Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-10-18
2002-01-15
Cook, Rebecca (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06339088
ABSTRACT:
TECHNICAL FIELD
This invention relates to a composition for treatment of external secretion disorders except hypolacrimation, and more particularly to a composition for treatment of hyposalivation and a so-called “dry mouth syndrome”
BACKGROUND ART
External secretions are discharges that are discharged directly by way of a glandular cell, or through an excretory duct or the like onto a body surface or into a lumen. One of well-known external secretions is saliva, and the others are secretion from nasal mucous membranes and mucous membranes of a respiratory tract, secretion from a stomach and an intestine, discharges from a vagina, perspiration, etc. Some of diseases resulting from disorder of the above-mentioned external secretion are: dryness of various parts of body such as so-called “dry mouth syndrome” (xerostomia), “dry nose syndrome” (xeromycteria), “dry skin” (xeroderma), “dry vagina syndrome” (symptom of vaginal dryness); and chronic pancreatitis, chronic gastritis, and chronic bronchitis due to depression of external secretion.
It is true that there are a variety of factors that cause disorder of external secretion, some of which still remain unidentified. One of the factors is known as “Sjögren's syndrome”, an autoimmune disease. “Sjögren's syndrome” is characterized by a symptom of dryness due to infiltration of phlogocyte onto an acinus of an exocrine gland and around an excretory duct, and destruction and atrophy of the acinus and an epithelial cell of the excretory duct that follows. One of the characteristic symptoms is eye and mouth dryness, as well as dryness of skin, nose, throat, bronchia, vulva, and vagina. Among these, dryness of a respiratory tract may induce infections of the lung, and in a worst case, may cause a serious disorder such as pneumonia that may lead to death. Although disorder of external secretion may cause serious diseases as mentioned above, merely a symptomatic treatment such as artificial hydration has been conducted so far. Therefore, development of a fundamental treatment to improve depressed external secretion humor has been demanded.
One of the diseases resulting from disorder of external secretion which has been a current keen interest in the medical and pharmaceutical field is the “dry mouth syndrome” (xerostomia). The “dry mouth syndrome” causes various disorders such as feeling of thirst, xerosis of tunics mucosa oris, urtication, dysmaesesis, dyspepsia because of dryness of lip and inside the mouth due to decrease of secretion of saliva resulting from some cause. Also, the dry mouth syndrome may allow stay of food remnants inside the mouth, which may Read to dental caries.
There are various factors of causing the dry mouth syndrome. As generalized factors, the followings are known: febrile diseases, dehydration, endocrinopathy (myxedema, Basedow's disease, diabetes insipidus, etc.), dysbolism (diabetes, uremia, liver cirrhosis, etc.), deficiency of vitamin-A, B, autoimmune diseases (Sjögren's syndrome, progressive scleroderma, etc.), anemia, bleeding, aging, various medications (sedatives, parasympatholytic drugs, antihistamines, etc.). As local factors, sialadenitis, atrophy of salivary gland, sequela of radiotherapy, malformation (ectodermal dysplasia, etc.) and so forth are known.
As mentioned above, the causes of the dry mouth syndrome vary including ones which still remain unidentified. As a therapy for the dry mouth syndrome, there have been conducted several treatments such as drinking liquid all day long little by little, chewing gum or the like, and using artificial saliva. All these treatments are, however, symptomatic treatments, and providing a medicament that can establish a fundamental measures to improve decrease of saliva secretion has been strongly demanded.
Generally, a healthy person discharges 1 to 1.5 litter of saliva a day through a pair of left and right grand salivary glands (parotid gland, submandibular gland, sublingual gland) and small salivary glands (labial glands, lingual glands, palatine glands, buccal glands). Saliva is discharged in response to a stimulant that may harm a human body to dilute the same or maintain the physiological pH value thereof, as well as helping mastication and deglutition of foods. Further, saliva dissolves the food, makes a person taste the food, and helps him smoothly utter a word by keeping a wet state inside the mouth. There are two types of saliva: one is a continuous type that keeps on discharging a small amount without a particular stimulant and the other is a reflective type that is discharged in response to stimulation by food, gnatho-movement, taste of food, and the like. In any case, saliva secretion is one of essential physiological functions, and hence, improving decreased saliva secretion is particularly significant in treating the dry mouth syndrome.
DISCLOSURE OF THE INVENTION
This invention intends to solve the problems described above, and one of the objects is to provide a composition for treatment that is effective in external secretion disorders except hypolacrimation, and more particularly effective in at least one of diseases selected from hyposalivation and dry mouth syndrome.
Another object of this invention is to provide a method for treating a disease of a subject that suffers from external secretion disorders except hypolacrimation, and more particularly at least one of diseases selected from hypo salivation and dry mouth syndrome.
Still another object of this invention is to provide a use of pharmaceutical composition for treatment of external secretion disorders except hypolacrimation, and more particularly to treat at least one of diseases selected from hyposalivation and dry mouth syndrome.
The composition for treatment that solves the above problems and is effective in external secretion disorders except hypolacrimation (for instance, hyposalivation and dry mouth syndrome) has a feature that the composition comprises an aldose reductase inhibitor as an active ingredient.
The aldose reductase inhibitor may preferably comprise a compound represented by the general formula (I):
wherein
A and B are independently lower alkylene, and
X, Y, and Z are independently halogen, or a pharmacologically acceptable salt thereof. Preferably, in the general formula (I), A and B are independently methylene, X is chlorine, Y is bromine, and Z is fluorine.
The composition for treatment may preferably be in the form of preparation for oral local administration, and more preferably in the form of preparation for sublingual administration.
The method, according to another aspect of this invention, that solves the above problems and treats external secretion disorders except hypolacrimation has a feature that an aldose reductase inhibitor of an effective amount is administered to a subject in need of a treatment of external secretion disorders except hypolacrimation (for instance, hyposalivation and dry mouth syndrome).
Further, the use of pharmaceutical composition, according to still another aspect of this invention, that solves the above problems and treats external secretion disorders except hypolacrimation has a feature that an aldose reductase inhibitor is used to manufacture a pharmaceutical composition so as treat the external secretion disorders except hypolacrimation (for instance, hyposalivation and dry mouth syndrome).
BEST MODE FOR CARRYING OUT THE INVENTION
The inventors previously found and stated that a compound having an aldose reductase inhibiting-effect plays an important role in improving hypolacrimation and dry eye syndrome. Now, the inventors have also found as a further result of their researches that this compound is effective in improving external secretion disorders except hypolacrimation, particularly in improving hyposalivation and dry mouth syndrome, and come up with this invention.
The invention is explained in the following.
(1) a composition for treatment of external secretion disorders except hypolacrimation which comprises, as an active ingredient, an aldose reductase inhibitor;
(2) the composition for treatme
Kato Ichie
Ueno Ryuji
Cook Rebecca
R-Tech Ueno. Ltd.
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