Methods and compositions for treating conditions associated with an abnormal inflammatory responses
Inventors
Glick, Gary D. • Franchi, Luigi • Santus, Giancarlo
Assignees
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Publication Number
US-10292951-B2
Publication Date
2019-05-21
Expiration Date
Abstract
This disclosure features chemical entities (e.g., a compound exhibiting activity as a mitochondrial uncoupling agent or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof; e.g., a compound, such as niclosamide or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof; e.g., a compound, such as a niclosamide analog, or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof) that are useful, e.g., for treating one or more symptoms of a pathology characterized by an abnormal inflammatory response (e.g., inflammatory bowel diseases) in a subject (e.g., a human). This disclosure also features compositions as well as other methods of using and making the same.
Core Innovation
The invention provides solid pharmaceutical compositions containing an inner phase that is a wet granulated solid preparation comprising niclosamide, or a pharmaceutically acceptable salt thereof. The inner phase further comprises one or more disintegrants, one or more diluents, and one or more binders, and the compositions further include an external phase comprising one or more glidants and/or one or more lubricants.
The invention also provides enema preparations in which a first component contains the defined solid pharmaceutical composition having a wet granulated inner phase with niclosamide, or a pharmaceutically acceptable salt thereof, plus disintegrants, diluents, and binders, and an external phase with glidants and/or lubricants. A separately contained second component comprises one or more liquids and optionally one or more other pharmaceutically acceptable excipients forming a liquid carrier.
Specific enema formulations further include water and named excipients together with niclosamide, or a pharmaceutically acceptable salt thereof, including methyl cellulose, povidone, methylparaben, propylparaben, sodium dihydrogen phosphate dehydrate, disodium phosphate dodecahydrate, crospovidone, lactose monohydrate, magnesium stearate, and talc.
Claims Coverage
The independent claims cover four distinct aspects: niclosamide solid pharmaceutical compositions with a wet-granulated inner phase and an external phase; a specific niclosamide solid composition with particular excipients; an enema preparation with separately contained solid and liquid components; and an enema formulation comprising specific excipients together with niclosamide. Across these claims, the inventive features center on wet granulation-based solid compositions and two-component enema preparations and formulations for enema delivery.
Wet granulated inner phase and external phase for niclosamide solid compositions
A solid pharmaceutical composition comprising an inner phase which is a wet granulated solid preparation comprising niclosamide, or a pharmaceutically acceptable salt thereof, one or more disintegrants, one or more diluents, and one or more binders, and an external phase comprising one or more glidants and/or one or more lubricants.
Specific excipient inner and external phases for niclosamide solid compositions
A solid pharmaceutical composition comprising an inner phase which is a wet granulated solid preparation comprising niclosamide, or a pharmaceutically acceptable salt thereof, crospovidone, lactose monohydrate, and povidone, and an external phase comprising magnesium stearate and talc.
Two separately contained components enema preparation with solid niclosamide phase and liquid carrier
An enema preparation comprising a separately contained first component and a separately contained second component, wherein the first component comprises a solid pharmaceutical composition with an inner phase that is a wet granulated solid preparation comprising niclosamide, or a pharmaceutically acceptable salt thereof, one or more disintegrants, one or more diluents, and one or more binders, and an external phase comprising one or more glidants and/or one or more lubricants, and the second component comprises one or more liquids and optionally one or more other pharmaceutically acceptable excipients together forming a liquid carrier.
Enema formulation with specified excipients and niclosamide
An enema formulation comprising water, methyl cellulose, povidone, methylparaben, propylparaben, sodium dihydrogen phosphate dehydrate, disodium phosphate dodecahydrate, crospovidone, lactose monohydrate, magnesium stearate, talc, and niclosamide, or a pharmaceutically acceptable salt thereof.
The independent claims collectively cover niclosamide, or a pharmaceutically acceptable salt thereof, in solid pharmaceutical compositions defined by wet-granulated inner phases with disintegrants, diluents, and binders, and external phases with glidants and/or lubricants, together with enema preparations and formulations that use separately contained solid and liquid components and a specified enema excipient set.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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