stable MPLC with the optimal values of 1:1.76, 50.55 °C, and 2.02 h, respectively. Characterization studies supported the formation of a complex. MPLC and MPLC SNPs both enhanced the aqueous solubility (~ 32-fold and ~ 39-fold), dissolution rate around ~ 98% via biphasic release pattern, and permeation rate of ~ 97%, respectively, compared with MGN and MGN SNPs. Liver function tests and in vivo antioxidant studies exhibited that MPLC SNPs significantly preserved the CCl4-intoxicated liver marker and antioxidant marker enzymes, compared with MGN SNPs. The oral bioavailability of MPLC SNPs was increased appreciably up to ~ 10-fold by increasing the main pharmacokinetic parameters such as Cmax, Tmax, and AUC. Thus, MPLC SNPs could be engaged as a nanovesicle delivery system for improving the biopharmaceutical and antioxidant potential of MGN.

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Acknowledgments

The corresponding author is thankful to Dr. Milind J. Umekar, Principal, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur, for providing instrument facilities to complete this research work. The author is also thankful to Dr. Shirish P. Jain, Principal, Rajarshi Shahu College of Pharmacy, Buldhana, for constant financial and technical support to complete this manuscript on time.

Funding

The current research work did not receive any funding from government agencies.

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Authors and Affiliations

  1. Rajarshi Shahu College of Pharmacy, Malvihir, Botha Road, Buldhana, Maharashtra, India

    Darshan R. Telange

  2. Smt. Kishoritai Bhoyar College of Pharmacy, Nagpur, Maharashtra, India

    Nazish K. Sohail & Atul T. Hemke

  3. Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM’s NMIMS (Deemed to be University), V.L.Mehta Road, Vile Parle (W), Mumbai, Maharashtra, India

    Prashant S. Kharkar

  4. School of Pharmacy and Technology Management, SVKM’s NMIMS (Deemed to be University), Polepally SEZ, Jadcherla, Mahbubnagar, Hyderabad, Telangana, India

    Anil M. Pethe

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  1. Darshan R. Telange
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  2. Nazish K. Sohail
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  3. Atul T. Hemke
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Contributions

Darshan Telange: conceptualization, investigation, methodology, writing of the original draft, writing the review, and editing

Nazish Sohail: methodology, investigation, and data curation

Atul Hemke: validation and data curation

Prashant Kharkar: investigation, methodology, and writing of the original draft

Anil Pethe: conceptualization, supervision, investigation, and visualization

Corresponding author

Correspondence to Darshan R. Telange.

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Conflict of interest

The authors declared that they have no conflict of interest.

Ethical approval

The Institutional Animal Ethical Committee (IAEC) of Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur, sanctioned and approved the experimental protocols (SKBCOP/IAEC/2017–2018, dated August 13, 2018) for the current study. The studies were carried out according to the ethical guidelines available by the Committee for Purpose of Control and Supervision of Experiments on Animals (CPCSEA).

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Telange, D.R., Sohail, N.K., Hemke, A.T. et al. Phospholipid complex-loaded self-assembled phytosomal soft nanoparticles: evidence of enhanced solubility, dissolution rate, ex vivo permeability, oral bioavailability, and antioxidant potential of mangiferin. Drug Deliv. and Transl. Res. 11, 1056–1083 (2021). https://doi.org/10.1007/s13346-020-00822-4

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