Use of gingerols for cancer patients suffering from nausea and emesis induced by chemotherapy
Inventors
Assignees
Publication Number
US-8435575-B2
Publication Date
2013-05-07
Expiration Date
2030-05-13
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Abstract
This invention is for an improved method for making enhanced ginger capsules and for using these capsules for treating nausea and emesis in cancer patients.
Core Innovation
This invention provides an improved method for producing enhanced ginger capsules and their use in treating nausea and emesis in cancer patients. The innovation utilizes extracts of ginger rhizome containing defined amounts of 6-gingerol, 8-gingerol, 10-gingerol, and 6-shogaol within specific ratios, delivered in an oil-based capsule or gelcap, for oral administration to humans and animals. The method for making these enhanced extracts employs supercritical, critical, or near-critical fluids, optionally with polar cosolvents, to yield highly purified and bioactive gingerol and shogaol compositions.
The problem addressed by this invention, as described in the background section, is the persistent incidence of nausea and vomiting in cancer patients undergoing chemotherapy. Despite the availability of 5-HT3 receptor antagonist antiemetics, a significant proportion of patients continue to experience both acute and delayed nausea, as well as anticipatory nausea and emesis, which are not well controlled by current pharmacologic agents and are associated with undesirable side effects.
The invention specifically describes compositions of ginger extract with a ratio of 6-shogaol to 6-gingerol between 0.04 to 0.40, which are believed to improve efficacy in treating nausea. These formulations include oil-based delivery systems, such as capsules or gelcaps, containing defined concentrations of gingerols and shogaol, along with optional antioxidants and emulsifying agents to improve solubility and bioavailability. The extraction method allows for the precise production of extracts with targeted constituent concentrations, supporting consistent dosing for clinical applications.
Claims Coverage
There are two independent claims, covering the ginger extract formulation for treating nausea and a method of treating nausea in humans using the formulation.
Formulation of ginger extract for treatment of nausea
A formulation of an extract of ginger rhizome for the treatment of nausea in humans comprising: - 20-40 mg of extract of ginger rhizome in an oil base held in a capsule or gelcap. - The extract contains 15-25% 6-gingerol, 1-5% 8-gingerol, 1-5% 10-gingerol, and 1-5% 6-shogaol. - The combined content of 6-gingerol, 8-gingerol, 10-gingerol, and 6-shogaol totals 4-14 mg per capsule or gelcap. - Designed for oral administration every three to four hours as needed for the treatment of nausea.
Method of treating nausea in humans with the ginger formulation
A method of treating nausea in humans comprising: - Administering an effective amount of the specified ginger extract formulation containing oil and optional components as described. - The administration can be every three to four hours. - The treatment regimen can be initiated three days before chemotherapy, performed on the day of chemotherapy, and continued through three days after the end of chemotherapy.
The primary coverage of the claims is a defined ginger extract oil-based capsule or gelcap for oral administration to treat nausea in humans, and the therapeutic method using this formulation for managing chemotherapy-related nausea.
Stated Advantages
The extract formulation is of particular utility for cancer patients suffering from nausea and emesis induced by chemotherapy.
Offers a method for making highly purified gingerols and shogaols with specific ratios, enhancing efficacy for the treatment of nausea.
The extraction process using supercritical, critical, or near-critical fluids allows fine-tuning of solvation power for improved yield and purity.
The formulation is designed to minimize clinically significant adverse effects commonly associated with current antiemetics.
Documented Applications
Treatment of nausea and emesis in cancer patients undergoing chemotherapy.
Treating nausea in humans and animals using ginger extract formulations.
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