Compositions of bile acids and phenylbutyrate compounds
Inventors
Cohen, Joshua • Klee, Justin • Ma, David Wai Fung
Assignees
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Publication Number
US-11583542-B2
Publication Date
2023-02-21
Expiration Date
Abstract
The present disclosure relates to compositions including a phenylbutyrate compound and a bile acid, and methods of processing such compositions.
Core Innovation
The invention provides a composition that includes a combination of sodium phenylbutyrate and taurursodiol (TURSO), with the sodium phenylbutyrate and the TURSO having a ratio by weight of about 3:1. The composition further includes dextrates, sorbitol, maltodextrin, and porous silica, each present at defined weight-percent ranges, and is characterized by a measurable Carr’s index of about 24 or less.
A specific embodiment defines a further composition with about 29.2% w/w of sodium phenylbutyrate and about 9.7% w/w of TURSO, together with dextrates, sorbitol, sucralose, maltodextrin, flavorants, porous silica, sodium phosphate dibasic, and sodium stearyl fumarate. This embodiment also requires that the composition has a measurable Carr’s index of about 24 or less.
The document additionally emphasizes component-driven formulation and measurable physical-property targets to support performance and stability in the resulting composition. The problem addressed is formulated for dual-API compositions directed to synergistic neurodegenerative disease treatment, including neurodegenerative diseases such as ALS, Alzheimer’s, MS, Parkinson’s, Huntington’s, and stroke.
Claims Coverage
The provided independent claims are clm-00001 and clm-00021, each defining a specific composition with measurable Carr’s index of about 24 or less. The inventive coverage is grounded in component identity and amounts, and for clm-00001, the sodium phenylbutyrate:TURSO weight ratio of about 3:1.
Sodium phenylbutyrate/TURSO composition with defined ranges and 3:1 ratio
A composition comprising about 27% to about 32% w/w of sodium phenylbutyrate, about 8% to about 12% w/w of taurursodiol (TURSO), about 14% to about 17% w/w of dextrates, about 3.5% to about 4.5% w/w of sorbitol, about 25% to about 32% w/w of maltodextrin, and about 0.05% to about 1.5% w/w of porous silica, wherein the sodium phenylbutyrate and the TURSO have a ratio by weight of about 3:1 and the composition has a measurable Carr’s index of about 24 or less.
Specific sodium phenylbutyrate/TURSO composition with additional excipients and Carr’s index limit
A composition comprising about 29.2% w/w of sodium phenylbutyrate, about 9.7% w/w of taurursodiol (TURSO), about 15.6% w/w of dextrates, about 3.9% w/w of sorbitol, about 1.9% w/w of sucralose, about 28.3% w/w of maltodextrin, about 7.3% w/w of flavorants, about 0.9% w/w of porous silica, about 2.7% w/w of sodium phosphate dibasic, and about 0.5% w/w of sodium stearyl fumarate, wherein the composition has a measurable Carr’s index of about 24 or less.
Overall, the claim coverage is directed to narrowly defined compositions containing sodium phenylbutyrate and TURSO, including a 3:1 by-weight ratio in clm-00001, together with defined carbohydrate excipients and porous silica, and requiring a measurable Carr’s index of about 24 or less. A further independent embodiment additionally specifies sucralose, flavorants, sodium phosphate dibasic, and sodium stearyl fumarate with fixed weight-percent amounts while maintaining the Carr’s index limitation.
Stated Advantages
Improved composition performance/stability as supported by measurable Carr’s index target (about 24 or less).
Carr’s index constrained to about 24 or less, with dependent refinements down to about 20, 21, 22, or 23, as an explicit measurable property of the composition.
Documented Applications
Synergistic neurodegenerative disease treatment using a dual-API composition including taurursodiol (TURSO) and sodium phenylbutyrate.
Neurodegenerative diseases including ALS, Alzheimer’s, MS, Parkinson’s, Huntington’s, and stroke.
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