WO2017004396A1 - Composition à mâcher pour fournir du gsh - Google Patents

Composition à mâcher pour fournir du gsh Download PDF

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Publication number
WO2017004396A1
WO2017004396A1 PCT/US2016/040447 US2016040447W WO2017004396A1 WO 2017004396 A1 WO2017004396 A1 WO 2017004396A1 US 2016040447 W US2016040447 W US 2016040447W WO 2017004396 A1 WO2017004396 A1 WO 2017004396A1
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WIPO (PCT)
Prior art keywords
mammal
minutes
units
masticating
blood
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PCT/US2016/040447
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English (en)
Inventor
Denis Gustavo Berndt Briceno
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Nucorplabs Inc
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Nucorplabs Inc
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Publication of WO2017004396A1 publication Critical patent/WO2017004396A1/fr
Anticipated expiration legal-status Critical
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K5/00—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
    • C07K5/02—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing at least one abnormal peptide link
    • C07K5/0215—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing at least one abnormal peptide link containing natural amino acids, forming a peptide bond via their side chain functional group, e.g. epsilon-Lys, gamma-Glu
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • A61K38/063—Glutathione
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers

Definitions

  • GSH reduced glutathione
  • atripeptide consisting of glycine, glutamic, acid and cysteine
  • GSH reduced glutathione
  • They can be broadly classified in two types: as an antioxidant and as a key molecule in detoxification of endo- and xenobiotics.
  • GSH is the most abundant intracellular non-protein thiol and as such is critical for the maintenance of the intracellular redox homeostasis.
  • ROS reactive oxygen species
  • mGSH Mitochondrial glutathione
  • ROS reactive oxygen species
  • Mitochondria are the primary intracellular sites of oxygen consumption during exercise and the major source of reactive oxygen species (ROS), most of them produced from the mitochondrial respiratory chain.
  • ROS reactive oxygen species
  • the ratio between reduced and oxidized glutathione (GSH / GSSG) can act as a marker of antioxidant status in various pathological and physiological conditions, including exercise.
  • GSH also plays a role in the metabolization of lactic acid produced during exercise. During muscle contraction, lactic acid, a major source of protons, is rapidly produced by increased glycolytic metabolism, lowering the pH and inhibiting muscle contraction. Animal and human studies indicate that long term supplementation using high doses of GSH can inhibit the decrease in intermuscular pH after exercise.
  • GSH a nucleophile
  • electrophilic metabolites of endo- and xenobiotics to form GSH adducts. These are excreted after further metabolism to form the corresponding cysteine adduct, in many cases, the N-acetylcysteine adduct.
  • NAPQI N-acetyl-p-benzoquinoneimine
  • GSH plays an important role in the detoxification of ethanol and acute ethanol administration leads to GSH depletion in the liver and other tissues. Hepatic GSH levels have been shown to be depleted after acute ethanol administration in animals. When GSH levels are enhanced by administration of GSH or its precursors, the depletion of GSH levels by ethanol is prevented. (Richie JP Jr. Glutathione depletion and recovery after acute ethanol administration in the aging mouse Biochem Pharmacol. 2007 May 15;73(10):1613-21. Epub 2007 Jan 30.)*
  • GSH has been used as injectable form, for therapies related to ethyl alcohol or drug intoxication (anti-neoplastic chemotherapy, anti-tuberculosis, neuroleptics, anti-depression and paracetamol, acting as antidote for poison). It also may assist in prophylaxis and treatment of the damages from ionizing radiation.
  • GSH supplementation orally, intravenous, etc.
  • the impact of long term GSH supplementation is limited unless the subject is continuously depleted, as in the case of chronic patients, or supplementation is done using a large dose (grams per day) for a very long period (months).
  • GSH GSH in its injectable form is not an option for healthy individuals and oral supplementation of GSH, mainly in form of capsules, powder, liquid pills, etc., has limited effectiveness due to their very poor bioavailability.
  • Orally administered and ingested GSH is successively degraded to y-glutamyl-X (where X is another aminoacid) and cystenyl-glycine. Cystenyl-glycine is degraded into cysteine and glycine by peptidases.
  • Chewing gum has been proved to be an excellent delivery system for drugs and nutrients, increasing bioavailability and the rate at which nutrients and other molecules are absorbed by the human body.
  • Examples are nicotine, caffeine and vitamin loaded chewing gum.
  • the present invention provides an effective and fast delivery system and its use by healthy individuals during situations and conditions of acute GSH depletion in the body.
  • the present invention provides a chewable delivery system for GSH in the form of a chewable base composition comprising a gum base and reduced glutathione.
  • the present invention further provides a method of reducing blood alcohol concentration in a human, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; ii) providing a human who has consumed ethyl alcohol and has a blood alcohol level, or who will imminently consume ethyl alcohol and thereby induce a blood alcohol level; and iii) masticating by the human the one or more units of the chewable composition for a time sufficient to release a quantity of the reduced glutathione into the oral cavity of the human, for absorption into the blood; thereby reducing the blood alcohol concentration in the mammal.
  • the method can also ameliorate the rate of alcohol metabolization in the mammal.
  • the masticating of the units can begin after the human has consumed ethyl alcohol.
  • the method can reduce the blood alcohol concentration in the mammal within 20 minutes, including within 10 minutes, and including within 5 minutes.
  • the present invention further provides a method of reducing a rise in blood alcohol concentration in a mammal following consumption of a quantity of ethyl alcohol, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; and ii) masticating by the mammal the one or more units of the chewable composition for a time sufficient to release a quantity of reduced glutathione into the oral cavity of the mammal, for absorption into the blood, prior to or while consuming a quantity of ethyl alcohol that is sufficient to effect a rise in the blood alcohol concentration of a mammal; thereby reducing the rise in blood alcohol concentration in the mammal.
  • the consumed quantity of ethyl alcohol is sufficient to effect a rise in the blood alcohol concentration of the mammal to at least 0.1 gm/L.
  • the masticating of the one or more units of the chewable composition can be prior to the consuming of the quantity of ethyl alcohol.
  • the present invention further provides a method of reducing a perception of fatigue in a mammal during or after an intense exercise, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; and ii) masticating by the mammal the one or more units of the chewable composition for a time sufficient to release a quantity of the reduced glutathione into the oral cavity of the mammal, for absorption into the blood, prior to or while performing an intense exercise that results in a perception of fatigue in the mammal that is associated with glutathione depletion in the blood of the mammal; thereby reducing the perception of fatigue in the mammal during or after the intense exercise,
  • the masticating of the one or more units of the chewable composition can be prior to performing an intense exercise.
  • the present invention further provides a method of ameliorating a recovery from a perception of fatigue in a mammal during or after an intense exercise, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; and ii) masticating by the mammal the one or more units of the chewable composition for a time sufficient to release a quantity of the reduced glutathione into the oral cavity of the mammal, for absorption into the blood, prior to or while performing an intense exercise that results in a perception of fatigue in the mammal that is associated with glutathione depletion in the blood of the mammal; thereby ameliorating the recovery from the perception of fatigue in the mammal during or after the intense exercise.
  • the masticating of the one or more units of the chewable composition can be prior to performing an intense exercise.
  • the present invention provides a method of reducing a hastened depletion of glutathione or ameliorating the recovery of glutathione in a mammal, caused by an acute depleting event, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; ii) providing a mammal that is experiencing, or who will imminently experience, an acute depleting event that hastens an acute depletion of glutathione in the mammal; and iii) masticating by the mammal the one or more units of the chewable composition for a time sufficient to release a quantity of the reduced glutathione into the oral cavity of the mammal, for absorption into the blood; thereby reducing the hastened depletion of, or ameliorating the recovery of, glutathione in the mammal, during or after the acute depleting event.
  • a method further reduces the effects of the hastened depletion of glutathione caused by the acute depleting event, on the condition of the mammal.
  • the acute depleting event can be a condition or activity of the human or mammal that can extend up to 3 days, and more particularly up to 3 hours, in which the depletion of GSH in the body is caused by the acute depleting event at a rate or to an extent that exceeds the depletion rate or extent of the body during normal daily living.
  • the acute depleting event can be the consumption of ethyl alcohol, intense exercise, stress, migraines, administration of a drug or medicament; administration of acetaminophen, an influence, exposure or consumption of a heavy metal, a bacterial or viral infection, an event that results in an accumulation of lactic acid in the blood, and an event that results in an increase in free radicals into the cells of the mammal.
  • the method reduces the effects of the these acute depleting event on the mammal or human.
  • the present invention also provides a unit of a chewable composition, the unit comprising: a chewable base core comprising a gum base, a sweetener, and 0.5 - 15%, by weight of the chewable base core, an active ingredient consisting of reduced glutathione; and a coating surrounding the chewable base core, having a harder structure than the chewable base core, and comprising a sweetener.
  • the active ingredient can be 1.0 - 5.0 %, by weight of the chewable base core.
  • the coating can provide a moisture barrier around the chewable base core.
  • the present invention further provides a method to improve physical performance in a mammal engaged on physical effort, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; and ii) masticating by the mammal the one or more units of the chewable composition for a time sufficient to release a quantity of the reduced glutathione into the oral cavity of the mammal, for absorption into the blood; thereby improving the physical performance in the mammal engaged on physical effort.
  • the present invention further provides a method to reduce blood lactate concentration in a mammal that has performed intense physical effort, comprising the steps of: i) providing one or more units of a chewable composition comprising a gum base and an amount of reduced glutathione; and ii) masticating by the mammal the one or more units of the chewable composition for a time sufficient to release a quantity of the reduced glutathione into the oral cavity of the mammal, for absorption into the blood; thereby reducing blood lactate concentration in the mammal that has performed intense physical effort.
  • the acute GSH depletion is produced by alcohol ingestion, or by exercise, particularly intense exercise, in mammals and humans, particularly humans.
  • An acute depleting event can also be a condition of the mammal or human, or of the environment, which begins hastening the depletion of GSH in the body within 1 hour, including within 30 minutes, and within 5 minutes, including an almost immediate hastening of GSH depletion, after the onset of the acute depleting event.
  • An acute depleting event can be the consumption of ethyl alcohol, intense exercise, stress, migraines, administration of a drug or medicament, including the administration of acetaminophen, an influence, an exposure to or consumption of a heavy metal, a bacterial or viral infection, an event that results in an accumulation of lactic acid in the blood, and an event that results in an increase in free radicals into the cells of the mammal.
  • the method herein including the masticating of the one or more units of the chewable composition for absorption of GSH into the blood, begins reducing the hastened depletion of glutathione in the mammal within 20 minutes, including within 10 minutes, and including within 5 minutes after the onset of mastication, and including an almost immediate reduction in the hastened depletion of GSH after the onset of mastication.
  • the time for masticating is at least one minute, and preferably up to about 10 minutes.
  • the resulting reduction in the acute depletion of glutathione in the mammal when masticating the quantity of the reduced glutathione is a greater reduction than that when instead a same quantity of reduced glutathione is ingested orally.
  • the amount of the reduced glutathione in a dose of one or more of the units of the chewable composition is at least 30 mg, including between 50 and 800 mg, including at least 100 mg, preferably between about 100 and 600 mg, preferably between about 200 and 400 mg, and more preferably at least about 300 mg.
  • the time for masticating is at least one minute, and preferably up to about 10 minutes.
  • the administration and mastication of the chewable compositions comprising glutathione described in the invention transport the glutathione through the oral mucosa and into the blood. Without being bound by any particular theory, it is believed that the glutathione absorbed into the blood immediately begins to be taken up into any and all cells of the body. Consequently, measuring the glutathione concentration in the plasma or serum is an inaccurate measure or indication of the level of glutathione in the body, or its level or rate of depletion or recovery. It is believed that at any time up to 95%, or more, of the glutathione in the body is contained within cells.
  • the invention provides a safe, convenient, efficient and effective composition and method for supplementing the replenishment of GSH before or during a period of GSH depletion, including hastened depletion, by the administration of the GSH in a chewable base composition.
  • the chewable base comprises: a water- insoluble gum base selected from the group of suitable natural and synthetic elastomers and rubbers; a bulking water-soluble portion comprising about 10%-70% of sugars or polyalcohol in powder form, selected from the group consisting of, but not limited to, sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose, levulose, galactose, corn syrup solids and the like, alone or in combination, and powder sugar alcohols selected from the group consisting of, but not limited to, sorbitol, erythritol, xylitol, mannitol, maltitol, isomalt and combinations thereof; 0.1 - 6.0% of softeners and plasticizers selected from the group consisting of, but not limited to, glycerin, oils, waxes of fats, including but not limited to hydrogenated vegetable oils soybean oil, cottonseed oil, palm oil,
  • the chewable base also can comprise one or more emulsifier comprising about 0,01- 5% by weight, more preferably 0,5 - 2% by weight, thereof, selected from the group consisting of, but not limited to, lecithin, diglycerides of fatty acids, glycerol mono and distearate, glycerol triacetate, acetylated monoglyceride, sugar and polyol esters, and mixtures thereof, one or more high impact sweeteners selected from the group consisting of, but not limited to, acesulfame, aspartame, sucrose, stevia, fructose, maltose, glucose, saccharine and combinations thereof, and the use of one or more suitable flavoring agents selected from the group consisting of natural or artificial sources in liquid or powder form.
  • one or more emulsifier comprising about 0,01- 5% by weight, more preferably 0,5 - 2% by weight, thereof, selected from the group consisting of, but not limited to, lecithin,
  • the administration of the chewable compositions comprising GSH described in the invention can increase the alcohol metabolization rate by more than 50% in healthy individuals, within a period of time of one hour or less, including 30 minutes, 15 minutes, 10 minutes and 5 minutes, using a low dose of at least about 30 mg, and including about 100 mg and about 300 mg of GSH.
  • compositions were able surprisingly to produce a traceable impact on both the alcohol-related and exercise-related depletion models. Therefore, the chewable compositions described in this invention are an effective delivery system for GSH and can be used by healthy individuals during circumstances of acute GSH depletion.
  • GSH in the body At any time in the body, up to 95% of the GSH in the body is contained within the cells of the body, include red blood cells and white blood cells. While the plasma and serum may contain GSH being transported within the blood, such levels are not a reliable or predictable measure of GSH level, or of the level of depletion. While methods exist for determining the level of GSH in cells or whole blood, in the references described and incorporated herein, good evidence of the effects of GSH depletion, and of the recovery of GSH levels, can be determined by the improvement in the effects or the performance of the human condition.
  • Example 1 Preferable compositions
  • compositions were prepared in order to assess the efficacy of the administration of a chewable composition comprising GSH in healthy individuals during acute GSH depletion situations.
  • the softener, the rest of the glycerol and liquid sorbitol were added and mixed by 10 minutes. After the previous mix was homogeneously mixed, the temperature was reduced to 35°C by using a cooling jacket. Once the temperature was set to 35°C the flavor, the softener and menthol were added and mixed for 5 minutes. Finally, the L-Glutathione (Kohjin Life Sciences Co. Ltd) was added and mixed for 10 additional minutes until homogeneous.
  • Table 2 shows the percentage of GSH released from composition No.l and composition No.2 at every minute during the 10 minute period of mastication. Tests were performed in triplicate.
  • Results of Table 3 show the average BAC concentration measured by breathalyzer Alcoscan A17000 during a period of four hours in 15 subjects after administration of 100ml of whisky (40% v/v; approximately 32 grams of pure ethanol). Significant improvements in the rate of alcohol metabolization were observed with composition No.l and composition No.2. The results for alcohol metabolization rate are shown in Table 4 (detoxification is consider finished when a level of 0.05 g/L or less is achieved using the breathalyzer Alcoscan A17000).
  • Example 4 Intense exercise-related acute GSH depletion as a model for assessing GSH chewable composition supplementation
  • Each trial day subject ran on a treadmill set at a fixed slope of 0 at an initial speed of 9 km/h, followed by an increase of 1 km/h and 1° slope every two minutes until subjects could not maintain the work required (having reached their maximal exercise capacity before fatigue). Subjects had a 30 minutes recovery rest. During this period individuals were administered with each composition as follow: Day 1, placebo (6 pieces); Day 2, Composition No.2 (6 pieces).
  • compositions were consumed in a period of 30 minutes after the trial divided in doses of two pieces (each dose chewed for 10 minutes).
  • Active resting Immediately after, an active resting interval (third interval) was performed consisting on a treadmill walk at 4.5 km/h for 16 minutes. During this interval a total of eight pieces of placebo or composition No.l (240 mg of GSH) were administered in consecutive doses of two pieces chewed each for 4 minutes.
  • Second exhaustion test Immediately after the active resting, subjects repeated another supramaximal continuous running time limit (Tlim) exercise test performed at 130% Vomax until exhaustion (fourth interval).
  • Tlim supramaximal continuous running time limit
  • composition No.l and placebo were administered as follows:

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  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Molecular Biology (AREA)
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Abstract

L'invention concerne un système d'administration à mâcher pour fournir du GSH comprenant une base de gomme et du glutathion réduit, pour apporter un supplément en GSH dans les cas de déplétion aiguë en GSH, et utilisable en cas de déplétion aiguë en GSH provoquée par une ingestion d'alcool et un exercice physique intense. La concentration d'alcool dans le sang peut être diminuée ou améliorée en mastiquant la composition à mâcher pendant une durée suffisante pour libérer une certaine quantité de glutathion réduit dans la cavité buccale du mammifère, pour diminuer ou améliorer la concentration d'alcool dans le sang de celui-ci. Le fait de mâcher la composition à mâcher permet également de diminuer ou d'améliorer la sensation de fatigue chez le mammifère pendant ou après un exercice physique intense.
PCT/US2016/040447 2015-06-30 2016-06-30 Composition à mâcher pour fournir du gsh Ceased WO2017004396A1 (fr)

Applications Claiming Priority (4)

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US201562186992P 2015-06-30 2015-06-30
US62/186,992 2015-06-30
US201662298075P 2016-02-22 2016-02-22
US62/298,075 2016-02-22

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000019977A1 (fr) * 1998-10-08 2000-04-13 Biovail Technologies Ltd. Composition et procede d'un systeme d'administration de chewing gum medicamenteux
WO2001072138A1 (fr) * 2000-03-27 2001-10-04 F.T. Holding S.A. Chewing gum contenant des composes d'acides amines soufres
US20030211172A1 (en) * 2002-05-10 2003-11-13 Jones Jeremy Park Composition and method for substantially reducing the deleterious effects of alcohol on the body
WO2008140372A1 (fr) * 2007-05-16 2008-11-20 Mcneil Ab Formulation nicotinique orale enrobée, tamponnée aux acides aminés
US20100137226A1 (en) * 2006-06-07 2010-06-03 Kyowa Hakko Bio Co., Ltd Fatigue-reducing agent
FR2972327A1 (fr) * 2011-03-11 2012-09-14 Le Stum Lab Composition nutraceutique mucoadhesive comprenant une association d'antioxydants
US20150132275A1 (en) * 2012-05-28 2015-05-14 Biohit Oyj Composition for preventing headaches

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000019977A1 (fr) * 1998-10-08 2000-04-13 Biovail Technologies Ltd. Composition et procede d'un systeme d'administration de chewing gum medicamenteux
WO2001072138A1 (fr) * 2000-03-27 2001-10-04 F.T. Holding S.A. Chewing gum contenant des composes d'acides amines soufres
US20030211172A1 (en) * 2002-05-10 2003-11-13 Jones Jeremy Park Composition and method for substantially reducing the deleterious effects of alcohol on the body
US20100137226A1 (en) * 2006-06-07 2010-06-03 Kyowa Hakko Bio Co., Ltd Fatigue-reducing agent
WO2008140372A1 (fr) * 2007-05-16 2008-11-20 Mcneil Ab Formulation nicotinique orale enrobée, tamponnée aux acides aminés
FR2972327A1 (fr) * 2011-03-11 2012-09-14 Le Stum Lab Composition nutraceutique mucoadhesive comprenant une association d'antioxydants
US20150132275A1 (en) * 2012-05-28 2015-05-14 Biohit Oyj Composition for preventing headaches

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CLINLAB NAVIGATOR: "Alcohol (ethanol, Ethyl Alcohol).", 6 October 2013 (2013-10-06), pages 1, Retrieved from the Internet <URL:http://www.clinlabnavigator.com/alcohol-ethanol-ethyl-alcohol.html> [retrieved on 20160822] *
GOHIL, K ET AL.: "Blood Glutathione Oxidation During Human Exercise.", JOURNAL OF APPLIED PHYSIOLOGY., vol. 64, no. 1, 1988, pages 115 *
SASTRE, J ET AL.: "Exhaustive Physical Exercise Causes Oxidation of Glutathione Status in Blood: Prevention by Antioxidant Administration.", AMERICAN JOURNAL OF PHYSIOLOGY, vol. 263, 1992, pages R992 *

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