Niclosamide formulations and methods of use
AssigneeThe Florida State University Research Foundation, Inc.
InventorsEric HOLMES, Gary OSTRANDER
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Abstract
The present invention concerns compositions comprising at least one niclosamide compound, such as niclosamide or a pharmaceutically acceptable salt thereof, and at least one permeability enhancer, such as glycerol or dimethylpalmityl-ammonio propanesulfonate (PPS), and their use of such compositions as niclosamide agents. Advantageously, the niclosamide compound is capable of being transported across a Caco-2 cell membrane by at least 150% relative to the amount capable of being transported across the Caco-2 cell membrane in the absence of the permeability enhancer. Compositions, including oral dosage forms, and methods for delivering niclosamide compounds, such as for treatment or prevention of human coronavirus infections, are also provided.
Claims10
A solid oral dosage form consisting of (a) niclosamide or a pharmaceutically acceptable salt thereof, (b) a permeability enhancer selected form the group consisting of dimethylpalmityl-ammonio propanesulfonate (PPS), sodium salicylate, ethylenediamine tetraacetic acid, citric acid, chitosan, chitosan derivatives, N-trimethyl chitosan chloride, monocarboxymethyl-chitosan, palmitoyl carnitine chloride, acyl carnitine, ethylene glycol tetraacetic acid, 3-alkylamido-2-alkoxypropyl-phosphocholine, glycerol monocaprylate, piperine, 1-methylpiperazine, and mineral oil, (c) a pharmaceutically acceptable carrier, and (d) an enteric- or pH-sensitive coating or layer,
- wherein the enteric- or pH-sensitive coating or layer surrounds the dosage form, and
- wherein the permeability enhancer increases bioavailability of niclosamide or a pharmaceutically acceptable salt thereof by at least 1.5 times the amount of the bioavailability of niclosamide or a pharmaceutically acceptable salt thereof in the absence of the permeability enhancer.
Dependencies are inferred from the claim text.