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Title:
NATURAL LAXATIVE COMPOSITION COMPRISING PRUNES, RAISINS, APRICOTS, DATES, FIGS, OLIVE OIL, SENNA AND HONEY
Document Type and Number:
WIPO Patent Application WO/2008/096171
Kind Code:
A2
Abstract:
Natural laxative composition for treating and preventing constipation with colon cleansing action. The present invention relates to the field of gastrointestinal medicine and discloses the natural laxative composition. The composition is prepared from the following ingredients: dried stone-out prunes, seedless raisins, dried stone-out apricots, dried stone-out dates, dried figs, olive oil, grape seed oil, dried alexandrian senna and honey. This laxative composition is primarily intended for effective treatment and preventing constipation of various severity. This composition is also developed for cleansing of the bowel by removing fecal impaction which results to improved digestion and regular bowel movement.

Inventors:
FILIPENKO, Vitaliy (21c Grafton Road, Kentish TownLondon, Greater London NW5 3DX, GB)
MOISA, Cornelia (21c Grafton Road, Kentish TownLondon, Greater London NW5 3DX, GB)
Application Number:
GB2008/050071
Publication Date:
August 14, 2008
Filing Date:
February 06, 2008
Export Citation:
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Assignee:
FILIPENKO, Vitaliy (21c Grafton Road, Kentish TownLondon, Greater London NW5 3DX, GB)
MOISA, Cornelia (21c Grafton Road, Kentish TownLondon, Greater London NW5 3DX, GB)
International Classes:
A61K36/736; A61K35/64; A61K36/482; A61K36/60; A61K36/63; A61K36/87; A61P1/10
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Claims:

Claims

[1] The natural laxative composition which is prepared from the following ingredients: dried stone-out prunes, seedless raisins, dried apricots, dried stone-out dates, dried figs, olive oil, grape seed oil, dried alexandrian senna and honey.

[2] A laxative composition as claimed in claim 1 comprising other pharmaceutically acceptable ingredients.

[3] Use of natural soluble and insoluble fiber from dried fruits in combination with senna herb in a laxative preparation as claimed in claim 1.

[4] The natural laxative composition as claimed in claim 1 to provide potassium ions

(K+) in the colonic mucus and to counteract the depletion of potassium ions caused by senna herb.

[5] The natural laxative composition as claimed in claim 1 that has dual action comprising of constipation treatment and gentle colon cleanse.

[6] A laxative composition as claimed in claim 1 obtained in different dosage forms selected from soft paste, liquid, powder for dilution, bar, easy-to-swallow encapsulated powder and other dosage forms that may be applicable to those ingredients claimed in claim 1.

[7] A method of treatment for relieving constipation by administering the natural laxative composition as claimed in claim 1.

[8] A method of treatment for relieving constipation as claimed in claim 7 comprising administering the natural laxative composition as claimed in claim 1 in a different dosage selected from soft paste, liquid, powder for dilution, bar, easy-to-swallow encapsulated powder and other dosage forms that may be applicable to those ingredients claimed in claim 1.

[9] A method of gentle and effective colon cleanse by administering the natural laxative composition as claimed in claim 1.

[10] A method of gentle and effective colon cleanse as claimed in claim 9 comprising administering the natural laxative composition as claimed in claim 1 in a different dosage selected from soft paste, liquid, powder for dilution, bar, easy- to-swallow encapsulated powder and other dosage forms that may be applicable to those ingredients claimed in claim 1.

Description:

Description

NATURAL LAXATIVE COMPOSITION FOR TREATING AND PREVENTING CONSTIPATION WITH COLON CLEANSING

ACTION

Background Art BACKGROUND

[1] Constipation is a condition of the digestive system where a person experiences hard feces that are difficult to eliminate; it may be extremely painful, and in severe cases (fecal impaction) lead to symptoms of bowel obstruction.

[2] Constipation is a symptom rather than a disease and is the most common digestive disorder among human beings and the rate of this disorder increases with age. Older adults are five times more likely to have problems with constipation than young people. Today in Great Britain, according to some sources, more than 50% of the population is suffering with constipation, in Germany the number is 30%, and in France about 20%. In Eastern European countries on average more than 50% of the population suffers from constipation!

[3] Constipation is caused by a number of factors including irritable bowel syndrome, lack of dietary fiber, inadequate water intake, eating disorders, some medications, psychiatric disorders, haemorrhoids, hormonal disturbances, diseases of the colon such as bowel cancer and other factors.

[4] Laxatives are the most commonly used medicines to help relieve constipation. There are several types of laxatives available on the market: bulk- forming laxatives such as bran (Trifyba) and ispaghula husk (Fybogel); osmotic laxatives such as lactulose; and stimulant laxatives like senna (e.g. Senokot). They all work in different ways to help relieve or prevent constipation. On the other hand, each of these laxatives has certain contraindications as it may cause severe side-effects and worsen the constipation condition even further posing risk to a person's health.

[5] Bulk-forming laxatives on their own may not help for several days to a week or more as they do not produce stimulating effect on the bowel. Also you need to increase you daily intake amount gradually until you get the desired effect. Because of that bulk- forming laxatives can cause wind and swelling in the abdomen. They can also block up the bowel.

[6] Osmotic laxatives work by drawing more water into the bowel. Over-using this type of laxatives can be extremely dangerous as it can damage the bowel and lead to an imbalance of essential chemicals in the body.

[7] Stimulant laxatives are usually comprised of herbal ingredients such as senna, aloe,

cascara or other laxative plants which work by speeding up bowel movement. Senna is most widely used laxative herb and has become a primary ingredient in the wide range of laxative medicines available on the market.

[8] Major problem with senna laxative is that if used in high doses or for prolonged periods of time, it can reduce the level of colonic potassium ions (K+) in the colonic mucus which results in electrolyte disturbances and fluid imbalances. This is one of the primary factors leading to 'lazy-bowel syndrome' - a dependency on laxatives to have any bowel movements as the muscles of the stomach and intestines gradually lose the ability to contract without being stimulated by the laxative. Considerable potassium depletion can be very dangerous for those with heart rhythm irregularities.

[9] The issue of nutrients depletion and bowel dependency becomes even more serious when it comes to administration of senna by children. Generally, senna laxatives are not recommended for children under age of 10-12 years old (some source state - 6 years!). This assumes that senna is safe and poses no health risk to those aged 10 to 18. The truth is that taking senna at this age may course far more serious health damage than in adult because till the age of 21 our body is still growing and developing. The body must be provided with nutrients, such as proteins, vitamins, minerals and other materials it needs for energy, growth, repair, and healthy functioning. Depletion of essential nutrients and vitamins (e.g.-potassium) caused by senna herb at the early age may result in irreversible dysfunction of the intestine tract, which in turn may lead to serious chronic problems with the entire digestive system at the later stages of life.

[10] Other disadvantage of senna laxatives sold today is that they contain none or little amount of natural fiber and moisture therefore they do not add sufficient amount of bulk and water to the stool. As a result, the laxative properties of senna medicines are limited only by stimulation action of sennocides and that leads to negative side-effects such as stomach cramps, wind, diarrhoea and other adverse reactions. Increasing number of reports show that senna laxatives with little or no fiber quite often do not bring any expected relief from constipation and sometimes make it even worse.

[11] Some of the senna laxatives available today have been improved by adding active ingredients that are very high in fiber content such as 'bran' and 'husk'.

[12] Bran is the hard outer layer of cereal grains. Although raw bran is very rich is dietary fiber and contains some vitamins, it is quite unpalatable. It doesn't provide the other nutrients found in fiber-rich foods such as wholemeal bread, wholegrain cereals, dried fruits, etc. Moreover, bran can reduce your body's ability to absorb calcium, magnesium, iron and zinc. Phytate (phytic acid) found in cereal fiber (bran) also binds with calcium, iron and zinc making them indigestible, which in turn causes malabsorption. Bran has also been shown to cause faecal losses of calcium, iron, zinc, phosphorus, nitrogen, fats, fatty acids and sterols, thus depleting the body of these

materials. Cooked bran has even less effect on the intestine than does a comparable amount of raw bran.

[13] Husk (hull) comes from the seeds from psyllium grain. Some people with irritable bowel syndrome feel worse when taking it and may do better with soluble fiber found in fruits, dried fruits and vegetables. People with an obstruction of the bowel or people with diabetes who have difficulty regulating their blood sugar should not use psyllium at all. Psyllium can also cause gas, and a laxative a day may keep some people in the bathroom all day. Psyllium is contraindicated in those hypersensitive to psyllium or to any component of a psyllium-containing product. It is also contraindicated in those with intestinal obstruction, fecal impaction, difficulty in swallowing and esophageal narrowing. Therefore supplemental psyllium must be taken with adequate amounts of fluids. Inadequate fluid intake may cause psyllium to swell and block the throat, esophagus or intestines.

[14] There are the potential hazards cited by the FDA in US: * Psyllium might impair absorption of minerals or fat-soluble vitamins. * Inactive ingredients in some brands might lessen psyllium's effectiveness. * Because no experience available, use of this product is not recommended in children below the age of 12.

[15] Thus, despite being rich source of dietary fiber, both bran and husk are not entirely safe as laxative because of potential health risk and adverse side-effects. Generally, its administration must be limited to a certain period of time and treatment for children and elderly people should be supervised by health specialist.

[16] Finally, most of the laxatives containing senna with fiber available today are produced in the form of tablets, capsules or powder. These types of dosage forms are very poor and inefficient means of delivering sufficient fiber to the intestine due to the small size of the tablet or capsule, lack of moisture and safety issues during administration. As mentioned before, bulk-forming laxative pills must be taken with enough water to prevent choking. These pills can get caught in the throat or esophagus and swell.

[17] To make matters even worse, most of the laxative remedies available today have quite unpleasant taste which deters people, particularly children from using these laxatives on a regular basis.

[18] As a result of all these problems, there remains a strong need for more advanced laxative medicine that will tackle those problems and eliminate negative side effects and adverse reactions described above. STATEMENT OF INVENTION

[19] The present invention comprehends a natural laxative composition which is prepared from the following ingredients: dried stone-out prunes, seedless raisins, dried stone-out apricots, dried stone-out dates, dried figs, olive oil, grape seed oil, dried alexandrian

senna and honey.

[20] The present invention proposes the senna-based composition which contains high amount of specifically selected ingredients high in potassium in order to maintain the levels of potassium ions (K+) in the colonic mucus and to counteract the negative effect of senna on colonic potassium ions and to prevent 'lazy-bowel syndrome'.

[21] The present invention proposes a laxative composition that contains high amounts of natural soluble and insoluble fiber other than bran and husk in composition with senna herb. Due to large amount and high moisture, fiber from dried fruits produces fast and effective bulk-forming action combined with stimulating effect of senna herb.

[22] The present invention proposes laxative composition that does not require any fluid intake. Also unlike most of the bulk-forming medicines, it does not require gradual increase in the intake amount and it starts working next day.

[23] It is an objective of the present invention to provide gentle and safe colon cleansing effect by gradually removing old hard fecal mass from the intestine walls.

[24] It is another objective of the present invention to provide effective laxative medicine which is unlike prior art, is very safe for administration by children from the age of 6 and elderly people.

[25] It is yet another objective of the present invention to provide a laxative medicine developed into high-moisture paste with delicious and sweet taste for easy and pleasant administration.

ADVANTAGES

[26] High content of potassium in selected ingredients will make sure that the amount of potassium in the colon mucus is not depleted. It means that this medicine can be administered for much longer time periods without experiencing any adverse side-effects.

[27] The present invention is a laxative composition that contains full spectrum of nutritional elements such as vitamins, minerals, carbohydrates, fats and proteins needed for healthy nutritious balance in the body.

[28] The laxative composition contains only natural ingredients and contains no chemical components, preservatives, salt, sugar, lactose, starch, glycerine, gluten, or other added elements, which means healthier choice for customers.

[29] This laxative composition effectively cleanses the bowel by removing fecal impaction which leads to improved digestion and can assist those who are trying to restore energy levels and get rid of excessive weight. INTRODUCTION TO DRAWINGS

[30] Figl is a detailed view of macro nutrients content in given invention presented in the table format.

[31] Fig2 is a detailed view of micro nutrients content in given invention presented in the

table format.

DETAILED DESCRIPTION

[32] The proposed invention comprises of the following ingredients: dried stone-out prunes: (45Og), seedless raisins (50g), dried stone-out apricots (500g), dried stone-out dates (50g), dried figs (45Og), olive oil (125g), grape seed oil (125g), dried alexandrian senna(400g) and honey (10Og).

[33] Each of the above-listed ingredients plays important role in providing unique constipation treatment properties of present laxative composition.

[34] Dried fruits are rich source of natural dietary fiber therefore make primary contribution into bulk-forming properties of this laxative preparation. Prunes, apricots and figs have high moisture content and are very rich in soluble and insoluble fiber (Figure 1). Thanks to their high moisture and fiber content and large amounts of the stool- loosening sugars such as sorbitol or fructose, they prevent constipation and have the ability to move the intestines. In addition to providing bulk and decreasing the transit time of fecal matter, thus decreasing the risk of colon cancer and haemorrhoids, insoluble fiber found in these dried fruits also provides food for the 'friendly' bacteria in the large intestine. When these helpful bacteria ferment insoluble fiber, they produce a short-chain fatty acid called butyric acid, which serves as the primary fuel for the cells of the large intestine and helps maintain a healthy colon. Dates are highly beneficial in the treatment of constipation as the roughage provided by it stimulates sluggish bowels. They help the intestine perform their function effectively and establish a colony of friendly bacteria in the intestines. Raisins are one of the few fruits that contain a reasonable level of tartaric acid that works together with fiber to help proper elimination of old fecal masses and help keep the colon healthy. Raisins decrease transit time and an increase in fecal weigh. They also reduce concentration of bile acids in the stools. All these bulk-forming and cleansing properties combined with well-known stimulant properties of senna herb make this laxative preparation far superior and more effective than those senna laxatives that don't contain fiber or those that contain fiber sourced from bran or husk.

[35] Figs, olive oil, grapeseed oil and honey aid digestion by cleansing and soothing the intestine. Due to their properties this laxative preparation is easily digested by sensitive stomach and doesn't cause problems during administration in contrast to senna laxatives manufactured in the form of tablets, capsules and powder. This is important feature particularly when laxative composition is administered by children from 6 years old and elderly people. Not only olive oil, grape seed oil and honey are tolerated well by the stomach but they also produce a positive effect on constipation. Olive oil activates the secretion of bile and pancreatic hormones, lowers the incidence of gallstones and increases the laxative strength and colon cleansing properties of the

whole composition. Grape seed oil is ecologically sound product which is low in saturated fat, contains natural chlorophyll and valuable antioxidants. Honey has a bactericidal effect on various gut bacteria known to cause diarrhoea and dysentery. Because sugar molecules in honey can convert into other sugars (e.g. fructose to glucose), honey is easily digested by the most sensitive stomachs, despite its high acid content. It helps kidneys and intestines to function better. Hence honey is beneficial for maintaining a healthy digestive system as well as combating illnesses such as constipation.

[36] Present invention contains wide spectrum of nutritional elements such as vitamins, minerals, carbohydrates, fats and proteins needed for healthy nutritious balance in the body. All of the dried fruits contained in the present invention have high amounts of iron, potassium, magnesium, copper and other valuable nutrients (Figure 2). High content of potassium contained in dried fruits will maintain the balance of potassium ions (K+) in the colonic mucus and counteract the negative effect of senna on colonic potassium ions and to prevent 'lazy-bowel syndrome'. By largely eliminating the risk of potassium depletion, this composition can be safely administered for longer periods of time not only by adults but also by children from age of six and elderly people. Also, high concentration of potassium and vitamin A in prunes, dates, figs, raisins and apricots stimulates enzymatic processes. These processes melt down fecal wall wastes and dissolve blockages. Lastly, high concentration of potassium prevents fluid retention caused by constipation.

[37] The exact values of macro nutrients (fiber, carbohydrates, sugar, protein, fat, etc.) and micro-nutrients (vitamins and minerals) contained in the ingredients of present composition can be observed from the Figure 1 and Figure 2.

[38] Finally, both olive oil and grape seed oil uniquely enhance the flavors of ingredients instead of overpowering them and leave no greasy aftertaste. Due to smoothness of oils, high content of glucose and fructose, individual natural taste of each type of dried fruit present composition has delicious and sweet taste for pleasant and easy administration by both children and adults.

[39] The preparation of the proposed invention is conducted in the following order. 40Og of dry senna leaf is fine-chopped using herb mincer or chopper. Chopped senna bits are steeped in 1800 ml of water that has just been boiled in suitable container. The container (saucepan, etc.) should be tightly sealed with lid and left for 2-3 hours so senna can absorb water. After that, the concoction should be chilled for 2 hours until reaching room temperature. All dried fruits must be soaked and thoroughly washed in the water and then placed in the electrical food processor or blender or any other suitable equipment and processed until they become smooth mixture. Then 125ml of olive oil and 125ml of grape seed oil are poured in paste and stirred properly until

completely absorbed. Without straining, senna concoction is added to the mixture and stirred to get smooth blend of all ingredients. Lastly, lOOg of honey is thoroughly stirred with mixture in order to obtain uniform high-moisture paste.

[40] The resulting composition is placed into suitable plastic or glass container and is ready for administration. Normal intake dose is one tea-spoon before sleep, but it can be increased or reduced depending on the severity of the constipation. Due to high- moisture and high natural fiber content present invention doesn't require any fluid intake before or after administration in contrast to existing bulk- forming laxatives. This laxative preparation starts working the next day without need to gradually increase the dosage for effective constipation relief. The medicine can be taken up to 30 days to bring deep colon cleansing effect and restore natural bowel movement without developing dependency and causing adverse side-effects. With adequate processing applied the above-described composition can also be developed into various forms such as: liquid, powder for dilution, bar, easy-to-swallow encapsulated powder, and other various dosage forms that may be applicable to those ingredients.

[41] Although foregoing invention has been described in details, for purpose of clarity and understanding, it will be obvious in the art the numerous modifications, alterations, and variations will be possible and practicable, while still remaining within the spirit of the invention and the scope of appended claims. Heading

[42]