Reverse thermal hydrogel preparations for use in the treatment of disorders of the urothelium

A technology of gel and gel-forming agent, which is applied in the directions of urological diseases, medical preparations without active ingredients, and medical preparations containing active ingredients, etc.

Inactive Publication Date: 2015-02-25
THERACOAT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Even though the physical properties of thermoreversible poloxamer compositions, especially the dependence on temperature to maintain viscosity, are often responsible for the high efficacy of poloxamer compositions, the compositions disclosed in '685 only provide The limited range of viscosities of the gel composition in the liquid and gel states, probably due to the need for a sufficiently low viscosity for the composition to exit the syringe and be injected into the patient

Method used

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  • Reverse thermal hydrogel preparations for use in the treatment of disorders of the urothelium
  • Reverse thermal hydrogel preparations for use in the treatment of disorders of the urothelium
  • Reverse thermal hydrogel preparations for use in the treatment of disorders of the urothelium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Before testing Botulinum Toxin (BTX), it is added to Gel A as a treatment agent for bladder diseases, such as bladder spasm. The activity of botulinum in the gel and its release in the gel will be confirmed as follows:

[0088] The activity of BTX was determined by intramuscular injection into mice (Hsd: ICR female mice). Compared with the published method "Comparison of the effect of type A, B and F botulinum neurotoxin on the safety factor of mice" (Aoki , Korea, Journal of Toxicology, 2001, Issue 39, paragraphs 1815-1820), the above content is incorporated into the present invention by reference in its entirety. The commercially available BTX-A was dissolved in saline or gel, or released from the gel by saline to observe the effect of local muscle weakening (saline injection as a negative control group). The dose injected by the test animals was about 20 units / kg body weight, and the injection was injected into the right hind limb of each test animal with a dose volume...

Embodiment 2

[0094] The following will combine the TheraCoat system for the treatment of bladder disease and observe the promoting effect of mixing for the treatment of bladder disease with a cystitis rat model. The test method is disclosed in "A type of botulinum toxin is administered to the bladder of rats to inhibit COX-2 and EP4 expression, and to inhibit the cyclophosphamide-induced cystitis of bladder hyperactivity" (Chuang, YC; Yoshimura, N.; Huang , CC; Wua, M. Chinese Journal of Urology, Issue 56, pages 159-167), the above content is incorporated into the present invention by reference in its entirety. Intraperitoneal injection of cyclophosphamide induces chronic cystitis (75 mg / kg injection on day 1, day 4 and day 7). On the second day, a polyethylene tube (PE-50) was inserted into the rat's bladder through the urethra. The bladder was emptied and instilled with and without BTX gel or saline (1 ml, 20 U / ml Allergan). On the 8th day, the animals were anesthetized, and the Miller ...

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Abstract

A method for maintaining and / or enhancing the efficacy of a pharmaceutically active agent in a sustained-release treatment of a bladder disorder is disclosed. In preferred embodiments, the pharmaceutically active agent is botulinum toxin. The method comprises obtaining a biocompatible mucoadhesive thermoreversible hydrogel; and incorporating said pharmaceutically active agent for treatment of a bladder disorder into said biocompatible mucoadhesive thermoreversible hydrogel. The use of a biocompatible mucoadhesive thermoreversible hydrogel comprising a pharmaceutically active agent such as botulinum toxin in the treatment of bladder disorders, and a method for treating bladder disorders by the use of such a composition that does not require injection of the pharmaceutically active agent into the bladder wall, are also disclosed.

Description

[0001] References for related applications [0002] This case refers to the US provisional application application number: 61 / 621,525, application date: April 8, 2012, the disclosure of which is incorporated herein by reference and claims the priority of the provisional application. Technical field [0003] The present invention relates to a preparation and a method of using the preparation to treat urothelial dysfunction caused by bladder disease, and in particular to a thermoreversible gel added with an active ingredient, such as botulinum Preparations. Background technique [0004] Urinary Incontinence (UI) caused by urothelial disorders affects 200 million people worldwide. The National Institutes of Health estimates that up to 25 million American adults have experienced or will experience transient or chronic urinary incontinence. The International Continence Association estimates that 75-80% of these patients are women, and there will be 900-1.3 billion. People have troubles...

Claims

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Application Information

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IPC IPC(8): A61K9/00
CPCA61K9/0019A61K47/32A61K9/0034A61K38/4893A61K47/10A61K47/38A61P13/10A61P21/00
Inventor 吉尔·哈金马瑞纳·卡纳瑞米哈尔·耶书仑
Owner THERACOAT
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