Methods of treating a gastrointestinal spasm associated with chemotherapy or radiation therapy
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Assignees
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Publication Number
US-9408869-B2
Publication Date
2016-08-09
Expiration Date
Abstract
Methods of treating a gastrointestinal spasms associated with chemotherapy or radiation therapy are provided, such methods not requiring the use of systemic drugs that have shown to (i) provide slow relief, (ii) cause adverse side effects, (iii) limit activities, (iv) worsen existing gastrointestinal conditions, (v) be unrecommended in several gastrointestinal conditions that include gastrointestinal spasms, or (vi) be unrecommended in the absence of diarrhea.
Core Innovation
The invention relates to methods for inhibiting the onset of, and treating, a gastrointestinal spasm associated with the administration of chemotherapy or radiation therapy in a subject. The method includes administering an effective amount of an orally delivered formulation that includes a water soluble tannin or water soluble polyphenol combined with hydrogen peroxide in a pharmaceutically acceptable excipient.
The formulation is defined by compositional constraints including a tannin molecular weight ranging from about 170 Daltons to about 4000 Daltons and a tannin:peroxide weight ratio ranging from about 1:1000 to about 10:1. In additional embodiments, the polyphenol is water-extracted from pomegranate husk and green tea leaf and combined with hydrogen peroxide prior to administering, and the hydrogen peroxide concentration ranges from about 0.001% to about 2.0% based on total dry weight of the composition.
The composition inhibits the onset of, and treats, gastrointestinal spasm associated with chemotherapy or radiation therapy when compared to a second subject in a control group exposed to the chemotherapy or radiation therapy but in which the composition was not administered. The document also describes improved aqueous peroxide stability of dry complexes showing bound peroxide content relative to free hydrogen peroxide.
Claims Coverage
The partial content provides four independent claims covering methods for inhibiting onset and treating gastrointestinal spasm associated with chemotherapy or radiation therapy. Across the independent claims, the coverage includes a water soluble tannin or water soluble polyphenol combined with hydrogen peroxide, with defined molecular weight and ratio ranges, and efficacy demonstrated versus a control group not receiving the composition.
Water soluble tannin combined with hydrogen peroxide for chemotherapy/radiation-associated GI spasm treatment
Administering an effective amount of a formulation to a subject with a gastrointestinal spasm associated with chemotherapy or radiation therapy, where the formulation has a water soluble tannin combined with hydrogen peroxide in a pharmaceutically acceptable excipient, and where the composition inhibits onset and treats the gastrointestinal spasm compared to a control group not administered the composition.
Defined tannin molecular weight and tannin:peroxide weight ratio
The tannin has a molecular weight ranging from about 170 Daltons to about 4000 Daltons, and the tannin:peroxide weight ratio ranges from about 1:1000 to about 10:1, with inhibition of onset and treatment compared to a control group not administered the composition.
Formulation produced by removing free hydrogen peroxide before excipient mixing
Administering an effective amount of a composition produced from a process including combining a water soluble tannin with hydrogen peroxide at a tannin:peroxide weight ratio of about 1:1000 to about 10:1 with a tannin molecular weight of about 170 Daltons to about 4000 Daltons, removing free hydrogen peroxide from the combination, and mixing the combination with a pharmaceutically acceptable excipient to create the formulation, with inhibition of onset and treatment compared to a control group not administered the composition.
Selecting a desired formulation concentration for administration
The administering includes selecting a desired concentration of the formulation for the administering, where the composition inhibits onset and treats gastrointestinal spasm associated with chemotherapy or radiation therapy compared to a control group not administered the composition.
Pomegranate husk and green tea leaf water-extracted polyphenol combined with hydrogen peroxide
Administering an effective amount of a composition having a water soluble polyphenol that was water-extracted from pomegranate husk and green tea leaf and combined with hydrogen peroxide prior to the administering, where the polyphenol comprises a tannin and has molecular weight from about 170 Daltons to about 4000 Daltons, and the composition inhibits onset and treats gastrointestinal spasm compared to a control group not administered the composition.
Hydrogen peroxide concentration in defined range for the polyphenol composition
The hydrogen peroxide concentration ranges from about 0.001% to about 2.0% based on total dry weight of the composition, with the polyphenol comprising a tannin and the composition inhibiting onset and treating gastrointestinal spasm compared to a control group not administered the composition.
Water-extracted polyphenol from green tea leaf and pomegranate husk combined with hydrogen peroxide before administration
Administering an effective amount of a composition produced from a process including extracting a water soluble polyphenol from a combination of green tea leaf and pomegranate husk, combining the polyphenol with hydrogen peroxide prior to the administering, and selecting a desired concentration for the composition, with hydrogen peroxide concentration ranging from about 0.001% to about 2.0% based on total dry weight and the polyphenol comprising a tannin and having molecular weight from about 170 Daltons to about 4000 Daltons.
Diluting to desired concentration prior to administering
The process includes diluting the composition to the desired concentration for the administering, and the composition inhibits onset and treats gastrointestinal spasm associated with chemotherapy or radiation therapy compared to a control group not administered the composition.
Across the independent claims, the coverage centers on orally administered compositions comprising a water soluble tannin or water soluble polyphenol combined with hydrogen peroxide, with defined tannin molecular weight about 170 to about 4000 Daltons and, in one claim, a defined tannin:peroxide weight ratio about 1:1000 to about 10:1. Additional independent claims further require removing free hydrogen peroxide, using water-extracted pomegranate husk and green tea leaf polyphenol, and selecting and/or diluting to a desired concentration, while hydrogen peroxide concentration is specified as about 0.001% to about 2.0% based on total dry weight in those formulations.
Stated Advantages
Inhibiting the onset of, and treating, a gastrointestinal spasm associated with chemotherapy or radiation therapy compared to a control group not administered the composition.
Improved aqueous peroxide stability of dry complexes showing bound peroxide content versus free hydrogen peroxide.
Documented Applications
Treatment of chemotherapy- or radiation-therapy-associated gastrointestinal spasms in a subject, with inhibition of onset and symptom relief endpoints described such as abdominal pain, bloating, forceful defecation, forceful vomiting, defecation urgency, constipation, and incontinence.
Use in irritable bowel syndrome (IBS), including an open-label pilot study described in the document.
Prophylaxis in the context of alcohol overindulgence described in the document.
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