AU2007101185A4 - A natural product to relieve the symptoms of GERD - Google Patents

Description

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION INNOVATION PATENT A NATURAL PRODUCT TO RELIEVE THE SYMPTOMS OF GASTROESOPHAEGAL REFLUX DISEASE [GERD] MANIFESTING AS GASTRIC DISTRESS, ACID REFLUX AND HEARTBURN.

The following statement is a full description of this invention, including the best method of performing it known to me: A NATURAL PRODUCT TO RELIEVE THE SYMPTOMS OF c GASTROESOPHAEGAL REFLUX DISEASE [GERD] MANIFESTING AS U GASTRIC DISTRESS, ACID REFLUX AND HEARTBURN.

t' FIELD OF INVENTION The present invention relates generally to the easing and relief of the symptoms of GERD gastroesophageal reflux disease (gastric acid, reflux and heartburn), 0 and more specifically to over the counter (OTC) natural compounds and the preparation of remedial products and therapeutic uses thereof to relieve GERD.

BACKGROUND TO THE INVENTION SGERD is characterised by the backflow (reflux) of acid or stomach contents from Sthe stomach to the esophageus. The main symptoms are heartburn, stomach pain, throat discomfort and difficulty swallowing. There is no cure for GERD the symptoms can only be relieved or managed.

An estimated 60% of the population suffers from regular or intermittent bouts of reflux and heartburn. Feedback Research Services, a healthcare research firm in the USA has found that 44% of American adults who suffer recurring, chronic heartburn and acid reflux, spend over US$1 billion each year on over the counter remedies alone.

Heartburn, a burning sensation is the most common symptom of acid reflux. It is caused by stomach acid backing up into the esophageus and throat. It can cause severe pain, difficulty swallowing and sleep disturbance. It is worse after eating, lying down flat, bending over or exercising. One section of the community particularly affected by reflux and heartburn is pregnant women, especially in their third trimester. People with elevated blood pressure are often unable to use current treatments to relieve their gastric reflux because of the high sodium content of these products.

Consumers are becoming increasingly cautious about the type and quantity of drugs and chemicals they ingest, whether self medicating with over the counter preparations or using prescribed drugs.

Until now, the treatment for GERD was either prescription drugs or OTC antacids. The five types of medications currently available are: Antacids. They are available without a prescription and claim to neutralise stomach acid. They do not heal damage to the esophagus caused by stomach acid.

(ii) Foaming agents. They are available without a prescription and claim to work by covering the contents of the stomach with foam to prevent reflux. They do not heal the damage from stomach acid.

(iii) H2 blockers (technically antihistamines). Medications that claim to reduce the acid levels in the stomach by blocking the chemical used to make acid. They are OTC and prescription.

(iv) Proton pump inhibitors (PPI). Medications that claim to reduce the amount of acid in the stomach by inhibiting its production. They are OTC and prescription.

O Prokinetics. Medications that claim to strengthen the lower esophageal Ssphincter (LES) muscle, which helps food to pass through the digestive system Smore quickly. They do not affect the level of stomach acid produced.

The vast majority of prescription or OTC antacids contain combinations of the following: alumina, calcium carbonate, sodium bicarbonate, magnesia, magnesium carbonate, magnesium alginate, simethicone.

Significant difficulties with the current range of OTC or prescription medications to treat GERD have been reported. They include: oO Prescription drugs like Prilosec, Prevacid or Nexium may help treat symptoms in the short-term (4 to 8 weeks, maximum), but if these drugs are taken for longer 0periods they can stimulate the stomach to produce increased amounts of acid.

SThis occurs because the body produces excess of a hormone called Gastrin r"- 0when these drugs are taken. Over production of Gastrin has been shown to lead Sto cancer in the esophagus or pancreas as cells in these areas grow too large as a reaction to the over production of Gastrin, and greatly increase the risk of developing cancer in these areas.

'Propulsid' was widely used in the USA for acid reflux and subsequently withdrawn from the market a few years ago after causing many deaths. Taking these prescription drugs with other medications, has been shown to cause serious reactions.

Antacids like Pepcid, Zantac, Tagamet, Rolaids, Quick Eze and Tumrns only mask the underlying problem of heartburn and acid reflux. Most antacids contain excessive amounts of minerals such as Sodium, Aluminum, Calcium, and Magnesium. Excessive mineral imbalances can be very harmful, leading to cancer, hypertension or possibly Alzheimer's Disease.

The Proton Pump Inhibitors like Prilosec and Prevacid, and the H2 blocker agents like Zantac, Pepcid and Tagament have been shown to be quite harmful.

These drugs dramatically reduce the amount of hydrochloric acid in the stomach, drastically diminishing the ability to digest food properly. This reduction in the amount of stomach acid also reduces a very important defense mechanism against food borne infections and increases the likelihood of severe gastric upset or even food poisoning. British medical scientists have recently linked PPI drugs to Osteoporosis.

Cisapride, a member of the Prokinetics class was withdrawn from the market for causing long QT syndrome (a serious heart condition).

If let untreated over a period of time, GERD, can progress from being painful or irritating to causing coughs and asthma attacks, fluid in the sinus and middle ear, esophagitis (irritation and ulcers in the esophagus lining), Barrett's esophagus, Stricture (scarring in the esophagus), dissolving teeth enamel to requiring surgery.

There is a tendency amongst chronic suffers of GERD to over medicate.

Symptoms of overdose can be similar to the medication's side effects, but are usually more severe. They include: t"- Continuing feeling of discomfort Bone pain N Severe and continuing constipation Persistent loss of appetite Mood or mental changes Muscle pain or twitching Nausea, vomiting, colitis Nervousness and restlessness Unusual tiredness or weakness Slow breathing Swelling of wrists or ankles Excessive weight loss Difficult or painful urination Irregular heartbeat Dizziness or lightheadedness oo00 There is an increased risk in taking Antacids for some groups in the community.

Antacids are frequently used to relieve heartburn and indigestion associated with pregnancy. There have been reports that taking high doses of antacids during pregnancy may cause side effects in babies after birth. In addition, pregnant women who tend to retain water should avoid medications with high level of sodium (salt), such as antacids. Antacids containing Aluminum, calcium or magnesium may pass into breast milk with the potential to cause problems in nursing infants.

Young children may experience significant side effects when taking medications like antacids containing aluminum or magnesium. This is particularly true of children who are dehydrated or who have kidney disease.

Antacids that contain Aluminum can worsen certain conditions in elderly people, especially those with bone density problems osteoporosis) or Alzheimer's disease. Prescription drugs can build up toxins in the body, especially in the elderly because the metabolism slows down and the body is less able to process the medication effectively.

A number of drug and other adverse interactions with antacids have been reported. Many antacids contain a warning that patients who take them should consult their physicians before taking any additional prescriptions, OTC medications, nutritional supplements or herbal medications. The reported adverse reactions include the following substances: Tetracycline antibiotic (can decrease the effects of both medications) Cellulose sodium phosphate (used to prevent formation calcium containing kidney stones) Fluoroquinolones (medications used to treat bacterial infections) Isoniazid (medication used to prevent tuberculosis) Ketoconazole (medication used to treat fungal infections) Methenamine (antibiotic used to treat urinary tract infections) Mecamylamine (antihypertensive used to treat high blood pressure) ACID BUSTER acts in quite a different way. It doesn't mask the symptoms, suppress the stomach acid or empty the stomach of food as prescription drugs and OTC antacids do. It is a potent alkalizing compound that actually changes the Ph of acid to become neutral or alkaline. (The human body functions best with an acid/alkaline balance between Ph It contains herbs that settle an upset stomach and aid the synthesis of the bile acid used to digest fats and animal proteins.

S ACID BUSTER is made from 100% natural ingredients and contains no chemicals, animal derivatives, salt, alcohol, caffeine, sugar, yeast, milk or dairy derivatives, eggs, peanuts, starch, gluten, wheat, soy beans, crustacean shell fish (crab, shrimp, lobster), S artificial colours, artificial flavours. Extensive testing has shown no contraindications or S adverse interactions.

00 oo SSUMMARY OF THE INVENTION The invention has four embodiments.

SThe first embodiment is a liquid containing a number of active ingredients: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, ,D-limonene, figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless grapes, passionfruit, pear, pineapple, umeboshi plum, watermelon from 10% to about In 00 b) Pure vegetable juices/extracts, including but not limited to alfalfa, Sasparagus, avocado, basil, black radish, cayenne (capsicum), cucumber, endive, Skale, kelp, karengo (Porphyra columbina), kudzu root, lecithin, parsley, seaweed, R 10 sprouts and watercress, wheat grass from 10% to about Sc) Stomach and digestive tract calmatives including but not limited to ulmus Srubra, peppermint, zingiber officinale roscoe, fritillary bulb, cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal proteins including but not limited to pepsinogen, glycine and fructus crataegi from 1% e) A natural thickening agent including but not limited to agar agar, pectin or psyllium mucilage from 0.01% to about f) A natural, alkalising sweetener including but not limited to Stevia rebaudiana from 0.01% 1%.

g) An alkalising food preservative (if necessary), including but not limited to Natamycin, nisin, propionic acid, benzoic acid or sorbic acid 0.01% 0.1%.

The product is designed to neutralise gastric acid. It is a liquid that is swallowed when the symptoms and indicators of gastric distress and acid reflux occur or prior to eating acid producing foods. Usually one 20ml dose is sufficient to relieve the acid reflux symptoms. Further doses may be required if symptoms persist in more severe cases. It can also be taken just prior to eating.

This embodiment can be packaged in a range of dispensers and delivery methods such as but not limited to a glass or plastic bottle, a glass or plastic bottle with measured dose fitting, sealed straws (plastic or water proofed paper) containing a single, measured dose.

The second embodiment is a powder, containing a number of active ingredients: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, Dlimonene figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless grapes, passionfruit, pear, pineapple, umeboshi plum, watermelon, from 10% to about b) Pure vegetable juices/extracts, including but not limited to alfalfa, asparagus, avocado, basil, black radish, cayenne (capsicum), cucumber, endive, kale, kelp, karengo (Porphyra columbina), kudzu root, lecithin, parsley, seaweed, sprouts and watercress, wheat grass from 10% to about O c) Stomach and digestive tract calmatives including but not limited to ulmus Srubra, peppermint, zingiber officinale roscoe, fritillary bulb, cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal proteins including but not limited to pepsinogen, glycine and fructus crataegi from

C

c 1%-10% e) A natural, alkalising sweetener including but not limited to Stevia rebaudiana from 0.01% 1%.

00 The pure fruit juices are vacuumed distilled to obtain a powder (and blended with a natural sweetener if necessary). The product can be added and dissolved 0 easily in water or an alkaline fruit or vegetable juice, then drunk.

The product is designed to neutralise gastric acid. It is a powder, dissolved in a Sliquid that is swallowed when the symptoms and indicators of gastric distress and c 15 acid reflux occur or prior to eating acid producing foods. Usually one spoonful dissolved in a small glass of water or fruit/vegetable juice is sufficient to relieve the acid reflux symptoms. Further doses may be required if symptoms persist in more severe cases.

This embodiment can be packaged in a glass or plastic jar with screw top, a glass or plastic jar with a flip top. It can also be packaged in single use sachets (or straws) containing a measured dose of the powdered product.

The third embodiment is a compressed lozenge, containing a number of active ingredients: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, D-limonene, figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless grapes, passionfruit, pear, pineapple, umeboshi plum, watermelon, from 10% to about b) Pure vegetable juices/extracts, including but not limited to alfalfa, asparagus, avocado, basil, black radish, cayenne (capsicum), cucumber, endive, kale, kelp, karengo (Porphyra columbina), kudzu root, lecithin, parsley, seaweed, watercress, wheat grass from 10% to about c) Stomach and digestive tract calmatives including but not limited to ulmus rubra, peppermint, zingiber officinale roscoe, fritillary bulb cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal proteins including but not limited to pepsinogen, glycine and fructus crataegi from 1% e) A natural thickening agent including but not limited to agar agar, pectin or psyllium mucilage from 0.01% to about f) A natural, alkalising sweetener including but not limited to Stevia rebaudiana from 0.01% 1%.

The pure fruit juices are vacuumed distilled to obtain a powder (and blended with a natural sweetener if necessary). The powder is then compressed into a lozenge form, being a single dose.

O The product is designed to neutralise gastric acid. It is a lozenge that is sucked Sor chewed when the symptoms and indicators of gastric distress and acid reflux Soccur or prior to eating acid producing foods.. Usually one lozenge is sufficient to relieve the acid reflux symptoms. Further lozenges may be required if symptoms S 5 persist in more severe cases.

This embodiment can be packaged in a paper/aluminium roll (like "Lifesaver" sweets), a push out blister sheet or a box or bag containing individually wrapped lozenges.

00 oo The fourth embodiment is a capsule, containing a number of active ingredients: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, Dlimonene, figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless Sgrapes, passionfruit, pear, pineapple, umeboshi plum, watermelon from 10% to about b) Pure vegetable juices/extracts, including but not limited to alfalfa, asparagus, avocado, basil, black radish cayenne (capsicum), cucumber, endive, kale, kelp, karengo (Porphyra columbina), kudzu root, lecithin, parsley, seaweed, watercress, wheat grass from 10% to about c) Stomach and digestive tract calmatives including but not limited to ulmus rubra, peppermint, zingiber officinale roscoe, fritillary bulb cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal proteins including but not limited to pepsinogen, glycine and fructus crataegi from 1% e) A natural thickening agent including but not limited to agar agar, pectin or psyllium mucilage from 0.01% to about f) A natural, alkalising sweetener including but not limited to Stevia rebaudiana from 0.01% 1%.

g) A capsule shell consisting of but not limited to cellulose, agar and glycerol.

It may be coated with a natural flavour to increase palatability and minimise any aftertaste.

The pure fruit juices are vacuumed distilled to obtain a powder (and blended with a natural sweetener if necessary). The product can be added and dissolved easily in water or an alkaline fruit or vegetable juice, then drunk.

The product is designed to neutralise gastric acid. It is a capsule that is swallowed when the symptoms and indicators of gastric distress and acid reflux occur or prior to eating acid producing foods. Usually 2 capsules taken with a small glass of water or fruit/vegetable juice is sufficient to relieve the acid reflux symptoms. Further doses may be required if symptoms persist in more severe cases.

This embodiment can be packaged in a glass or plastic jar with screw top, a glass or plastic jar with a flip top. It can also be packaged in blister packs.

0 In further embodiments, additional active ingredients may be added to enhance the acid neutralising/alkalising properties of the invention as well as its capacity to settle an N upset stomach and aid the synthesis of bile acid used to digest fats and animal proteins.

SIn other embodiments the active ingredients may be added or eliminated or used in different combinations.

00

Claims (3)

1. 2. A product to relieve the symptoms of gastric acid, reflux and heartburn by neutralising gastric acid, wherein the delivery system is powder containing a number of active ingredients including but not limited to: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, D- limonene, figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless grapes, passionfruit, pear, pineapple, umeboshi plum, watermelon from 10% to about t- O b) Pure vegetable juices/extracts, including but not limited to alfalfa, Sasparagus, avocado, basil, cayenne (capsicum), cucumber, endive, kale, kelp, Skarengo (Porphyra columbina), kudzu root, parsley, black radish, seaweed, lecithin, watercress, wheat grass from 10% to about c) Stomach and digestive tract calmatives including but not limited to ulmus rubra, peppermint, zingiber officinale roscoe, fritillary bulb cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal 0o proteins including but not limited to pepsinogen, glycine and fructus crataegi from 1%-10% 0 e) A natural thickening agent including but not limited to agar agar, pectin or Spsyllium mucilage from 0.01% to about f) A natural, alkalising sweetener including but not limited to Stevia c rebaudiana from 0.01% 1%. Additional active ingredients may be added to enhance the acid neutralising and alkalising properties of the invention. The pure fruit juices are vacuumed distilled to obtain a powder (and blended with a natural sweetener if necessary). The product can be added and dissolved easily in water or an alkaline fruit or vegetable juice, then drunk. The product is designed to neutralise gastric acid, settle an upset stomach and aid the synthesis of bile acid used to digest fats and animal proteins. It is a powder, dissolved in a liquid that is swallowed when the symptoms and indicators of gastric distress and acid reflux occur or prior to eating acid producing foods.. Usually one 5ml spoonful dissolved in a small glass of water or fruit/vegetable juice is sufficient to relieve the acid reflux symptoms. Further doses may be required if symptoms persist in more severe cases.
2. 3. A product to relieve the symptoms of gastric acid, reflux and heartburn by neutralising gastric acid, wherein the delivery system is lozenge containing a number of active ingredients including but not limited to: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, D- limonene, figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless grapes, passionfruit, pear, pineapple, umeboshi plum, watermelon from 10% to about b) Pure vegetable juices/extracts, including but not limited to alfalfa, asparagus, avocado, basil, cayenne (capsicum), cucumber, endive, kale, kelp, karengo (Porphyra columbina), kudzu root, parsley, black radish, seaweed, soy sprouts and lecithin, watercress, wheat grass from 10% to about c) Stomach and digestive tract calmatives including but not limited to ulmus rubra, peppermint, zingiber officinale roscoe, fritillary bulb, cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal proteins including but not limited to pepsinogen, glycine and fructus crataegi from 1% O e) A natural thickening agent including but not limited to agar agar, pectin or psyllium mucilage from 0.01% to about f) A natural, alkalising sweetener including but not limited to Stevia 1 rebaudiana from 0.01% 1%. 5 Additional active ingredients may be added to enhance the acid neutralising and alkalising properties of the invention. The pure fruit juices are vacuumed distilled to obtain a powder (and blended with t a natural sweetener and alkaline preservative if necessary). The powder is then oO compressed into a lozenge form, being a single dose. The product is designed to neutralise gastric acid, settle an upset stomach and _aid the synthesis of bile acid used to digest fats and animal proteins. It is a lozenge that is sucked or chewed when the symptoms and indicators of gastric distress and acid reflux occur or prior to eating acid producing foods. Usually one lozenge is sufficient to relieve the acid reflux symptoms. Further lozenges may be required if symptoms persist in more severe cases.
3. 4. A product to relieve the symptoms of gastric acid, reflux and heartburn by neutralising gastric acid, wherein the delivery system is capsule containing a number of active ingredients including but not limited to: a) Pure fruit juices/extracts, including but not limited to cantaloupe, dates, D-limonene, figs, kiwifruit, lemon, lime, mango, melon, papaya, sweet seedless grapes, passionfruit, pear, pineapple, umeboshi plum, watermelon from 10% to about b) Pure vegetable juices/extracts, including but not limited to alfalfa, asparagus, avocado, basil, cayenne (capsicum), cucumber, endive, kale, kelp, karengo (Porphyra columbina), kudzu root, parsley, black radish, seaweed, lecithin, watercress, wheat grass from 10% to about c) Stomach and digestive tract calmatives including but not limited to ulmus rubra, peppermint, zingiber officinale roscoe, fritillary bulb cuttle bone, meadowsweet from 1% d) Substances to aid the synthesis of bile acid used to digest fats and animal proteins including but not limited to pepsinogen, glycine and fructus crataegi from 1% Additional active ingredients may be added to enhance the acid neutralising and alkalising properties of the invention. The pure fruit juices are vacuumed distilled to obtain a powder (and blended with a natural sweetener if necessary). The powder is then formed into a capsule form. The product is designed to neutralise gastric acid, settle an upset stomach and aid the synthesis of bile acid used to digest fats and animal proteins. It is a capsule that is taken when the symptoms and indicators of gastric distress and acid reflux occur or prior to eating acid producing foods. Usually two capsules are sufficient to relieve the acid reflux symptoms. Further capsules may be required if symptoms persist in more severe cases.