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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 3
First page : ( 1137) Last page : ( 1141)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00209.7

Physicochemical Characterization and In-Vitro Dissolution Behavior of Artemether and Lumefantrine: Hydroxypropyl-β-Cyclodextrin Inclusion Complex

Rathi Sanjesh*, Patel Dhaval, Shah Shrenik

Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Gujarat, India-382355

*Corresponding Author E-mail: rathi.sanjesh@gmail.com

Online published on 22 April, 2020.

Abstract

The objectives of this research were to prepare and characterize inclusion complexes of Artemether and Lumefantrine with hydroxypropyl-β-cyclodextrin (HP-β-CD) and to study the effect of complexation on the dissolution rate of Artemether and Lumefantrine, water-insoluble drugs. The stoichiometric ratio determined by phase solubility analysis for inclusion complexes of Artemether and Lumefantrine with HP-β-CD was 1: 1.5. Binary complexes were prepared by different methods such as kneading and physical mixing method and were further characterized using DSC and FT-IR. These studies indicated that a complex prepared by kneading method had successful inclusion of the Artemether and Lumefantrine molecule into the cyclodextrin cavity. The mean dissolution time for Artemether and Lumefantrine decreased significantly after preparing complexes using kneading method compare to its physical mixture and plain form. The similarity factor indicated a significant difference between the release profiles of Artemether and Lumefantrine from complexes and to its physical mixture and plain form. Hard gelatin capsules containing single dose of Artemether and Lumefantrine (20-120mg) with cyclodextrins had significant improvement in the release profile of both drugs as compared to market formulation containing multiple dose (80–480 mg tablet) of Artemether and Lumefantrine without cyclodextrin.

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Keywords

Artemether, Lumefantrine, hydroxypropyl-β-cyclodextrin, inclusion complexation, DSC and FT-IR.

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