Oral Nanoemulsion of Fenofibrate: Formulation, Characterization, and In Vitro Drug Release Studies.

Gulati, N; Kumar Chellappan, D; Tambuwala, M; A A Aljabali, A; Prasher, P; Kumar Singh, S; Anand, K; Sharma, A; Kumar Jha, N; Gupta, G; Dua, K; Dureja, H

Oral Nanoemulsion of Fenofibrate: Formulation, Characterization, and In Vitro Drug Release Studies.

Gulati, N Kumar Chellappan, D Tambuwala, M A A Aljabali, A Prasher, P Kumar Singh, S Anand, K Sharma, A Kumar Jha, N Gupta, G Dua, K

Dureja, H

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Publisher:: Mary Ann Liebert
Publication Type:: Journal Article
Citation:: Assay and Drug Development Technologies, 2021, 19, (4), pp. 246-261
Issue Date:: 2021-05

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Field	Value	Language
dc.contributor.author	Gulati, N
dc.contributor.author	Kumar Chellappan, D
dc.contributor.author	Tambuwala, M
dc.contributor.author	A A Aljabali, A
dc.contributor.author	Prasher, P
dc.contributor.author	Kumar Singh, S
dc.contributor.author	Anand, K
dc.contributor.author	Sharma, A
dc.contributor.author	Kumar Jha, N
dc.contributor.author	Gupta, G
dc.contributor.author	Dua, K https://orcid.org/0000-0002-7507-1159
dc.contributor.author	Dureja, H
dc.date.accessioned	2022-01-07T00:56:26Z
dc.date.available	2022-01-07T00:56:26Z
dc.date.issued	2021-05
dc.identifier.citation	Assay and Drug Development Technologies, 2021, 19, (4), pp. 246-261
dc.identifier.issn	1540-658X
dc.identifier.issn	1557-8127
dc.identifier.uri	http://hdl.handle.net/10453/152802
dc.description.abstract	Nanoemulsions (NMs) are one of the most important colloidal dispersion systems that are primarily used to improve the solubility of poorly water soluble drugs. The main objectives of this study were, first, to prepare an NM loaded with fenofibrate using a high shear homogenization technique and, second, to study the effect of variable using a central composite design. Twenty batches of fenofibrate-loaded NM formulations were prepared. The formed NMs were subjected to droplet size analysis, zeta potential, entrapment efficiency, pH, dilution, polydispersity index, transmission electron microscopy (TEM), Fourier transform infrared spectrophotometry, differential scanning calorimetry (DSC), and in vitro drug release study. Analysis of variance was used for entrapment efficiency data to study the fitness and significance of the design. The NM-7 batch formulation demonstrated maximum entrapment efficiency (81.82%) with lowest droplet size (72.28 nm), and was thus chosen as the optimized batch. TEM analysis revealed that the NM was well dispersed with droplet sizes <100 nm. Incorporation of the drug into the NM was confirmed with DSC studies. In addition, the batch NM-7 also showed the maximum in vitro drug release (87.6%) in a 0.05 M sodium lauryl sulfate solution. The release data revealed that the NM followed first-order kinetics. The outcomes of the study revealed the development of a stable oral NM containing fenofibrate using the high shear homogenization technique. This approach may aid in further enhancing the oral bioavailability of fenofibrate, which requires further in vivo studies.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	Mary Ann Liebert
dc.relation.ispartof	Assay and Drug Development Technologies
dc.relation.isbasedon	10.1089/adt.2021.012
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	0304 Medicinal and Biomolecular Chemistry, 0306 Physical Chemistry (incl. Structural), 1115 Pharmacology and Pharmaceutical Sciences
dc.subject.classification	Medicinal & Biomolecular Chemistry
dc.subject.mesh	Biological Availability
dc.subject.mesh	Calorimetry, Differential Scanning
dc.subject.mesh	Colloids
dc.subject.mesh	Drug Compounding
dc.subject.mesh	Drug Liberation
dc.subject.mesh	Drug Stability
dc.subject.mesh	Emulsions
dc.subject.mesh	Fenofibrate
dc.subject.mesh	Hypolipidemic Agents
dc.subject.mesh	Microscopy, Electron, Transmission
dc.subject.mesh	Nanoparticles
dc.subject.mesh	Solubility
dc.subject.mesh	Biological Availability
dc.subject.mesh	Calorimetry, Differential Scanning
dc.subject.mesh	Colloids
dc.subject.mesh	Drug Compounding
dc.subject.mesh	Drug Liberation
dc.subject.mesh	Drug Stability
dc.subject.mesh	Emulsions
dc.subject.mesh	Fenofibrate
dc.subject.mesh	Hypolipidemic Agents
dc.subject.mesh	Microscopy, Electron, Transmission
dc.subject.mesh	Nanoparticles
dc.subject.mesh	Solubility
dc.title	Oral Nanoemulsion of Fenofibrate: Formulation, Characterization, and In Vitro Drug Release Studies.
dc.type	Journal Article
utslib.citation.volume	19
utslib.location.activity	United States
utslib.for	0304 Medicinal and Biomolecular Chemistry
utslib.for	0306 Physical Chemistry (incl. Structural)
utslib.for	1115 Pharmacology and Pharmaceutical Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health/GSH.Pharmacy
utslib.copyright.status	closed_access	*
pubs.consider-herdc	false
dc.date.updated	2022-01-07T00:56:24Z
pubs.issue	4
pubs.publication-status	Published
pubs.volume	19
utslib.citation.issue	4

Abstract:

Nanoemulsions (NMs) are one of the most important colloidal dispersion systems that are primarily used to improve the solubility of poorly water soluble drugs. The main objectives of this study were, first, to prepare an NM loaded with fenofibrate using a high shear homogenization technique and, second, to study the effect of variable using a central composite design. Twenty batches of fenofibrate-loaded NM formulations were prepared. The formed NMs were subjected to droplet size analysis, zeta potential, entrapment efficiency, pH, dilution, polydispersity index, transmission electron microscopy (TEM), Fourier transform infrared spectrophotometry, differential scanning calorimetry (DSC), and in vitro drug release study. Analysis of variance was used for entrapment efficiency data to study the fitness and significance of the design. The NM-7 batch formulation demonstrated maximum entrapment efficiency (81.82%) with lowest droplet size (72.28 nm), and was thus chosen as the optimized batch. TEM analysis revealed that the NM was well dispersed with droplet sizes <100 nm. Incorporation of the drug into the NM was confirmed with DSC studies. In addition, the batch NM-7 also showed the maximum in vitro drug release (87.6%) in a 0.05 M sodium lauryl sulfate solution. The release data revealed that the NM followed first-order kinetics. The outcomes of the study revealed the development of a stable oral NM containing fenofibrate using the high shear homogenization technique. This approach may aid in further enhancing the oral bioavailability of fenofibrate, which requires further in vivo studies.

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http://hdl.handle.net/10453/152802