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A composition for treating gastrointestinal distress

A pharmaceutical composition and a technology for gastrointestinal discomfort, which are applied in the directions of pharmaceutical combinations, pharmaceutical formulations, and medical preparations containing active ingredients, etc., can solve the problems of spread of antitumor effects, low effects, and poor delayed-type nausea and vomiting effects.

Inactive Publication Date: 2006-10-11
SUNNY PHARMTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Use 5-HT 3 Receptor antagonists such as ondansetron, granisetron, and tropisetron have been shown to be less effective for delayed nausea and vomiting than for acute symptoms
5-HT 3 Potency of receptor antagonists shown to be less effective for moderately emetogenic chemotherapy than for cisplatin-containing regimens
However, if the effect is blocked in the first phase, the tumor killing effect of radiation therapy and chemotherapy may also be affected, because the generation of reactive oxygen species to destroy double-stranded DNA is the main mechanism of radiation therapy and chemotherapy to kill tumors

Method used

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  • A composition for treating gastrointestinal distress
  • A composition for treating gastrointestinal distress
  • A composition for treating gastrointestinal distress

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1: Compositions containing HDAC inhibitors for the treatment and prevention of mucositis induced by chemotherapy and radiotherapy

[0059] Methods to selectively reduce mucosal incidence without compromising the tumoricidal effects of chemotherapy and radiation therapy are long-term goals of cancer therapy. This example discloses a bio-based, topically administered mucositis treatment. The receptivity of the mucous membranes to the vehicle and the duration of exposure to the medical treatment are important for the effectiveness of agents for the treatment of mucositis. However, there are only a few vehicles or vehicles available for this approach.

[0060] An HDAC inhibitor, phenyl butyrate, was formulated as a gum in a water soluble resin with a food grade sweetener. The backbone of the water-soluble resin is a non-ionic polyethylene oxide polymer for bonding, lubrication, adhesion, and softening properties, which can meet the requirements of the United State...

Embodiment 2

[0062] Example 2: Using HDAC inhibitors to treat mucositis induced by radiotherapy and prevent malnutrition and fatigue

[0063] In order to evaluate the efficacy of oral gum formulated with 5% phenyl butyrate in water-soluble resin (designated ASN-02) for the treatment of radiation-induced mucositis, the hamster animal model established by Dr. Steve Sonis (Harvard School of Dental Medicine , Brigham and Women's Hospital, Boston, Mass.).

[0064] At the beginning of the study, 5 to 6 week old male golden Syrian hamsters weighing approximately 90 g were anesthetized with sodium pentobarbital (80 mg / kg) intraperitoneally. The left cheek pouch was everted with a lead shield, fixed and separated. Mucositis was induced with a standardized course of acute radiation. A single dose of radiation (40Gy / dose) was administered to the left cheek pouch of each experimental animal, which was designated as day 0. The radiation is generated by a linear accelerator, and a 6 MeV electron beam...

Embodiment 3

[0067] Example 3: HDAC Inhibitors Long-Termly Suppress Abnormal Proinflammatory Cytokines Induced by Radiation Treatment

[0068]The development of mucositis induced by radiation treatment is thought to be due to the upregulation of persistent pro-inflammatory cytokines such as TNF-α induced by radiation treatment. The mRNA levels of the major pro-inflammatory cytokine TNF-α were therefore measured using the RNase protection assay kit for multiple cytokines (Riboquant; Pharmingen, San Diego, CA), which included a template set to generate 32P-labeled Antisense RNA probe set that hybridizes to the target TNF-α mRNA and the endogenous control GAPDH. After the labeled probe hybridizes to the target RNA, the unprotected RNA will be treated with ribonuclease (RNase), and the protected RNA fragments can be resolved by 6% polyacrylamide colloid and phosphorimaging (Molecular Dynamics Corp., Sunnyvale, CA) records. The amount of each mRNA was quantified using Densitometry and the dat...

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Abstract

A composition and method for treating and / or preventing acute and chronic gastrointestinal distress including nausea, vomiting, lactose intolerance, obstructive symptoms, diarrhea, mucositis, bleeding, weight loss, and malnutrition in a subject who is immunocompromised or receives a planned course of chemotherapy and / or radiotherapy. The method comprises administering a histone deacetylase inhibitor or in conjunction with a second agent to the subject. A composition and method using a histone deacetylase inhibitor for protecting normal tissues from chemotherapy and / or radiotherapy-induced injuries without the risk of tumor protection in cancer therapy is also provided. It is further provided a composition and method for treating and / or preventing cachexia, cancer-related fatigue, or chronic fatigue syndrome.

Description

technical field [0001] The present invention relates to the use of inhibitors of histone deacetylase (HDAC) for the treatment or prevention of acute and chronic gastrointestinal (GI) distress caused by chemotherapy and radiation therapy Nausea, vomiting, lactose intolerance, obstructive symptoms, diarrhea, catarrh, bleeding, weight loss, and malnutrition. Background technique [0002] A. Acute gastrointestinal discomfort such as nausea and vomiting caused by chemotherapy and radiation therapy [0003] Nausea and vomiting associated with chemotherapy and radiation therapy can lead to significant declines in quality of life and physical and cognitive function, delaying or interrupting potential treatments. [0004] In fact, nausea and vomiting associated with chemotherapy and radiation therapy can be so severe that patients refuse further treatment. Five episodes of nausea and vomiting were associated with chemotherapy and / or radiation therapy: (1) acute chemotherapy and rad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61P1/04A61P1/08A61P1/14A61P43/00
CPCA61K31/19A61K31/60A61K38/12A61K31/166A61K38/07A61P1/00A61P1/02A61P1/04A61P1/08A61P1/14A61P37/02A61P43/00A61K2300/00
Inventor 钟邑林贝南谋
Owner SUNNY PHARMTECH
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