Method and composition for treating obesity
Inventors
Castagna, Michael • Kendall, David • Kraft, Kelly • Smutney, Chad C. • Grant, Marshall
Assignees
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Publication Number
US-12370137-B2
Publication Date
2025-07-29
Expiration Date
Abstract
A method for treating obesity associated to Prader Willi Syndrome and/or binge eating is disclosed. The method utilizes a rapid drug delivery system which delivers small molecules and peptides to the lungs by oral inhalation.
Core Innovation
The invention relates to an inhalable dry powder pharmaceutical composition effective in the treatment of obesity associated with Prader Willi Syndrome. The composition comprises fumaryl diketopiperazine in a crystalline, amorphous, or crystalline composite form, and pramlintide together with a leucine component. The composition is formulated as microparticles for pulmonary inhalation.
The invention further specifies the aerosol performance of the inhalable dry powder composition by requiring that about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm. This microparticle size distribution is used in the inhalable dry powder pharmaceutical composition that includes fumaryl diketopiperazine and pramlintide, and that is effective for treating obesity associated with Prader Willi Syndrome.
In additional forms, the invention combines pramlintide with insulin in the inhalable dry powder composition, where the insulin comprises up to about 30% (wt %) of the pharmaceutical composition and the composition comprises microparticles with the same aerodynamic diameter distribution. In further forms, the invention includes pramlintide together with insulin and a serotonin receptor agonist, where the serotonin receptor agonist is a triptan, and includes specified triptans as active agents.
Claims Coverage
The partial content identifies four independent claims. Across these independent claims, the core inventive content repeatedly centers on fumaryl diketopiperazine-based inhalable dry powder microparticles with a specified aerodynamic diameter distribution, combined with pramlintide alone or together with insulin and/or a serotonin receptor agonist, for treating obesity associated with Prader Willi Syndrome.
Fumaryl diketopiperazine inhalable dry powder with pramlintide and leucine microparticles
An inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine, leucine and pramlintide, wherein the inhalable dry powder pharmaceutical composition is in the form of microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm, wherein the composition is effective in the treatment of obesity associated with Prader Willi Syndrome.
Fumaryl diketopiperazine inhalable dry powder with pramlintide and insulin up to 30 wt%
An inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine, an aliphatic amino acid selected from the group consisting of alanine, glycine, leucine, isoleucine, norleucine and serine; optionally a pharmaceutically acceptable excipient; and two active agents consisting of pramlintide and insulin, wherein the insulin is present and comprises up to about 30% (wt %) of the pharmaceutical composition, wherein said inhalable dry powder pharmaceutical composition comprises microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm, and wherein the composition is effective in the treatment of obesity associated with Prader Willi Syndrome.
Fumaryl diketopiperazine inhalable dry powder with pramlintide, insulin, and serotonin receptor agonist
An inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine, an aliphatic amino acid selected from the group consisting of alanine, glycine, leucine, isoleucine, norleucine and serine; optionally a pharmaceutically acceptable excipient; and three active agents consisting of a serotonin receptor agonist, pramlintide, and insulin, wherein the insulin comprises up to about 30% (wt %) of the pharmaceutical composition, wherein said inhalable dry powder pharmaceutical composition comprises microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm, and wherein the composition is effective in the treatment of obesity associated with Prader Willi Syndrome.
Fumaryl diketopiperazine inhalable dry powder with pramlintide and specified aliphatic amino acid options
An inhalable dry powder pharmaceutical composition comprising a crystalline, amorphous, or crystalline composite form of fumaryl diketopiperazine, an aliphatic amino acid selected from the group consisting of alanine, glycine, leucine, isoleucine, norleucine and serine; optionally, a pharmaceutically acceptable excipient; and an active agent consisting of pramlintide, effective in the treatment of obesity associated with Prader Willi Syndrome, wherein said inhalable dry powder pharmaceutical composition comprises microparticles, and about 35% to about 75% of the microparticles have an aerodynamic diameter of less than 5.8 μm.
Across the independent claims, the patent coverage is directed to inhalable dry powder microparticle formulations using fumaryl diketopiperazine in crystalline, amorphous, or crystalline composite form, with a specified aliphatic amino acid component and pramlintide as an active agent. The claims require that about 35% to about 75% of microparticles have an aerodynamic diameter of less than 5.8 μm and that the composition is effective for treating obesity associated with Prader Willi Syndrome. Additional claim forms include insulin up to about 30 wt% and, in another form, a serotonin receptor agonist in addition to pramlintide and insulin.
Stated Advantages
Effective in the treatment of obesity associated with Prader Willi Syndrome.
Documented Applications
Treatment of obesity associated with Prader Willi Syndrome using an inhalable dry powder pharmaceutical composition comprising fumaryl diketopiperazine and pramlintide.
Treatment of obesity associated with Prader Willi Syndrome using an inhalable dry powder pharmaceutical composition comprising fumaryl diketopiperazine with pramlintide and insulin up to about 30 wt%.
Treatment of obesity associated with Prader Willi Syndrome using an inhalable dry powder pharmaceutical composition comprising fumaryl diketopiperazine with pramlintide, insulin, and a serotonin receptor agonist, including specified triptans.
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