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Publication Number
US-9730927-B2
Publication Date
2017-08-15
Expiration Date
Abstract
The invention relates to compositions for the treatment of obesity and related diseases comprising a) an active substance being not flibanserin, selected from the group consisting of active substances for the treatment of obesity and obesity related diseases and b) flibanserin, optionally in the form of pharmacologically acceptable acid addition salts thereof.
Core Innovation
The invention relates to flibanserin for treating and preventing obesity and obesity-related disorders. The disclosure addresses obesity-related diseases including metabolic syndrome (syndromeX), diabetes (type II), dyslipidaemia, hypertension, and osteoarthritis, and concerns flibanserin in the free base form and pharmaceutically acceptable acid addition salts, hydrates, and solvates.
The invention further concerns pharmaceutical compositions combining flibanserin with at least one non-flibanserin anti-obesity active substance selected from orlistat, phentermine, sibutramine, and topiramate. The flibanserin component is optionally in the form of the free base and/or pharmaceutically acceptable acid addition salts, and optionally in the form of hydrates and/or solvates.
The disclosure also reports that flibanserin administration reduces body weight gain in rat studies in a dose-dependent manner, supporting efficacy for obesity treatment and promoting weight loss. The overall contribution is the use of flibanserin, including specified salt and solvate/hydrate forms, either alone for obesity management or together with selected anti-obesity and comorbidity-active ingredients in a pharmaceutical composition.
Claims Coverage
The independent claim identified is directed to one pharmaceutical composition containing flibanserin together with an additional active substance selected from orlistat, phentermine, sibutramine and topiramate, with flibanserin optionally provided as the free base and/or pharmaceutically acceptable acid addition salts and/or hydrates/solvates. The dependent claims refine the salt forms of flibanserin and impose quantitative constraints on flibanserin and/or the selected non-flibanserin active.
Flibanserin combination with selected non-flibanserin anti-obesity actives
A pharmaceutical composition comprising an active substance being not flibanserin, selected from the group consisting of orlistat, phentermine, sibutramine and topiramate and pharmaceutically acceptable salts thereof, and flibanserin optionally in form of the free base and/or the pharmaceutically acceptable acid addition salts and/or optionally in form of the hydrates and/or solvates thereof.
Flibanserin as a phosphoric acid addition salt
The pharmaceutical composition in which flibanserin is provided as a pharmaceutically acceptable acid addition salt formed with phosphoric acid.
Flibanserin dose range constraint
The pharmaceutical composition specified to contain flibanserin in an amount between 0.01 to 400 mg.
Flibanserin narrowed dose range
The pharmaceutical composition specified to contain 2.0 to 200 mg of flibanserin.
Orlistat amount constraint within the composition
The pharmaceutical composition is defined with orlistat as the active substance in an amount between about 100 mg and 400 mg.
Selected flibanserin acid addition salt group (multiple acid options)
The pharmaceutical composition in which flibanserin is formulated as a pharmacologically acceptable acid addition salt selected from salts formed with succinic acid, hydrobromic acid, acetic acid, fumaric acid, maleic acid, methanesulphonic acid, lactic acid, phosphoric acid, hydrochloric acid, sulphuric acid, tartaric acid, and citric acid, and mixtures thereof.
Across the independent claim and related dependents, the core coverage centers on pharmaceutical compositions combining flibanserin, optionally as free base, acid addition salts, and/or hydrates/solvates, with a selected non-flibanserin anti-obesity active, with dependent claims further constraining flibanserin salt type and amount ranges for flibanserin and/or orlistat.
Stated Advantages
Reduces body weight gain in rat studies in a dose-dependent manner, supporting efficacy for obesity treatment and promoting weight loss.
Documented Applications
Treating and preventing obesity and obesity-related disorders.
Managing obesity-related diseases including metabolic syndrome (syndromeX), diabetes (type II), dyslipidaemia, hypertension, and osteoarthritis.
Using flibanserin in pharmaceutical compositions, including combinations with selected anti-obesity actives.
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