Kind code of ref document: The present invention relates to a dried composition Afor reconstitution with water, comprising: The present invention provides a composition comprising colic include the dimethicone, used during diagnostic, therapeutic or surgical procedures on the intestine and especially the colon such as when radiological examinations of the digestive surgery or colonoscopies.
Colonoscopy is a technique of visual exploratory examination of the inner wall of the colon. Colonoscopy allows notably to detect abnormalities polyps, The colon must be completely clean for accurate examination.
The patient should follow a few days before the colonoscopy, a special diet and should be fasting on the day of the exam. The day before the exam, the patient must ingest usually in less than an hour, twice two liters of saline purgative, called bowel preparation, causing diarrhea and to empty the colon.
The effectiveness of colic preparations directly affects the quality and reviewing performance. And can have serious consequences for the ignorance of precancerous lesions.
To date, six families of products are typically used: Hyperosmotic preparations magnesium citrate act by osmotic mechanism causing a water use through the intestinal wall. They are well tolerated and require low volumes of preparation, however selles liquides comme de leau gaseuse remain little used because of their hazards on renal function and electrolyte disturbances they cause.
They are against indicated if renal disease, heart, liver, and in case of abnormal blood biological constants. Caution is selles liquides comme de leau gaseuse in selles liquides comme de leau gaseuse on diuretics, anti-inflammatories, steroids, antidepressants and lithium.
However, they have a better acceptability of the preparation. Their main advantage over molecules cited above is that they do not suffer of cons-indications and precautions. This last point simplifies the prescription protocols and avoids mistakenly prescribe a preparation to a patient at risk by age, an associated defect, a drug interaction or pregnancy. Macrogols allow proper cleaning of all segments of the colon.
However, their acceptability is poor. Overall, preparations by macrogols require the selles liquides comme de leau gaseuse of a large quantity of liquid four liters in a short time. Finally, the salty preparations PEG is generally well tolerated.
Improved tolerance taking Macrogols is a major issue. Because of their citrus aroma, they must be absorbed ice, thus patients are tempted to swallow them selles liquides comme de leau gaseuse which causes the phenomena of nausea and vomiting.
Vomiting is the manifestation of a defect of gastric emptying. Drink with a straw preparation selles liquides comme de leau gaseuse been proposed, but in practice this solution is hardly compatible with the ingestion of large volumes of liquid four liters. Currently available preparations recommend taking a cold or ice to improve tolerance but taking icy liquid favors nausea and vomiting significantly decreasing the rate of gastric emptying.
There is therefore an interest in providing a solution to limit or even eliminate, nausea and vomiting. The presence of foam in the digestive lumen during colonoscopy is also known. It improves the quality of preparation and above it prevented the formation of foam in the colon.
The phenomenon may therefore appear on a perfectly clean and hide the mucous colon. Regardless of the increase in volume, optimizing bowel preparation involves preparation for the card. Fractional preparation split dosing with half the dose taken the day before and the second half taking five to seven hours before the exam provides a better preparation than the total intake of the product yesterday.
There is therefore an interest in providing colic preparations can be taken fractionally to enhance their acceptability. There is also an interest in improving the taste presentation colic preparations to enhance their acceptability.
There is an interest in providing a solution to the production of abundant foam during the mechanical washing of the colon. Other goals become apparent on reading the description of the invention that follows. These objectives are met by the present invention which provides a dehydrated composition Ain particular for reconstitution with water, comprising: The composition of the invention may also comprise sodium citrate. Preferably, the composition of the invention is free of sodium citrate.
The dimethicone and simethicone belong to the class of linear polydimethylsiloxane and have the general formula: Advantageously, the use selles liquides comme de leau gaseuse dimethicone or simethicone in colonic preparations prevents foam formation in the colon or cause extremely rapid coalescence of the bubbles if they are formed. Osmotic agents, including sodium chloride, potassium chloride and sodium bicarbonate, are important to ensure a physiologic osmolarity of the selles liquides comme de leau gaseuse and to avoid absorption or electrolyte leakage through the intestinal wall.
Preferably, the present invention provides a dehydrated composition Ain particular for reconstitution with water and comprising a polyethylene glycol PEG particularly PEG or PEGsodium sulfate, sodium chloride, chloride potassium, sodium bicarbonate, dimethicone, flavoring agents as defined above.
La composition peut en outre comprendre du citrate de sodium. The composition may further comprise sodium citrate. Advantageously, the reconstitution of the preparation with water allows to obtain a preparation for cleaning of the intestine. The selles liquides comme de leau gaseuse invention therefore also relates to such a dehydrated composition for use for washing the colon, including prior an exploratory examination of the colon, for example colonoscopy.
The present invention also relates to a composition reconstituted by dissolution in water of the composition A according to the invention, the reconstituted composition is an aqueous composition comprising water and the composition A according selles liquides comme de leau gaseuse the invention. The amount of water to add to the composition 1 is between 0. The composition A of the present invention is in the form of powder, granules or any other form adapted as dehydrated composition and capable of being reconstituted by addition of water.
The powder presentation is preferred. The preferential packaging of the composition A in a unit sachet. The electrolyte content of the reconstituted solution of the present invention is such that can be treated as zero plasma electrolytes intestine exchanges.
The pH of the reconstituted solution of the present invention is between 3. The composition A according to the invention comprises from 0. The reconstituted composition comprises from 1. Preferably the compound capable of generating contractions of the intestine, preferably PEG is between 30 and g in the composition A. Le sulfate de sodium est compris entre 0 et 10 g dans la composition A. The sodium sulfate is between 0 and 10 g in the composition A. The amount of osmotic agent that promotes retention of water and the osmotic pressure is between 1 and 10 g in the composition A.
Preferably, the osmotic agent is a mixture of sodium chloride, potassium chloride and sodium bicarbonate, sodium chloride is between 1 and 2. Polyethylene glycol of the composition A may be chosen from polyethylene glycol typically implemented in colonic preparations. After reconstitution with water typically adding from 0. The present invention also relates to a new plan of administration of these preparations colic.
The administration of the preparation according to the invention will induce reconstituted bowel movements sought in diagnostic, therapeutic or surgical on the intestine and especially the colon as for example during radiological examination of the gastrointestinal surgery, or colonoscopies.
The flavors of agents included in the formulation are intended first to allow the hot consumption of the said solution, but also improve the taste and so foster tolerance and acceptability of decision colic preparations by patients. A high rate of gastric emptying decreases the phenomena of dyspepsia such as nausea. A judgment or a major slowing gastric emptying causes vomiting.
The inventors have surprisingly shown that taking the formulation of the invention was as effective and better tolerated than existing preparations. The effectiveness of the composition according to the invention was higher and better tolerated than the preparation with PEG said low volume. Moreover, the inventors have asked patients to choose between conventional preparations cold or hot PEG and patients all have preferred to take the cold preparation because of the bad taste of the classic PEG preparations.
The combination of PEG with citric acid or ascorbic acid and selles liquides comme de leau gaseuse ascorbate Moviprepreduces the amount of liquid ingested but requires to drink the cold mixture or maintain the preparation cool before use.
The inventors have shown that patients tended to quickly drink cold preparations which led to nausea and vomiting. Taking all or part of the composition according to the invention in the form of a hot solution, especially in the form of liquid food, causes a change in behavior of the patients with a significantly slower absorption of the solution thereby improving its efficiency and tolerance. Thus, the inventors have shown that the composition according to the invention induces a laxative effect identical or superior to the conventional preparations with an increased tolerance and acceptability on the part of patients.
In a first embodiment, the invention relates to a dried composition A1 comprising: The composition A1 may also include sodium citrate. Preferably, the composition A1 of the invention is free of sodium citrate. In a second embodiment, the invention relates to a formulation A2 comprising: La composition A2 peut en outre comprendre du citrate de sodium. The composition A2 may further comprise sodium citrate. Preferably, the composition A2 of the invention is free of sodium citrate.
In a second embodiment, the invention relates to a dehydrated preparation A3 comprising: La composition A3 peut en outre comprendre du citrate de sodium. The composition A3 may further comprise sodium citrate.
Preferably, the composition A3 of the invention is free of sodium citrate. In the context of the present invention, the term "sugar substitute" designate particular sweeteners, advantageously, the sugar substitutes are selected from saccharin, cyclamate, aspartame, acesulfame-K, thaumatin, sucralose, stevia, polyalcohols and polydextrose, preferably stevia.
Advantageously, the formatting colic preparations according to the invention allows the consumer 60 and improves the taste of so-called preparations and therefore the patient acceptability. Ainsi, il est possible de selles liquides comme de leau gaseuse Thus, it is possible to: The present invention also relates to a kit comprising: In particular for use sequenced such as colonic preparation, for washing the colon.
Preferably, the kit comprises a statement indicating that the dinner on the day before colonoscopy, must be replaced by taking a composition according to the invention comprising at least one vegetable as input, the second composition according to the invention comprising at least one vegetable as flat, of the composition according to the invention comprising at least selles liquides comme de leau gaseuse fruit dessert and a composition according to the invention comprising at least one plant extract or aroma as hot or cold beverage, preferably hot, and decision, on the day of the colonoscopy of the second composition according to the invention comprising at least one plant extract or aroma as hot or cold beverage, preferably hot.
Preferably, the kit comprises a statement indicating that the dinner on the day before colonoscopy, must be replaced by the outlet of a composition A1 comprising at least one vegetable as input, the second composition A1 comprising at least a vegetable as flat, composition A2 comprising at least one fruit dessert and a composition A3 comprising at least one plant extract or aroma as hot or cold beverage, and taken on the day of the colonoscopy the second composition A3 comprising at least one plant extract or aroma as hot or cold drink.
Particularly advantageously, the compositions according to the invention, especially A1A2 and A3can be used as colonic preparation selles liquides comme de leau gaseuse colonoscopic examination. Thus, the present invention provides a system, prior to colonoscopy, comprising the following steps: Preferably, the prior system of colonoscopy, comprising the steps of: The present invention also encompasses a kit comprising at least one composition A according to the invention and comprising at least selles liquides comme de leau gaseuse dried composition Bfor selles liquides comme de leau gaseuse with water, comprising:
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