WO2007000648A1 - Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity - Google Patents

Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity Download PDF

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Publication number
WO2007000648A1
WO2007000648A1 PCT/IB2006/001746 IB2006001746W WO2007000648A1 WO 2007000648 A1 WO2007000648 A1 WO 2007000648A1 IB 2006001746 W IB2006001746 W IB 2006001746W WO 2007000648 A1 WO2007000648 A1 WO 2007000648A1
Authority
WO
WIPO (PCT)
Prior art keywords
oral cavity
disorders
colostrum
treatment
calcium folinate
Prior art date
Application number
PCT/IB2006/001746
Other languages
French (fr)
Inventor
Rosa Gobbi
Original Assignee
You Biomedical Research 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 You Biomedical Research S.R.L filed Critical You Biomedical Research S.R.L
Priority to EP06779775A priority Critical patent/EP1906979A1/en
Publication of WO2007000648A1 publication Critical patent/WO2007000648A1/en

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Classifications

    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20—Milk; Whey; Colostrum
    • 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
    • A61K8/67—Vitamins
    • 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
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/98—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin
    • A61K8/981—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin of mammals or bird
    • A61K8/986—Milk; Derivatives thereof, e.g. butter
    • 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
    • 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

Definitions

  • This invention relates to pharmaceutical formulations based on animal colostrum and calcium folinate for the treatment of disorders of the oral cavity, and the use of colostrum and calcium folinate to treat said disorders.
  • disorders of the oral cavity means, in particular, inflammatory and degenerative disorders of the oral cavity such as ulcers, lesions, leukoplakia, stomatitis, denture-induced stomatitis, gingivitis, periodontal disease, alveolar pyorrhoea, mucositis, sores and ulcers caused by chemotherapy and radiotherapy.
  • disorders of the oral cavity have numerous aetiological agents, including poor oral hygiene, infectious agents, autoimmune disease, treatment with immunosuppressant agents, avitaminosis, local mechanical traumas, and so on.
  • the treatment may involve the administration of disinfectants, astringents, antibacterial agents (chlorhexidine, benzydamine, quaternary ammonium salts), anti-inflammatory agents (salicylates), antibiotics (penicillins and tetracyclines), antifungals (ketoconazole), corticosteroids (dexamethasone, prednisolone and triamcinolone acetonide), and local anaesthetics (benzocaine and lidocaine), as well as better oral hygiene and the elimination of any mechanical factors such as malocclusion, replacement of dentures, etc.
  • pharmacological treatment often involves undesirable side effects, or may be limited or precluded by the patient's condition.
  • a further problem is that the contact time between the oral mucosa and the active agent is generally short.
  • compositions designed to treat disorders of the oral cavity generally contain adhesive agents such as cellulose, pectin or gelatin derivatives; however, they are relatively unpleasant for the user, as they often give the impression of having grit between the teeth.
  • the purpose of this invention is to eliminate the problems described above with the use of topical pharmaceutical formulations containing animal colostrum and calcium folinate for the treatment of disorders of the oral cavity.
  • the animal colostrum will be obtained from any type of mammal, but preferably from cattle or horses.
  • colostrum When administered to patients suffering from disorders of the oral cavity, colostrum exerts an anti-inflammatory effect and rapidly restores the physiological conditions normally present in the buccal mucosa. Moreover, colostrum possesses an excellent ability to adhere to the oral mucosa, thus giving the formulations according to the invention sufficient contact times for treatment of disorders of the oral cavity.
  • Calcium folinate to treat anaemia caused by folic acid deficiency due to increased demand, an insufficient dietary intake or reduced use, is well established. Calcium folinate is also used in case of methotrexate overdose and to prevent and reduce the toxic effects resulting from treatment with high doses of methotrexate.
  • the topical pharmaceutical formulations according to the invention contain colostrum in powder or liquid form in the amount of up to 30% in volume, and calcium folinate in the amount of 1 to 100 mg.
  • the powdered colostrum may be in freeze-dried or spray-dried form.
  • the formulations according to the invention include mouthwashes in liquid form or in sachets to be diluted at the time of use, for application to the oral cavity by gargling and rinsing with undiluted solution, sprays, gingival gels for gum massage, toothpastes, or tablets to be dissolved slowly in the mouth.
  • the compositions according to the invention are prepared according to conventional pharmaceutical techniques for the preparation of topical formulations for treatment of the oral cavity.
  • the formulations according to the invention will be used by the patient 1 to 3 times a day, especially in the morning and at night after cleaning the teeth.
  • the formulations may contain colostrum mixed with antibacterial agents such as chlorhexidine and benzydamine, anti-inflammatory agents, local anaesthetics such as lidocaine and benzocaine, plant extracts with an astringent or anti-inflammatory action such as essential oils of sage, fennel, mint and clove, and so on.
  • antibacterial agents such as chlorhexidine and benzydamine
  • anti-inflammatory agents such as lidocaine and benzocaine
  • local anaesthetics such as lidocaine and benzocaine
  • plant extracts with an astringent or anti-inflammatory action such as essential oils of sage, fennel, mint and clove, and so on.
  • the formulations will also contain the conventional excipients used to prepare topical oral formulations.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Birds (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Developmental Biology & Embryology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Disclosed are formulations in the form of mouthwashes, gingival gels, toothpastes or other forms suitable for topical buccal administration containing colostrum and folates as active ingredients. The compositions according to the invention are useful in the treatment of disorders of the oral cavity such as ulcers, lesions, leukoplakia, stomatitis, denture-induced stomatitis, gingivitis, periodontal disease, alveolar pyorrhoea, mucositis, sores and ulcers caused by chemotherapy and radiotherapy.

Description

PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND CALCIUM FOLINATE FOR THE TREATMENT OF DISORDERS OF THE ORAL CAVITY
This invention relates to pharmaceutical formulations based on animal colostrum and calcium folinate for the treatment of disorders of the oral cavity, and the use of colostrum and calcium folinate to treat said disorders.
"Disorders of the oral cavity" means, in particular, inflammatory and degenerative disorders of the oral cavity such as ulcers, lesions, leukoplakia, stomatitis, denture-induced stomatitis, gingivitis, periodontal disease, alveolar pyorrhoea, mucositis, sores and ulcers caused by chemotherapy and radiotherapy. Disorders of the oral cavity have numerous aetiological agents, including poor oral hygiene, infectious agents, autoimmune disease, treatment with immunosuppressant agents, avitaminosis, local mechanical traumas, and so on.
Depending on the aetiology of the disorder, the treatment may involve the administration of disinfectants, astringents, antibacterial agents (chlorhexidine, benzydamine, quaternary ammonium salts), anti-inflammatory agents (salicylates), antibiotics (penicillins and tetracyclines), antifungals (ketoconazole), corticosteroids (dexamethasone, prednisolone and triamcinolone acetonide), and local anaesthetics (benzocaine and lidocaine), as well as better oral hygiene and the elimination of any mechanical factors such as malocclusion, replacement of dentures, etc.. However, pharmacological treatment often involves undesirable side effects, or may be limited or precluded by the patient's condition. A further problem is that the contact time between the oral mucosa and the active agent is generally short.
In order to increase this contact time, compositions designed to treat disorders of the oral cavity generally contain adhesive agents such as cellulose, pectin or gelatin derivatives; however, they are relatively unpleasant for the user, as they often give the impression of having grit between the teeth.
The need for an agent which, while performing a significant anti- inflammatory and antibacterial action against said disorders, does not cause adverse effects and at the time same provides a sufficient contact time with the oral mucosa, is therefore strongly felt.
The purpose of this invention is to eliminate the problems described above with the use of topical pharmaceutical formulations containing animal colostrum and calcium folinate for the treatment of disorders of the oral cavity.
According to this invention, the animal colostrum will be obtained from any type of mammal, but preferably from cattle or horses.
When administered to patients suffering from disorders of the oral cavity, colostrum exerts an anti-inflammatory effect and rapidly restores the physiological conditions normally present in the buccal mucosa. Moreover, colostrum possesses an excellent ability to adhere to the oral mucosa, thus giving the formulations according to the invention sufficient contact times for treatment of disorders of the oral cavity.
The use of calcium folinate to treat anaemia caused by folic acid deficiency due to increased demand, an insufficient dietary intake or reduced use, is well established. Calcium folinate is also used in case of methotrexate overdose and to prevent and reduce the toxic effects resulting from treatment with high doses of methotrexate.
It has now been discovered that the combination of colostrum and calcium folinate, administered to patients suffering from inflammatory and degenerative disorders of the oral cavity, has an anti- inflammatory action and restores the normal physiological conditions on the mucous membranes of the oral cavity. The topical pharmaceutical formulations according to the invention contain colostrum in powder or liquid form in the amount of up to 30% in volume, and calcium folinate in the amount of 1 to 100 mg.
The powdered colostrum may be in freeze-dried or spray-dried form. More particularly, the formulations according to the invention include mouthwashes in liquid form or in sachets to be diluted at the time of use, for application to the oral cavity by gargling and rinsing with undiluted solution, sprays, gingival gels for gum massage, toothpastes, or tablets to be dissolved slowly in the mouth. The compositions according to the invention are prepared according to conventional pharmaceutical techniques for the preparation of topical formulations for treatment of the oral cavity.
The formulations according to the invention will be used by the patient 1 to 3 times a day, especially in the morning and at night after cleaning the teeth.
According to a further aspect of the invention, the formulations may contain colostrum mixed with antibacterial agents such as chlorhexidine and benzydamine, anti-inflammatory agents, local anaesthetics such as lidocaine and benzocaine, plant extracts with an astringent or anti-inflammatory action such as essential oils of sage, fennel, mint and clove, and so on.
The formulations will also contain the conventional excipients used to prepare topical oral formulations.

Claims

1. Topical pharmaceutical formulations containing colostrum and calcium folinate for the treatment of disorders of the oral cavity.
2. Pharmaceutical formulations as claimed in claim 1, containing colostrum in the amount of up to 30% in volume and calcium folinate in the amount of 1 to 100 mg.
3. Formulations as claimed in claims 1 and 2, wherein the colostrum is equine or bovine.
4. Formulations as claimed in claims 1 and 2, in the form of mouthwashes in liquid form or in sachets to be diluted at the time of use, for application to the oral cavity by gargling and rinsing with undiluted solution, sprays, gingival gels for gum massage, toothpastes or tablets to be dissolved slowly in the mouth.
5. Formulations as claimed in the preceding claims, wherein the powdered colostrum is freeze-dried or spray-dried.
6. Use of colostrum and calcium folinate to prepare a medicinal product for the treatment of disorders of the oral cavity.
PCT/IB2006/001746 2005-06-29 2006-06-27 Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity WO2007000648A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06779775A EP1906979A1 (en) 2005-06-29 2006-06-27 Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001231A ITMI20051231A1 (en) 2005-06-29 2005-06-29 PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND FOLINATED CALCIUM FOR THE TREATMENT OF ORAL CABLE AFFECTIONS
ITMI2005A001231 2005-06-29

Publications (1)

Publication Number Publication Date
WO2007000648A1 true WO2007000648A1 (en) 2007-01-04

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2006/001746 WO2007000648A1 (en) 2005-06-29 2006-06-27 Pharmaceutical formulations containing colostrum and calcium folinate for te treatment of disorders of the oral cavity

Country Status (3)

Country Link
EP (1) EP1906979A1 (en)
IT (1) ITMI20051231A1 (en)
WO (1) WO2007000648A1 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US9796721B2 (en) 2015-07-02 2017-10-24 Acerta Pharma B.V. Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
US20190076497A1 (en) * 2017-09-11 2019-03-14 Kenneth Davin Fine Oral and intestinal health products
US10272083B2 (en) 2014-01-21 2019-04-30 Acerta Pharma B.V. Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
US10933097B1 (en) 2020-03-05 2021-03-02 King Saud University Method of treating a bacterial infection using colostrum

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4500711A (en) * 1977-03-21 1985-02-19 Burroughs Wellcome Co. Synthesis of leucovorin
FR2627386A1 (en) * 1988-02-22 1989-08-25 Serge Liotet Compsns. for topical application to eyes - contg. colostrum lactoserum and vitamin=a
WO1994016675A1 (en) * 1993-01-26 1994-08-04 Horse Vitality Ltd. Pharmaceutical and dermocosmetic compositions containing equine colostrum
WO1998051316A1 (en) * 1997-05-09 1998-11-19 Vander Way Limited Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4500711A (en) * 1977-03-21 1985-02-19 Burroughs Wellcome Co. Synthesis of leucovorin
FR2627386A1 (en) * 1988-02-22 1989-08-25 Serge Liotet Compsns. for topical application to eyes - contg. colostrum lactoserum and vitamin=a
WO1994016675A1 (en) * 1993-01-26 1994-08-04 Horse Vitality Ltd. Pharmaceutical and dermocosmetic compositions containing equine colostrum
WO1998051316A1 (en) * 1997-05-09 1998-11-19 Vander Way Limited Pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of affections of the oral cavity

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
RU2645082C2 (en) * 2011-12-30 2018-02-15 Инномед С.А. COMBINATION OF GROWTH FACTORS, CYTOKINES, ANTIBACTERIAL/ANTIVIRAL FACTORS, STEM CELL FACTORS, C3a/C4a COMPLEMENT PROTEINS AND CHEMOTAXIC 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
US10272083B2 (en) 2014-01-21 2019-04-30 Acerta Pharma B.V. Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
US9796721B2 (en) 2015-07-02 2017-10-24 Acerta Pharma B.V. Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
US20190076497A1 (en) * 2017-09-11 2019-03-14 Kenneth Davin Fine Oral and intestinal health products
US10933097B1 (en) 2020-03-05 2021-03-02 King Saud University Method of treating a bacterial infection using colostrum
US11779608B2 (en) 2020-03-05 2023-10-10 King Saud University Method of treating a bacterial infection using colostrum

Also Published As

Publication number Publication date
EP1906979A1 (en) 2008-04-09
ITMI20051231A1 (en) 2006-12-30

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