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EP3634457A1 - Traitement de la candidose buccale - Google Patents

Traitement de la candidose buccale

Info

Publication number
EP3634457A1
EP3634457A1 EP18723067.7A EP18723067A EP3634457A1 EP 3634457 A1 EP3634457 A1 EP 3634457A1 EP 18723067 A EP18723067 A EP 18723067A EP 3634457 A1 EP3634457 A1 EP 3634457A1
Authority
EP
European Patent Office
Prior art keywords
composition
human
essential oil
animal subject
oil
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP18723067.7A
Other languages
German (de)
English (en)
Inventor
Patrick Hulisani DEMANA
Eugene Ivan OLIVIER
Gedeon MULAMBA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Limpopo, University of
Original Assignee
Limpopo, University of
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 Limpopo, University of filed Critical Limpopo, University of
Publication of EP3634457A1 publication Critical patent/EP3634457A1/fr
Withdrawn legal-status Critical Current

Links

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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • 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

Definitions

  • THIS INVENTION relates to treatment of oral candidiasis in a human or animal subject.
  • the invention provides a composition that is useful for treatment of oral candidiasis in a human or animal subject.
  • the invention also provides a composition for use in the treatment of oral candidiasis in a human or animal subject.
  • the invention further provides for the use of one or more essential oils in the preparation of a composition for treating oral candidiasis in a human or animal subject.
  • the invention still further provides for a method of treating oral candidiasis in a human or animal subject.
  • the invention also provides for the use of a composition in the treatment of oral candidiasis in a human or animal subject.
  • the invention further provides a method of preparing a composition that is useful for treatment of oral candidiasis in a human or animal subject.
  • FUNGAL INFECTIONS have become a major cause of morbidity and mortality among immuno-compromised patients. About 50 fungal species, or 30% of known fungal species cause diseases in humans.
  • Oral candidiasis is a fungal infection of the mouth cavity mostly caused by Candida albicans. This disease occurs in babies, infants, adults, diabetic patients and may be fatal in people with a compromised immune system.
  • Candida albicans is the most common cause of fungal infection and is responsible for candidiasis.
  • C. albicans resides in the gastrointestinal tract, respiratory tract, vaginal area, and mouth, as a part of the normal microflora.
  • Candida species are opportunistic pathogens and under favourable conditions such as changes in the body environment, can proliferate, overgrow, and local or systemic candidiasis may occur.
  • the present invention seeks to provide for the treatment of oral candidiasis in human or animal subjects suffering therefrom.
  • composition that is useful for treatment of oral candidiasis in a human or animal subject, the composition comprising a masticatory gum base that includes and/or carries at least one essential oil that is effective against Candida albicans.
  • the composition is therefore, in one embodiment thereof, effectively a medicated chewing gum (MCG), comprising at least one essential oil as an active pharmaceutical agent (API).
  • MCG medicated chewing gum
  • API active pharmaceutical agent
  • MIC Minimum Inhibitory Concentration
  • the composition may include more than one essential oil. A combination of two essential oils is preferred.
  • the essential oil may be selected from
  • the essential oil may be natural, or it may be synthetic.
  • the peppermint oil when natural oils are used, the peppermint oil be that of Mentha piperita, and the lemongrass oil may be that of Cymbopogon citratus.
  • the synthetic oils when synthetic oils are used, the synthetic oils may be based on that of Mentha piperita in the case of synthetic peppermint oil and on that of Cymbopogon citratus in the case of synthetic lemongrass oil.
  • Lemongrass oil is most preferred for the composition, and it is therefore preferred for the composition to comprise at least lemongrass oil.
  • the composition of the invention comprises two essential oils.
  • the essential oils may be in a volumetric ratio, based on their combined volume, of 75%:25%, 50%:50%, or 25%:75%.
  • the composition may include one or more additives, such as excipients, colourants, flavourants, sweeteners, and compression adjuvants such as glidants, anti-adherants and lubricants.
  • Suitable gum bases may include Health in Gum ® by CAFOSA (Barcelona, Spain), and Pharmagum ®. Health in Gum ® is preferred.
  • Pharmagum ® is a commonly used direct compression excipient. It is a mixture of polyols or sugars with a gum base. It can be compacted into a gum with a conventional tablet press offering rapid and cost effective development of a gum delivery system. It is typically available in three forms namely Pharmagum S, M and C.
  • Pharmagum M has a 50% greater gum base content compared to Pharmagum ® S.
  • Pharmagum ® S consists primarily of gum base and sorbitol.
  • Pharmagum ® M contains gum base, mannitol and isomalt. Formulations made with Pharmagum ® M & S are similar in appearance to a tablet.
  • the composition may have a coating applied to it.
  • the coating may be a film coating, involving deposition of the coating by spraying a thin film of a polymer formulation onto the composition.
  • Another possibility is sugar coating.
  • the coating may be an edible coating, i.e. suitable for human or animal consumption.
  • Film coating may increase the total weight of the coated composition by 2 to 7%, and sugar coating may increase the total weight of the composition by 30 to 50%. Such coating may assist in improving stability of the composition, due to the volatile nature of some essential oils.
  • the essential oil may be included in the coating. It will be appreciated that in such a case the gum base would be regarded as carrying the essential oil as opposed to including it when the essential oil is included within the gum base.
  • the gum base may, of course, include the essential oil, or carry the essential oil, or include and carry the essential oil.
  • the composition may therefore have the essential oil included in the gum base, may have the essential oil included in the coating (in which case the gum base carries the essential oil), or may have the essential oil included both the gum base and in the coating.
  • Coating is preferred due to the volatile nature of the essential oils. Thus, a coating is expected to afford the composition with stability insofar the essential oil is concerned.
  • composition, coated or uncoated may comprise the essential oil or combination of essential oils in a concentration of from about 0.5 to about 30% by weight, based on the weight of the composition. More generally, effective concentrations may be determinable by means of the MIC test, whether with reference to lemongrass oil, peppermint oil, or any other effective essential oils or combinations thereof.
  • the composition is preferably formed into a predetermined shape, e.g. through use of a tablet press or similar shaping equipment. Such forming would typically occur / have occurred prior to coating, with coating thus succeeding forming.
  • composition according to the first aspect of the invention for use in a method of treating oral candidiasis in a human or animal subject.
  • IN ACCORDANCE WITH A THIRD ASPECT OF THE INVENTION IS PROVIDED use of at least one essential oil that is effective against Candida albicans in the manufacture of a composition for treating oral candidiasis in a human or animal subject.
  • the composition may be a composition according to the first aspect of the invention.
  • a method of treating oral candidiasis in a human or animal subject including masticating or having a in a human or animal subject masticate a composition comprising a masticatory gum base which contains at least one essential oil which is effective against Candida albicans.
  • the composition may be a composition according to the first aspect of the invention.
  • IN ACCORDANCE WITH A FIFTH ASPECT OF THE INVENTION IS PROVIDED use of a composition of the first aspect of the invention in treating oral candidiasis in a human or animal subject.
  • IN ACCORDANCE WITH A SIXTH ASPECT OF THE INVENTION IS PROVIDED a method of preparing a composition for treating oral candidiasis in a human or animal subject, the method including
  • a masticatory gum base that includes at least one essential oil that is effective against Candida albicans; and/or coating a / the masticatory gum base with a coating that includes at least one essential oil that is effective against Candida albicans.
  • the composition may be a composition according to the first aspect of the invention.
  • an essential oil that is effective against Candida albicans for use in treating oral candidiasis in a human or animal subject.
  • the essential oil may be as hereinbefore described in accordance with the first aspect of the invention.
  • the essential oil may be as hereinbefore described in accordance with the first aspect of the invention.
  • the composition may be a composition according to the first aspect of the invention.
  • GUM BASES DETERMINE the release profile of active ingredients and flavours, and define the characteristics of chewing gums, such as texture, softness, hardness, elasticity, crumbliness, stickiness and mouth feel.
  • Health in gum ® is the preferred gum base for the composition according to the invention. This is so since it is a free flowing directly compressible co-processed gum material, which lends itself to simple processing in producing medicated chewing gums, such as that provided by the composition according to the invention. It is manufactured under cGMP conditions and complies with food chemical specifications and is 'generally regarded as safe' (GRAS) product regulated by FDA title 21 C.F.R Section 172.615.
  • GRAS safe'
  • Heath in gum ® and analogues thereof are mixtures of polyols (sorbitol/xylitol/mannitol) and of sugar with gum, plasticizers and anticaking agents.
  • such gum materials can be directly compressed on a pharmaceutical in-house tablet compression machine, which enables rapid and low cost production.
  • Liquid flavour 0.55% 0.85% 0.60%
  • the active pharmaceutical ingredient in a medicated chewing gum can be included in the gum core or coat or in both.
  • the API varies from 0.5-30% of the final gum weight.
  • a saliva soluble drug will be completely released from the MCG within 10-15 minutes of chewing whereas a lipophilic drug will first dissolve in the gum base and then be slowly and completely absorbed.
  • FORMULAS OF EXEMPLARY COMPOSITIONS in accordance with the invention in the form of antifungal masticatory gums, preferably using Health in Gum ® by CAFOSA as the gum base, include:
  • THE USE OF CHEWING GUM for active pharmaceutical agent delivery offers advantages including fast onset of action due to the rapid release of the active pharmaceutical agent from the dosage form in the buccal cavity; good bioavailability because the active pharmaceutical agent avoids the first pass metabolism; ease of administration, patient acceptability especially for children; and aesthetic and attractive appeal.
  • Disadvantages of medicated chewing gums include pain in the facial muscles; earache in children; ulcers in the oral cavity due to some flavouring agents and adherence of chewing gum to enamel dentures and fillers.
  • medicated chewing gums are defined as solid single dose preparations with a base consisting mainly of gum that are intended to be chewed but not to be swallowed, providing a slow steady release of the medicine contained. It is a drug delivery system containing a gum base and one or more active pharmaceutical ingredients released by the action of chewing and intended to be used for the treatment of local diseases or systemic delivery after absorption through the buccal mucosa.
  • Chewing gums have been used worldwide since ancient times after man experienced the pleasure of chewing a variety of substances.
  • the first commercial chewing gum named 'state of Maine pure spruce gum' was marketed in the United States in 1848 and the first patent was filed as a dentifrice in 1869.
  • the first medicated chewing gum Aspergum ® containing acetylsalicylic acid, as active for headaches, was launched in 1928.
  • the success story of nicotine chewing gum for smoking cessation in the 1980s has led to more general acceptance of chewing gum as a drug delivery system.
  • "Chewing Gum” was approved as a term for a pharmaceutical dosage form by the commission of European Council.
  • Drugs are formulated into various solid dosage forms including tablets, capsules etc. and semi-solid dosage forms such as creams, ointments and gels. Chewing gum is being used worldwide as a convenient modified release drug delivery system.
  • An essential oil is a concentrated hydrophobic liquid containing volatile compounds.
  • the liquid is generally obtained by steam or hydro distillation from leaves, stems, flowers, bark or roots of a plant.
  • Essential oils are also defined as volatile substances containing a complex mixture of chemical compounds (terpenes, monoterpenes, terpenoids, alcohols, aldehydes, and ketones) synthesised from plants which in contact with air can evaporate.
  • Essential oils from plants are generally recognized as safe (GRAS).

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (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)
  • Mycology (AREA)
  • Medical Informatics (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Confectionery (AREA)
  • Medicinal Preparation (AREA)

Abstract

Une composition qui est utile pour le traitement de la candidose buccale chez un sujet humain ou animal comprend une base de gomme à mastiquer qui contient et/ou porte au moins une huile essentielle qui est efficace contre Candida albicans.
EP18723067.7A 2017-06-07 2018-04-24 Traitement de la candidose buccale Withdrawn EP3634457A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA201703890 2017-06-07
PCT/IB2018/052843 WO2018224897A1 (fr) 2017-06-07 2018-04-24 Traitement de la candidose buccale

Publications (1)

Publication Number Publication Date
EP3634457A1 true EP3634457A1 (fr) 2020-04-15

Family

ID=62116918

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18723067.7A Withdrawn EP3634457A1 (fr) 2017-06-07 2018-04-24 Traitement de la candidose buccale

Country Status (3)

Country Link
EP (1) EP3634457A1 (fr)
WO (1) WO2018224897A1 (fr)
ZA (1) ZA201908255B (fr)

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014031357A (ja) * 2012-08-03 2014-02-20 Shigeru Abe 香りのよい抗カンジダ活性組成物

Also Published As

Publication number Publication date
ZA201908255B (en) 2020-11-25
WO2018224897A1 (fr) 2018-12-13

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