WO2004047842A1

WO2004047842A1 - Treatment of immune system dysfunction

Info

Publication number: WO2004047842A1
Application number: PCT/IB2003/003888
Authority: WO
Inventors: Charles Scheepers
Original assignee: Moore, Bronwyn; Moore, David, Daniel
Priority date: 2002-11-28
Filing date: 2003-09-12
Publication date: 2004-06-10
Also published as: AU2003260818A1; AU2003260818A8

Abstract

A composition is provided that includes Pyrazinamide, Ethambutol, Praziquantel, Niclosamide, Mebendazole, Rifampicin, Metronidazole, Dapsone, Isoniazid, and Corticosteroid. The inventionextends to a dosage form including the composition, a method of preparing the composition, and a method of treatment of a subject with a compromised immune system, by administeringthe composition.

Description

TREATMENT OF IMMUNE SYSTEM DYSFUNCTION

THIS INVENTION relates to the treatment of subjects with compromised immune systems, e.g. subjects infected with the human immunodeficiency virus (HI virus, or HIV).

According to a first aspect of the invention there is provided a composition which includes the following ingredients:

Pyrazinamide,

Ethambutol,

Praziquantel, Niclosamide,

Mebendazole,

Rifampicin,

Metronidazole,

Dapsone, Isoniazid, and

Corticosteroid.

The ingredients may be present in the composition, approximately in the following relative percentages, by mass: Pyrazinamide - 21%,

Ethambutol - 21%,

Praziquantel - 10.5%, Niclosamide 10.5%,

Mebendazole 10.5%,

Rifampicin 10.5%,

Metronidazole 5.25%,

Dapsone 5.25%,

Isoniazid 5.25%, and

Corticosteroid 0.175%.

The composition may further include one or more of: mepyramine, marealeate, methylhydroxybenzoate, tartranzine, gum/acacia powder, and/or magnesium stearate. The mass percentages in which these ingredients may be present in the composition may be about:

Mepyramine 0.5%,

Marealeate 2%,

Methylhydroxybenzoate 0.2%,

Gum/acacia powder 3%, and

Magnesium stearate 1 %.

According to another aspect of the invention there is provided a dosage form including approximately 250mg to 500mg, typically about 380mg (in combination), of the ingredients described hereinabove, and/or a dosage form in the form of a gel tablet, including the composition described hereinabove. According to a further aspect of the invention there is provided a method for preparing a composition, said method comprising: grinding the ingredients described hereinabove; combining the ground ingredients; and encapsulating the combined, ground ingredients, e.g. in a gel tablet.

According to yet a further aspect of the invention, there is provided a method of treatment of a subject with a compromised immune system, e.g. a subject infected with the HI virus, by administering to said subject, a composition or a dosage form, as described hereinabove.

The method may include administering dosages of said composition, each including about 3,8g of the ingredients described hereinabove, twice daily to said subject, for a treatment period of about three months. Each dosage may include about 10 gel tablets as described hereinabove, and the gel tablets may be taken orally, with water.

The method may further include administering oxygen to said subject, by inhalation, three times per week for the duration of the treatment period.

The method may further include administering an inhalant to said subject, three times per week for the duration of the treatment period. Said inhalant may comprise one or more of lemon grass oil, lemon juice, and sodium chloride. The inhalant may include about 2,5ml of lemon grass oil, 2,5ml of lemon juice, and/or 2,5ml of sodium chloride.

According to yet a further aspect of the invention, there is provided the use of a composition as described hereinabove in the manufacture of a preparation for the treatment of a subject with a compromised immune system, e.g. a subject infected with the HI virus.

According to yet a further aspect of the invention, there is provided a substance or composition for use in a method of treatment of a subject with a compromised immune system, e.g. a subject infected with the HI virus, said substance or composition comprising a composition as described hereinabove, and said method comprising administering said substance or composition to said subject.

The invention will now be described, by way of non-limiting example.

EXAMPLE: A composition in accordance with an embodiment of the invention is prepared by grinding the following masses of ingredients into a powder: 72g of Praziquantel, 72g of Niclosamide, 72g of Mebendazole, 72g of Rifampicin, 36g of Metronidazole, 36g of Dapsone, 36g of Isoniazid, and 1.2g of Corticosteroid.

Optionally, the combined, ground ingredients are further combined with mepyramine, marealaeate, methylhydroxybenzoate, gum/acacia powder, and magnesium stearate in the following approximate percentages of the mass of the combined ingredients:

Mepyramine 0.5%,

Marealeate 2%,

Methylhydroxybenzoate 0.2%,

Gum/acacia powder 3%, and

Magnesium stearate 1 %.

The ingredients are then encapsulated in a suitable shell, to produce about 1800 dosage forms, e.g. in the form of gel tablets, each including approximately 380mg (in combination), of the ingredients. The gel tablets are used in the treatment of a subject with a compromised immune system, e.g. a subject infected with the HI virus in any of the symptomatic developmental stages of the infection, to ameliorate symptoms associated with the condition.

The symptoms may include: dysentery and associated gastric complications, including diarrhoea, abdominal discomfort, intestinal distress, blockage of the bile duct, obstruction of the intestines, vomiting, cysts in the intestines, indigestion, anaemia, incontinence, blood in stools and urine, loss of weight, and toxicity of the gastric system; fibrosis of the liver, enlargement of the liver, jaundice, cirrhosis of the liver and toxicity of the liver; hardening and toxicity of the spleen; oedema of the face, torso, and legs; muscle spasms; central nervous system complications, including HIV encephalopathy,

HIV dementia, fits, chronic headaches, blockage of cerebrospinal fluid causing hypertension and inflammation, palpitations, lassitude, muscle spasms, difficulty in concentration, reduced motor function, delirium, restlessness, minimised brain function due to blockage of capillaries, and meningitis; lung complications, including shortness of breath, unproductive cough, blood stained sputum, greenish sputum, pain in the chest, pleurisy, pericarditis, cyanosis, and tuberculosis; temperature fluctuations, including mild to chronic fevers, racing temperature, and shivering; bladder infections, including bladder cancer and obliteration of the ureter; lymphatic system disorders, including enlargement of glands, and blockage of the system; skin infections, including carposi's sarcoma, blisters, ulcers, thickening of the skin, nodules on the skin especially on face, ears, chest and abdominal wall, loss of hair, herpes simplex, and herpes febrillis; sexual organ dysfunction, including destruction of testes, enlarged breasts in males, enlarged nipples in females, heavy discharge, drop, and vaginal and penal thrush; and lobar and broncho-pneumonia, including symptomatic onset of these diseases.

The subject is treated by orally administering a dosage of 10 of the gel tablets with water, twice daily for a treatment of about three months, after meals, for the duration of the treatment period. The blood pressure and temperature of the subject is monitored during mornings and evenings in the treatment period.

In additional, oxygen and/or an inhalant are administered to the subject using a liquid vapour nebuliser, mask, and/or inhaler pump, three times per week for the duration of the treatment period. The oxygen is substantially pure and serves to clear the lungs of the subject and is transferred to the subject's brain, via the blood stream.

The inhalant comprises 2,5ml of lemon grass oil, 2,5ml of pure lemon juice, and 2,5ml of sodium chloride, and is administered in a liquid vapour.

The invention described holds the advantages of a ameliorating the symptoms associated with infection of a subject with the HI virus.

Claims

CLAIMS:

1. A composition characterised in that it includes the following ingredients:

Pyrazinamide,

Ethambutol,

Praziquantel,

Niclosamide,

Mebendazole,

Rifampicin,

Metronidazole,

Dapsone,

Isoniazid, and

Corticosteroid.

2. A composition as claimed in Claim 1 , characterised in that the ingredients are present in the composition in the following approximate relative percentages, by mass:

Pyrazinamide - 21%,

Ethambutol - 21%,

Praziquantel - 10.5%,

Niclosamide - 10.5%,

Mebendazole - 10.5%,

Rifampicin - 10.5%, Metronidazole - 5.25%,

Dapsone - 5.25%,

Isoniazid - 5.25%, and

Corticosteroid _ 0.175%.

3. A composition as claimed in Claim 1 or Claim 2, characterised in that the composition further includes at least one of: mepyramine, marealeate, methylhydroxybenzoate, tartranzine, gum/acacia powder, and magnesium stearate.

4. A composition as claimed in Claim 3, characterised in that the approximate mass percentages in which the ingredients are present in the composition are:

Mepyramine 0.5%,

Marealeate 2%,

Methylhydroxybenzoate 0.2%,

Gum/acacia powder 3%, and

Magnesium stearate 1 %.

5. A dosage form characterised in that it includes approximately

250mg to 500mg, of the composition as claimed in any one of Claims 1 to 4.

6. A dosage form as claimed in Claim 5, characterised in that it includes approximately 380mg of the composition as claimed in any one of Claims 1 to 4.

7. A dosage form as claimed in Claim 5 or Claim 6, characterised in that it is in the form of a gel tablet.

8. A method for preparing a composition, said method being characterised by the steps of: grinding the ingredients of the composition as described in any one of Claims 1 to 4; combining the ground ingredients; and encapsulating the combined, ground ingredients.

9. A method of treatment of a subject with a compromised immune system, characterised by administering to said subject, a composition as claimed in any one of Claims 1 to 4, or a dosage form as claimed in any one of Claims 5 to 7.

10. A method as claimed in Claim 9, characterised by administering dosages of said composition, each including about 3,8g of the composition as claimed in any one of Claims 1 to 4, twice daily to said subject, for a treatment period of about three months.

11. A method as claimed in Claim 10, characterised in that each dosage includes about 10 dosage forms as claimed in any one of Claims 5 to 7.

12. A method as claimed in Claim 11 , characterised in that the dosage forms are taken orally, with water.

13. A method as claimed in any one of Claims 9 to 12, characterised by administering oxygen to said subject, by inhalation.

14. A method as claimed in any one of Claims 9 to 13, characterised by administering to said subject, an inhalant comprising at least one of lemon grass oil, lemon juice, and sodium chloride.

15. A method as claimed in Claim 14, characterised in that said inhalant includes about 2,5ml of lemon grass oil, 2,5ml of lemon juice, and 2,5ml of sodium chloride.

16. Use of the composition as claimed in any one of Claims 1 to 4 in the manufacture of a preparation for the treatment of a subject with a compromised immune system.

17. A substance or composition for use in a method of treatment of a subject with a compromised immune system, characterised in that said substance or composition comprises a composition as claimed in any one of Claims 1 to 4, and said method comprises administering said substance or composition to said subject.

18. A composition as claimed in Claim 1 , substantially as herein described.

19. A dosage form as claimed in Claim 5, substantially as herein described.

20. A method as claimed in Claim 8, substantially as herein described.

21. A method as claimed in Claim 9, substantially as herein described.

22. Use as claimed in Claim 16, substantially as herein described.

23. A substance or composition for use in a method of treatment as claimed in Claim 17, substantially as herein described.

24. A new composition, a new dosage form, a new method for preparing a composition, a new method of treatment, new use of a composition as Claimed in any one of Claims 1 to 4, or a substance or composition for a new use in a method of treatment, substantially as herein described.