WO2009043134A1 - Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite - Google Patents

Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite Download PDF

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Publication number
WO2009043134A1
WO2009043134A1 PCT/CA2007/001743 CA2007001743W WO2009043134A1 WO 2009043134 A1 WO2009043134 A1 WO 2009043134A1 CA 2007001743 W CA2007001743 W CA 2007001743W WO 2009043134 A1 WO2009043134 A1 WO 2009043134A1
Authority
WO
WIPO (PCT)
Prior art keywords
formulation
agent
nystatin
fungal
preservative
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.)
Ceased
Application number
PCT/CA2007/001743
Other languages
English (en)
Inventor
Deepak Bhasin
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.)
Myrex Pharmaceuticals Inc
Original Assignee
Myrex Pharmaceuticals Inc
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 Myrex Pharmaceuticals Inc filed Critical Myrex Pharmaceuticals Inc
Priority to CA2701583A priority Critical patent/CA2701583A1/fr
Priority to EP07866180A priority patent/EP2203152A4/fr
Priority to PCT/CA2007/001743 priority patent/WO2009043134A1/fr
Publication of WO2009043134A1 publication Critical patent/WO2009043134A1/fr
Priority to US12/752,721 priority patent/US20100190735A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/41—Amines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/42—Amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/60—Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/63—Steroids; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005—Antimicrobial preparations

Definitions

  • the present invention relates to oral hygiene and in particular, to mouthwashes for the treatment and prophylaxis of mucositis and stomatitis of the oral cavity and to a method of using such a mouthwash
  • Mouthwashes are typically used as part of an oral hygiene regime which may also include brushing and flossing to maintain a satisfactory level of oral hygiene
  • Such mouthwashes are generally classified as cosmetic, therapeutic or a combination of the two Cosmetic rinses are commercial over-the-counter products that help remove oral debris before or after brushing, temporarily suppress bad breath, diminish bacteria in the mouth and refresh the mouth with a pleasant taste
  • Therapeutic rinses often have the benefits of their cosmetic counterpart, but also contain an added active ingredient, for example chlorhexidine that helps protect against some oral diseases such as gingivitis
  • such mouthwashes are alcohol-based [0004]
  • available mouthwashes are unsuitable for hospital patients presenting with oral complications as a result of, for example, infection or other lesions as
  • the present invention provides an oral rinse formulation comprising one or more of the following components in combination with pharmaceutically acceptable excipients or additives a) at least one corticosteroid, b) at least one anti-histamine, c) at least one topical anaesthetic, d) at least one anti-fungal antibiotic agent [0017]
  • the formulation can include an antibiotic agent [0018]
  • the invention provides a method of treating or preventing mucositis or stomatitis comprising applying to a patient the above mentioned oral rinse formulation [0019]
  • the invention provides a stable, anti-fungal oral rinse formulation comprising - an anti-fungal agent, - a phosphate buffer, - a preservative, - a chelating agent, and, - an antioxidant [0020]
  • the anti-fungal agent is chosen from nystatin and amphotericin B In a
  • the present invention provides, in one embodiment, a mouthwash comprising one or more of the following active ingredients - at least one corticosteroid, - at least one anti-histamine, - at least one topical anaesthetic, - at least one anti-fungal antibiotic agent [0022]
  • the formulation may include an antibiotic agent as well
  • the invention provides a mouthwash formulation comprising an anti-fungal agent, a phosphate buffer, a preservative, a chelating agent and an antioxidant
  • This formulation preferably also includes at least one corticosteroid, at least one antihistamine, and at least one topical anaesthetic
  • the anti-fungal agent of this formulation comprises nystatin or amphotericin B and, most preferably, nystatin
  • the mouthwash in accordance with the present invention is used in the treatment and/or prophylaxis of oral
  • Step 4 Mix solution from step 2 and nystatin suspension from step 3. Add 1.2 mL NFB mixed berry flavor. Mix well.
  • Step 5 Measure pH. If it is not 6.5 ⁇ 0.5, adjust to pH 6.5 ⁇ 0.5 with 100 mM phosphate buffer (Na 2 HPO 4 ).
  • Step 6 Adjust final volume to 300 mL with water. Mix well and verify pH again.
  • the formulation (300 ml) will have the composition as listed in the following table. Items marked as * comprise the active drug ingredients. Items marked as ** comprise the alternative components used for a placebo formulation.
  • formulations were stored at room temperature and tested upon formulation (i.e. time - 0) and at 2, 3 and 4 month time points for identity, potency, pH, preservative assay, physical appearance and color.
  • Formulation B8 was used for testing stability and the results of this analysis at the various time points are provided in Tables 2 to 5.
  • Table 3 Sample characteristics after 2 months (at room temperature and at 40°C)
  • Table 5 Sample characteristics after 4 months (at room temperature and at 40°C)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Birds (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention a trait à une forme pharmaceutique de type bain de bouche, destinée au traitement ou à la prophylaxie d'une mucite ou d'une stomatite. Ladite forme pharmaceutique comprend un ou plusieurs des composants suivants en association avec des additifs ou des excipients acceptables sur le plan pharmaceutique : a) au moins un corticostéroïde ; b) au moins un antihistaminique ; c) au moins un anesthésique topique ; et, d) au moins un agent antibiotique antifongique. L'invention a également trait à une forme pharmaceutique stable contenant de la nystatine, ainsi qu'un agent tampon, un conservateur, un agent chélateur et un anti-oxydant.
PCT/CA2007/001743 2006-03-28 2007-10-03 Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite Ceased WO2009043134A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA2701583A CA2701583A1 (fr) 2007-10-03 2007-10-03 Bain de bouche et son procede d'utilisation en vue du traitement d'une mucite ou d'une stomatite
EP07866180A EP2203152A4 (fr) 2007-10-03 2007-10-03 Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite
PCT/CA2007/001743 WO2009043134A1 (fr) 2007-10-03 2007-10-03 Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite
US12/752,721 US20100190735A1 (en) 2006-03-28 2010-04-01 Mouthwash and Method of Using Same for the Treatment of Mucositis or Stomatitis

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CA2007/001743 WO2009043134A1 (fr) 2007-10-03 2007-10-03 Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US11/692,737 Continuation-In-Part US20070231274A1 (en) 2006-03-28 2007-03-28 Mouthwash and Method of Using Same for the Treatment of Mucositis or Stomatitis

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/752,721 Continuation-In-Part US20100190735A1 (en) 2006-03-28 2010-04-01 Mouthwash and Method of Using Same for the Treatment of Mucositis or Stomatitis

Publications (1)

Publication Number Publication Date
WO2009043134A1 true WO2009043134A1 (fr) 2009-04-09

Family

ID=40525790

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2007/001743 Ceased WO2009043134A1 (fr) 2006-03-28 2007-10-03 Bain de bouche et son procédé d'utilisation en vue du traitement d'une mucite ou d'une stomatite

Country Status (3)

Country Link
EP (1) EP2203152A4 (fr)
CA (1) CA2701583A1 (fr)
WO (1) WO2009043134A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150374772A1 (en) * 2013-02-07 2015-12-31 Tomás Bernardo GALVÁN GONZÁLEZ Oral antiseptic composition useful for treating oral mucositis
US9956211B2 (en) 2011-04-29 2018-05-01 Moberg Pharma Ab Pharmaceutical compositions comprising a local anaesthetic such as bupivacaine for local administration to the mouth or throat
EP4480481A1 (fr) * 2023-06-22 2024-12-25 Assistance Publique-Hopitaux De Paris Mepyramine pour utilisation dans le traitement topique de la mucosite orale
CN121622702A (zh) * 2026-02-02 2026-03-10 荆州市中心医院(长江大学附属荆州医院) 一种唑类药物在制备抗真菌药物中的应用

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4678772A (en) * 1983-02-28 1987-07-07 Yissum Research Development Company Of The Hebrew University Of Jerusalem Compositions containing glycyrrhizin
US4961926A (en) 1987-11-19 1990-10-09 Sloan-Kettering Institute For Cancer Research Methods for prevention and treatment of mucositis with granulocyte colony stimulating factor
US5102870A (en) 1989-04-14 1992-04-07 Schering Ag Treatment and prevention of oral mucositis with growth factors
CA2103351A1 (fr) * 1991-04-11 1992-10-29 Drore Eisen Methode de traitement utilisant un rince-bouche a base de steroides
US5545668A (en) 1993-03-30 1996-08-13 Skubitz; Keith M. Oral glutamine to reduce stomatitis
US5635489A (en) 1992-09-21 1997-06-03 Oncogene Science, Inc. Methods of prevention of oral mucositis with transforming growth factor β
WO1999020310A1 (fr) 1997-10-20 1999-04-29 Epicyte Pharmaceutical Inc. Chaine j et analogues utilises comme conjugues de ciblage de cellules epitheliales
US5945089A (en) 1998-11-05 1999-08-31 I-Dent International Corporation Method of treating mucositis
US6025326A (en) 1995-07-07 2000-02-15 Intrabiotics Pharmaceuticals, Inc. Compositions and methods for the prevention and treatment of oral mucositis
CA2444885A1 (fr) * 2001-04-24 2002-10-31 The General Hospital Corporation Procedes et compositions de traitement de lesions buccales et oesophagiennes
US20030236217A1 (en) 2002-05-21 2003-12-25 Shalwitz Robert A. Treatment of mucositis
US6828308B2 (en) 2000-07-28 2004-12-07 Sinclair Pharmaceuticals, Ltd. Compositions and methods for the treatment or prevention of inflammation
US6946118B1 (en) 1999-09-14 2005-09-20 Orapharma, Inc. Formulations for treating or preventing mucositis
US20070231274A1 (en) * 2006-03-28 2007-10-04 Myrex Pharmaceuticals Inc. Mouthwash and Method of Using Same for the Treatment of Mucositis or Stomatitis

Family Cites Families (1)

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Publication number Priority date Publication date Assignee Title
US6685917B2 (en) * 2000-11-22 2004-02-03 Rxkinetix, Inc. Treatment of mucositis

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4678772A (en) * 1983-02-28 1987-07-07 Yissum Research Development Company Of The Hebrew University Of Jerusalem Compositions containing glycyrrhizin
US4961926A (en) 1987-11-19 1990-10-09 Sloan-Kettering Institute For Cancer Research Methods for prevention and treatment of mucositis with granulocyte colony stimulating factor
US5102870A (en) 1989-04-14 1992-04-07 Schering Ag Treatment and prevention of oral mucositis with growth factors
CA2103351A1 (fr) * 1991-04-11 1992-10-29 Drore Eisen Methode de traitement utilisant un rince-bouche a base de steroides
WO1992018133A1 (fr) 1991-04-11 1992-10-29 Drore Eisen Procede de traitement par bains de bouche a base de steroides
US5635489A (en) 1992-09-21 1997-06-03 Oncogene Science, Inc. Methods of prevention of oral mucositis with transforming growth factor β
US5545668A (en) 1993-03-30 1996-08-13 Skubitz; Keith M. Oral glutamine to reduce stomatitis
US6025326A (en) 1995-07-07 2000-02-15 Intrabiotics Pharmaceuticals, Inc. Compositions and methods for the prevention and treatment of oral mucositis
WO1999020310A1 (fr) 1997-10-20 1999-04-29 Epicyte Pharmaceutical Inc. Chaine j et analogues utilises comme conjugues de ciblage de cellules epitheliales
US5945089A (en) 1998-11-05 1999-08-31 I-Dent International Corporation Method of treating mucositis
US6946118B1 (en) 1999-09-14 2005-09-20 Orapharma, Inc. Formulations for treating or preventing mucositis
US6828308B2 (en) 2000-07-28 2004-12-07 Sinclair Pharmaceuticals, Ltd. Compositions and methods for the treatment or prevention of inflammation
CA2444885A1 (fr) * 2001-04-24 2002-10-31 The General Hospital Corporation Procedes et compositions de traitement de lesions buccales et oesophagiennes
WO2002085402A1 (fr) 2001-04-24 2002-10-31 The General Hospital Corporation Procedes et compositions de traitement de lesions buccales et oesophagiennes
US20030236217A1 (en) 2002-05-21 2003-12-25 Shalwitz Robert A. Treatment of mucositis
US20070231274A1 (en) * 2006-03-28 2007-10-04 Myrex Pharmaceuticals Inc. Mouthwash and Method of Using Same for the Treatment of Mucositis or Stomatitis

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CARMONA, A.: "''Toxicidades y tratamiento de soporte de la radioquimioterapia aplicados a los tumores de cabeza y cuello'' [''Toxicities and palliative treatment of chemoradiation applied to head and neck tumors'']", REVISIONES EN CANCER, vol. 21, no. 1, 14 May 2007 (2007-05-14), pages 31 - 38, XP008132722 *
CHAN ET AL.: "Survey of topical oral solutions for the treatment of chemo- induced oral mucositis", JOURNAL OF ONCOLOGY PHARMACY PRACTICE, vol. 11, no. 4, December 2005 (2005-12-01), pages 139 - 143, XP008132775 *
FONSECA: "Basics of compounding for dentistry, part 1: Effective approaches and formulations", INTERNATIONAL JOURNAL OF PHARMACEUTICAL COMPOUNDING, vol. 10, no. 2, 2006, pages 122 - 127 *
GROESCHKE ET AL.: "Stability of amphotericin B and nystatin in antifungal mouthrinses containing sodium hydrogen carbonate", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 42, no. 3, 2006, pages 362 - 366, XP025145818 *
J. GROESCHKE ET AL.: "Stability of Amphotericin B and Nystatin in Antifungal Mouthrinses Containing Sodium Hydrogen Carbonate", J. PHARM. AND BIOMED. ANAL., vol. 42, no. 3, 2006, pages 362 - 366, XP028005188, DOI: doi:10.1016/j.jpba.2006.04.011
See also references of EP2203152A4 *
SIMON ET AL.: "Management of oral complications associated with cancer therapy in pediatric patients", ASDC JOURNAL OF DENTISTRY FOR CHILDREN, vol. 58, no. 5, September 1991 (1991-09-01), pages 384 - 389, XP008132801 *

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9956211B2 (en) 2011-04-29 2018-05-01 Moberg Pharma Ab Pharmaceutical compositions comprising a local anaesthetic such as bupivacaine for local administration to the mouth or throat
US10493068B2 (en) 2011-04-29 2019-12-03 Moberg Pharma Ab Pharmaceutical compositions comprising a local anaesthetic such as bupivacaine for local administration to the mouth or throat
US20150374772A1 (en) * 2013-02-07 2015-12-31 Tomás Bernardo GALVÁN GONZÁLEZ Oral antiseptic composition useful for treating oral mucositis
US9801916B2 (en) * 2013-02-07 2017-10-31 Tomás Bernardo Galvan Gonzalez Oral antiseptic composition useful for treating oral mucositis
EP4480481A1 (fr) * 2023-06-22 2024-12-25 Assistance Publique-Hopitaux De Paris Mepyramine pour utilisation dans le traitement topique de la mucosite orale
WO2024261233A1 (fr) * 2023-06-22 2024-12-26 Assistance Publique - Hopitaux De Paris Mépyramine destinée à être utilisée dans le traitement topique d'une maladie affectant la muqueuse buccale
CN121622702A (zh) * 2026-02-02 2026-03-10 荆州市中心医院(长江大学附属荆州医院) 一种唑类药物在制备抗真菌药物中的应用

Also Published As

Publication number Publication date
EP2203152A4 (fr) 2011-05-25
CA2701583A1 (fr) 2009-04-09
EP2203152A1 (fr) 2010-07-07

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