Composition for and method of treating neurological conditions
Inventors
ADDINGTON, Otis C. • Newman, Robert A.
Assignees
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Publication Number
US-10226497-B2
Publication Date
2019-03-12
Expiration Date
Abstract
A method of treating neurological condition in a subject by administration of a pharmaceutical composition that excludes cardiac glycoside and excludes polysaccharide obtained from Nerium species or Thevetia species. Alzheimer's disease, Huntington's disease or stroke are treated by administering a therapeutically effective amount of the pharmaceutical composition to a subject.
Core Innovation
The described invention relates to pharmaceutical dosage forms and neuroprotective compositions obtained from Nerium species or Thevetia species for treating neurological conditions. The extracts and fractions are defined by exclusion of cardiac glycosides and polysaccharide, including exclusion of oleandrin and neriifolin, and by enrichment of specific constituents.
The fraction or composition is characterized as consisting essentially of oleandrigenin, oleanolic acid, ursolic acid, and betulinic acid, while excluding cardiac glycosides and polysaccharides obtained from Nerium or Thevetia species. The approach addresses treatment of neurological conditions including Alzheimer’s disease, Huntington’s disease, stroke/ischemic brain injury, and tauopathies/amyloid-beta pathology.
The document also describes treatment regimens including recurring extended administration with periodic assessment of clinical/therapeutic response and dose escalation and/or de-escalation to reach a desired clinical endpoint. For stroke, the document describes time-delayed treatment with administration of an initial dose of the fraction or neuroprotective composition followed by assessment of clinical/therapeutic response and continuation or adjustment of dose as needed.
Claims Coverage
The partial content includes two independent claims. One is directed to a pharmaceutical dosage form containing a defined fraction with essential constituents and exclusions, and another is directed to a dosage form containing a neuroprotective composition prepared from a supercritical fluid extract and fractionation with defined constituents and exclusions. Across these independent claims, there are two main inventive feature clusters: the defined extract fraction/composition and the preparation context and fractionation framing as dosage forms for neuroprotection and neurological treatment.
Pharmaceutical dosage form with defined fraction excluding cardiac glycoside and polysaccharide
A pharmaceutical dosage form comprising at least one pharmaceutical excipient and an effective amount of a fraction of extract of Nerium species or Thevetia species, wherein said fraction consists essentially of oleanolic acid, ursolic acid, betulinic acid, and oleandrigenin, and wherein said fraction excludes cardiac glycoside and polysaccharide obtained from Nerium species or Thevetia species.
Dosage form with neuroprotective composition obtained from supercritical fluid extract excluding oleandrin, neriifolin, and polysaccharide
A dosage form comprising at least one pharmaceutical excipient and an effective amount of a neuroprotective composition obtained from a supercritical fluid extract of Nerium species or Thevetia species, wherein said composition excludes oleandrin, neriifolin, and polysaccharide obtained from Nerium species or Thevetia species, and wherein said composition consists essentially of oleandrigenin, oleanolic acid, ursolic acid and betulinic acid, and wherein said composition has been prepared by fractionation of said extract.
Overall claim coverage centers on Nerium/Thevetia-derived fractions or neuroprotective compositions defined by essential steroid/triterpene constituents (oleandrigenin, oleanolic acid, ursolic acid, betulinic acid) with explicit exclusion of cardiac glycosides, including oleandrin and neriifolin, and exclusion of polysaccharides. Dependent claim sets further frame use for neurological conditions and include recurring extended administration and time-delayed stroke treatment with response assessment and dose escalation or de-escalation.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating neurological conditions including Alzheimer’s disease, Huntington’s disease, stroke/ischemic brain injury, and tauopathies/amyloid-beta pathology, including embodiments involving amyloid beta accumulation in neuronal synapses and formation of amyloid fibrils and/or amyloid plaques.
Time-delayed treatment of stroke using an initial dose followed by assessment of clinical and/or therapeutic response and continuation or dose escalation/de-escalation to achieve a desired clinical endpoint.
Recurring extended administration with periodic assessment of clinical/therapeutic response and dose escalation/de-escalation.
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