Oral formulations of metronidazole and methods of treating an infection using same

Inventors

Guarino, Jr., Bernard J.DORAN, JAMIE L.RADOVIC, ZORANASullivan, KevinBalboni, Armand Louis

Assignees

Appili Therapeutics Inc

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Publication Number

US-12257236-B2

Patent

Publication Date

2025-03-25

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 described invention relates to an oral pharmaceutical liquid suspension formulation comprising metronidazole or a pharmaceutically acceptable salt thereof and magnesium aluminum silicate that is a natural product. The suspension is characterized by the inclusion of magnesium aluminum silicate as a natural product and by optional formulation components, including excipients and flavoring agents.

The formulation further includes, in different embodiments, at least one flavoring agent together with metronidazole and magnesium aluminum silicate, where the magnesium aluminum silicate is a natural product. The flavoring agents are specified to include natural flavors, artificial flavors, mint, peppermint, and selected fruit flavors such as cherry, strawberry, and raspberry, including mixtures thereof.

The document also describes treatment use of the oral pharmaceutical liquid suspension by administering to a patient an effective amount for treating an infection. The method recites an infection-treating step using a suspension that contains metronidazole and magnesium aluminum silicate as a natural product, optionally including at least one flavoring agent, and includes infection types and patient populations in dependent claim language.

Claims Coverage

The provided independent claims cover four core areas: an oral pharmaceutical liquid suspension containing metronidazole and a natural product magnesium aluminum silicate; the same base suspension further including at least one flavoring agent; a specific named formulation composition with defined excipients and strawberry and peppermint flavoring agents; and a method of treating an infection by orally administering the suspension.

Oral pharmaceutical liquid suspension with natural product magnesium aluminum silicate

An oral pharmaceutical liquid suspension comprising metronidazole or a pharmaceutically acceptable salt thereof and magnesium aluminum silicate, wherein the magnesium aluminum silicate is a natural product.

Oral pharmaceutical liquid suspension with natural product magnesium aluminum silicate and flavoring agent

An oral pharmaceutical liquid suspension comprising metronidazole or a pharmaceutically acceptable salt thereof, magnesium aluminum silicate, and at least one flavoring agent, wherein the magnesium aluminum silicate is a natural product.

Oral pharmaceutical liquid suspension with defined excipients and strawberry and peppermint flavoring agents

An oral pharmaceutical liquid suspension 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, wherein the magnesium aluminum silicate is a natural product.

Method of treating an infection by administering the suspension with natural product magnesium aluminum silicate

A method of treating an infection in a patient comprising administering an effective amount of an oral pharmaceutical liquid suspension comprising metronidazole or a pharmaceutically acceptable salt thereof and magnesium aluminum silicate; or metronidazole or a pharmaceutically acceptable salt thereof, magnesium aluminum silicate, and at least one flavoring agent, wherein the magnesium aluminum silicate is a natural product.

Across the independent claims, the central inventive concept is an oral metronidazole liquid suspension that uses magnesium aluminum silicate as a natural product, optionally combined with flavoring agents and used for orally treating infections in patients.

Stated Advantages

Improved palatability compared with metronidazole tablets and crushed-and-compounded controls.

Taste-masking of bitter or metallic aftertaste via magnesium aluminum silicate and optional flavoring agents.

Documented Applications

Treatment of an infection in a patient by orally administering an effective amount of the disclosed oral pharmaceutical liquid suspension containing metronidazole and natural product magnesium aluminum silicate.

Treatment contexts explicitly include bacterial, fungal, and protozoan infections, including amebiasis and enumerated diseases: pelvic inflammatory disease, endocarditis, bacterial vaginosis, dracunculiasis, giardiasis, and trichomoniasis.

Use for pediatric patients and geriatric patients in the infection-treatment method.

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