Composition and method for inhibiting, preventing, or ameliorating complications associated with ingestion of a medicinal, chemical, or biological substance or agent

a technology of biological substance and compound, applied in the direction of antinoxious agents, drug compositions, peptide/protein ingredients, etc., can solve the problems or in some instances preventing, death, injury, or other harm by producing diarrhea, so as to prevent or reduce the likelihood of, or prevent death, injury or other harm the effect and reducing the likelihood of reducing the likelihood o

Inactive Publication Date: 2013-06-06
AMANA PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The composition effectively reduces the risk of harm by inducing rapid diarrhea upon excessive ingestion, preventing the absorption and toxicity of the pharmaceutically active agent, thereby reducing morbidity and mortality from accidental or intentional overdoses.

Problems solved by technology

In one aspect, when a pharmaceutically active agent, which is safe when ingested at a recommended level or below a threshold amount, is ingested by a subject in excess, either by intentional or accidental overdose, and thereby becoming potentially lethal, toxic, or otherwise harmful or undesirable, the compositions and methods described herein reduce the likelihood of, or in some instances prevent, death, injury, or other harm by producing diarrhea in the subject ingesting the excess composition comprising the pharmaceutically active agent.
If a subject takes a prescribed dose or a dose below a threshold amount, however, the pharmaceutical agent in the therapeutic composition has its proper or intended pharmacological effect, and the therapeutic composition would not induce diarrhea or other undesired side effects in the subject.

Method used

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  • Composition and method for inhibiting, preventing, or ameliorating complications associated with ingestion of a medicinal, chemical, or biological substance or agent
  • Composition and method for inhibiting, preventing, or ameliorating complications associated with ingestion of a medicinal, chemical, or biological substance or agent
  • Composition and method for inhibiting, preventing, or ameliorating complications associated with ingestion of a medicinal, chemical, or biological substance or agent

Examples

Experimental program
Comparison scheme
Effect test

example 1

Establishment of STa Dose-Response Curve of STa to Establish Diarrheagenic Dose in a Population of Adult Mice

Diarrheal Response Assay

[0128]0.5 ml of 10% glucose solution with STa at different dilutions were administered to adult male Swiss Webster mice (each weighing 27-33 grams) by gavage. Mice were weighed prior to STa challenge. At each dilution of STa, 10 mice were utilized for establishing a statistical characterization of the diarrheal response (mean and standard deviation). After STa challenge, at approximately 90 minutes, the animals were sacrificed and the gut is removed and weighed. The remaining carcass is also weighed. The gut / body weight ratio is established as the in-vivo assay of quantifying the diarrheal response to exogenous STa.

[0129]Results are shown below:

Mouse GroupMean (Gut / BodyStandard(10 Mice in each Group)Weight) RatioDeviationControl (Saline).1084.0066 10 MU of STa.1066.0094100 MU of STa.1144.00651000 MU of STa .1339.0047***One MU is the amount of toxin whi...

example 2

Dose-Response Curve for Acetaminophen-Induced Hepatotoxicity

[0132]Data from several studies suggests that acetaminophen is responsible for 39 percent of all cases of acute liver failure in the United States. E.g., Lee, New England J. Med. (2003) 349: 474-485, Shankar et al., Toxicol. Sci. (2003) 73: 220-234. Acetaminophen-induced hepatotoxicity is also a well-established model of fulminant hepatic failure. E.g., Newsome et al., Liver Transplantation (2000) 6: 21-31.

Acetaminophen Administration

[0133]Food, but not water, will be removed 12 hours before acetaminophen administration. The method for acetaminophen administration will be as described by Walker et al, Lab Invest. (1980) 42:181-189. Briefly, acetaminophen will be dissolved in warm distilled water at various dilutions and given to mice by gavage at a volume of 0.5 ml. At each dilution of acetaminophen, 5 mice will be utilized for statistical characterization (mean and standard deviation) of physiologic responses to acetaminop...

example 3

Evaluation of Protective Drug Delivery Model to Prevent Acetaminophen-Induced Hepatic Failure in Adult Mice

[0138]In this section, a formulation of acetaminophen combined with STa will be evaluated for preventing hepatotoxicity due to acute acetaminophen overdosing. There will be three experimental groups and one control group. Group A will include mice administered a hepatotoxic dose of acetaminophen in a particulate (solid) form after a diarrheagenic dose of STa. Group B will include mice administered a hepatotoxic dose of acetaminophen dissolved in solution after a diarrheagenic dose of STa. Group C will include mice administered a therapeutic dose of acetaminophen in particulate (solid) form after a non-diarrheagenic dose of STa. The control group will consist of mice administered a hepatotoxic dose of acetaminophen in particulate (solid) form without any STa administration. Each experimental group and the control group will consist of 5 mice. Mice will be weighed at the beginni...

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PUM

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Abstract

The application relates, in part, to a therapeutic composition comprising a pharmaceutically active agent and a diarrheagenic agent.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims priority to and the benefit of U.S. Provisional Application No. 60 / 691,044, filed on Jun. 16, 2005, the content of which is hereby incorporated by reference in its entirety.BACKGROUND[0002]A therapeutic drug can be toxic or lethal if ingested at or above a specified dosage. A chemical substance or biological agent not intended for oral consumption can have dire health or safety consequences if ingested. Worldwide, thousands of accidental or intentional overdosing or poisoning incidents result in significant morbidity and mortality each year. Healthcare and other costs stemming from treating patients who suffer from complications associated with overdosing on medicines or ingestion of harmful chemical or biological substances or agents are staggeringly high.[0003]A medication, a chemical substance, or a biological agent can be ingested beyond a safe quantity in any of a variety of contexts. For example, and without l...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): A61K38/10A61K31/167
CPCA61K31/167A61K38/10A61K45/06A61P1/10A61P39/00A61K9/28
InventorSAEED, MOHAMMED
OwnerAMANA PHARMA CORP