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WO2018104877A1 - Compositions comprenant du boswellia sacra (arbre à encens) pour le traitement de l'hyperplasie prostatique bénigne - Google Patents

Compositions comprenant du boswellia sacra (arbre à encens) pour le traitement de l'hyperplasie prostatique bénigne Download PDF

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Publication number
WO2018104877A1
WO2018104877A1 PCT/IB2017/057681 IB2017057681W WO2018104877A1 WO 2018104877 A1 WO2018104877 A1 WO 2018104877A1 IB 2017057681 W IB2017057681 W IB 2017057681W WO 2018104877 A1 WO2018104877 A1 WO 2018104877A1
Authority
WO
WIPO (PCT)
Prior art keywords
boswellia sacra
compositions
zinc
treatment
vitamin
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/IB2017/057681
Other languages
English (en)
Inventor
Danilo RIVA
Gloria PUMILIA
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.)
Industria Farmaceutica Nova Argentia SpA
Original Assignee
Industria Farmaceutica Nova Argentia SpA
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 Industria Farmaceutica Nova Argentia SpA filed Critical Industria Farmaceutica Nova Argentia SpA
Publication of WO2018104877A1 publication Critical patent/WO2018104877A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • 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)
    • A61K36/32—Burseraceae (Frankincense family)
    • A61K36/324—Boswellia, e.g. frankincense
    • 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)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate

Definitions

  • the present invention concerns the field of compositions containing natural active ingredients, in particular Boswellia Sacra, and the formulations for oral administration containing them.
  • BPH benign prostatic hypertrophy
  • BPH represents one of the most common pathologies in adult men; 50 % of men aged 50-60 years and 90% of men of average age 80 years suffer from a stage that requires therapy (1 ), after 70 years the percentage increases: 8 out of 10 men suffer from this.
  • the pathology begins as structural modification of the gland, already around 30 years of age, but it generally clinically manifests itself after 40 years of age. The older one gets, the more often it occurs.
  • the daily problem often the source of worry, anxiety and serious discomfort for young or older men, is "counterbalanced" with some good news, which must not overshadow the checks: BPH cannot degenerate into prostatic neoplasia.
  • the harmful alterations of the bladder muscle are slow and chronic, firstly reversible, then irreversible. Initially they appear with difficulty in urinating that coincides with problematic emptying of the bladder, with impulsive stimuli and the daily and nightly increase of stream hesitancy. With the obstructive phase there is reduction, difficulty in starting urination and incomplete emptying of the bladder.
  • the therapy can, however, only be effective after at least 3 months of treatment and the essential element is the reduction of production by the body of the enzyme 5- alpha reductase and moreover it is worth remembering that the plant is capable of giving relief only from the functional disturbances caused by BPH, but is unable to reduce the size of the prostate.
  • compositions containing Boswellia sacra and their use for the treatment of benign prostatic hyperplasia.
  • compositions containing Boswellia sacra in combination with Serenoa repens, Vitamin D3 and zinc allow the effective treatment of BPH, thus overcoming the aforementioned problems.
  • Boswellia sacra potently inhibits the growth of human prostate tumour through the inhibition of angiogenesis induced by signaling pathways VEGFR2.
  • Vitamin D can regulate the proliferation, apoptosis, and cellular differentiation towards tumour cells: supplementing with vitamin D is therefore important to prevent the occurrence of prostate cancer and/or the progression of the tumour in the patient suffering from this tumour.
  • Zinc reduces the secretion of prolactin and prolactin increases the intake of testosterone in the prostate, the intake of this mineral determines a reduction of the level of prostatic DHT which makes it possible to obtain particularly interesting results in the treatment of benign prostatic hyperplasia.
  • the synergic activity of this composition ensures a clear reduction of obstructive symptoms (difficulty in starting urination or dysuria, intermittent stream, incomplete emptying of the bladder, weak stream and effort required for urination), irritative symptoms (pollakiuria and nocturia - increased frequency of urination and increased need to urinate during the night, respectively), urgency (since the need to empty the bladder cannot be delayed) burning during urination, perineal tension.
  • obstructive symptoms difficulty in starting urination or dysuria, intermittent stream, incomplete emptying of the bladder, weak stream and effort required for urination
  • irritative symptoms polylakiuria and nocturia - increased frequency of urination and increased need to urinate during the night, respectively
  • urgency since the need to empty the bladder cannot be delayed burning during urination, perineal tension.
  • Serenoa repens is meant to indicate the sterol lipid extract obtained by extraction with C02 and with high titer in fatty acids (85%)
  • Boswellia sacra is meant to indicate a fluid extract of gum-resins containing >40 gr/Kg of AKBA and > 30 gr/Kg of ⁇ - ⁇ + ⁇ - ⁇ + ⁇ .
  • the volatile fraction contains cembranoid diterpenes, incensole and incensole acetate with quantity > 65 gr/Kg.
  • This type of boswellia represents the only available source of liquid extracts of gum-resins of Boswellia sacra capable of providing a unique series of applications: greater solubility, non-ethanolic formulation, greater bioavailability, high content of volatile compounds with bioactive properties (incensole acetate).
  • Zinc is normally present in salt form like for example monoanhydrous sulphate
  • composition according to the invention can also contain other active ingredients like for example selenium.
  • the aforementioned components are present in the following percentages calculated over the total weight of the composition:
  • Boswellia sacra 10 - 35%
  • Vitamin D3 0.005 - 0.60%
  • a particularly preferred composition consists of : Serenoa Repensa 74.840%
  • Vitamin D3 0.002%
  • compositions according to the invention are formulated in the form of soft capsules thus consisting of the oily liquid content consisting of the aforementioned active ingredients and possible excipients and an outer casing normally consisting of bovine gelatin, glycerine, titanium dioxide and possibly suitable dyes.
  • the final soft capsules have a weight of between 700 and 1 300 mg.
  • the soft capsules and the technology for producing them are well known and make it possible to obtain an excellent bioavailability and stability of the active ingredients and greater speed of action since the casing breaks within a few minutes releasing the substances, which become available more quickly and in this way also the absorption in the intestine is quicker with respect to solid formulations.
  • the preparation process essentially provides for the solubilisation of the zinc salt and of the selenium with the oils of Serenoa repens, Boswellia sacra and Vitamin D3 and then the injection of said mixture in the capsules during their formation.
  • the composition obtained is loaded into a colloid mill, consisting of a frusto-conical rotor that rotates, at extremely high speed, inside a stator.
  • the distance between rotor and stator can be adjusted so as to obtain the desired consistency of the emulsion: all of this always at controlled temperature.
  • This process reduces the size of the particles of the emulsion to about 0.65 mm, once the texture of the mixture has been approved this is then introduced into the tank to then pass to the encapsulation step,
  • the reactor is loaded with 60 % of the Glycerine necessary to make the softgels (24.5 kg), Titanium dioxide (1 .8 kg) and chlorophyll (0.239Kg), mixing the components for 30 minutes: then the remaining glycerine (16.3 kg) and the gelatin (88.8 kg) is loaded and the mixing is continued for another 20 minutes.
  • the resulting composition is passed through a sieve with porosity of 1 mm.
  • the product thus obtained is transported in containers at controlled temperature of

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des compositions contenant du Boswellia sacra, et des formulations associées sous la forme de capsules souples utiles pour le traitement de l'hyperplasie prostatique bénigne.
PCT/IB2017/057681 2016-12-07 2017-12-06 Compositions comprenant du boswellia sacra (arbre à encens) pour le traitement de l'hyperplasie prostatique bénigne Ceased WO2018104877A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000124361A IT201600124361A1 (it) 2016-12-07 2016-12-07 Composizioni contenenti Boswellia Sacra per il trattamento dell'iperplasia prostatica benigna
IT102016000124361 2016-12-07

Publications (1)

Publication Number Publication Date
WO2018104877A1 true WO2018104877A1 (fr) 2018-06-14

Family

ID=58545075

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2017/057681 Ceased WO2018104877A1 (fr) 2016-12-07 2017-12-06 Compositions comprenant du boswellia sacra (arbre à encens) pour le traitement de l'hyperplasie prostatique bénigne

Country Status (2)

Country Link
IT (1) IT201600124361A1 (fr)
WO (1) WO2018104877A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6200573B1 (en) * 1999-12-03 2001-03-13 Starcor Pharmaceuticals, Inc. Method of medical management for lower urinary tract symptoms and benign prostatic hyperplasia
US20020001633A1 (en) * 1999-09-10 2002-01-03 Chase Revel Method and composition for the treatment of benign prostate hypertrophy (BPH) and prevention of prostate cancer
WO2009103477A1 (fr) * 2008-02-22 2009-08-27 Indena S.P.A. Compositions destinées au traitement de l'hypertrophie bénigne de la prostate, de la prostatite, de la prostatose et du cancer de la prostate

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020001633A1 (en) * 1999-09-10 2002-01-03 Chase Revel Method and composition for the treatment of benign prostate hypertrophy (BPH) and prevention of prostate cancer
US6200573B1 (en) * 1999-12-03 2001-03-13 Starcor Pharmaceuticals, Inc. Method of medical management for lower urinary tract symptoms and benign prostatic hyperplasia
WO2009103477A1 (fr) * 2008-02-22 2009-08-27 Indena S.P.A. Compositions destinées au traitement de l'hypertrophie bénigne de la prostate, de la prostatite, de la prostatose et du cancer de la prostate

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
A AL-HARRASI ET AL: "Antiglycation and Antioxidant Activities and HPTLC Analysis of <i>Boswellia sacra</i> Oleogum Resin: The Sacred Frankincense", TROPICAL JOURNAL OF PHARMACEUTICAL RESEARCH, vol. 12, no. 4, 28 August 2013 (2013-08-28), pages 597 - 602, XP055199042, ISSN: 1596-5996, DOI: 10.4314/tjpr.v12i4.23 *
PAN YING-NI ET AL: "Comparative studies of pharmacokinetics and anticoagulatory effect in rats after oral administration of Frankincense and its processed products", JOURNAL OF ETHNOPHARMACOLOGY, vol. 172, 25 June 2015 (2015-06-25), pages 118 - 123, XP029252937, ISSN: 0378-8741, DOI: 10.1016/J.JEP.2015.06.029 *
XIAO NI ET AL: "Frankincense essential oil prepared from hydrodistillation of Boswellia sacra gum resins induces human pancreatic cancer cell death in cultures and in a xenograft murine model", BMC COMPLEMENTARY AND ALTERNATIVE MEDICINE, BIOMED CENTRAL LTD., LONDON, GB, vol. 12, no. 1, 13 December 2012 (2012-12-13), pages 253, XP021135926, ISSN: 1472-6882, DOI: 10.1186/1472-6882-12-253 *

Also Published As

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IT201600124361A1 (it) 2018-06-07

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