Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof

Definitions

• the present invention relates to the treatment of skin 5 conditions such as rosacea and similar inflammatory dermatoses, and m particular to the treatment of certain kinds of rosacea, and also perioral papular and pustular acne, and other papulopustular dermatoses.
• Rosacea is a chronic inflammatory disease which affects the face. It is characterised by episodic flushing, erythema, and telangiectasia affecting the cheeks, chin, forehead, and nose. It may be further complicated by inflammatory swelling, papules and pustules.
• H. Pylori Gram-negative bacterium Helicobacter pylori
• rosacea and similar inflammatory skin dermatoses can be effectively treated by administering to a patient a treatment regime comprising I) erythromycm, clarithromycm or an analogue or derivative thereof, n) metronidazole or an analogue or derivative thereof, and m) a gastrointestinal hydrogen pump inhibitor, such as omeprazole or an analogue or derivative thereof.
• the three drugs may be formulated for simultaneous, separate or sequential use.
• the triple drug combination according to the present invention functions in achieving the desired results.
• One possibility is that there may be a causal relationship between the dermatoses to be treated and H. pylori , such that eradication of H. pylori may lead to resolution of these dermatoses.
• Another possibility is that as, certain instances, the presence of H. pylori has been found m pustules on the skin, the triple drug combination may act directly to eradicate that external form of H. pylori .
• triple drug combination works m another manner, such that any apparent relationship between its use m the present invention and H .pylori may simply be coincidental, such that further study will be necessary elucidate its precise mode of action Description of the Invention
• the preferred treatment regime comprises erythromycm or clarithromycm, metronidazole and omeprazole, and the most preferred treatment regime comprises clarithromycm, metronidazole and omeprazole.
• analogues or derivatives of any of these drugs may be used provided that their combined administration achieves the desired result.
• another similar-acting macrolide antibiotic to erythromycm or clarithromycm may be used, for instance azithromycm or dirithromyc .
• lanzoprazole or any other drug which acts to inhibits a gastrointestinal hydrogen pump may be used instead of omeprazole.
• the three drugs may be useful which have a similar or equivalent pharmacological mode of action to the drugs named above.
• Pharmaceutically- acceptable salt forms of the drugs may also be used.
• Treatment may be by administration of the three drugs by any suitable means. Conveniently, however, the three drugs will be administered by one or a combination of oral administration, topical application to a patient's skin, or parenteral administration, e.g. intravenous, intramuscular or subcutaneous administration. For instance, one or more of the three drugs may be formulated for administration by a different route to the other drug(s) . Typically, it is desirable to administer omeprazole or an analogue thereof orally, but the other drugs may be formulated for oral, topical or parenteral administration, or any combination thereof. For instance, it may be preferred to administer omeprazole orally and the other two drugs topically, optionally as a combined topical formulation.
• the triple drug combination may take the form of separate pills containing each of the separate drugs, for simultaneous, separate or sequential administration.
• the three drugs will be combined into a single dosage form, preferably a tablet, capsule or linctus, for patient convenience.
• the drugs are incorporated into a suitable pharmaceutically-acceptable carrier.
• suitable pharmaceutically-acceptable carrier Such formulations have not been disclosed in the prior art, and constitute further aspects of the claimed invention.
• the relative proportions of the three drugs necessary for effective treatment may vary depending on the route of administration, and the particular patient to be treated.
• a patient will receive 200 to 600 mg, preferably 300 to 500 mg of erythromycin, clarithromycin or an analogue thereof, 200 to 500 mg, preferably 300 to 500 mg, metronidazole, and 10 to 100 mg, preferably 20 to 60 mg, omeprazole, on a daily basis.
• a particularly preferred treatment regime comprises about 250 mg erythromycin, clarithromycin or an analogue thereof, about 400 mg metronidazole and about 20 mg omeprazole.
• Treatment periods vary from patient to patient, from one week to a number of years .
• a score of one is given if less than half the area involved is affected by that parameter, and a score of two if half or more of the area is affected.
• the scores for the different parameters in the different facial areas are added together to give a total score for the patient.
• Each patient was subjected to clinical photography, and then treated with an oral dosage of 20 mg omeprazole, 400 mg metronidazole, and 250 mg clarithromycin for one week.
• Disease severity scoring and clinical photography were repeated at the end of weeks 6, 12, 18, and 24, and fourteen patients were followed for a period of 52 weeks.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Molecular Biology (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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Applications Claiming Priority (4)

Publications (1)

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Cited By (1)

Citations (8)

• 2001
  • 2001-03-09 CA CA002413923A patent/CA2413923A1/en not_active Abandoned
  • 2001-03-09 EP EP01910045A patent/EP1263445A1/de not_active Withdrawn
  • 2001-03-09 AU AU37628/01A patent/AU3762801A/en not_active Abandoned
  • 2001-03-09 WO PCT/GB2001/001047 patent/WO2001066117A1/en not_active Application Discontinuation

Patent Citations (9)

Non-Patent Citations (5)

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