Compositions and methods for the treatment of anorectal disorders

a technology for anorectal disorders and compositions, applied in the field of compositions and methods for the treatment of anorectal disorders, can solve the problems of causing pain, prolapse and thrombosis, and causing considerable suffering and disability, and achieves the effects of reducing the risk of recurrence, and improving the effect of recurren

Inactive Publication Date: 2006-09-07
STREHKEHN INT LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0034] As noted above, methods of treating anorectal disorders are also provided herein. The methods of the invention comprise administering to a subject a suitable formulation of one or more of the c

Problems solved by technology

While hemorrhoids and anal fissures do not garner the attention given to life threatening diseases, they are responsible for considerable suffering and disability, affecting over 26 million people in the U.S., Europe, and Japan.
Commonly, internal hemorrhoidal tissue bulges into the anal canal during defecation and results in bleeding and pain.
As the tissue enlarges, further bleeding, pain, prolapse and thrombosis can ensue.
The thrombosis of hemorrhoids is yet another cause of bleeding and pain.
Post-hemorrhoidectomy pain is severe, disproportionate to the surgery itself, and requires the use of narcotic analgesics, which unfortunately complicate recovery by causing constipation.
Others have reported that the addition of lateral internal sphincterotomy to routine hemorrhoidectomy is unnecessary and carries the added risk of incontinence (Mathai, V. et al., Br J Surg.
However, ATP and VIP, either separately or together, could not account for all inhibitory neurotransmission in gastrointestinal smooth muscle, and their roles have not been established in man (Burleigh, D. E. e

Method used

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  • Compositions and methods for the treatment of anorectal disorders
  • Compositions and methods for the treatment of anorectal disorders
  • Compositions and methods for the treatment of anorectal disorders

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0199] This example illustrates the effect of cGMP mimetics, alone and in combination with a NO donor in a rat internal anal sphincter (IAS) relaxation model.

[0200] Male Sprague-Dawley rats (300-400 gm) were anesthetized with ketamine (90 mg / kg), xylazine (9 mg / kg) given intramuscularly and supplemented as needed with ⅓rd dose. Rats were gently restrained on their backs on a heated surgical table (Harvard Apparatus) for the duration of the experiments. The diuretic effects of anesthesia was offset by rehydration with saline through an intraperitoneal implanted 24 gauge angiocatheter (VWR, San Francisco, Calif.). The constriction / relaxation measurement assembly included a Millar catheter / transducer (1.67 mm diameter.) connected to a Digi-Med Low Pressure Analyzer (Micro-Med) accurate for pressure measurements between −50 and 150 mmHg. The data were integrated and converted to waveforms with the Digi-Med System Integrator software. Blood pressure changes were monitored using an arter...

example 2

[0205] This example illustrates the effect of phosphodiesterase inhibitors in a rat internal anal sphincter relaxation model.

[0206] Using the same experimental protocol described above, an application of 20 μL of a 5% zaprinast solution in 1-methyl-2-pyrrolidinone reduced mean IASP by 21% over 32 minutes compared with vehicle treatment alone. The effect of phosphodiesterase inhibitors could be further enhanced by minimal concentrations of NO donors, such as nitroglycerin that produced a quicker onset and sustained sphincter relaxation without headache and other adverse reactions observed with high dose of NO donors alone (see FIG. 4).

example 3

[0207] This example illustrates the effect of a potassium channel opener (minoxidil) in a rat internal anal sphincter constriction / relaxation model.

[0208] Following the same experimental protocol as described above, a single 20 μl dose of a 4% solution of minoxidil in 62.5% propylene glycol resulted in a 64% reduction of the IASP over 2.5 hours following treatment. The vehicle alone had little effect on IASP (see FIG. 5).

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Abstract

Compositions and methods for the treatment of anorectal disorders are provided in which certain combinations of NO donors, PDE inhibitors, superoxide (O2−) scavengers, β-adrenergic agonists, cAMP-dependent protein kinase activators, α1-adrenergic antagonists, L-type Ca2+ channel blockers, estrogens, ATP-sensitive K+ channel activators and smooth muscle relaxants are used.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority under 35 U.S.C. 119(e) of U.S. Patent Application No. 60 / 222,267, filed Jul. 31, 2000. This application also is a Continuation-In-Part and claims priority to U.S. patent application Ser. No. 09 / 460,306, filed Dec. 13, 1999; U.S. patent application Ser. No. 09 / 595,390 filed on Jun. 14, 2000; and U.S. patent application Ser. No. 09 / 769,621 filed Jan. 23, 2001 which each claim priority from U.S. Provisional Application No. 60 / 112,325, filed Dec. 14, 1998; U.S. Provisional Application No. 60 / 139,916, filed Jun. 17, 1999 and U.S. Provisional Application No. 60 / 155,318, filed Sep. 21, 1999. The disclosure of each of the above priority documents is incorporated herein by reference in its entirety.STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] This invention was made with government support under Grant Number 1 R43 DK 56563-01 awarded by the National Institute...

Claims

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Application Information

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IPC IPC(8): A61K31/522A61K31/519A61K31/513A61K31/198A61K9/48A61K9/20A61K31/21A61K31/137A61K31/495A61K31/50A61K31/655
CPCA61K9/0031A61K31/198A61K31/21A61K31/505A61K31/513A61K31/519A61K31/52A61K31/522
Inventor PARKS, THOMAS P.MAK, VIVIENLEE, JUNG-CHUNGLEE, CHARLES
Owner STREHKEHN INT LTD
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