ES2331830B2 - INTESTINAL TRANSIT CORRECTOR. - Google Patents

Abstract

Corrector of intestinal transit.

The present invention relates to a corrective composition of the intestinal transit comprising the less an expanded hydrocolloid on an inert load. The present invention also relates to a method of obtaining said laxative composition as well as the use thereof as liquid laxative formulation easily dispersible in beverages and / or foods.

Description

Corrector of intestinal transit.

Field of the Invention

The present invention is framed within the pharmaceutical field, specifically in the field of treatment of constipation.

Specifically the present invention relates to a liquid pharmaceutical composition containing at least one expanded hydrocolloid on an inert load. The present invention also relates to a method of obtaining said laxative composition as well as the use thereof as easily dispersible laxative formulation in beverages and / or foods.

Background of the invention

Normally, in the classic medical office, the The practitioner's first question used to be directed to find out the evacuation frequency and texture of the patient's fecal bolus. The elementary daily control of the state of health, normally start with these two parameters, that is, the shape and frequency detoxification, since most of the diseases in Its initial phases usually begin with constipation.

This symptom can sometimes cover up others. pathologies Citing a few examples, constipation can to provoke:

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\ vtcortauna self-intoxication reflected by:

to.

Headaches

b.

halitosis

C.

fatigue

d.

irritability

and.

mental depression

F.

bilesity

g.

vomiting

h.

gas

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\ vtcortauna hemorrhoids

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\ vtcortauna heart diseases

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\ vtcortauna intestinal cancer

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\ vtcortauna appendicitis

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\ vtcortauna rheumatism, etc.

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Constipation, or constipation, is the difficulty, or insufficiency, in the elimination of feces, which causes excessive permanence of excreta in the last stretch of the digestive tract.

According to Hurst (1921) "constipation is a state of the organism, characterized by the fact that the waste of a meal, ingested eight hours before defecating, no are removed within 48 hours. "However, in the case of people undergoing a diet with few residues, the bowel movement rate 2-3 times per week should not be considered abnormal, if defecation passes effortless.

Stool removal (food waste undigested) normally begins between 8 and 72 hours after food intake Normally, 3/4 of the food ingested are removed in 4 days; the rest can sometimes remain in the intestine up to 9 days, thus avoiding its total emptying. The traffic speed decreases in the elderly, and above all, in people with reduced activity.

During the meal, the intestine discharges its content to the colon. The colon can accumulate up to 3 liters of Cud. Alimentary bolus. Considering the daily volume of the chyme of approx. 500 ml, this volume is reduced in the colon to 100 ml due to water resorption 150-200 ml accumulation of feces in the rectum, it causes distension (dilation muscle - critical pressure of the sigmoid and distended colon), giving the physiological reflex of defecation. For these reasons, in the In most cases, normal defecation occurs daily, Or every two days. Nature does not wait and you have to go to your called before suffering the negative consequences for health. Normal hygienic practices advise daily emptying routine post-pandrial, preferably after of breakfast, to avoid excessive dehydration of the bolus fecal, since under these conditions, 15 ml or so of water, for every 100 ml of the fecal bolus, you can determine the difference between soft and hard stools, that is, between normal defecation and the constipation. Maintaining the necessary moisture content in stool, compaction is avoided and plasticity is maintained necessary for bowel movement.

The frequency of defecation has little importance and may vary according to the individual (diet, status nervous, hygiene, order, etc.), oscillating between 3 bowel movements Daily and 3 weekly. The effort to evacuate determines the degree of constipation. By ignoring the warning of the passage of feces to the rectum, the sensory mechanism adapts, or numbs, by changing the defecation rate Delayed defecation results in a increased water absorption, increasing stool consistency and hypersecretion of mucus by sickle cell. A mass excessive dehydration becomes too hard, and requires a conscious effort during defecation. An orderly person, that understands the value of your health and the great danger that the retention of toxic residues of food by your body, I should spend a few minutes at least once a day and at a fixed time to evacuate rotten waste from your body, without wait for his warning, that is, one would get used to defecate every day at fixed times, even without feeling like it.

In the case of pregnancy constipation, other factors play an important role, for example, in last months of pregnancy, the increase in the volume of the fetus, which press on the part of the rectum and sigmoid. This fact not It matters if there is normal peristalsis and consistency of the intestinal content is also normal, since no there is a danger of constipation; otherwise the complications, whose remedy is usually worse than disease. Daily habit of defecation and feeding appropriate and with sufficient fluid intake, eliminate practically, the danger of constipation.

Taking into account all the factors involved In the process of constipation, it is necessary to control traffic intestinal for which exogenous substances capable of regulate said transit. For this reason, to facilitate the passage and the Excessively dehydrated stool removal is administered a Endless products called laxatives, purgatives, etc., capable of cause defecation, with, sometimes, very pathological consequences serious.

Laxative abuse can cause destruction of neurons that consequently causes loss, to irreversible times, of normal bowel function, giving diarrhea and addiction or dependence on laxatives, especially in the older age and in cases of indiscriminate self-medication. Discovering the abuse of laxatives that causes diarrhea nonspecific, the cost of treating these diarrhea can be reduce by 80%.

For the correction of constipation with the minimal damage to health there are health information campaigns to the patient aimed primarily at addressing certain practices how:

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\ vtcortauna the adoption of correct dietary habits, with intestinal reeducation,

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\ vtcortauna the use of mass-forming laxatives (bolus boosters),

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\ vtcortauna Reduction of the use of irritant laxatives or bowel stimulants.

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The publication "Medicines Information" (USP-DI) contains certain statements regarding with preventive or curative treatments: "laxatives oral bowel enhancers, lubricants and stool softeners are indicated as prophylaxis in patients who should not make efforts during defecation, such as for example, those with an episiotomy wound, hemorrhoids thrombosed pain, fissures or perianal abscesses, hernias of the abdominal wall and diaphragmatic stenosis ano-rectal or after myocardial infarction. "

"Bolus-enhancing oral laxatives intestinal and stool softening laxatives are preferable to treat constipation that may appear during pregnancy and postpartum to help restore the normal bowel function, or to avoid efforts, if they exist hemorrhoids".

"In severe cases of constipation, such such as fecal impaction, mineral oil and laxatives stool softeners administered orally or rectally are indicated to soften impacted feces. "

The mechanism of action of laxatives (Constipation correctors) mentioned is as follows:

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\ vtcortauna Increasing products of the intestinal bolus: absorb and retain water and expand to achieve increased volume and water content in the feces

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\ vtcortauna lubricating products: increase water retention, facilitate the passage of content through the intestine

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\ vtcortauna stool softening products: reduce the surface tension of the interface favoring the permeation of liquid in the stool to form a softer mass.

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Finally an "ideal" laxative should meet the following requirements:

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\ vtcortauna do not irritate the gastrointestinal tract,

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\ vtcortauna Lack of toxicity.

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\ vtcortauna act only on the descending and sigmoid colon,

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\ vtcortauna produce normal defecation in a short time,

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\ vtcortauna The laxative action should cease rapidly, with recovery of normal bowel activity.

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These requirements are met by some laxatives bolus boosters because they maintain the volume of bolus so that it does not become dehydrated, allow to have soft texture and not they irritate the mucosa of the colon, they manage to form a demulcent gel, lubricant and non-digestible and do not interfere with the process digestive.

However, these types of products are not free of side effects since the laxatives forming dough needs abundant water in its administration, that is, a glass of water for dispersion and another glass after administration, which ensures its effectiveness; otherwise, they can cause intestinal obstruction, which reverses the result that is expected with the use of this type of substances. The Incomplete hydration can cause colic diverticulosis, etc.

In the state of the art there are numerous patents relating to different oral laxative formulas, in their most irritants of the intestinal mucosa, stimulants, or going aimed at plant substances that favor the increase of fecal bolus

Thus we have for example the international patent WO9729755 which refers to an aqueous laxative syrup comprising lactulose and lactitol and / or maltitol as active components of the laxative composition aimed at the treatment of constipation or portal systemic encephalopathy.

On the other hand, European patent EP 00307689 is refers to a laxative composition, more particularly to a laxative composition containing a therapeutic amount of simethicone or dimethicone.

On the other hand, the international patent WO0200226 refers to a synthetic mass forming laxative that comprises a crosslinked polymer formed by a monomer partially neutralized hydrophilic up to 75%, up to 3% in weight of a polysaccharide gum and up to 2% by weight of a crosslinker; the percentages being by weight with respect to the monomer hydrophilic

International Patent WO03018034 refers to an antacid and laxative tablet used for hyperacidity, secretion acid and constipation, in particular to a tablet containing magnesium oxide particles that do not blacken and are substantially free of difficulties for the formation of tablets and the appearance of spots during the formation of tablet, has a high magnesium oxide content and is taken easily because it quickly disintegrates in the mouth when administered together with water.

The Spanish patent ESO487749 refers to a procedure for obtaining a seed-based laxative of plantain and senna fruits consisting of the following stages: 1) grinding of plantain seeds and fruits of sen homogenization of ground products in a weight ratio of 4 to 5 parts of plantain for 1 sen, drying the formed composition; 2) kneading of the composition obtained with the minimum possible water; 3) granulate of the kneaded composition, drying it until wet maximum residual of 35 percent, followed by a graging process, after incorporating usual additives. The granulation is done in a cord press, using a separation knife to the press exit.

European patent EP00956777 refers to a synthetic mass forming laxative comprising a polymer crosslinked graft formed by a hydrophilic monomer partially neutralized up to 75%, up to 3% by weight of a polysaccharide gum and up to 2% by weight of a crosslinker, the percentages being by weight with respect to the hydrophilic monomer. The Polysaccharide gum is gum arabic, tragacanth or gum xanthan.

The researcher's patents Marcel-Jacques Chicouri, as the Spanish patent ES2087834, refer to new laxative compositions and their procurement procedure The new pharmaceutical compositions of laxative action, contain as active ingredients a laxative mucilaginous emollient, of plant origin, which can be ispágula or guar gum, and a powdered laxative lubricant, consisting of hardened microspheres that incorporate oil from paraffin or petrolatum, and a mixture or combination of one or more inert diluents or excipients. The procedure includes mix the emollient powder laxative with the microspheres until you get a homogeneous mixture and sift and dilute the mixture resulting with one or more pharmaceutically excipients acceptable. These compositions are suitable for use as laxative in the treatment of constipation.

However the researcher's compositions Chicouri MJ, are based on a mixture of ispágula (Psyllum) with paraffin oil, both in powder form, representing the fiber (bolus booster) and lubricant. Then they are added sennosides or other compounds with stimulating properties.

However none of these formulations are refers to a mild laxative liquid, with a pleasant taste, easily dilutable (dispersible) in water, soda, or food, without influencing on the organoleptic properties of diluents, which acts also as fiber (bolus booster) and lubricant compatible with intestinal mucus, but without the disadvantages of high doses of ispágula, neither of the side effects and contraindications of the oil.

Brief Description of the Invention

The present invention relates to a Soft laxative liquid formulation, pleasant taste, easily dispersible in water, soda, or liquid food, which does not alter the organoleptic properties of diluents, which acts as bolus booster and as a mucus compatible lubricant intestinal.

The liquid laxative formulation, composed of a mucilage, it is capable of forming a hydrated and resistant film, giving a huge contact surface when coating with the film the particles of a dispersed inert liquid. The movie hydrated does not dehydrate or metabolize during the passage through the gastrointestinal tract, does not release the inert liquid, nor reduce the hydrated volume This prevents bolus dehydration fecal and maintains the plasticity of feces with low doses of mucilago, without metabolic interference of the inert liquid, which it crosses the gastrointestinal tract intact and is eliminated unchanged with feces.

Detailed description of the invention

The objective of the present invention is the obtaining a liquid pharmaceutical composition with action corrector of constipation, in the form of a liquid that represents to an expanded hydrocolloid on an inert load. Hydrocolloid it is an inert fiber, that is, non-digestible, with high power of water absorption, which plasticizes stool and prevents its drying out, or  excessive dehydration

The present invention is based on an emulsion liquid, dispersion or stable microencapsulation of a liquid non-toxic inert stabilized by a non-toxic hydrocolloid, able to cross the gastrointestinal tract without altering, without digest or interfere with normal digestion processes.

An object of the invention is the preparation of a seaweed extract mucilage, oil emulsification medicinal, homogenization to particle size of 2-15 microns, ripening, adding flavoring and preservative The components of the present composition are:

1. Paraffin oil

Paraffin oil, also called indistinctly liquid paraffin, mineral oil, dense petroleum jelly oil, medicinal oil, etc., is recommended as a laxative in children over 6 years of age at a daily dose of 5-20 ml.
(1.5 - 5 ml / kg / day) and in adults at 15-60 ml.

Paraffin oil as such, meets, in a certain way grade, with the requirements of the ideal laxative, but causes many problems, such as:

-

\ vtcortauna poor distribution in the bolus,

-

\ vtcortauna reduced absorption of vitamins and fat-soluble medications,

-

\ vtcortauna runoff through the anal sphincter,

-

\ vtcortauna oily taste after administration,

-

\ vtcortauna possibility of pulmonary aspiration of oil droplets causing lipid pneumonia,

-

\ vtcortauna healing delays in the alimentary canal after operation,

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\ vtcortauna colic and gas by wrapping foods that ferment later,

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\ vtcortauna interaction with medications (vit. K, etc.).

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\ vtcortauna in chronic use, possibility of irritating intestinal lining, reacting as a foreign body.

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2. Carragahen Mucilage

Carragahen mucilage is obtained from seaweed (Lichen of Ireland, Chondrus Crispus ), with many applications in human medicine and food.

Mucilages are hydrocolloids that are used mainly to stabilize multiphase systems, such as feed emulsions. Your European identification number As a food additive is E-407 (Carrageenan). Currently the mucilages acquire importance as fiber food, demulcent, emollients, etc.

As the main factor to avoid or reduce constipation in most cases is to avoid dehydration of the bolus to avoid excessive absorption The volume of the bolus and its plasticity are maintained from the water. The strong water retention by the hydrocolloid formed by the molecules of carragahen and gum arabic, potentiated by glycerin, stabilizes the film on the emulsion particles, which allows a complete mixture with the bolus that in turn prevents dehydration of feces and reduction of their volume.

Chemically, Carragahen is a polymer with a molecular weight of 25,000 daltons, composed of molecules of sulfated galactose. These algae are currently grown industrially in several countries.

Carragahen is mainly used in the food industry as thickener, suspending, gelling, stabilizer of dairy products, meat, desserts, etc. Too It has wide use in cosmetics and pharmacy. It is a colloid that prevents syneresis.

Pharmacodynamically it is an emollient, demulcent, toxin absorber, immunostimulant and trainer Cud. Alimentary bolus. It is indicated in gastritis, ulcer gastrointestinal, atonic dyspepsia, diarrhea, dysentery, Respiratory system conditions (flu, colds, bronchitis, pharyngitis, emphysema, asthma, tuberculosis), dermatitis, cystitis, etc.

Pharmacokinetically, carragahen is considered food fiber resistant to digestive tract enzymes digestive (stomach and small intestine), but capable of being fermented by colon microflora (Bifidobacteria).

It is considered that it can reduce cholesterol serum (LDL), reduce the absorption of lipids and carbohydrates, modify the glycemic and insulinic response and protect the intestine thickness of diseases

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3. Arabic gum or Acacia fiber

Gum arabic is a polymer formed in the exudate of the plant called Acacia senegal . It is a dietary polysaccharide composed of arabinose, rhamnose and glucuronic acid.

The main job in the food industry It is as emulsifier, stabilizer, thickener, etc. It has a value Caloric half starch. It is also considered as fiber food with 95% soluble fiber, low caloric and not carcinogenic

Demulcent action, mucous softener inflamed or irritated; eliminates tenesmus and defecation painful Resists the action of digestive enzymes and stimulates the Bifidobacteria growth.

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4. Glycerin

Glycerin, in addition to fulfilling the mission of sweetener, helps with its moisturizing, plasticizing action, emollient, thickener, dispersant and lubricant.

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5. Benzoic Acid

It is a low toxic preservative (oral LD50 rat - 2,000 mg / kg) used at very low doses. The daily intake of 4-6 g does not produce toxicity but irritation gastric

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Therefore, the hydrophilic phase composed of the Carragahen mucilage and the gum arabic and glycerin mucilage, stabilizes the emulsion where paraffin oil acts as a charge encapsulated inert, without exerting its pharmacological action. He Mucilage, compatible with the intestinal mucus, is responsible for the lubrifying, emollient, softening and bolus forming action food

The variable auxiliary components of the Pharmaceutical forms for improving properties organoleptic in the case of oil-based laxative preparations of paraffin, they can totally change pharmacodynamic properties and pharmacokinetics of these laxatives. Clinical trials demonstrate the great pharmacokinetic variation of emulsions of  paraffin according to the type of emulsion.

Comparing the oil only with the emulsion stabilized with agar-agar, and with the emulsion stabilized with carragahen, it was observed in the case of oil alone, the presence of 30% free oil in the stool, 8% in the case of emulsion stabilized with agar-agar and, in the case of stabilization with carragahen, no free oil appeared and the emulsion particles had a similar distribution to the managed. This indicated the stability of the emulsion during the passage through the gastrointestinal tract.

The behavior in different ways pharmaceuticals in laboratory animals during transit Intestinal has also confirmed these facts. This indicates that the Pharmacological action is not always due to paraffin oil, which It is inhibited in the latter case.

A preferred quantitative composition is the next:

100

The method of obtaining the intestinal corrector It has the following stages:

a) Preparation of the hydrophilic phase (mucilage): Lichen of Ireland ( Chondrus Crispus )

Select in the market lichen branch, with maximum permissible humidity of 15% and maximum purity. Selection by viscosity of the 6% mucilage. Drying and matter selection premium acquired in ships on canvases, rejecting stems poor Crushing lichen on branch to get size of approx. 1 cm in length

In a reactor with steam heating chamber and paddle shaker (4 rpm) boil 100 liters of deionized water. Take 6 kg of crushed lichen and wash with cold water; pour the lichen washed in the reactor containing the water under stirring. Boil 30 minutes with stirring.

Pass the hot mucilage to a reactor Dual capacity intermediate, equipped with propeller stirrer, after passing through sieves and a Lavall centrifuge.

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b) Preparation of the lipophilic phase

Pour 100 liters of dense paraffin oil into a reactor with similar characteristics to that cited in step a). Stir and heat slowly and add 6 kg of rubber crushed arabic, after passing through sieve, until reaching the temperature of 23 ° C.

In a small stainless steel container They weigh 20 kg of glycerin at 20-30 ° C.

All vessels are connected with tubes, valves and pumps to the intermediate emulsion reactor primary.

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c) Formation of the primary emulsion

Pour simultaneously to the intermediate reactor and while stirring the lipophilic phase and glycerin. Keep stirring for 30 minutes

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d) Homogenization

The emulsion formed passes through a colloidal mill u homogenizer by ultrasound, pressure and blades adjusted for an average particle size of 5-15 microns, towards the cooling tank. After lowering the temperature at 45 ° C, the flavoring (vanillin) and the preservative (benzoic acid).

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e) Gel break

It is left in the refrigeration tank for 20-24 hours, for gel formation and lowering temperature up to about 24 ° C. It is stirred and taken sample for se particle size analysis and rest of parameters

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f) Packaging

Thanks to an industrial dispenser is performed Commercial packaging

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Examples of realization

The following specific examples to be provided here serve to illustrate the nature of the present invention. These examples are included for purposes only. illustrative and should not be construed as limitations to the invention claimed here.

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Example 1 Animal testing

With the emulsion (hydrocolloid), comparatively with other similar and control products, tests were carried out with mice and rats, to observe:

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\ vtcortauna effect on defecation (frequency and volume of stool) 17 hours after administration,

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\ vtcortauna stool oil removal (% retention or absorption).

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\ vtcortauna changes in particle size distribution (emulsion stability).

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In assessing the effect on defecation 30 male mice and 15 male rats were used. Mice are distributed in 3 groups of 10 animals each, and rats in 3 Groups of 5 animals. The mice received 10 ml of oil (20 ml of emulsion) / kg, and rats 5 ml, respectively. He told himself number of bowling issued by each animal and its total weight. The Amount of oil removed with feces was determined by extraction.

In determining the stability of emulsion as it passed through the intestinal tract, 20 were used male mice and 10 male rats. The mice were distributed in 2 Groups of 10 animals and rats in 5 animals. It was administered 20 ml of emulsion / kg (of mouse) (corresponding to 10 ml oil) and 10 ml of emulsion / kg (rat).

In the stool extract the size was determined of particles in an improved Neubauer chamber, taking Microscope photographs with Polaroid MicroCam. The distribution it was obtained from the diameter of 100 particles counted.

The most accurate determination of the curve of particle distribution (granulometric analysis) is obtained with a Mastersizer 2000 team.

The result of tests in rats and mice indicates that 83% of the emulsion is eliminated along with the feces in a period of 17 hours and without changing the frequency of distribution of particle size.

This liquid emulsion, obtained by means Mechanical and stabilized by hydrocolloids, it has the following Advantages compared to other similar products:

-

\ vtcortauna is distributed homogeneously in the intestinal food bolus,

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\ vtcortauna it has protective action of the mucosa of the intestinal tract,

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\ vtcortauna penetrates the feces without emulsion breakage, that is, without oil release,

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\ vtcortauna It is compatible with the mucus of the intestinal wall,

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\ vtcortauna does not penetrate the intestinal mucosa because it has the largest particle size,

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\ vtcortauna The hydrophilic colloid increases the water retention power,

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\ vtcortauna administered diluted is distributed evenly in the bolus and does not drain through the anal sphincter,

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\ vtcortauna The hydrocolloid provides mechanical, chemical and biological protection of the inflamed mucosa,

-

\ vtcortauna It does not smear the mucous membranes, nor does it form bags with oil,

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\ vtcortauna Increase the intestinal bolus by not metabolizing or dehydrating, giving a soft consistency to the stool,

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\ vtcortauna It lacks side effects due to lack of surfactants or free oil,

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\ vtcortauna Organoleptically it is a formulation of pleasant taste, texture and smell, which facilitates the administration guidelines and compliance by the patient,

-

\ vtcortauna Being a liquid formulation, it is easy to administer and distribute in the stomach and intestine, which facilitates its therapeutic effect.

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Pharmacological action

The stable complex of medicinal oil in the fiber-mucilage together with seaweed extract marinas (carrageenan), with vanilla flavor, mixes well with water and with the bolus, promoting in 6-8 hours a normal smooth defecation, effortlessly. Also no interferes with normal processes of digestion or dehydration and does not produce colic or gas. The mucilage, in the external phase, it also has an emollient action on the mucosa Gastric and intestinal.

Therapeutic indications for Liquid composition object of the present invention are the idiopathic constipation correction, fecal retention functional, encopresis, etc. In general, it is a reeducator bowel in coprostasis, which without proper treatment could have toxic consequences It is advisable for all types of constipation both alone and adjuvant, especially in people sensitive such as children, the elderly, pregnant women, nursing mothers, etc. It lacks purgative and irritating action and calms the mucosa irritated

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Comparative table of preparations based on medicinal oil

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one

10

Paraffin oil does not mix with water nor with the bolus, so its distribution or distribution It is very lacking. Bile acids probably facilitate cast, but in a poor and irregular way. On the other hand, the taste and organoleptic properties hinder its administration. Therefore, the documents present in the state of the technique that refer to oily formulations for purposes laxatives have a problem to manage producing annoying esopharyngeal reflux for having a completely oily base as well as an administration difficulty owning some properties unpleasant organoleptic for the patient.

However, with the present invention, solve the problem posed by these formulations, since at transform 1 ml of oil into particles of ten microns of diameter is achieved to increase the specific contact area with the intestine In addition, once the surface increase is achieved by reducing the particle size, it is necessary to stabilize this system that thermodynamically is very unstable, by means of the Interfacial tension reduction. This is how to cancel the Three phenomena responsible for emulsion instability:

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\ vtcortauna film breakage coalescence,

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\ vtcortauna aggregate formation flocculation,

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\ vtcortauna cremation by density difference between both phases.

The interdependence of the factors of stability (density, particle radius, viscosity) is reflected in the Stokes formula, which allows to calculate the speed from separation. The formation of an emulsion also depends on others. factors such as the diffusion coefficient of the emulsifier, the dynamics of its absorption, the dynamics of the elasticity of the film and of the interface, etc. The liquid mechanical oil emulsion of paraffin stabilized by hydrophilic colloids has mainly particles of 2 to 15 microns or higher, unable to cross mucous The emulsion is very stable both in storage and in the intestine. The stabilizing emulsifiers are hydrocolloids. natural non-digestible, which alone increase the bolus nutritional and prevent dehydration.

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Properties of paraffin oil according to the form pharmaceutical

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2

3

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As you can see above, the data experimental suggest that the formulation object of the present invention presents the best physicochemical properties as well as optimal laxative behavior. Therefore, the formulation object of the present invention meets the desired properties for a laxative corrector of intestinal transit so that It is a mild laxative liquid formulation, with a pleasant taste, easily dilutable (dispersible) in water, soda or food, without influence the organoleptic properties of diluents, which It also acts as fiber (bolus booster) and lubricant compatible with intestinal mucus, but without the disadvantages of high high doses of ispágula, neither of side effects and of oil contraindications

A first aspect that protects this invention is a corrective composition of intestinal transit gentle suitable for oral administration comprising a expanded hydrocolloid on an oily inert charge forming particles with a size of at least 2 to 15 microns.

Another important aspect of the present invention is that the hydrocolloid is selected from the group formed by mucilage of seaweed and plant mucilage, alone or in combination, of preferred form the mucilage comes from the Lichen of Ireland and / or from Gum arabic. Preferably the mucilage is of origin commercial called Carrageenan (E 407).

Another important aspect of the present invention is that the oil inert load is liquid paraffin.

Another important aspect of the present invention is that the composition is in liquid form, as a liquid emulsion, stable dispersion or microencapsulation of liquid.

Another important aspect of the present invention is that the composition preferably comprises:

101

A second important aspect of this invention relates to a process for the preparation of a Corrective composition of intestinal transit for administration oral that includes the following stages:

to)

Select a mucilage in the form of dry extract of carrageenan algae and prepare a mucilage by adding the extract to boiling water in stirring,

b)

Enter the product obtained from step a) in a double capacity intermediate reactor, equipped with stirrer helix, obtaining the hydrophilic phase of the composition laxative,

C)

Mix in a third reactor paraffin oil with gum arabic, stir and heat to a temperature of at least 23 ° C,

d)

Emulsify the hydrophilic phase of stage b) together with the lipophilic phase of step c) while adding glycerin, forming a primary emulsion,

and)

Homogenize the primary emulsion of stage d) until a particle size of 5 to 15 microns is obtained or higher,

F)

Stir and add a flavoring and preservative after lowering the temperature to 45 ° C, obtaining a formulation primary liquid, in the form of suspension, emulsion, dispersion, hydrocolloid and stable microencapsulation of liquid and transfer the formulation obtained to a refrigeration tank, until reaching a temperature of 24 ° C, and

g)

Transfer the formulation obtained in step f) to a dispenser for product packaging.

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Additionally when in the procedure for the preparation of the transit corrective composition Intestinal mucilage is used that is not of commercial origin (such as Carrageenan E-407), in addition to The procedure includes the following stages prior to stage b) previously cited and replacing stage a) above cited:

to)

Select a mucilage that comes from algae marine and / or plant,

b)

Dry crush the vegetable selected in the stage previous

C)

Wash the crushed vegetable with cold water previous

d)

Boil the washed vegetable with stirring in a reactor from the previous stage

and)

Sift and centrifuge the boiled mucilage of the stage d).

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A third important aspect of this invention refers to the use of the composition for the preparation of a laxative or transit corrective composition gastrointestinal, which is administered as a dispersible solution  in drinks and / or food.

Finally cite that the composition object of the The present invention has the advantages of having a pleasant taste, being easily dispersible in water, soda, or liquid food, not alter the organoleptic properties of diluents and act as a bolus booster and as a mucus compatible lubricant intestinal.

The objective of the present invention is the obtaining a liquid or semi-liquid pharmaceutical composition with corrective action of constipation, in the form of a liquid that represents an expanded hydrocolloid on an inert load. He hydrocolloid is an inert fiber, that is, non-digestible, with high water absorption power, which plasticizes stool, and prevents its drying, or excessive dehydration.

The present invention is based on an emulsion liquid, dispersion or stable microencapsulation of a liquid non-toxic inert stabilized by a non-toxic hydrocolloid, able to cross the gastrointestinal tract without altering, without digest or interfere with normal digestion processes.

An object of the invention is the preparation of a seaweed extract mucilage, oil emulsification medicinal, homogenization to particle size of at least 2-15 microns, ripening, adding flavoring and preservative

The liquid laxative formulation, composed of a mucilage, it is capable of forming a hydrated and resistant film, giving a huge contact surface, when coated with the film the particles of a dispersed inert liquid. The hydrated film, does not dehydrate or metabolize during pass through the gastrointestinal tract, not releasing the inert fluid, nor reducing the hydrated volume. This avoids the dehydration of the fecal bolus, and the plasticity of stool, with low dose of mucilage and without metabolic interference of the inert liquid, which crosses the tract intact gastrointestinal and is eliminated unchanged with feces.

Claims (11)

1. Corrective composition of the intestinal transit suitable for oral administration characterized in that it comprises an expanded hydrocolloid on an oily inert charge forming particles with an average size of 2 to 15 microns and because the composition is in liquid form, such as liquid emulsion, dispersion , or stable microencapsulation of liquid. 2. Corrective composition of the intestinal transit suitable for oral administration according to claim 1, characterized in that the hydrocolloid is selected from the group consisting of seaweed mucilage and plant mucilage, alone or in combination. 3. Corrective composition of the intestinal transit suitable for oral administration according to claim 2, characterized in that the mucilage preferably comes from the Lichen of Ireland and / or the Gum arabic. 4. Corrective composition of the intestinal transit suitable for oral administration according to claim 3, characterized in that the mucilage is preferably the dry extract of Carrageenans. 5. Corrective composition of the intestinal transit suitable for oral administration according to claim 1, characterized in that the oil inert load is liquid paraffin. 6. Corrective composition of the intestinal transit suitable for oral administration according to the preceding claims, characterized in that it preferably comprises:

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7. Procedure for the preparation of a corrective composition of the intestinal transit for oral administration as defined in claim 1 characterized in that it comprises the following steps:

to)

Select a mucilage in the form of dry extract of seaweed of commercial origin of the carrageenan type and prepare a mucilage by adding the extract to the boiling water in agitation,

b)

Enter the product obtained from step a) in a double capacity intermediate reactor, equipped with stirrer helix, obtaining the hydrophilic phase of the composition laxative,

C)

Mix in a third reactor paraffin oil with gum arabic, stir and heat to a temperature of at least 23 ° C,

d)

Emulsify the hydrophilic phase of stage b) together with the lipophilic phase of step c) while adding glycerin, forming a primary emulsion,

and)

Homogenize the primary emulsion of stage d) until you get a particle size of 5 to 15 microns or higher,

F)

Stir and add a flavoring and preservative after lowering the temperature to 45 ° C, obtaining a formulation primary liquid, in the form of suspension, emulsion, dispersion, hydrocolloid and stable microencapsulation of liquid, transfer the formulation obtained to a refrigeration tank, until reaching a temperature of 24 ° C, and

g)

Transfer the formulation obtained in step f) to a dispenser for product packaging.

Method for the preparation of a corrective composition of the intestinal transit according to claim 7, characterized in that when the mucilage of stage a) of claim 7 is not of commercial origin, said stage a) is replaced by the following steps:

to)

Select lichen on branch,

b)

Dry crush the lichen on selected branch in stage a),

C)

Wash the crushed lichen from the stage with cold water b),

d)

Boil the washed lichen with stirring in a reactor from stage c),

and)

Sift and centrifuge the boiled mucilage of the stage d).

9. Procedure for the preparation of a corrective composition of the intestinal transit for oral administration according to claim 7 characterized in that step e) is performed with a colloid mill or homogenizer by ultra-sounds, pressure and blades adjusted for a medium size of particles of 5-15 microns. 10. Use of the composition as defined in the claims 1 to 6 for the preparation of a composition laxative or corrective gastrointestinal transit. 11. Use of the composition as defined in the claims 1 to 6 for the preparation of a composition oral laxative in liquid form easily dispersible in drinks and / or food.