MXPA97006457A - Composition for the treatment of diarrhea, its use and its preparation - Google Patents

Abstract

The present invention relates to a composition for treating diarrhea comprising carrots, rice, bananas and glucose in the form of powder, carrots and rice already cooked and dried before being milled into powder, the composition may also contain one or more pineapple , apples, soy and maltodextrin powder, an effective amount of the composition is administered to a patient, such as an infant, to treat and relieve diarrhea

Description

COMPOSITION PflRfl THE TREATMENT OF DIARRHEA, ITS USE AND ITS PREPARATION BACKGROUND OF THE INVENTION This invention relates to a composition for treating diarrhea, as well as to the use and preparation of said composition. Diarrhea is a diffuse and recurrent disease that attacks adults, children, infants and warm-blooded animals around the world. It has been estimated that in the United States, 16.5 million children under the age of five suffer from 21 to 37 million episodes of diarrhea each year, 10% of such episodes leading to a visit to the doctor. You have 200 thousand of the children are hospitalized and from 325 to 425 of the children die, most of them are infants under one year. On a global basis, after respiratory infections, diarrhea diseases are the leading cause of death among children under the age of five. In this way, it is evident that the control of this condition deserves the attention of the medical and veterinary communities and needs a therapeutic agent that can be administered easily, that is effective and of low cost. The proper relationship of nutrients, waste, electrolytes and water through the intestines depends on an appropriate balance of absorption and secretion of water and electrolytes by the intestinal epithelium. However, there are many forces that interfere with the normal functioning of the body, leading to diarrhea. These forces may involve many infections, for example, chemical or radiation, and may reflect the condition of the immune system, such as in HTV syndrome. The function of the anti-diarrhea agent is not usually to attack the cause of the condition, but to alleviate the symptoms and discomfort associated with that condition. The organisms responsible for diarrhea in Luyen those that cause arnibiasis, cholera, infectious colitis, and bacteremia (in particular of Salmonella) and of the specific organisms, Eschepchia coli, Giardia lamblia, Isospora belli, Shigella, Strongyloides stercoralis enterotoxi eniae and invasive , and essentially all organisms for which anti-microbial therapy that causes diarrhea in immunocompromised hosts is effective. Other organisms guilty of producing diarrhea include viruses, such as cyto egalovirus, enteric adenovirus, picornavirus, and rotavirus. Also, several parasites may be responsible for the condition. Included in this group, in addition to those already mentioned, are the species Entamoeba histolytica, Cryptosporidium and Microsporidia. Some of the chemical agents that cause diarrhea are adrenergic neuron-blocking agents, such as reserpine and guanethidine; antimicrobials, such as suflonamides, tetracyclics and most of the broad-spectrum agents; bile acids, secretions of the carcmoid turnor, for example, 5-hydroxytptamine and vaeoactive intestinal peptide; inert agonists and inhibitors of col inestarase; fatty acids; osmotic laxatives, such as sorbito and cathartic saline; prokinetic agents, such as metoclopharnide and dornpepdone; prostaglandins; quinidine; and laxative stimulants. In spite of the above, in an article in Ped al Aals 23: 523-524 (October 1994), the I) r. Robert A. Hoel-'elinan warns that: Non-antimicrobial medications should not be used for the treatment of diarrhea in infants and children since they do not provide any benefit and may worsen diarrhea by delaying intestinal mobility and thus the expulsion of organisms and toxins responsible for diarrhea, and preventing absorption and secretion. from the intestinal par-ed. Some drugs that delay intestinal mobility, such as diphenoxylate hydrochloride-atropine sulfate and loperated hydrochloride, can also cause respiratory depression, coma, and death.

PREVIOUS TECHNIQUE Among many cures described for diarrhea is that claimed in the U.S. Patent. No. 115,517, which involves a composition that contains opium, sugar, nutmeg and brandy. In the patent of E.U.A. Do not. 133,213, a similar composition consisting of white oak bark, cinnamon, cloves, dandelion root and brandy is claimed. While the first two patents were issued in the last century, the most recent treatment of diarrhea involves the administration of an aqueous oat extract, as claimed in the U.S. Patent. No. 4,765,901, issued in 1988. For the other side, in the Patent of E.U.A. No. 4,261,981, a method is claimed for preparing a composition from ragweed leaves, said composition being useful for treating diarrhea. Even more recently, two patents, Patent of E.U.A. No. 5,149,541 and U.S. Pat. No. 5,234,916, assigned to Procter- & Gamble Company, are concerned about the treatment of diarrhea with a drinking mix composition containing psyllium husk and a divalent cationic salt of a strong inorganic acid selected from magnesium sulfate, calcium sulfate, calcium chloride, sulfate zinc and / or zinc chloride and a vehicle for it. In the patent of E.U.A. No. 5,149,541, the same type of mix product is claimed for drinking, although the particular particle size distribution is also cited. Even more recently, the U.S. Patent. 5,330,755, issued July 19, 1994, issued to Nestec S.A., contains claims directed to a process for producing a locust bean product by treating sugar-free carob pods with steam over heated to pasteurize and dry the carob tree. The method of treating diarrhea by administering to a patient a pod of algarrobo in particle having more soluble soils in water is claimed in the assignee's first patent 5,043,160. The failure of the previous therapeutic agents to be presently recognizable testifies to their ineffectiveness in controlling diarrhea. However, several products are currently popular in the United States to treat this condition. These products include Imodiurn.RTM. (Loperamide hydrochloride, a piperidine opioid), Lomot? LR (diphenoxylate hydrochloride with atropine sulfate, diphenoxylate being related to narcotic mepepdine), sold by G.D. Searle a Co., and Pepto -?)? Srnol.RTM. (A bismuth subsalicylate composition) sold by Procter and Gamble. However, although opioids are described in The Pharmacology of Basis of Therapeutics by Goodman and Girnans, Eighth Edition, Pergamon Press, New York, (1990) on pages 924-925 as being effective in treating moderate to severe diarrhea, it is warned that opioids should not be used in patients with chronic ulcerative colitis or acute bacillary dysentery or ibian, since they seem to aggravate the ulceration procedure in the colon and may cause the development of toxic megacolon. It is said that many traditional remedies have little or no value in the treatment of acute infectious diarrhea; These include kaolin, pectin, lactobacillus and muscarinic antagonists. It has also been said that clonidine is effective in the treatment of diabetic patients with watery diarrhea syndrome. The substances available in the market provide balanced electrolytes to replace the losses of the mother plant and provide maintenance requirements. These products include Pedialyte * and Rehydralite *, sold by Ross Laboratories and provide water, dextrose, potassium citrate, sodium chloride and sodium citrate. These compositions are expensive and are rarely stored in homes for immediate use when diarrhea begins. Therefore, clear liquids such as ginger, soda, gelatin, tea, apple juice, and chicken broth are used, none of which contain appropriate concentrations of glucose or electrolyte, probably doing more harm than good. In any case, unlike the present invention, the above drugs are not inexpensive, natural substances that are ex- tremely effective in eliminating diarrhea symptoms.

BRIEF DESCRIPTION OF THE INVENTION The present invention provides a product that is active in the treatment of diarrhea in humans, including infants and children, as well as in warm-blooded animals, generally including dogs, horses and birds. In addition, the claimed composition does not have the disadvantages exhibited by the products now on the market.

The present invention involves a composition comprising carrots, rice and glucose prepared in a manner described subsequently. The composition may also include one or more of bananas, pi, soy and apples. In general, the formulations employed to treat diarrhea comprise from about 40 to about 60% by weight of dried carrots, from about 10 to about 25% by weight of dry cooked rice, and from about 7 to about 15%. in glucose weight. In addition, 0.5 grams of rnaltodextrin is included in each formulation to bind the composition. However, although it has been shown that the above amounts provide desirable results, the most important consideration is the effectiveness of the composition. It is expected that slightly more or less than one component can be used with respect to another without significantly changing the recorded results. The additional presence of bananas, pi to, soy and / or apples, has been found to improve the activity of the composition, in addition to making people more palatable to the patient. Due to the acidity of the pi a, the weight percentage of this component is kept at a relatively low value, as shown in the examples. On the other hand, while soy is useful, due to its fiber, the taste of soy is not universally popular. This property determines the amount of soybeans used. The weight of apples present in any particular formulation would usually approximate that of bananas. However, it is important that each component, as indicated below, be cooked, then dried and ground into a fine powder before being administered to a patient for the treatment of diarrhea.

DETAILED DESCRIPTION OF THE INVENTION The materials for formulating the anti-diarrhea composition are prepared as follows: Carrots - These are washed, sliced and placed in water, without salt, until the water reaches the boiling point. They are cooked for about 10 to 15 minutes until they soften and then drain and put in a food dehydrator. The carrots are dehydrated in a vacuum with a minimum of heat. This can take 24 hours to obtain a completely dry product. Afterwards, the dried carrots are ground into a fine powder. However, it has been observed that said powder has a scratchy feeling when touched by the fingers. Rice Cereal - This ingredient is used in the form obtained as a commercial preparation, ie Gerbers rice cereal *. It dehydrates, if it is not properly dried, and then it is ground. When the rice is in the form of a powder, it is added to the carrots and mixed dry. Bananas - Yellow bananas are sliced, dehydrated in a vacuum dehydrator and ground-into a powder. The fruit is mixed dry with the other components of the composition. Pineapple - The fruit is very much sliced and placed in a vacuum dehydrator, where the water is removed. The dry pi is ground into a powder and added to the other components. Because the pineapples have a pronounced acid taste, the amount of pineapple, by weight, is limited to about 5 grams per charge of the composition containing about 70 to 120 grams of material. Soy - This is prepared with its capsule. The soybeans are cooked until softened, then dried and milled. Apparently infants do not like this taste. While natural flavors have been added to disguise the taste, such flavors usually have excess sugar and cause problems, themselves. To avoid problems, bananas are added instead of the separate natural flavors and glucose is used to sweeten. Of course, other sugars that can be digested can be used instead of glucose, but they can be more expensive. Apples - These can be used, up to about 15 grams, to improve the flavor of the composition. The apples are sliced, cooked like carrots and then dehydrated in the vacuum dehydrator. Apple puree is not used as diarrhea worsens. To prepare the composition, a miller "Gloria Bean Coffee Grinder" was used. As previously mentioned, everything was ground into a fine powder. As already noted, carrots tend to be a little scratchy. However, even with carrots, most of it becomes a fine powder. It has been found that the composition containing a vegetable, a grain and a fruit, including carrots and rice, is beneficial in particular.

ADMINISTRATION The powder composition can be administered to a co-infant or an addition to a formula, with a non-carbonated soda, such as cola or ginger, or with nonfat yogurt. Yogurt, although a dairy product, used in small amounts, with the formulation, is effective in controlling diarrhea in infants. However, there is no real restriction as to the manner in which the formulation is administered to a patient. Yes. an unpleasant vehicle or component is avoided, the patient will more likely ingest the composition. It is critical to the efficacy of the invention that the patient swallows the composition. Although the composition has been used primarily to control diarrhea in infants, children and adults, it has also been used for the same purpose with animals. Newborn horses often develop diarrhea at 9 days old. Previously, Pepto-Bismol * has been administered in relatively large amounts. On the other hand, two doses of the present product (4 tablespoons for the first dose and a smaller amount for the second dose) stop the diarrhea in the newborn horse. In the administration to a foal, two tablespoons of the composition were mixed with hot water and given with a bottle. However, since the horse refused to swallow the composition, the product was mixed with the mare's milk and administered through a tube in the horse's stomach. This stopped the diarrhea. Likewise, a dog was treated with the present product with similar results. The product stopped the diarrhea. A parakeet suffering from diarrhea was administered a bit of the formulation with a little food. The type of results were obtained where diarrhea is relieved. It was found that several different formulations are effective in stopping diarrhea and are accepted by patients. These products are described in the following examples: EXAMPLE 1 The listed ingredients were prepared as previously described and formulated in a composition in the indicated amounts.

Carrots 40 grams Rice cereal 10 grams Bananas 15 grams Pi to 5 grams Glucose 10 grams Mult i dext fight 1/2 gram EXAMPLE 2 Carrots 40 grams Cer-eal of arro; 10 grams Bananas 15 grams Glucose 10 grams Mul idext ri to 1/2 gram EXAMPLE 3 Carrots 40 grams Rice cereal 20 grams Pi to 5 grams Glucose 10 grams Multidextrine 1/2 gram EXAMPLE 4 Carrots 40 bouquets Rice cereal 20 grams Soy 15 grams Glucose 10 grams Multidextrine 1/2 bouquet EXAMPLE 5 Carrots 40 bouquets Rice cereal 20 grams Soy 5 grams Bananas 15 grams Pi to 5 grams Glucose 10 grams Apple 15 bouquets Multidextrine 1/2 gram EXAMPLE 6 Carrots 40 grams Rice cereal 20 grams Soy 5 grams Bananas 15 grams Glucose 10 grams Mult idextri na 1/2 gr-arno EXAMPLE 7 Carrots 40 grams Rice cereal 20 grams Soy 5 grams Pineapple 5 grams Glucose 10 grams Multidextrine 1/2 gr-arno In addition, the apple can be replaced by banana and the pineapple can be used in small amounts in each formulation.

DOSE Because the composition is composed of completely natural products, there is no doubt of toxicity for the patient. In humans, the dose depends on the age of the patient. Infants are fed 1/2 teaspoon of the formulation with fluid, while children, adults and large animals are administered more in proportion, as shown below: Dosage in humans administered 3 times a day: Age Quantity 0-3 months average teaspoon 3-6 months 1 teaspoon 6-12 months 1 ^ teaspoon 1-2 years 2 teaspoons 2-6 years 1 tablespoon 6-12 years 1 to 1; spoonful over 12 years 2 tablespoons Powder is given to a patient suffering from loose bowel movement. Veterinary doses depend to a large extent on the size of the animal. When the animal weighs less than 4.53 kg, half teaspoon of the composition is administered. In larger animals, the dose depends on the size and severity of the condition. The form of the composition is not limited to a powder. It can also be given as a capsule or as a tablet. The capsules include any conventional capsule form, such as those made from gelatin, and the tablets are those conventionally used in the pharmaceutical field. The tablets can be chewing tablets or other types that the patient prefers. Also, the powder can be placed in a compatible liquid and offered for sale or administration in this form. The powder, if kept in a freezer, will maintain its effectiveness over a long period. The powder placed in a freezer for almost a year was still effective in treating a case of diarrhea. When the composition is administered to a patient, it cures the symptoms of diarrhea, which usually do not recur. The mechanism by which this is carried out is not understood, but has been documented by patients who have been treated. Since it can not be determined whether the specific size of the powder particles contributed to the activity of the composition, the particles were measured and found to have a particle size distribution as shown below.

Example No. Size of mesh size Amount of nominal or past average retained pa icle (μ) (%) 1 148 > 60 25.27 < 270 26.13 2 178 > 60 30.29 < 270 25.58 3 149 > 60 25.12 < 270 25.58 4 168 > 60 23.4 < 270 16.26 5 131 > 60 17.95 < 270 24.81 6 162 > 60 22.45 < 270 16.04 7 182 > 60 24.8 < 270 15.41 The nominal average particle size was determined from the sieve analysis data using the Sigmaplot for Uindows (version 2.0). From the above data, it is evident that the size of the powder particles is between 131 and 182 microns, the average being approximately 165 microns. Regardless of the freedom of toxic effect compositions, it is not prescribed for patients suffering from very high fever, lethargy or bloody diarrhea. These symptoms are indicative of bacterial diarrhea, as well as bactepeinia and sepsis, thus giving rise to a suspicion of other severe systemic disturbances. However, in the usual case of diarrhea, as previously described, the composition is quite effective and its use is free of adverse effects. Only the preferred embodiment of the invention and some examples of its versatility are shown and described in the present description. It should be understood that the invention is not only capable of being used in various other combinations and environments, but also of changes or modifications within the scope of the concept of the invention as expressed herein.

Claims (40)

NOVELTY OF THE INVENTION CLAIMS

1. - A therapeutic composition for the treatment of diarrhea comprising carrots, rice and glucose in the form of powder, carrots and rice well cooked and dried before being milled into a powder.

2. The composition according to claim 1, further characterized in that it also includes bananas in a dry and powder form.

3. The composition according to claim 2, further characterized in that it also includes pineapple in a dry and powder form.

4. The composition according to claim 1, further characterized in that it also includes pineapple in a dry and powder form.

5. The composition according to claim 1, further characterized in that it also includes soy in a dry and powder form.

6. The composition according to claim 2, further characterized in that it also includes soy in a dry and powder form.

7. The composition according to claim 3, further characterized in that it also includes soy in a dry and powder form.

8. - The composition according to claim 1, further characterized in that it also includes apples in a dry and powder form.

9. The composition according to claim 7, further characterized in that it also includes apples in a dry and powder form.

10. The composition according to claim 3, further characterized in that it also includes apples in a dry and powder form.

11. The composition according to claim 1, further characterized in that the carrots are present on a scale of about 40 to about 60% by weight based on the entire composition.

12. The composition according to claim 2, further characterized in that the carrots are present on a scale of about 40 to about 60% by weight based on the entire composition.

13. The composition according to claim 2, further characterized in that the bananas are present on a scale of up to about 25% by weight based on the entire composition.

14. The composition according to claim 12, further characterized in that the bananas are present on a scale of up to about 25% by weight based on the entire composition.

15. The composition according to claim 1, further characterized in that the height of the fight is present in an amount of about 0.5 grams based on a combined weight of the other components in the scale of about 70 to about 120 grams. .

16. The composition according to claims 3 and 15, further characterized in that it comprises 40 g of carrots, 10 g of rice, 15 g of pineapples, 5 g of pi a, 10 g of glucose and 0.5 g of maltodextpna.

17. The composition according to claims 2 and 15, further characterized in that it comprises 40 g of carrots, 10 g of rice, 15 g of bananas, 5 g of glucose and 0.5 g of maltodext.

18. The composition according to claims 4 and 15, further characterized in that it comprises 40 g of carrots, 20 g of rice, 5 g of pineapple, 10 g of glucose and 0.5 g of maltodext na.

19. The composition according to claims 5 and 15, further characterized by comprising 40 g of carrots, 20 g of rice, 10 g of glucose, 15 g of soybeans and 0.5 g of maltodext squabble.

20. The composition according to claims 9 and 15, further characterized in that it comprises 40 g of carrots, 20 g of rice, 15 g of bananas, 5 g of pineapple, 10 g of glucose, 5 g of soy, 15 g of apple and 0.5 g of maltodext na.

21.- The composition in accordance with the 99 6 and 15, also characterized because it comprises 40 g of carrots, 20 g of rice, 15 g of bananas, 10 g of glucose, 5 g of soybeans and 0.5 g of maltodextrin.

22. The composition according to claim 1, further characterized in that it comprises 0 g of carrots, 20 g of rice, 15 g of bananas, 10 g of glucose, 5 g of soybeans and 0.5 g of tri a maltode.

23. A process for preparing a therapeutic composition according to claim 1, further characterized in that the carrots are washed, sliced and boiled in water until tender.; then vacuum-dried with a minimum of heat; and ground into a fine powder; the rice kernel is dried under vacuum with a minimum of heat, like carrots, and ground into a fine powder; and the carrots, rice and glucose are mixed together and further ground into a fine powder.

24. The use of a composition according to claim 1 in the preparation of a medicament for treating and alleviating diarrhea in a patient suffering from diarrhea.

25. The use according to claim 24, further characterized in that the composition also includes bananas in a dry and powder form.

26. The use according to claim 24, further characterized in that the composition also includes pi a in a dry and powder form.

27. - The use according to claim 24, further characterized in that the composition also includes soy in a dry and powder form.

28. The use according to claim 24, further characterized in that the composition also includes apples in a dry and powder form.

29. The use according to claim 24, further characterized in that the medicament is administered in a vehicle selected from the group consisting of sweetened aqueous drink and non-fat yogurt.

30. The use according to claim 24, further characterized in that the medicament is administered mixed with food.

31. The use according to claim 24, further characterized in that the medication is administered mixed with breast milk.

32. The use according to claim 24, further characterized in that the patient is a human being.

33. The use according to claim 32, further characterized in that the patient is an infant.

34. The use according to claim 32, further characterized in that the patient is a child.

35.- The use according to claim 32, further characterized in that the patient is an adult.

36. The use according to claim 24, further characterized in that the patient is a warm-blooded animal.

37.- The use according to claim 36, further characterized in that the animal is a horse.

38.- The use according to claim 36, further characterized because the animal is a dog.

39.- The use according to claim 36, further characterized in that the animal is a parakeet.

40. The use according to claim 24, further characterized in that the medicament is administered in a form selected from the group consisting of powders, capsules and tablets.