NZ507229A - Treating food allergies - Google Patents

Abstract

The use of either cetyl myristate or a mixture of cetyl myristate and cetyl palmitate in the manufacture of a medicament for the treatment or prophylaxis of food allergy and/or intolerence.

Description

New Zealand Paient Spedficaiion for Paient Number 507229 Soi 2a <7 NEW ZEALAND PATENTS ACT, 1953 PROVISIONAL SPECIFICATION "Treating Food Allergies" We, MERACOL CORPORATION LIMITED, a company duly incorporated under the laws of New Zealand of 1 St Georges Bay Road, Parnell, Auckland, New Zealand, do hereby declare this invention to be described in the following statement: Intellectual Property Office of NZ 28 SEP 2000 Received The present invention relates to a method of treatment and/or prophylaxis of food allergies and/or food intolerances.

BACKGROUND Common symptoms of food allergies and/or food intolerances can be recognized by the appearance of hives, itching and eczema on the skin the respiratory system of a person can also be affected with the swelling of the throat, sneezing, coughing, wheezing and nasal stuffiness, the gastro intestinal tracts can also be affected at the same time causing vomiting, diarrhea and cramping. An Anaphylactic shock can occur in very severe cases. An Anaphylactic shock is a dramatic allergic reaction in a person which can result in the person collapsing and sometimes death can occur where the oesophagus swells blocking the air passage.

All of these symptoms can occur together or the allergic reaction may only affect one of the body's functions.

Food Allergies occur when the bodies immune system reacts to a food protein. Normally the sequence of events is that the protein is digested by the body, however the protein passes directly into the blood stream where it is identified by the bodes immume system as a foreign substance and is then attacked by the immune system. This attack causes antibodies to be released by the immune system that attacks the food protein. This starts a series of chemical changes that can cause swelling and irritation in various locations of the body eventually leading to the symptoms identified above. It is hypothesised that such an allergic reaction involves the mast cells in the body releasing specific Immunoglobulin E (IgE) into the body.

Food intolerance unlike food allergies is triggered by a physical reaction to a food and/or food additives. It is not yet known whether this reaction involves the immune system, this is still a point in contention. However symptoms similar to that of a food allergy occur and often a misdiagnosis of a food allergy is made when in fact it is a food intolerance.

It is appreciated that food sensitivites is a broad term used to describe any adverse reactions to foods and includes food allergies and/or food intolerances.

In both cases, the conditions of food allergies and/or food intolerances is known for inhibiting a persons eating habits which in turn affects the persons way of living including eating habits, social interaction and enjoying a normal way of life.

Often the best way for a person to avoid such food allergies and/or intolerances is to avoid the foods that cause such allergic reactions.

The present invention has surprisingly determined that the administration (particularly by ingestion) of cetyl myristate, and particularly cetyl myristate in conjunction with cetyl palmitate, provides an effective treatment of at least the symptoms of food allergies and/or food intolerances Cetyl myristate and cetyl palmitate can each be sourced from animals or vegetables. Cetyl myristate is not to be mistaken for cetyl myristoleate which is also a fatty acid derived traditionally from spermaceti by saponification and more recently from the tallow of bovine(s).

Reference is made to US Patent No.4,113,881 where it is disclosed that the administration of an effective amount of cetyl myristoleate to a mammal is useful in inhibiting or relieving the symptoms of inflammatory rheumatoid arthritis in mammals. Also in US 5,569,676 there is disclosure of the use of cetyl myristoleate in the treatment of osteoarthritis.

It is thought that cetyl myristate has a negligible anti-arthritic activity in laboratory experiments and reference is made to the website www.gcinutrients.com/Newletter.com. However this point is arguable and a product known as cetyl myristate sold by Amerex Corporation of 770 Sycamore Avenue, Suite J148, Vista, CA 92083, USA purports that cetyl myristate is useful for the treatment of arthritis.

Cetyl myristate is derived from the saturated fatty acid, myristic acid. This acid is found in nutmeg butter, in the fats of Myristicaceae, in palm seed fats, milk fats and also sperm whale oil. Reference is made to US 2,481,365 which discloses the preparation of myristic acid from tall-oil fatty acids. It is to be noted that Amerex Corporation source the cetyl myristate used in their products from sunflower oil. See their website at www.hollinet.com.

Cetyl palmitate is derived from the fatty acid, palmitic acid which occurs as the glycerol ester in many oils and fats such as palm oil or Chinese vegetable tallow. A synthetic method of preparation is to react palmitoyl chloride and cetyl alcohol in the presence of magnesium. See the Merck Index, 12th edition at page 336. Reference is also made to US patent 3,169,099 which discloses a biosynthetic method of producing cetyl palmitate.

It is an objection of the present invention to provide a medicament to aid in the treatment of food allergies and/or food intolerances or at least which will provide an alternative to existing treatments or to provide the public with a useful choice.

DISCLOSURE OF INVENTION As indicated earlier the present invention is directed to the treatment and/or prophylaxis of at least the symptoms of food allergies and/or food intolerances reliant upon administration (whether by self administration or otherwise) of either cetyl myristate or cetyl myristate and cetyl palmitate (whether given simultaneously in admixture or not or given serially).

The present invention also encompasses the prospect of dosage forms that in some instances might contain cetyl myristate alone and in other instances both cetyl myristate and cetyl palmitate and dosage regimes that might use one dosage form or both.

In a first aspect the invention is a method of treatment and/or prophylaxis of a mammal for at least the symptoms of food allergies and/or food intolerances which comprises or includes administering or having self administered to such mammal an effective amount of either (a) cetyl myristate, or (b) cetyl myristate and cetyl palmitate.

Preferably said administration is orally of (b) whether as a mixture of both cetyl myristate and cetyl palmitate, or serially.

Preferably the effective amount is of (b).

Preferably said administration is with a mixture of cetyl myristate in conjunction with cetyl palmitate where the cetyl myristate comprises from 50 to 98% w/w of the mixture.

Preferably said effective amount of (a) or (b) is by means of one or more capsules.

The method also extends to related conditions, eg; accelerated wound healing where a composition as disclosed in US Patent 4,775,291 can at least sometimes be supplemented by use of the present invention methodology.

In another aspect the invention is an oral pharmaceutical composition for treating food allergies and/or food intolerances which comprises or includes both cetyl myristate and cetyl palmitate.

In still another aspect the invention is an oral pharmaceutical composition for treating food allergies and/or food intolerances which comprises or includes both cetyl myristate and cetyl palmitate.

Preferably said cetyl myristate comprises at least 50% by weight of the composition.

Preferably said composition also includes at least one pharmaceutically acceptable excipient and/or diluent.

In still another aspect the invention is an oral dosage unit effective in the treatment of food allergies and/or food intolerances, said dosage unit having either (a) cetyl myristate, or (b) a mixture of cetyl myristate and cetyl palmitate.

Preferably said dosage unit has (b) and said cetyl myristate in any such mixture comprises from 50 to 98% w/w of the mixture.

In another variant the dosage unit has (a) only and there is between 5 to 400 mg of cetyl myristate.

Preferably in the dosage use, where (b) is present, there is from 5 to 400 mg of the mixture of cetyl myristate and cetyl palmitate.

Preferably (a) or (b) is in a capsule.

Preferably said capsule also includes a pharmaceutically acceptable excipient and/or diluent.

Preferably the dosage unit includes silicon dioxide.

Preferably the dosage unit also contains calcium phosphate and/or magnesium oxide.

Preferably the dosage unit also includes additionally at least one trace element.

In another aspect the invention is a liquid dosage unit being also an oral dosage unit as aforesaid.

In another aspect the invention is the use, in the manufacture of oral dosage units for the treatment or prophylaxis of at least the symptoms of food allergies and/or food intolerances in a mammal, of (a) cetyl myristate, or (b) a mixture of cetyl myristate and cetyl palmitate, or (c) cetyl palmitate.

In another aspect the invention is the use, in the manufacture of oral dosage units for the treatment of food allergies and/or food intolerances or prophylaxis of at least the symptoms of food allergies and/or food intolerances in a mammal, of (i) cetyl myristate and (ii) cetyl palmitate.

The mixture can use cetyl myristate available from a commercial source such as EHP Products Inc., PO Box 20727, Mt Pleasant, SC 29465 or at Amerex Corporation, 770 Sycamore Avenue Suite J148 Vista, California 92083.

The mixture can use cetyl palmitate derived from a source such as, for example, Quimica Croda, S.A. de C.V, Circuito Medicos No.47. Apdo. Postal 71-A Cd. Satelite, 53100 Naucalpan, Edo. de Mexico, Mexico or online at www.butterburandsage.com.

Most ideally however the mixture is synthetised from starting materials utilising the procedures as disclosed in New Zealand Patent Specification No. 332959 which involves reacting both myristic acid and palmitic acid with a cetyl alcohol at an elevated temperature in the presence of at least one acid catalyst and at least one aromatic hydrocarbon. The aromatic hydrocarbon fraction then contains the cetyl myristate and cetyl palmitate from whence it can be crystallised.

The full content of NZ 332959 is here incorporated by way of reference.

This crystallised form can then be ground up, dissolved and mixed with a suitable general pharmacy liquid to be administered to a person. The crystals are usually dissolved in hot water before adding to the pharmacy liquid which is usually a sugar syrup available from most pharmaceutical companies. The liquid is made up to a concentration of 70 w/v. | Alternatively the crystals may be ground up into a powder and combined with magnesium oxide, silicon oxide and fine di-calcium phosphate. This powder can then be transferred into capsules for oral ingestion into the body. The capsules used are VEGICAP™ that are non-gelatin containing.

The mode of administration is preferably oral. The dosage unit can be either a swallowable capsule or some alternative (preferably having the active ingredient(s) as a waxlike solid or can be an orally consumable liquid composition (eg; made up with a general pharmacy type carrier such as methyl cellulose)).

Other modes of administration can include transdermal, sublingual, parenteral, and suppository delivery.

The oral administration for the treatment of food allergies and/or food intolerances can be in addition to any other medicament administered for such ailment whether administered orally, topically, parenterally, sublingually, etc.

In practice the present invention will involve ideally oral self administration of effective quantities of cetyl myristate alone or more preferably as a mixture of both cetyl myristate and cetyl palmitate.

Preferably in any such mixture the cetyl myristate comprises at least about half of the mixture or the serial application on a weight to weight basis. It is envisaged that daily doses will vary depending on patient needs and may range from 1 to 20 capsules per day. A capsule ideally contains between 5 to 370 mg of the mixture or cetyl myristate.

Trials with a variety of patients reliant upon dosage forms of cetyl myristate alone have shown favourable responses insofar as relief from the symptoms of food allergies and/or food 7 intolerances is concerned. It has been found however that enhanced benefits occur where there is at least a small proportion of cetyl palmitate in addition to the cetyl myristate and it is to the use of one such ratio of these active ingredients that the following trial examples relate.

Examples of use follows. Each briefly describes the patient's condition before and after the stated treatment using dosage forms (ie; "of the invention") each having about 350 mg of the mixture of cetyl myristate and cetyl palmitate. That mixture comprises by weight 95% cetyl myristate and 5% cetyl palmitate by weight manufactured by the process as disclosed in NZ Patent Specification No. 332959. In addition added excipients were present in the non gelatin two part capsule case.

Accordingly the present invention consists in a method of treatment for food allergies and/or food intolerances which comprises administering or having self administered to such human or other mammal an effective amount of either (a) cetyl myristate, or (b) cetyl myristate and cetyl palmitate.

Preferably said administration and/or self administration is by ingestion.

Preferably the administration and/or self administration is with a mixture of cetyl myristate in conjunction with cetyl palmitate where the cetyl myristate comprises from 50 to 98% w/w.

In a further aspect the present invention consists in the use of an effective amount of either (a) cetyl myristate, or (b) cetyl myristate and cetyl palmitate in the manufacture of a dosage unit or pharmaceutical composition for oral ingestion useful in the treatment of food allergies and/or food intolerances.

Preferably said use involves the use of an appropriate encompassing capsule.

The present invention also consists in a pharmaceutical composition for treating food allergies and/or food intolerances which comprises an effective amount of cetyl myristate with an effective amount of cetyl palmitate.

In a further aspect the present invention consists in a dosage unit effective in the treatment of food allergies and/or food intolerances said dosage unit comprising either (a) cetyl myristate in an appropriate orally deliverable dosage unit, or (b) a mixture of cetyl myristate and cetyl palmitate in a suitable orally administrable dosage unit. 8 Preferably said cetyl myristate in any such mixture comprises from 50 to 98% w/w of the mixture.

In still a further aspect the present invention consists in a dosage unit in the form of a capsule capable of release of its content once ingested orally, said contents being a mixture of cetyl myristate with cetyl palmitate.

Preferably said cetyl myristate comprises from 50 to 98% w/w of the mixture.

Preferably said contents is a wax like powder.

Preferably said powder is placed inside a capsule eg. a gelatine capsule without an end.

Preferably said capsule may include a pharmaceutically acceptable excipient.

Preferably said pharmaceutically acceptable excipient is in solid form.

Preferably said pharmaceutically acceptable excipients includes trace elements such as calcium phosphate or magnesium oxide.

In still a further aspect the present invention consists in a liquid or other soluble form which comprises, a mixture of (a) cetyl myristate, or (b) a mixture of cetyl myristate and cetyl palmitate where the mixture maybe carried in a suitable liquid for oral ingestion useful in the treatment of food allergies and/or food intolerances.

Preferably said suitable liquid is a general pharmacy liquid.

Preferably said cetyl myristate and any such mixture comprises from 50-98% w/w of the mixture.

This invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features, and where specific integers are mentioned herein which have known equivalents in the art to which this invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

The invention consists in the foregoing and also envisages constructions of which the following gives example.

Trial Examples: • Patient 1 is a female in her early 50's.

Patient 1 has suffered severe cramping and diarrhea for the past 20 years. Her diet was primarily limited to dry toast, jacket potatoes, rice and water. Any other food produced pain and incontinent diarrhea where she was simply too afraid to eat for the problems that it may cause.

At the first appointment Patient 1 was provided with capsules of a dosage unit as described in this invention for a dosage regime of 4 capsules three times daily.

Within one month of taking this dosage regime she was feeling much better and the diarrhea had reduced significantly.

Within six months of maintaining this dosage regime her diet had now expanded to include small amounts of fruits, all vegetables and to a certain extent spicy foods. She regarded her life as 100% improved and she felt she had virtually returned to normal.

Patient 1 has been taking this dosage regime for the last 18 months and is now on a maintenance dosage of two capsules daily.

• Patient 2 is male and in his early 50's.

Patient 2 since his mid twenties had suffered severe cramping, diarrhea and was constantly having to pass bowel motions. He was unable to tolerate many foods including wheat and tomatoes. He believed his symptoms were bought on by his body reacting to such foods as wheat and tomatoes. He had eliminated much of this food from his diet however, he was unable to return to good health and was constantly suffering diarrhea and abdomen pain. He had been prescribed IMMODIUM™ and was taking up to 6 to 8 capsules at any one time.

In previous years Patient 2 had used BENTYL™, PHENOBARBITOL™ and LOMOTIL™. None of these medications provided any relief for his aliment. He had also been hospitalised a number of times for his symptoms.

At the first appointment Patient 2 was provided with capsules of a dosage unit as described in this invention for a dosage regime of 2 capsules three times daily.

After one month Patient 2 was able to eat wheat. He also carried out oral tests at the same time that showed his tolerance to wheat had increased 6 fold.

He has now maintained this dosage rate after three months and is now able to include in his diet all food items that previously caused diarrhea and pain. These items include wheat and tomatoes.

• Patient 3 is female and is in her mid thirties.

Patient 3 has been unable to tolerate many foods due to a pain that was produced throughout her entire body after eating . She was unable to determine exactly what food triggered such pain.

At the first appointment Patient 3 was provided with capsules of a dosage unit as described in this invention for a dosage regime of 1 capsule daily.

Within one week she was able to return to working out at the gym and she felt a great deal better. Patient 3 has now been on this dosage regime for more than 1 year where her diet has returned to normal and she now lives a full and active life.

• Patient 4 is female and in her late 20's.

Patient 4 has been diagnosed with Irritable Bowel Syndrome including multiple food allergies and/or intolerances. She was restricted to a diet of boiled chicken and rice. Even then she suffered from chronic and painful diarrhea. Her previous medication had included Glaxo's LOTRONEX™. She had been taking this medication for 5 months alone and had been enjoying a wide range of different foods including pizza, spaghetti, fruits and vegetables. LOTRONEX™ was however removed from the market and before her symptoms reappeared she started a course of the present invention.

At the first appointment she was provided with capsules of a dosage unit as described in this invention for a dosage regime of 4 capsules three times daily.

By 9 months she no longer had any food allergies and/or food intolerances and was Irritable Bowl Syndrome free. This enabled her to eat a full and normal diet without any of the chronic and painful diarrhea previously experienced.

She is now on a maintenance dosage of 3 capsules two times daily and states that she now lives a normal and healthy life.

Claims (17)

WHAT WE CLAIM IS:

1. A use of cetyl myristate and cetyl palmitate in the preparation of a medicament for treating a food allergy(s) and/or a food intolerances in a patient in need thereof

2. The use of claim 1 wherein said cetyl myristate comprises at least 50% by weight of the composition.

3. The use of any one of claims 1 to 2which also includes at least one pharmaceutically acceptable excipient and/or diluent.

4. Use of either (a) cetyl myristate, or (b) a mixture of cetyl myristate and cetyl palmitate. in the preparation of an oral dosage unit effective in the treatment of food allergy(s) and/or a food tolerance(s)

5. The use as claimed in claim 4 wherein said dosage unit has (b) and said cetyl myristate in any such mixture comprises from 50 to 98% w/w of the mixture.

6. The use as claimed in claim 4 wherein the dosage unit has (a) only and there is between 5 to 400 mg of cetyl myristate.

7. The use of claim 5 wherein said dosage unit contains from 5 to 400 mg of the mixture of cetyl myristate and cetyl palmitate.

8. The use of any one of claims 4 to 7 wherein (a) or (b) is in a capsule.

9. The use as claimed in claim 7 wherein said capsule also includes a pharmaceutically acceptable excipient and/or diluent.

10. The use of claim 9 wherein said excipient and/or diluent is selected from any one of the following; silicon dioxide, calcium phosphate, magnesium and/or at least one trace element.

11. The use, in the manufacture of oral dosage units for the treatment or prophylaxis of a food allergy(s) in a mammal, of (a) cetyl myristate, or (b) a mixture of cetyl myristate and cetyl palmitate

12. The use, in the manufacture of oral dosage units for the treatment or prophylaxis of a food intolerance(s) in a mammal, of (a) cetyl myristate or (b) cetyl myristate and cetyl palmitate.

13. The use of claim 11 or 12 wherein (b) is used. INTELLECTUAL PROPERTY OFFICE OF N.Z. - 5 MAR 2003 RECEIVED

14. The use of claim 13 wherein the ratio by weight of cetyl myristate to cetyl palmitate is 95:5.

15. The use of any one of claims 4 to 10 substantially as hereinbefore described.

16. The use of any one of claims 1 to 3 substantially as hereinbefore described.

17. The use of any one of claims 11 to 14 substantially as hereinbefore described. DATED THIS ^ DAY OF /V1arcj^2£CS- A] PAWfc/ PER ^— \GEWTS FOR THE APPLICANT h:\library\patents\djj\specs\431903cawpd INTELLECTUAL PROPERTY OFFICE OF N.Z. - 5 MAR 2003 REOIIVER