Eflornithine and sulindac, fixed dose combination formulation
Inventors
Shannon, Patrick • Bravo González, Roberto Carlos • Ducassou, Jean
Assignees
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Publication Number
US-11529326-B2
Publication Date
2022-12-20
Expiration Date
Abstract
Provided herein are fixed-dose combination formulations of a pharmaceutically effective amount of eflornithine together with a pharmaceutically effective amount of sulindac. Also provided are methods of use and of methods of manufacture of these formulations.
Core Innovation
The disclosed invention relates to fixed dose combination pharmaceutical formulations provided in a single dosage unit. The formulations comprise about 375 mg of eflornithine hydrochloride monohydrate and about 75 mg of sulindac, together with magnesium stearate in an amount from about 1 to about 1.5 weight percent.
The document describes multiple dosage forms for the fixed dose combination, including capsule, tablet, mini-tablets, granules, and oral delivery. The formulations may further include excipients and a lubricant such as magnesium stearate, and may be provided with optional modified, enteric, or pH-responsive coatings using selected coating compositions and coating weight percentages.
The disclosure links the approach to chemoprevention and treatment using combinations related to DFMO/eflornithine and sulindac/sulindac sulfone. The application is described in relation to familial adenomatous polyposis (FAP), with formulation-development work addressing capping, sticking, water-content stability, and dissolution behavior relative to single-agent tablets.
Claims Coverage
The provided independent claims cover two inventive features: a single-dosage-unit fixed dose combination composition and a method of treating familial adenomatous polyposis (FAP). The coverage centers on defined amounts of eflornithine hydrochloride monohydrate and sulindac, together with a magnesium stearate requirement.
Fixed dose combination in single dosage unit with defined eflornithine and sulindac amounts
A composition comprising a fixed dose combination in a single dosage unit of about 375 mg of eflornithine hydrochloride monohydrate and about 75 mg of sulindac.
Magnesium stearate at specified weight percent range
The composition further comprises magnesium stearate in an amount from about 1 to about 1.5 weight percent.
Treating familial adenomatous polyposis by administering the defined FDC composition
A method of treating familial adenomatous polyposis (FAP) in a patient in need thereof, comprising administering to the patient the fixed dose combination composition with about 375 mg eflornithine hydrochloride monohydrate, about 75 mg sulindac, and magnesium stearate from about 1 to about 1.5 weight percent.
The inventive coverage is directed to a single-dosage-unit fixed dose combination containing about 375 mg eflornithine hydrochloride monohydrate and about 75 mg sulindac, with magnesium stearate present from about 1 to about 1.5 weight percent, and to use of that composition for treating familial adenomatous polyposis (FAP).
Stated Advantages
Documented Applications
No documented applications found
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