Fixed-dose pharmaceutical composition comprising rifabutin, clarithromycin, and clofazimine
AssigneeRedHill Biopharma Ltd.
InventorsThomas Julius Borody, Patrick Gosselin
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AssigneeRedHill Biopharma Ltd.
InventorsThomas Julius Borody, Patrick Gosselin
Estimating the term…
Oral administration of a solid dosage form of the present invention comprising an effective amount of rifabutin, an effective amount of clarithromycin, an effective amount of clofazimine, and an effective amount of an absorption enhancer, is used to treat a subject suffering from, or susceptible to, Mycobacterium avium subspecies paratuberculosis infection. In an embodiment, the solid dosage form is sufficiently designed to result in a reduction in the increased metabolism of clarithromycin caused by rifabutin. In an embodiment, the solid dosage form is sufficiently designed to result in a reduction in the metabolism of rifabutin caused by clarithromycin. In an embodiment, the solid dosage form is sufficiently designed to result in a reduction in risk of a subject developing leucopenia or uveitis as a result of rifabutin.
A pharmaceutical composition comprising a co-formulated fixed-dose combination comprising rifabutin, clarithromycin, and a clofazimine-polymer solid dispersion, wherein the co-formulated fixed-dose combination comprises 60-120 mg rifabutin, 130-250 mg clarithromycin and 10-30 mg clofazimine.
A method of treating a bacterial infection in a subject in need of such treatment, the method comprising administering to the subject a pharmaceutical composition comprising a fixed-dose combination of rifabutin, clarithromycin, and a clofazimine-polymer solid dispersion, wherein the pharmaceutical composition comprises 60-120 mg rifabutin, 130-250 mg clarithromycin and 10-30 mg clofazimine.
Dependencies are inferred from the claim text.