WO1999048511A1 - Antifungal and antibacterial compositions containing melaleuca essential oil - Google Patents

Antifungal and antibacterial compositions containing melaleuca essential oil Download PDF

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Publication number
WO1999048511A1
WO1999048511A1 PCT/EP1998/001708 EP9801708W WO9948511A1 WO 1999048511 A1 WO1999048511 A1 WO 1999048511A1 EP 9801708 W EP9801708 W EP 9801708W WO 9948511 A1 WO9948511 A1 WO 9948511A1
Authority
WO
WIPO (PCT)
Prior art keywords
essential oil
melaleuca
antifungal
compositions containing
oil
Prior art date
Application number
PCT/EP1998/001708
Other languages
French (fr)
Inventor
Adriano Andriolli
Fausto Panni
Original Assignee
Farmila - Farmaceutici Milano S.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Farmila - Farmaceutici Milano S.R.L. filed Critical Farmila - Farmaceutici Milano S.R.L.
Priority to AU70404/98A priority Critical patent/AU7040498A/en
Priority to PCT/EP1998/001708 priority patent/WO1999048511A1/en
Publication of WO1999048511A1 publication Critical patent/WO1999048511A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Communicable Diseases (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to pharmaceutical compositions for the systemic administration of Melaleuca essential oil.

Description

ANTIFUNGAL MD ANTIBACTERIAL COMPOSITIONS CONTAINING
MELALEUCA ESSENTIAL OIL
The present invention relates to pharmaceutical compositions for the systemic administration of Melaleuca essential oil.
The plants belonging to the genus Melaleuca are a known source of essential oils which have been used for a long time in the topical treatment of infections sustained by fungi or bacteria. In particular, the use of an essential oil extracted by steam distillation of fresh leaves of Melaleuca alternifolia, which is a shrub growing exclusively in Australia, is widely diffused.
Melaleuca alternifolia oil (Tea tree oil) is characterized by a low concentration of 1,8 cineole (< 4.5%) and a high concentration of terpinen-4-ol (> 36%), and is commercially available in a stabilized form which fulfils such Pharmacopoeias standardizations as by the British Pharmaceutical Codex 1949 (p. 597-598), Martindale, The Extra Pharmacopoeia, 28th Ed., 1982 (p. 678) and The Dispensatory of the United States of America, 25th Ed., (p. 1610). The composition of Melaleuca alternifolia oil is reported, for example, in J. Agric, Food Chem. 1989, 37, 1330.
The interest in this active ingredient of the traditional medicine has increased recently, as proved by the numerous Patent applications concerning specific therapeutical or cosmetic uses.
JP-A-4198131 , for example, discloses compositions for the treatment of wounds and burns; GB-A-2293547 2 describes the use of Melaleuca oil for the treatment of infections of the oral cavity, gingivitis and periodontitiε; JP-A-6345616 discloses cosmetic uses as a deodorant and UV filter; finally, JP-4074138 describes the use of Melaleuca essential oil as a promoter of the transdermal absorption of medicaments.
All of the traditional, known uses as well as the recent Patent applications cited above claim exclusively the topical administration of Melaleuca essential oil. Now it has surprisingly been found that Melaleuca oil, when administered systemically and in particular orally, exerts bacteriostatic and antifungal effects without causing toxic side-effects.
Therefore, the present invention relates to pharmaceutical compositions which can be administered systemically, containing a Melaleuca essential oil as the active ingredient.
The compositions of the invention can be prepared according to conventional techniques and excipients, as described for example in Remington's Pharmaceutical
Sciences Handbook, Mack Pub. -Co., NY.
The compositions of the invention can be administered in forms suitable for the oral, parenteral or rectal administrations, the oral route being preferred. Suitable oral formulations include soft- or hard- gelatin capsules, granulates, sugar-coated pills and the like.
The essential oil can be prepared from plants of the genus Melaleuca belonging to the specie_s alternifolia, cajpuli, quinquenervia , uncinata, bracteata, optionally in a mixture thereof. The use of 3 the stabilized essential oil of Melaleuca alternifolia is particularly preferred.
The unit dosages can range from 10 to 100 mg of oil, preferably from 20 to 80 mg , most preferably from 30 to 60 mg of oil per 15 kg of body weight of the patient, to be administered one or more times daily.
The treatment can be prolonged up to 15 - 30 days. The compositions of the invention proved to be useful in the treatment of mycosis due to Candida, Aspergillus, Trycophyton and of infections of the urinary and respiratory tracts sustained by Gram- positive or Gram-negative bacteria.
The following examples further illustrate the invention. EXAMPLE 1
Soluble granulate Unitary formulation
Cane sugar g 2.400
Lactose O.P. g 2.355 Glucose solids g 0.100
Bitter cocoa g 0.050
Liquorice dry extract g 0.050
Melaleuca oil g 0.040
Sodium saccharin g 0.005 Total g 5. EXAMPLE 2 Capsules
Melaleuca alternifolia oil mg 40 Liquorice root powder mg 10 Lactose O.P. mg 170 Maize starch mg 70 Alcohol BG 96° mg 0.008 Magnesium stearate mg 10 mg 300 gelatin capsules size 1.

Claims

1. Pharmaceutical compositions systemically administrable containing Melaleuca essential oil as active ingredient.
2. Compositions according to claim 1, containing essential oil of Melaleuca alternifolia.
3. Compositions according to claim 1 or 2 which can be administered orally.
4. Oral compositions according to claim 3 in the form of capsules, tablets, granulates.
5. Compositions according to any of the above claims containing 20 to 80 mg of essential oil.
PCT/EP1998/001708 1998-03-24 1998-03-24 Antifungal and antibacterial compositions containing melaleuca essential oil WO1999048511A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU70404/98A AU7040498A (en) 1998-03-24 1998-03-24 Antifungal and antibacterial compositions containing melaleuca essential oil
PCT/EP1998/001708 WO1999048511A1 (en) 1998-03-24 1998-03-24 Antifungal and antibacterial compositions containing melaleuca essential oil

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP1998/001708 WO1999048511A1 (en) 1998-03-24 1998-03-24 Antifungal and antibacterial compositions containing melaleuca essential oil

Publications (1)

Publication Number Publication Date
WO1999048511A1 true WO1999048511A1 (en) 1999-09-30

Family

ID=8166917

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/001708 WO1999048511A1 (en) 1998-03-24 1998-03-24 Antifungal and antibacterial compositions containing melaleuca essential oil

Country Status (2)

Country Link
AU (1) AU7040498A (en)
WO (1) WO1999048511A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140248366A1 (en) * 2011-09-29 2014-09-04 P. Guinane Pty Ltd Animal feed composition

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2705571A1 (en) * 1993-05-24 1994-12-02 Perez Adrien Guy Combination of a fatty oil and one or more aromatic essential oils
GB2293547A (en) * 1994-09-27 1996-04-03 Joan Louise Hibberd Compositions containing tea tree oil
FR2748204A1 (en) * 1996-05-06 1997-11-07 Interexport Services Antiseptic use of distilled Melaleuca essential oil

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2705571A1 (en) * 1993-05-24 1994-12-02 Perez Adrien Guy Combination of a fatty oil and one or more aromatic essential oils
GB2293547A (en) * 1994-09-27 1996-04-03 Joan Louise Hibberd Compositions containing tea tree oil
FR2748204A1 (en) * 1996-05-06 1997-11-07 Interexport Services Antiseptic use of distilled Melaleuca essential oil

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CARSON C F ET AL: "ANTIMICROBIAL ACTIVITY OF THE ESSENTIAL OIL OF MELALEUCA ALTERNIFOLIA", LETTERS IN APPLIED MICROBIOLOGY, vol. 16, no. 2, 1993, pages 49 - 55, XP000198290 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140248366A1 (en) * 2011-09-29 2014-09-04 P. Guinane Pty Ltd Animal feed composition

Also Published As

Publication number Publication date
AU7040498A (en) 1999-10-18

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