WO2024075140A1 - Composition de réhydratation comprenant des électrolytes et contenant un post-biotique et du zinc - Google Patents

Composition de réhydratation comprenant des électrolytes et contenant un post-biotique et du zinc Download PDF

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Publication number
WO2024075140A1
WO2024075140A1 PCT/IN2023/050909 IN2023050909W WO2024075140A1 WO 2024075140 A1 WO2024075140 A1 WO 2024075140A1 IN 2023050909 W IN2023050909 W IN 2023050909W WO 2024075140 A1 WO2024075140 A1 WO 2024075140A1
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WIPO (PCT)
Prior art keywords
zinc
composition
rehydrating
amount
rehydrating composition
Prior art date
Application number
PCT/IN2023/050909
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English (en)
Inventor
Krutin Kaushik CHATURVEDI
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Krutin Kaushik CHATURVEDI
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Application filed by Krutin Kaushik CHATURVEDI filed Critical Krutin Kaushik CHATURVEDI
Publication of WO2024075140A1 publication Critical patent/WO2024075140A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • 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
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747Lactobacilli, e.g. L. acidophilus or L. brevis

Definitions

  • the present invention is in field of oral rehydration systems. More particularly, the present invention relates to rehydrating composition of electrolytes along with post biotic and zinc.
  • ORS is a simple treatment for dehydration caused by diarrhoea, cholera, too much exposure to heat etc. It is used around the world and specifically in the developing nations where it saves lives of children suffering from dehydration due to diarrhoea, second leading cause of death amongst children.
  • Zinc however, with the product has an important role in recovery from the symptoms of diarrhoea.
  • the use of zinc with oral rehydration solutions has been shown to affect positive impacts by reducing the duration and severity of diarrheal episodes.
  • Overall product gives an additive effect in the treatment of diarrhoea by maintaining mucosal integrity and improving electrolyte balance.
  • All 3 products ORS, Zinc and Postbiotics are available separately in market so it is not convenient for administration. According to available evidences, post-biotics do not need the viability in comparison with their parent cells and they exert health effects like live probiotic cells. Also, their preparation and application in various delivery systems is affordable, as discussed in article “Evaluating the Role of Postbiotics as a New Generation of Probiotics in Health and Diseases” by Homayouni-rad et al.
  • the object of the invention is to provide a rehydrating composition of electrolytes, zinc and post biotic for diarrhoea and restoring the gut microbial flora.
  • the present invention provides a rehydrating composition for diarrhoea and restoring the gut microbial flora.
  • the rehydrating composition contains a combination of electrolytes, Zinc and Post Biotics.
  • the present invention provides a rehydrating composition
  • a rehydrating composition comprising; i.
  • the ORS containing the Electrolytes selected from, but not limited to, Sodium Chloride, Potassium Chloride, Sodium Citrate or combinations thereof, in an amount ranging between 0.2 to 0.7 gm/lOOml; ii. Carbohydrates selected from glucose, dextrose, fructose, sucrose, maltodextrin and the like in an amount ranging between 1.2 to 2.5gm/ 100ml; iii. Zinc salts equivalent to zinc in an amount ranging between 2 to 6mg/100ml; and iv. Post biotics in an amount ranging between 25mg-30mg /100ml.
  • the rehydrating composition of the present invention may comprise at least one ingredient selected from the group consisting of flavorants, colorants, vitamins, sweeteners, dietary supplements and the like.
  • the post biotic Immuno-LP20 is selected from heat killed Lactobacillus plantarum L-137 (HK L-137), which is not viable when administered, however, after reaching the intestine, these heat killed cells release bacterial components with key immune modulating effects and also have antagonizing properties against pathogens.
  • HK L-137 heat killed Lactobacillus plantarum L-137
  • the zinc salts in the rehydrating composition of the present invention equivalent to the elemental zinc is selected from zinc sulfate, zinc sulfate monohydrate, zinc gluconate, zinc chloride, zinc citrate, zinc bicarbonate, zinc carbonate, zinc hydroxide, zinc lactate, zinc acetate, zinc fluoride, zinc bromide, and zinc sulfonate.
  • the rehydrating composition of the present invention is preservative free.
  • the pH of the rehydrating composition is in the range of 4.20 to 5.0 and the Osmolarity is 245mOsmol/lit.
  • the rehydrating composition of the present invention is ready to drink composition.
  • the present invention provides a process for manufacturing the rehydrating composition as depicted in Fig 1.
  • Fig 1 Depict the manufacturing process of the rehydrating composition.
  • the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “include” and “includes”) or “containing” (and any form of containing, such as “contain” and “contains”), are inclusive or open-ended and do not exclude additional, unrecited elements or process steps.
  • the rehydrating composition of the invention comprises a synergistic combination of electrolytes, Zinc and Post Biotics masked with delicious flavour which is suitable for the administration to all age groups including young children. Accordingly, the rehydrating composition of the invention comprises a combination of electrolytes with Zinc in a liquid ready to drink form in contrast to traditional dosage form of taking Zinc tablet supplementation additionally along with ORS.
  • the present invention relates to a rehydrating composition
  • a rehydrating composition comprising; i.
  • the ORS containing the electrolytes selected from, but not limited to, Sodium Chloride, Potassium Chloride, Sodium Citrate or combinations thereof, in an amount ranging between 0.2 to 0.7 gm/lOOml;
  • Carbohydrates selected from glucose, dextrose, fructose; sucrose, maltodextrin and the like in an amount ranging between 1.2 to 2.5gm/ 100ml;
  • Post biotics in an amount ranging between 25mg to 30mg/100ml.
  • the rehydrating composition of the present invention comprise of excipients selected from the group consisting of flavorants, colorants, vitamins, dietary supplements, sweeteners and the like in appropriate amount.
  • the flavors mask the salty taste of the rehydration composition and enhance the palatability.
  • the sweeteners may compliment the flavours used in the present composition and may include natural or artificial sweeteners.
  • the electrolytes of the ORS (Oral rehydrating solution) used in the present composition are as per the World Health Organisation (WHO) guidelines.
  • the carbohydrates used in the present composition are in anhydrous form.
  • the post biotic Immuno-LP20 is selected from heat killed Lactobacillus plantarum L-137(HK L-137), which is not viable when administered, however, after reaching the intestine, these heat killed cells release bacterial components with key immune modulating effects and also have antagonizing properties against pathogens.
  • the advantage of using postbiotics against probiotics is that Post biotics helps in preventing recurrence of diarrhoea and maintains the gut flora.
  • the probiotics are live cultures, majority of these live bacteria are destroyed by gastric juices, when consumed, and do not reach the intestine to give the desired effect.
  • the zinc salts in the rehydrating composition of the present invention equivalent to the elemental zinc is selected from zinc sulfate, zinc sulfate monohydrate, zinc gluconate, zinc chloride, zinc citrate, zinc bicarbonate, zinc carbonate, zinc hydroxide, zinc lactate, zinc acetate, zinc fluoride, zinc bromide, and zinc sufonate.
  • the composition comprises zinc sulphate monohydrate as a source of elemental zinc.
  • Zinc is essential mineral that helps in maintaining normal physiological functions of the body. ORS with zinc is widely recommended by UNICEF, WHO for treatment of diarrhoea.
  • the rehydrating composition of the present invention is preservative free.
  • the pH of the rehydrating composition is in the range of 4.20 to 5.0 and the Osmolarity is 245mOsmol/lit.
  • the rehydrating composition of the present invention is ready to drink (RH) composition.
  • the present invention discloses a rehydrating composition comprising; i. The ORS containing the Electrolytes, selected from Sodium Chloride in an amount of 0.26g/100ml, Potassium Chloride in an amount of 0.15gm/100ml, Sodium Citrate in an amount of 0.29gm/100ml; ii. Anhydrous dextrose in an amount of 1.35gm/100ml; iii. Zinc sulfate monohydrate equivalent to zinc in an amount of 4mg/100ml; and iv. Immuno-LP20 as Postbiotic in an amount of 25.0mg/100ml.
  • the rehydrating composition of the present invention is manufactured by the process known to a person skilled in the art. As a general procedure depicted in Fig 1, all the ingredients may be dry blended together; dispersed in water with agitated; and optionally heated to the appropriate temperature to dissolve all the constituents. The rehydrating composition is then packaged and sterilized to food grade standards as is known in the art.
  • the rehydrating composition of the present invention is packed in 6- layered aseptic tetra packs.
  • the rehydrating composition is stable for a period of 18 months without any added preservative in a ready to drink form.
  • the present invention relates to the rehydrating composition for treating diarrhoea and restoring the gut microbial flora. In yet another embodiment, the present invention relates to a method of treating diarrhoea and restoring the gut microbial flora comprising administering the rehydrating composition of the present invention to the subject in need.
  • the present invention disclose the ready to drink rehydrating composition packed in 6 layered aseptic tetra pack wherein one tetrapack of 200 ml provides 4 mg of Zinc, 0.52 g of NaCl, 0.3 g of KC1, 0.58 g Sodium Citrate and 2.7 g of Dextrose which is same as per recommendation of WHO.
  • the rehydrating composition of the present invention provides exact dosage and Osmolarity of ORS and Zinc which is recommended by WHO through combikit.
  • the rehydrating composition of one tetrapack of 200 ml according to the present invention provides 4 mg of Zinc, 0.52 g of NaCl, 0.3 g of KC1, 0.58 g Sodium Citrate and 2.7 g of Dextrose which is same as per recommendation of WHO.
  • Postbiotics used in the rehydrating composition helps in preventing recurrence of diarrhoea and maintains the gut flora.
  • the rehydrating composition provided in ready to drink liquid form prevents contamination which is generally seen while using contaminated water along with powder ORS that might cause some serious infections specially for infants.
  • the rehydrating composition as provided in the present invention has delicious fruit flavour, and easier to carry and thus, suitable for infants and children.
  • the rehydrating composition of the invention does not require any cold storage or cold chain.
  • the composition can be stored at cool temperatures.
  • Each pack of 200ml contains: -
  • Each pack of 200ml contains: -

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

La présente invention concerne le domaine des systèmes de réhydratation à administrer par voie orale. Plus particulièrement, la présente invention concerne une composition de réhydratation contenant des électrolytes ainsi qu'un post-biotique et du zinc.
PCT/IN2023/050909 2022-10-07 2023-10-07 Composition de réhydratation comprenant des électrolytes et contenant un post-biotique et du zinc WO2024075140A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202221057465 2022-10-07
IN202221057465 2022-10-07

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WO2024075140A1 true WO2024075140A1 (fr) 2024-04-11

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015175536A1 (fr) * 2014-05-12 2015-11-19 BiOWiSH Technologies, Inc. Compositions et méthodes pour améliorer la santé et la nutrition humaine
CN112617207A (zh) * 2020-12-18 2021-04-09 北京海思未来健康科技有限公司 一种含有补液盐和益生菌的组合物
WO2021204644A1 (fr) * 2020-04-06 2021-10-14 Société des Produits Nestlé S.A. Complément alimentaire de vitalité

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015175536A1 (fr) * 2014-05-12 2015-11-19 BiOWiSH Technologies, Inc. Compositions et méthodes pour améliorer la santé et la nutrition humaine
WO2021204644A1 (fr) * 2020-04-06 2021-10-14 Société des Produits Nestlé S.A. Complément alimentaire de vitalité
CN112617207A (zh) * 2020-12-18 2021-04-09 北京海思未来健康科技有限公司 一种含有补液盐和益生菌的组合物

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "ORAL REHYDRATION SALTS Production of the new ORS", WHO, UNICEF, 1 January 2006 (2006-01-01), XP093160658, Retrieved from the Internet <URL:https://iris.who.int/bitstream/handle/10665/69227/WHO_FCH_CAH_06.1.pdf?sequence=1&isAllowed=y> *
MUROSAKI S ET AL.: "Heat-killed Lactobacillus plantarum L-137 suppresses naturally fed antigen-specific IgE production by stimulation of IL -12 production in mice", J ALLERGY CLIN IMMUNOL., vol. 102, no. 1, July 1998 (1998-07-01), pages 57 - 64, XP005687498, DOI: 10.1016/S0091-6749(98)70055-7 *

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