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Composition and method for treating hemorrhoids and/or anorectal disorders

a technology of anorectal disorders and compositions, applied in the field of compositions of oilinwater emulsions, can solve the problems of affecting the hemorrhage of pregnant women, affecting the hemorrhage of the uterus, and affecting the hemorrhage of the uterus, and unable to achieve the desired tactile feeling of a cream and most likely the endurance at the si

Inactive Publication Date: 2010-03-04
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The composition provides improved compatibility and prolonged anesthesia, facilitating better hydration and delivery of active agents to hemorrhoidal tissues, offering enhanced relief from discomfort, pain, and itching.

Problems solved by technology

Hemorrhoids can be caused by constipation and the straining associated therewith as the excessive pressure involved can cause a fold of the membranous rectal lining to slip down, resulting in a pinching of the veins and subsequent irritation.
For example, pregnant women are prone to suffer hemorrhoids because of the pressure on the veins in the abdomen.
The water based system facilitates solublization of active ingredients but lacks the desirable tactile feeling of a cream and most likely the endurance at the site of treatment of a cream.
While this may facilitate preparation of the composition, the absence of water may impact the delivery of the active ingredient to body tissues.
Such an alkaline pH would impact the stability of many active agents and preservation of the integrity of the composition over time would require special efforts.
Self application of such a patch to affected hemorrhoidal tissue may be fraught with some difficulty.
However, known cream based preparations typically suffer the significant deficiency of not dissolving many topical anesthetic agents and / or vasoconstrictors which are desirable active agents.
While such agents may be physically dispersed in a cream, homogenous distribution as well as delivery to affected tissues may be problematic.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Anorectal Cream

[0059]The following example describes a pharmaceutical composition, which is exemplary of the oil-in-water emulsion for treating hemorrhoids and / or anorectal disorders of the present invention.

% W / WACTIVE INGREDIENTSPramoxine HCl, USP1.00Phenylephrine HCl, USP0.250Glycerin, USP14.4White Petrolatum, USP15.0INACTIVE INGREDIENTSMethylparaben, NF0.200Propylparaben, NF0.100Sodium Benzoate, NF0.200Disodium Edetate USP0.0500Mixed Tocopherols Antioxidant0.500Propyl Gallate and BHA in Propylene Glycol0.200Steareth-201.00Steareth-21.00Glyceryl Monostearate and Laureth-23 (70 / 30)3.00Stearyl Alcohol, NF5.00Cetyl Alcohol, NF5.00Sodium Carboxymethylcellulose, USP0.250Xanthan, NF0.100Citric Acid, USP0.200Aloe Vera Oil0.100Vitamin E Acetate, USP0.100D-Panthenol, USP1.00Purified Water, USP51.35

[0060]The composition of Example 1 was prepared by melting the oil component (i.e. white petrolatum for this example) and combining the melted oil with the emulsifiers, emollients, antioxidants ...

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Abstract

The invention provides an oil-in-water emulsion useful in the treatment of anorectal disorders comprising a local anesthetic, vasoconstrictor, glycerin and water, and method of preparation of the emulsion and a method for treating hemorrhoids using the composition of the invention.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]The present invention is directed to an oil-in-water emulsion composition useful in the treatment of anorectal disorders such as hemorrhoids and use of the composition in the treatment of anorectal disorders such as hemorrhoids.[0003]2. Description of Related Art[0004]Hemorrhoids, a common ailment suffered by as many as nine out of ten Americans at some point in their lives, are swollen varicose veins in the mucous membrane inside or just outside the rectum. Hemorrhoids can be caused by constipation and the straining associated therewith as the excessive pressure involved can cause a fold of the membranous rectal lining to slip down, resulting in a pinching of the veins and subsequent irritation. Other causes may include diseases of the digestive tract resulting in an infection and diseases which obstruct blood flow, putting increased pressure on the hemorrhoidal veins. For example, pregnant women are prone to suffer he...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/113A61K31/535
CPCA61K31/137A61K31/24A61K2300/00A61P9/14A61P43/00A61K31/74
Inventor AGISIM, GARY ROBERTKENNY, RICHARD JOHNSTILL, MIRON GERARDGILLIAM, ELLEN BLANDTAYLOR, HELEN ELIZABETH
Owner WYETH LLC