WO1998051316A1 - Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity - Google Patents

Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity Download PDF

Info

Publication number
WO1998051316A1
WO1998051316A1 PCT/EP1998/002613 EP9802613W WO9851316A1 WO 1998051316 A1 WO1998051316 A1 WO 1998051316A1 EP 9802613 W EP9802613 W EP 9802613W WO 9851316 A1 WO9851316 A1 WO 9851316A1
Authority
WO
WIPO (PCT)
Prior art keywords
colostrum
affections
treatment
oral cavity
pharmaceutical formulations
Prior art date
Application number
PCT/EP1998/002613
Other languages
French (fr)
Inventor
Luisa Bartorelli
Original Assignee
Vander Way Limited
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 Vander Way Limited filed Critical Vander Way Limited
Priority to AU80153/98A priority Critical patent/AU8015398A/en
Publication of WO1998051316A1 publication Critical patent/WO1998051316A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20Milk; Whey; Colostrum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/98Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin
    • A61K8/981Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin of mammals or bird
    • A61K8/986Milk; Derivatives thereof, e.g. butter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

  • the present invention relates to pharmaceutical formulations containing animal colostrum for the treatment of affections of the oral cavity, and the use of colostrum for the treatment of said affections.
  • "Affections of the oral cavity” means, in particular, stomatitis, prosthetic stomatitis, gingivitis, periodontal diseases, pyorrhea alveolaris; ucositis, chemotherapy and radiotherapy sores and ulcers; inflammations and ulcerations of the oral mucosa.
  • Treatment usually consists, in addition to a better oral hygiene, in the administration of disinfectants, astringents, antibacterials , such as chlorhexidine and quaternary ammonium salts; antibiotics, such as penicillin and tetracycline ⁇ ; antimycotics , such as ketoconazole; steroids, such as dexamethasone , prednisolone and triamcinolone acetonide; local anaesthetics, such as benzocaine and lidocaine; as well as the elimination of any mechanical factors such as malocclusion, substitution of prosthesis, and the like.
  • disinfectants astringents, antibacterials , such as chlorhexidine and quaternary ammonium salts
  • antibiotics such as penicillin and tetracycline ⁇
  • antimycotics such as ketoconazole
  • steroids such as dexamethasone , prednisolone and triamcinolone acetonide
  • local anaesthetics such as benzo
  • medicaments such as antibiotics, antimycotics and steroids can, of course, involves untoward side-effects, or it can be limited or precluded by the conditions of the patient.
  • An agent which, although exerting remarkable antiinflammatory and antibacterial actions on the above cited conditions, involve no undesired side-effects is therefore strongly needed.
  • the present invention aims at overcoming the above mentioned problems by using topical pharmaceutical formulations containing equine, bovine or anyway mammal, but preferably equine, colostrum, for the treatment of affections of the oral cavity.
  • the present invention further relates to the use of equine, bovine or anyway mammal, but preferably equine, colostrum, as an agent for the treatment of the affections of the oral cavity.
  • colostrum when administered to patients suffering from affections of the oral cavity, acts favourably exerting an antiinflammatory effect and restoring the physiological conditions of the buccal mucosa in a short time.
  • the pharmaceutical formulations of the invention comprise topical formulations containing powder or liquid colostrum in amounts up to 30% by volume of the formulation.
  • the powder colostrum can be in the freeze- dried or sprayzed form.
  • the formulations of the invention comprise collutorie ⁇ , liquid or in sachets to dilute before use, for the administration to the oral cavity by means of gurgles and washings with undiluted solutions, spray for nebulizations , gingival gels for gingival massages, tooth-pastes or tablets to dissolve slowly in the mouth.
  • compositions of the invention are prepared according to the conventional pharmaceutical techniques for the preparation of topical formulations for the treatment of the oral cavity.
  • the formulations of the invention will be used by the patient 1 to 3 times a day, particularly in the morning and at night after brushing teeth.
  • the formulations can contain colostrum mixed with antibacterial agents, such as chlorhexidine and benzidamine, antiinflammatory agents, local anaesthetics such as lidocaine and benzocaine , vegetable extracts having astringent or antiinflammatory action, essential oils of sage, fennel, peppermint and clove, and the like .
  • antibacterial agents such as chlorhexidine and benzidamine
  • antiinflammatory agents such as lidocaine and benzocaine
  • local anaesthetics such as lidocaine and benzocaine
  • vegetable extracts having astringent or antiinflammatory action such as fennel, peppermint and clove, and the like .
  • the formulations will also contain the conventional excipients used for the preparation of oral topical formulations .
  • 200 ml of gel contain (in % by volume): colostrum 20 propylene glycol 1 chlorhexidine digluconate 0.5 methyl p-hydroxybenzoate 0.7 propyl p-hydroxybenzoate 0.7 essential oils and flavours 1.2% micronized silica 10% water q.s. to 200 ml
  • collutory contain (in % by volume) colostrum 30 ethyl p-hydroxybenzoate 0.7 benzidamine 0.5 benzocaine 2.5 natural flavours 2 distilled water q.s. to 100 ml
  • Colostrum gingival gel 200 ml of gel contain (in % by volume): colostrum 20 micronized silica 10 fennel essential oil 1.5 sage essential oil 2.0 methyl p-hydroxybenzoate 1.5 propyl p-hydroxybenzoate 1.5 chlorhexidine digluconate 0.5 natural flavours 1.5 distilled water q.s. to 200 ml.

Abstract

Pharmaceutical formulations containing animal colostrum for the treatment of affections of the oral cavity.

Description

PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND THE USE OF COLOSTRUM FOR THE TREATMENT OF AFFECTIONS OF THE ORAL CAVITY
The present invention relates to pharmaceutical formulations containing animal colostrum for the treatment of affections of the oral cavity, and the use of colostrum for the treatment of said affections. "Affections of the oral cavity" means, in particular, stomatitis, prosthetic stomatitis, gingivitis, periodontal diseases, pyorrhea alveolaris; ucositis, chemotherapy and radiotherapy sores and ulcers; inflammations and ulcerations of the oral mucosa.
Poor oral hygiene, infections, local mechanical traumas, immune deficiencies, autoimmune disorders, avitaminosis , infective, toxic or irritating agents, systemic diseases, allergic sensitizations can be cited among the known agents responsible for the above mentioned oral affections.
Therapy mainly depends on the etiologic agent: treatment usually consists, in addition to a better oral hygiene, in the administration of disinfectants, astringents, antibacterials , such as chlorhexidine and quaternary ammonium salts; antibiotics, such as penicillin and tetracyclineε; antimycotics , such as ketoconazole; steroids, such as dexamethasone , prednisolone and triamcinolone acetonide; local anaesthetics, such as benzocaine and lidocaine; as well as the elimination of any mechanical factors such as malocclusion, substitution of prosthesis, and the like. The use of medicaments such as antibiotics, antimycotics and steroids can, of course, involves untoward side-effects, or it can be limited or precluded by the conditions of the patient. An agent which, although exerting remarkable antiinflammatory and antibacterial actions on the above cited conditions, involve no undesired side-effects is therefore strongly needed.
The present invention aims at overcoming the above mentioned problems by using topical pharmaceutical formulations containing equine, bovine or anyway mammal, but preferably equine, colostrum, for the treatment of affections of the oral cavity.
The present invention further relates to the use of equine, bovine or anyway mammal, but preferably equine, colostrum, as an agent for the treatment of the affections of the oral cavity.
Now it has surprisingly been found that colostrum, when administered to patients suffering from affections of the oral cavity, acts favourably exerting an antiinflammatory effect and restoring the physiological conditions of the buccal mucosa in a short time.
The pharmaceutical formulations of the invention comprise topical formulations containing powder or liquid colostrum in amounts up to 30% by volume of the formulation. The powder colostrum can be in the freeze- dried or sprayzed form.
More particularly, the formulations of the invention comprise collutorieε, liquid or in sachets to dilute before use, for the administration to the oral cavity by means of gurgles and washings with undiluted solutions, spray for nebulizations , gingival gels for gingival massages, tooth-pastes or tablets to dissolve slowly in the mouth.
The compositions of the invention are prepared according to the conventional pharmaceutical techniques for the preparation of topical formulations for the treatment of the oral cavity.
The formulations of the invention will be used by the patient 1 to 3 times a day, particularly in the morning and at night after brushing teeth.
According to a further aspect of the invention, the formulations can contain colostrum mixed with antibacterial agents, such as chlorhexidine and benzidamine, antiinflammatory agents, local anaesthetics such as lidocaine and benzocaine , vegetable extracts having astringent or antiinflammatory action, essential oils of sage, fennel, peppermint and clove, and the like .
The formulations will also contain the conventional excipients used for the preparation of oral topical formulations .
The following examples illustrate formulations according to the present invention.
EXAMPLE 1 20% Colostrum gingival gel
200 ml of gel contain (in % by volume): colostrum 20 propylene glycol 1 chlorhexidine digluconate 0.5 methyl p-hydroxybenzoate 0.7 propyl p-hydroxybenzoate 0.7 essential oils and flavours 1.2% micronized silica 10% water q.s. to 200 ml
EXAMPLE 2 30% Colostrum collutory
100 ml of collutory contain (in % by volume) colostrum 30 ethyl p-hydroxybenzoate 0.7 benzidamine 0.5 benzocaine 2.5 natural flavours 2 distilled water q.s. to 100 ml
EXAMPLE 3
20% Colostrum gingival gel 200 ml of gel contain (in % by volume): colostrum 20 micronized silica 10 fennel essential oil 1.5 sage essential oil 2.0 methyl p-hydroxybenzoate 1.5 propyl p-hydroxybenzoate 1.5 chlorhexidine digluconate 0.5 natural flavours 1.5 distilled water q.s. to 200 ml.

Claims

_LAJJ-tS
1. Topical pharmaceutical formulations containing colostrum for the treatment of affections of the oral cavity.
2. Pharmaceutical formulations according to claim 1, in which colostrum is equine, bovine or anyway mammal, but preferably equine, colostrum.
3. Formulations according to claims 1 and 2, in the form of collutory or tooth-paste containing powder or liquid colostrum.
4. Formulations according to the above claims, in which the powder colostrum is freeze-dried or ╬╡prayzed.
5. Formulations according to the above claims, further containing powder milk.
6. The use of colostrum for the preparation of a medicament for the treatment of affections of the oral cavity.
PCT/EP1998/002613 1997-05-09 1998-05-04 Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity WO1998051316A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU80153/98A AU8015398A (en) 1997-05-09 1998-05-04 Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT97MI001091A IT1291340B1 (en) 1997-05-09 1997-05-09 PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF ORAL CAVITY DISEASES
ITMI97A001091 1997-05-09

Publications (1)

Publication Number Publication Date
WO1998051316A1 true WO1998051316A1 (en) 1998-11-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/002613 WO1998051316A1 (en) 1997-05-09 1998-05-04 Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity

Country Status (3)

Country Link
AU (1) AU8015398A (en)
IT (1) IT1291340B1 (en)
WO (1) WO1998051316A1 (en)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999056758A1 (en) * 1998-04-30 1999-11-11 Northfield Laboratories Pty. Ltd. A food composition and method of using same
FR2783172A1 (en) * 1998-09-15 2000-03-17 Petit Leon Antoine Georges Le Lyophilized equine milk for the prevention and treatment of bucco-dental disorders such as gingivitis and periodontitis
WO2000059519A3 (en) * 1999-03-31 2001-01-11 Kapitz Carl Heinz Active agent and combination of active agents for human beings and animals
WO2003043517A2 (en) * 2001-04-03 2003-05-30 Sweetfrice U.S.A., Inc. Dentifrice compositions
US6645472B1 (en) * 2002-09-13 2003-11-11 Michael R. Anderson Oral hygiene powder composition and method
WO2007000648A1 (en) * 2005-06-29 2007-01-04 You Biomedical Research S.R.L Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity
EP2087896A1 (en) * 2008-02-05 2009-08-12 YOU Biomedical Research S.r.l. Topical compositions comprising colostrum, folates and honey of rose for the treatment of disorders of the oral cavity
ITMI20112446A1 (en) * 2011-12-30 2013-07-01 Bionest Ltd COMPOSITION FOR THE THERAPY OF INJURIES OF ORAL MUCOSA
WO2013098333A1 (en) 2011-12-30 2013-07-04 Bionest Ltd. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins c3a/c4a, immunoglobulins and chemotactic factors
WO2013098331A1 (en) 2011-12-30 2013-07-04 Bionest Ltd. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins c3a/c4a, and chemotactic factors
IT202000020971A1 (en) * 2020-09-03 2022-03-03 Solime S R L PROCEDURE FOR THE PREPARATION OF CONCENTRATED COLOSTRUM

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994016675A1 (en) * 1993-01-26 1994-08-04 Horse Vitality Ltd. Pharmaceutical and dermocosmetic compositions containing equine colostrum
EP0743060A1 (en) * 1995-04-28 1996-11-20 Sara Lee/DE N.V. Mouth-care products

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994016675A1 (en) * 1993-01-26 1994-08-04 Horse Vitality Ltd. Pharmaceutical and dermocosmetic compositions containing equine colostrum
EP0743060A1 (en) * 1995-04-28 1996-11-20 Sara Lee/DE N.V. Mouth-care products

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999056758A1 (en) * 1998-04-30 1999-11-11 Northfield Laboratories Pty. Ltd. A food composition and method of using same
FR2783172A1 (en) * 1998-09-15 2000-03-17 Petit Leon Antoine Georges Le Lyophilized equine milk for the prevention and treatment of bucco-dental disorders such as gingivitis and periodontitis
EP0995442A1 (en) * 1998-09-15 2000-04-26 LE PETIT Leon, Antoine, Georges, William Use of milk from equines for the manufacture of a preparation for the treatment of bucco-dental troubles
WO2000059519A3 (en) * 1999-03-31 2001-01-11 Kapitz Carl Heinz Active agent and combination of active agents for human beings and animals
WO2003043517A2 (en) * 2001-04-03 2003-05-30 Sweetfrice U.S.A., Inc. Dentifrice compositions
WO2003043517A3 (en) * 2001-04-03 2003-09-18 Frederic Dana Dentifrice compositions
US6645472B1 (en) * 2002-09-13 2003-11-11 Michael R. Anderson Oral hygiene powder composition and method
WO2007000648A1 (en) * 2005-06-29 2007-01-04 You Biomedical Research S.R.L Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity
EP2087896A1 (en) * 2008-02-05 2009-08-12 YOU Biomedical Research S.r.l. Topical compositions comprising colostrum, folates and honey of rose for the treatment of disorders of the oral cavity
ITMI20112446A1 (en) * 2011-12-30 2013-07-01 Bionest Ltd COMPOSITION FOR THE THERAPY OF INJURIES OF ORAL MUCOSA
WO2013098333A1 (en) 2011-12-30 2013-07-04 Bionest Ltd. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins c3a/c4a, immunoglobulins and chemotactic factors
WO2013098331A1 (en) 2011-12-30 2013-07-04 Bionest Ltd. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins c3a/c4a, and chemotactic factors
US9555084B2 (en) 2011-12-30 2017-01-31 Innomed S.A. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins C3a/C4a, immunoglobulins and chemotactic factors
EP3173087A1 (en) 2011-12-30 2017-05-31 Innomed S.A. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins c3a/c4a, and chemotactic factors
US10098927B2 (en) 2011-12-30 2018-10-16 Innomed S.A. Combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins C3A/C4A, immunoglobulins and chemotactic factors
IT202000020971A1 (en) * 2020-09-03 2022-03-03 Solime S R L PROCEDURE FOR THE PREPARATION OF CONCENTRATED COLOSTRUM
WO2022049531A1 (en) * 2020-09-03 2022-03-10 Solime' S.R.L. Process for the preparation of colostrum concentrate

Also Published As

Publication number Publication date
ITMI971091A0 (en) 1997-05-09
ITMI971091A1 (en) 1998-11-09
AU8015398A (en) 1998-12-08
IT1291340B1 (en) 1999-01-07

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