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Preparations for measuring gastric emptying abilityRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, In Vivo Diagnosis Or In Vivo TestingPreparations for measuring gastric emptying ability description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060153771, Preparations for measuring gastric emptying ability. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] The present invention relates to a technique for the diagnostic measurement of the gastric emptying rate. More specifically, the present invention relates to a preparation which can measure the reduction or acceleration of the gastric emptying rate in a noninvasive manner using the expired air, and a method for measuring the gastric emptying rate using the preparation. [0002] The present invention allows the safe and easy examination of reduction or acceleration of the gastric emptying rate. Specifically, the preparation of the present invention is useful for the objective diagnosis of the gastric motor function, and are useful for evaluating the pharmacological effects or therapeutic effects of drugs relating to the gastric motor function in individual subjects. BACKGROUND ART [0003] In the field of internal medicine, the treatment of stomach ulcer and duodenal ulcer has made a great transition from treatment by means of surgical procedures to noninvasive drug treatments as a result of progress made in drugs such as H.sub.2-antagonists, gastric inhibitors and the like. [0004] On the other hand, there has been an increase in subjects who, while showing no signs of ulcer in endoscopic examinations, nevertheless complain of symptoms such as vomiting, nausea, gastric fullness, heavy stomach, heartburn, anorexia, upper abdominal pain and the like (such subject is referred to collectively as "subjects with indefinite complaint"). Such indefinite complaint is generally diagnosed on the basis of the symptoms reported by the subject, and it is extremely difficult to diagnose such complaint in an objective and quantitative manner. Furthermore, the difficulty of such diagnosis delays appropriate treatment, and also causes a deterioration in the quality of life (QOL) of such subject with indefinite complaint. It has recently been found that such indefinite complaint reported by subject have a close correlation with a lowering of the gastric emptying rate (GER), and it has been reported that a lowering of the gastric emptying rate is observed in approximately half of all subjects suffering from indefinite complaints. [0005] Accordingly, it would appear that if it were possible to measure the gastric emptying rate easily and with high precision without imposing a burden on the subject, this would make a great contribution to the appropriate diagnosis and treatment of the subject suffering from indefinite complaint. [0006] However, conventional methods for measuring the gastric emptying rate are expensive, or are invasive so that such methods impose a psychological and physical burden on the subject. Moreover, the time for which the subject is constrained is long in the case of such methods, and the measurement precision is insufficient. For example, among conventional methods for measuring the gastric emptying rate, the isotope method (e. g., scintigraphy or the like) uses a radioactive isotope; as a result, the administration of this method is complicated. Furthermore, since this method requires an expensive .gamma.-ray camera, the use of this method is restricted to special facilities. Furthermore, in the case of the X-ray impermeable marker method, the marker is not discharged from the stomach simultaneously with the food contents, but is instead discharged from the stomach after all of the food contents have been discharged; as a result, the actual gastric emptying function cannot be accurately examined. Furthermore, in the case of the acetaminophen method, there is a danger of drug allergy and liver damage due to the side effects of acetaminophen; furthermore, since this drug is subject to other effects in the body such as absorption in the small intestine, metabolization by the liver, excretion from the kidneys and the like, the gastric emptying function cannot be accurately examined. Furthermore, since the concentration of acetaminophen in the blood is measured after administering acetaminophen, the invasive procedure of blood collection is required. [0007] Furthermore, methods such as a method in which the endogastric volume and saburra are measured by means of ultrasonic waves (ultrasound method), a method in which the gastric emptying rate is measured by MRI (magnetic resonance imaging method), a method in which the gastric motor function is evaluated by measuring an electrogastrogram (elctrogastrography) and the like have also been proposed as other methods for measuring the gastric emptying rate; however, such methods suffer from the following problems: (i) There are problems in the precision of the diagnostic method, (ii) there are no fixed criteria, so that evaluations vary according to the evaluator, and (iii) the subject must be constrained for a long period of time while the diagnosis is being made. DISCLOSURE OF THE INVENTION [0008] It is an object of the present invention to provide a preparation that allows the easy and noninvasive measurement of the gastric emptying function. More concretely, it is an object of the present invention to provide a preparation that allows the measurement and evaluation of the gastric emptying rate using the expired air. Furthermore, it is also an object of the present invention to provide a simple method for measuring the gastric emptying rate using the abovementioned preparation. Moreover, it is also an object of the present invention to provide a method for diagnosing and evaluating the gastric emptying function (gastric motor function) in examined subjects, and a method for evaluating the pharmacological effects and therapeutic effects of drugs relating to the gastric motor function in individual subjects, utilizing the abovementioned method for measuring the gastric emptying rate. [0009] Generally, when food is consumed and enters the stomach, it is gradually physically pulverized into small particles as a result of being subjected to the effects of gastric contractions (gastric peristalsis), as well as the effects of acids and enzymes. Then, at the point in time at which the food has been converted into particle with a size of approximately 1 to 2 mm, this food is transferred into the intestines via the pylorus. The present inventors focused on the mechanism of the gastric digestion and evacuation, to develop a method for the simple measurement of the gastric emptying rate. As a result, the present inventors found that in the case of a preparation (a stomach-soluble type <a disintegrate-release type sustained-release preparation>) that is prepared so that is gradually disintegrated and dissolved inside the stomach, there is a correlation between the endogastric elution behavior of the components of the preparation and the gastric emptying rate (gastric movement). On the basis of this finding, the present inventors confirmed that the gastric emptying rate can easily be measuring the elution behavior of the disintegrate-release type sustained-release preparation. Furthermore, the present inventors confirmed that, when a labeled compound excreted in the exhalation as carbon dioxide gas following metabolization is used in preparation of the abovementioned sustained-release preparation, the gastric emptying rate can be measured in a noninvasive manner from the excretion behavior of the labeled compound or metabolites thereof. [0010] The first preparation of the present invention (hereafter referred to as "a stomach-soluble preparation") was perfected on the basis of such findings. Specifically, the first preparation of the present invention ("a stomach-soluble preparation") is a preparation for measuring the gastric emptying rate as described in items 1 through 9 below: [0011] Item 1. A preparation for measuring the gastric emptying rate comprising a composition containing a compound (labeled compound) that is labeled with either an isotope of C or O, or with isotopes of both, and that is converted into labeled CO.sub.2 in the body and excreted in the exhalation, this preparation being a disintegrate-release type sustained-release preparation. [0012] Item 2. The preparation for measuring the gastric emptying rate according to item 1, wherein the behavior of the preparation following oral administration to the subject is such that: [0013] (i) the preparation remains inside the stomach for a certain period of time after entering the stomach, without being immediately discharged from the stomach, [0014] (ii) the surface of the preparation is gradually eroded by the gastric contraction so that the preparation is disintegrated, and as this erosion and disintegrate occurs, the labeled compound is gradually eluted into the stomach, and [0015] (iii) the eluted labeled compound is converted into labeled carbon dioxide gas inside the stomach and excreted in the exhalation, or is absorbed, metabolized and excreted in the exhalation as labeled carbon dioxide gas. [0016] Item 3. The preparation for measuring the gastric emptying rate according to item 1 or item 2, wherein the preparation can expand to a size that does not pass through the pylorus for a certain period of time following oral administration. [0017] Item 4. The preparation for measuring the gastric emptying rate according to any of items 1 through 3, which comprises an anti-disintegrator in addition to a labeled compound. [0018] Item 5. The preparation for measuring the gastric emptying rate according to item 4, wherein the anti-disintegrator is at least one member selected from a group consisting of water-soluble high-molecular weight compound, fat and oil, and sugars. [0019] Item 6. The preparation for measuring the gastric emptying rate according to item 4 or item 5, wherein the anti-disintegrator is at least one member selected from a group consisting of hydroxypropylcellulose, hydroxypropylmethylcellulose, ethylcellulose, cellulose acetate phthalate, hardened oil, carnauba wax, sugars and sugar alcohol. [0020] Item 7. The preparation for measuring the gastric emptying rate according to any of items 1 through 6, wherein the isotope is at least one member selected from a group consisting of .sup.13C, .sup.14C and .sup.18O. [0021] Item 8. The preparation for measuring the gastric emptying rate according to any of items 1 through 7, wherein the labeled compound is at least one member selected from a group consisting of alkali metal salt, alkaline earth metal salt and ammonium salt of carbonic acid, alkali metal hydrogencarbonate, alkaline earth metal hydrogencarbonate and ammonium hydrogencarbonate Continue reading about Preparations for measuring gastric emptying ability... Full patent description for Preparations for measuring gastric emptying ability Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Preparations for measuring gastric emptying ability patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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