WO2016181214A1 - Compositions et procédés destinés au traitement de la maladie à virus ebola - Google Patents

Compositions et procédés destinés au traitement de la maladie à virus ebola Download PDF

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Publication number
WO2016181214A1
WO2016181214A1 PCT/IB2016/000655 IB2016000655W WO2016181214A1 WO 2016181214 A1 WO2016181214 A1 WO 2016181214A1 IB 2016000655 W IB2016000655 W IB 2016000655W WO 2016181214 A1 WO2016181214 A1 WO 2016181214A1
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
extract
formulated
prepared
compositions
Prior art date
Application number
PCT/IB2016/000655
Other languages
English (en)
Inventor
Erick GBODOSSOU
Original Assignee
Gbodossou Erick
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 Gbodossou Erick filed Critical Gbodossou Erick
Publication of WO2016181214A1 publication Critical patent/WO2016181214A1/fr

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Classifications

    • 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
    • A61K9/08—Solutions
    • 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)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • 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)
    • A61K36/89—Cyperaceae (Sedge family)
    • A61K36/8905—Cyperus (flatsedge)
    • 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)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

Definitions

  • the invention relates generally to methods and compositions for the treatment of Ebola virus disease (EVD).
  • Compositions in accordance with the instant invention are prepared from Momordica balsamina, Aframomum melegueta and Cyperus articulatus and compositions or pharmaceutical formulations of the compositions are administered to patients suffering from EVD.
  • EVD formerly known as Ebola hemorrhagic fever
  • Ebola hemorrhagic fever is a severe and often fatal illness in humans.
  • the average fatality rate is around 50%, though fatality rates have been as high as 90% in past outbreaks.
  • Initial signs and symptoms of EVD infection may include elevated body temperature or subjective fever, chills, myalgias, and malaise. However, because of the nature of these symptoms, EVD often can be confused with other more common infectious diseases such as malaria, typhoid fever, meningococcemia, and other bacterial infections.
  • compositions - in particular pharmaceutical compositions - and methods for the treatment of EVD comprise an extract prepared from one or more plants selected from the group consisting of Momordica balsamina, Aframomum meleg et, and Cyperus articulates.
  • Pharmaceutical compositions further comprise one or more substances selected from the group consisting of a pharmaceutical ly-acceptable carrier, an excipient, a stabilizer, a solubilizer, and a preservative.
  • Pharmaceutical compositions may be formulated for oral, parenteral or topical administration.
  • Pharmaceutical compositions may also be formulated for sustained release. Formulations may be in the form of, e.g., a capsule, pill, or liquid suspension.
  • Method of treating EVD comprise administering a therapeutically effective amount of a pharmaceutical composition in accordance with the invention to a subject.
  • a preferred dosage may be from about 0.075 mg/kg/day to about 0.45 mg/kg/day.
  • Figure 1 shows the dose response curve of the control solution in HeLa cells.
  • Figure 2 shows the dose response curve of Extract A in HeLa (top) and HFF- I (bottom) cells. Concentration is shown in units of g/mL, not as molarity as indicated below the X-axis of the figure.
  • Figure 3 shows the dose response curve of Extract B in HeLa (top) and HFF- l (bottom) cells. Concentration is shown in units of g/mL, not as molarity as indicated below the X-axis of the figure.
  • Figure 4 shows the dose response curve of Extract C in HeLa (top) and HFF- I (bottom) cells. Concentration is shown in units of g/mL, not as molarity as indicated below the X-axis of the figure.
  • Figure 5 shows the dose response curve of Extract D in HeLa (top) and HFF- l (bottom) cel ls. Concentration is shown in units of g/mL, not as molarity as indicated below the X-axis of the figure.
  • Figure 6 shows the, dose response curve of Extract E in HeLa (top) and HFF- 1 (bottom) cells. Concentration is shown in units of g/mL, not as molarity as indicated below the X-axis of the figure.
  • Figure 7 shows the dose response curve of Extract F in HeLa (top) and HFF- 1 (bottom) cells. Concentration is shown in units of g/mL, not as molarity as indicated below the X-axis of the figure.
  • compositions in accordance with the instant invention comprise extracts derived from a leaf or leaves of one or more of Momordica balsamina, Aframomum melegueta and Cyperus articulatus.
  • Extracts of the foregoing plants may be prepared by a number of means. Maceration, crushing and grinding into a fine powder are particularly contemplated. While extracts may be prepared from one or more parts of these plants, the leaf of Momordica balsamina, the seed of Aframomum melegueta, and the root of Cyperus articulatus are particularly contemplated.
  • compositions in accordance with the instant invention may comprise an extract prepared from one part of one of the plants described herein. In other embodiments, compositions in accordance with the instant invention may comprise an extract prepared from more than one part of one of the plants described herein. In other embodiments, compositions in accordance with the instant invention may comprise an extract prepared from one or more parts of one or more of the plants described herein.
  • compositions in accordance with the present invention are formulated as pharmaceutical compositions.
  • pharmaceutical composition is intended to encompass a composition that is prepared, processed, and/or manufactured for use as a medicinal drug.
  • pharmaceutical compositions are formulated as pharmaceutically-acceptable salts. Lists of suitable salts are found in, for example, Remington: The Science and Practice of Pharmacy, 21 s ' Edition (Lippincott Williams & Wilkins, 2006).
  • compositions in accordance with the instant invention comprise a pharmaceutically-acceptable carrier. Suitable pharmaceuticaly- acceptable carriers are described, for example, in Remington: The Science and Practice of Pharmacy, 21 s ' Edition (Lippincott Williams & Wilkins, 2006).
  • pharmaceutical compositions in accordance with the instant invention comprise an excipient. Excipients encompass substances that facilitate processing of the active compounds into formulations for delivery to the site of action.
  • pharmaceutical compositions in accordance with the instant invention may comprise a stabilizer and/or a solubilizer. depending upon how the pharmaceutical composition is formulated.
  • pharmaceutical compositions in accordance with the instant invention may also comprise a preservative. Pharmaceutical compositions in accordance with the instant invention may also comprise other therapeutic agents intended to ameliorate one or more symptoms of EVD.
  • compositions in accordance with the instant invention may be formulated for administration in a variety of ways. Oral administration is particularly contemplated. Suitable formulations for oral administration include hard or soft gelatin capsules, pills, tablets, elixirs, suspensions, syrups or powders and controlled release forms thereof.
  • Suitable formulations for parenteral administration include aqueous solutions of the active compounds in water-soluble form, e.g., water-soluble salts.
  • Oily injection suspensions of the compositions may also be prepared and administered.
  • Suitable lipophilic solvents or vehicles include fatty oils, such as sesame oil or synthetic fatty acid esters (e.g., ethyl oleate or triglycerides).
  • Aqueous injection suspensions can contain substances that increase the viscosity of the suspension. These include, for example, sodium carboxymethyl cellulose, sorbitol, and dextran.
  • Suitable formulations for topical administration include any common topical formulation such as a solution, suspension, gel, ointment or salve and the like. Preparations of such topical formulations are well described in the art of pharmaceutical formulations as exemplified, for example, by Remington: The Science and Practice of Pharmacy, 21 s ' Edition (Lippincott Williams & Wilkins, 2006).
  • a carrier that increases the permeability of the skin e.g., dimethyl sulfoxide may be desirable.
  • the pharmaceutical compositions are formulated for sustained delivery of the compositions for a period of twenty-four hours to a month or more.
  • Such formulations are described, for example, in U.S. Patent Nos. 5,968,895 and 6, 1 80,608. Any pharmaceutically-acceptable, sustained-release formulation known in the art is contemplated.
  • administering or administration includes dispensing, delivering or applying a compound disclosed herein in a method disclosed herein, e.g., in a pharmaceutical formulation, to a subject by any suitable route for delivery of that compound to the desired location in the subject.
  • the compounds disclosed herein are administered in a therapeutically effective amount, i.e., an amount sufficient to achieve a desired result.
  • An effective amount is also one in which any toxic or detrimental effects associated with administration of the compound are outweighed by the therapeutically beneficial effects.
  • effectiveness may be determined by, e.g., improvement, regression and/or disappearance of clinically-observable symptoms.
  • Ebola viral titers may be measured in blood, urine and other subject fluids.
  • Effective amounts of the compounds used in the methods of the invention may vary according to factors such as the disease state, age, and weight of the subject, and the abi lity of any particular formulation to elicit a desired response in the subject. Dosage regimens can be adjusted to provide the optimum therapeutic response. Accordingly, dosages for the methods disclosed herein range from about 0.5 g to 13.5 g per day and more preferably 3.0 g to 9.0 g per day. The total amount may be administered in a single dose or may be divided into multiple dosages administered over a twenty-four hour period. Three doses of 1 .0 g to 3.0 g administered three times per day are particularly contemplated.
  • the dosage regimens are formulated in a way that the subject receives from 0.075 mg/kg/day to about 0.45 mg/kg/day of the pharmaceutical composition, and more preferably from 0.15 mg/kg/day to about 0.30 mg/kg/day of the pharmaceutical composition.
  • Example 1 The invention is now described with reference to the following Examples. These Examples are provided for the purpose of illustration only, and the invention is not limited to these Examples, but rather encompasses all variations which are evident as a result of the teachings provided herein. [0030] Example 1
  • the EC 5 o for the first test of the control solution was 81 ⁇ 5 nM.
  • the ECso for the second test of the control solution was 104 ⁇ 5 nM.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Virology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne des procédés et des compositions pour le traitement de la maladie à virus Ebola. En particulier, l'invention porte sur des compositions pharmaceutiques préparées à partir de Momordica balsamina, d'Aframomum melegueta et de Cyperus articulatus, et sur des méthodes de traitement de la maladie à virus Ebola comprenant l'administration d'une ou de plusieurs des compositions pharmaceutiques à un sujet humain souffrant de la maladie à virus Ebola.
PCT/IB2016/000655 2015-05-13 2016-05-13 Compositions et procédés destinés au traitement de la maladie à virus ebola WO2016181214A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562160735P 2015-05-13 2015-05-13
US62/160,735 2015-05-13

Publications (1)

Publication Number Publication Date
WO2016181214A1 true WO2016181214A1 (fr) 2016-11-17

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11166999B1 (en) 2020-08-18 2021-11-09 Morehouse School Of Medicine Method of treating coronavirus infections
US11266723B1 (en) 2020-08-18 2022-03-08 Morehouse School Of Medicine Methods and compositions for treating coronavirus infections
US11413320B2 (en) 2018-12-20 2022-08-16 Morehouse School Of Medicine Antiviral compositions and methods

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000035466A1 (fr) * 1998-12-11 2000-06-22 Peya Biotech Inc. Graines d'aframomum ameliorant l'activite du penis
WO2002062364A1 (fr) * 2001-02-05 2002-08-15 Gbodossou Erick Vidjin Agnih Composition antivirale a base de plantes medicinales pour combattre le vih/sida
US7384656B2 (en) * 2004-02-05 2008-06-10 Access Business Group International Llc Anti-allergy composition and related method
US20120009289A1 (en) * 2009-03-31 2012-01-12 Gbodossou Erick Vidjin Agnih Water-soluble antiviral product containing cyperus articulatus, for the treatment and prevention of acquired immunodeficiency syndrome (aids) and the variants thereof
US20120009286A1 (en) * 2009-03-31 2012-01-12 Gbodossou Erick Vidjin Agnih Water-soluble antiviral product containing momordica balsamina, for the treatment and prevention of acquired immunodeficiency syndrome (aids) and the variants thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000035466A1 (fr) * 1998-12-11 2000-06-22 Peya Biotech Inc. Graines d'aframomum ameliorant l'activite du penis
WO2002062364A1 (fr) * 2001-02-05 2002-08-15 Gbodossou Erick Vidjin Agnih Composition antivirale a base de plantes medicinales pour combattre le vih/sida
US7384656B2 (en) * 2004-02-05 2008-06-10 Access Business Group International Llc Anti-allergy composition and related method
US20120009289A1 (en) * 2009-03-31 2012-01-12 Gbodossou Erick Vidjin Agnih Water-soluble antiviral product containing cyperus articulatus, for the treatment and prevention of acquired immunodeficiency syndrome (aids) and the variants thereof
US20120009286A1 (en) * 2009-03-31 2012-01-12 Gbodossou Erick Vidjin Agnih Water-soluble antiviral product containing momordica balsamina, for the treatment and prevention of acquired immunodeficiency syndrome (aids) and the variants thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TRIVEDI ATAL BIHARI ET AL.: "Ebola virus - an ayurvedic approach.", INTERNATIONAL AYURVEDIC MEDICAL JOURNAL, vol. 3, no. 4, April 2015 (2015-04-01), pages 1199 - 1205, XP055328297 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11413320B2 (en) 2018-12-20 2022-08-16 Morehouse School Of Medicine Antiviral compositions and methods
US11166999B1 (en) 2020-08-18 2021-11-09 Morehouse School Of Medicine Method of treating coronavirus infections
US11266723B1 (en) 2020-08-18 2022-03-08 Morehouse School Of Medicine Methods and compositions for treating coronavirus infections
US11801285B2 (en) 2020-08-18 2023-10-31 Morehouse School Of Medicine Methods and compositions for treating coronavirus infections

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