Oral formulations of metronidazole and methods of treating an infection using same
Inventors
Guarino, Jr., Bernard J. • DORAN, JAMIE L. • RADOVIC, ZORANA • Sullivan, Kevin
Assignees
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Publication Number
US-11541035-B2
Publication Date
2023-01-03
Expiration Date
Abstract
The present disclosure provides oral pharmaceutical compositions comprising: 1) metronidazole or a pharmaceutically acceptable salt thereof; and magnesium aluminum silicate; or 2) metronidazole or a pharmaceutically acceptable salt thereof; magnesium aluminum silicate; and a flavoring agent. Methods of treating infection utilizing the oral pharmaceutical compositions are also provided.
Core Innovation
The invention relates to an oral pharmaceutical composition containing metronidazole formulated with sucrose, glycerin, purified water, magnesium aluminum silicate, microcrystalline cellulose, sucralose, sodium phosphate, one or more preservatives, strawberry flavoring agent and peppermint flavoring agent. The described formulation includes magnesium aluminum silicate Type 1C and the oral pharmaceutical composition as a suspension.
Magnesium aluminum silicate is described as masking bitter taste by adsorption and increasing viscosity, which relates to improved palatability. The disclosure also describes a metronidazole taste-masking approach using sweeteners and flavoring agents such as strawberry and peppermint in combination with the specified excipients.
The invention also addresses use of the metronidazole oral pharmaceutical composition for treating an infection in a patient by administering an effective amount of the composition comprising metronidazole and the specified excipients, preservatives, and strawberry and peppermint flavoring agents.
Claims Coverage
The document includes three independent claims. Across the independent claims, the main coverage centers on a metronidazole-containing oral formulation with a defined set of excipients and strawberry and peppermint flavoring agents, optionally refined to a suspension and to magnesium aluminum silicate Type 1C, and on using that composition to treat infections via administration of an effective amount.
Metronidazole oral pharmaceutical composition with strawberry and peppermint flavoring agent
An oral pharmaceutical composition comprising metronidazole, sucrose, glycerin, purified water, magnesium aluminum silicate, microcrystalline cellulose, sucralose, sodium phosphate, one or more preservatives, strawberry flavoring agent and peppermint flavoring agent.
Administration of metronidazole composition to treat an infection
A method of treating an infection in a patient, comprising administering to the patient an effective amount of an oral pharmaceutical composition comprising metronidazole, sucrose, glycerin, purified water, magnesium aluminum silicate, microcrystalline cellulose, sucralose, sodium phosphate, one or more preservatives, strawberry flavoring agent and peppermint flavoring agent.
Defined concentration metronidazole suspension
An oral pharmaceutical composition comprising 10.0% (w/v) metronidazole, 50% (w/v) sucrose, 10.0% (w/v) glycerin, purified water, 1.2% (w/v) magnesium aluminum silicate, 0.6% (w/v) microcrystalline cellulose, 0.25% (w/v) sucralose, 0.2% (w/v) sodium phosphate monobasic, 0.2% (w/v) sodium phosphate dibasic, 0.15% (w/v) methylparaben, 0.02% (w/v) propylparaben, 0.4% (w/v) natural strawberry flavor and 0.2% (w/v) natural peppermint flavor.
Collectively, the claims cover a metronidazole oral pharmaceutical composition defined by a specific excipient and flavoring system, treating infections by administering an effective amount of that composition, and a specific concentration embodiment of the same composition.
Stated Advantages
Magnesium aluminum silicate is described as masking bitter taste by adsorption and increasing viscosity, which relates to improved palatability.
Documented Applications
Treating infections in a patient using an effective amount of the metronidazole oral pharmaceutical composition, including bacterial, fungal, and protozoan infections and named diseases including C. difficile, trichomoniasis, amebiasis, bacterial vaginosis, pelvic inflammatory disease, endocarditis, dracunculiasis, and giardiasis.
Palatability evaluation of metronidazole oral formulations using Hedonic scales and bitterness scales.
Providing or assessing pediatric safety and efficacy and pharmacokinetic comparability or bioavailability in relation to C. difficile.
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