WO2023281272A1 - Nasal spray - Google Patents

Nasal spray Download PDF

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Publication number
WO2023281272A1
WO2023281272A1 PCT/GB2022/051762 GB2022051762W WO2023281272A1 WO 2023281272 A1 WO2023281272 A1 WO 2023281272A1 GB 2022051762 W GB2022051762 W GB 2022051762W WO 2023281272 A1 WO2023281272 A1 WO 2023281272A1
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WO
WIPO (PCT)
Prior art keywords
composition
composition according
nasal spray
iota carrageenan
naci
Prior art date
Application number
PCT/GB2022/051762
Other languages
French (fr)
Inventor
Bruce POLLINGTON
Original Assignee
Pollinner Limited
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 Pollinner Limited filed Critical Pollinner Limited
Publication of WO2023281272A1 publication Critical patent/WO2023281272A1/en

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    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof

Definitions

  • the composition contains no further active antibacterial, antiviral or antiallergenic agents.
  • the composition can comprise 0.5-0.9% w/w iota carrageenan, optionally 0.6-0.8% w/w iota carrageenan.
  • the composition can comprise 0.6-0.7% w/w iota carrageenan.
  • the composition can comprise 0.7-0.8% w/w iota carrageenan.
  • the composition can comprise 0.3-0.9% w/w NaCI, optionally 0.4-0.6% w/w NaCI, and preferably about 0.5% w/w NaCI.
  • a range of organic and inorganic buffer solutions can be used as the one or more buffering agents including those derived from inorganic acids such as hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric or nitric acid and the like; and salts prepared from organic acids such as acetic, propionic, succinic, glycolic, stearic, lactic, malic, tartaric, citric, ascorbic, pamoic, maleic, hydroxymaleic, phenylacetic, aspartic, glutamic, benzoic, salicylic, sulfanilic, acetoxybenzoic, fumaric, toluenesulfonic, naphthyldisulfonic, methanesulfonic, ethane disulfonic, oxalic or isethionic acid, and the like.
  • inorganic acids such as hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric or nitric acid
  • a nasal spray comprising the composition according to the first aspect of the invention in combination with a nasal spray delivery device charged with the composition.
  • the nasal spray may be configured to deliver 0.1 mg to 3.0mg, optionally 0.5mg to 1.5mg, of iota carrageenan per spray.
  • the composition according to the first aspect of the invention for use in a nasal spray as a medicament.
  • the composition can be for use in a nasal spray as an antibacterial medicament, an antiviral medicament or an antiallergenic medicament.
  • Carrageenans including iota-carrageen have been demonstrated to have a broad spectrum antiviral activity against a wide range of viruses including those associated with respiratory tract infection, including Respiratory Syncytial Virus, Influenza and Parainfluenza viruses, Rhinoviruses, Coronaviruses and Adenoviruses, noting that in some cases these pathogens can lead to systemic diseases and damage to non- respiratory organs and even multi organ failure, though the route of entry is via the upper respiratory tract.
  • Pet allergies arise as an allergic reaction to proteins found in an animal's skin cells, saliva or urine. Signs of pet allergy include those common to hay fever, such as sneezing and runny nose. Some people may also experience signs of asthma, such as wheezing and difficulty breathing. Carrageenans have a high affinity to protein particles due to electrostatic forces causing the large scale carrageenan molecules to envelop and hence sequestrate the smaller proteins associated with pet allergy.
  • a method of treating a condition comprising the steps of: providing a composition according to the first aspect of the invention in a nasal spray; and spraying the interior of the nose of a subject with the composition.
  • the condition can be an antibacterial, antiviral medicament or antiallergenic condition.
  • a method of manufacturing a composition according to the first aspect of the invention comprising the steps of: dissolving one of more buffering agents in de-ionised water to provide a buffer solution having a pH of 4.0-4.4; dissolving NaCI in the buffer solution in an amount sufficient that the composition comprises 0.1 -0.9% w/w NaCI; and adding iota carrageenan to the buffer solution with sufficient agitation to ensure dissolution of the iota carrageenan without substantial gel clump formation, wherein the iota carrageenan is added in an amount sufficient that the composition comprises 0.1-1.0% w/w iota carrageenan.
  • a final filtering stage can be advantageous to remove any inadvertent gel clumps that may have formed during mixing of the iota carrageenan.
  • a 400 micron mesh filter, or any other suitable filter grades, can be used.
  • the method of manufacturing the composition can be performed at a temperature between 20-25 degrees Celsius. In general, mixing below 18 degrees Celsius should be avoided to prevent excessive gel clump formation. While filtration will remove any gel clumps that form, this will adversely affect the iota-Carrageenan concentration present in the mixture.
  • Figure 1 is a cutaway drawing of a nasal spray delivery device containing a composition according to an embodiment of the invention.
  • the composition is an aqueous composition, and comprises 0.1 -1.0% w/w carrageenan, 0.1 -0.9% w/w NaCI and one or more acidic buffering agents or alkaline buffering agents to maintain the composition within a pH range of 4.0-4.4.
  • the composition comprises water in an amount to make the composition up to 100% by weight.
  • the composition consists essentially of carrageenan, NaCI, buffering agents and water.
  • Availability of the negative sulphate groups to bond is also a function of the concentration of the iota carrageenan since there is an equilibrium between ‘free’ iota carrageenan and carrageenan to carrageenan intermolecular linkages.
  • concentrations of the iota carrageenan, hydrogen ions and sodium cations have been selected to ensure that the composition is an advantageous state, providing an equilibrium state so that the composition becomes a thixotropic gel.
  • the composition provides a gel that has long-term stability at pH 4.0-4.4 and which can be readily broken into a free liquid for an optimal spray plume when a sheer stress is applied via activation of the spray pump.
  • composition returns to a gel state or a semi- gel-like state in the nasal cavity as a thin film once sprayed, which improves the efficacy of the composition.
  • a composition is provided which is particularly well suited to use in a nasal spray as a medicament.
  • Citric acid and sodium citrate are preferred as buffering agents owing to their compatibility with the components of the composition and their suitability for use in pharmaceutical compositions for inhalation.
  • the buffering agents are each present in a concentration of 1mM to 0.1M.
  • other suitable buffering agents may be used, for example, but not limited to, those derived from hydrochloric, hydrobromic, nitric, phosphoric, sulfamic and/or sulfuric acid and salts prepared from acetic, acetoxybenzoic, ascorbic, aspartic, benzoic, citric, ethane disulfonic, fumaric, glutamic, glycolic, lactic, maleic, hydroxymaleic, isethionic, malic, methanesulfonic, naphthyldisulfonic, oxalic, pamoic, propionic, phenylacetic, salicylic, stearic, succinic, sulfanilic, tartartic and/or tolu
  • the citric acid and sodium nitrate buffering agents maintain the pH of the composition once it has been administered into the nasal cavity, which also maintains its antimicrobial activity for a longer period than a solution that is not buffered.
  • the compound provides a broad spectrum of action on respiratory viruses, bacteria and allergens, including cat hair, dog hair and feather allergies.
  • the composition may be prepared by any suitable method, although a preferred method will now be described.
  • the composition may be prepared by dissolving the required amount of buffering agents in de-ionised water in the desired concentration to obtain a pH of 4.0-4.4.
  • the desired weight of NaCI is then dissolved in the buffer solution.
  • the desired mass of carrageenan is slowly added to the buffered saline solution with continuous mixing to ensure complete dissolution of the iota carrageenan while avoiding the formation of gel clumps.
  • a filtration stage may be advantageous for example with a 400 micron mesh filter, noting other mesh grades of filter may be acceptable.
  • a controlled room temperature between 20-25 degrees Celsius is ideal and mixing below 18 degrees Celsius should generally be avoided to prevent excessive gel clump formation. While filtration will remove any gel clumps that form this will adversely affect the iota-Carrageenan concentration present in the mixture.
  • Citric acid 2.32g, providing a 0.011 M solution of Citric acid Sodium citrate: 2.32g, providing a 0.009M solution of Na Citrate Water: 984.36g
  • composition described in the Example was incorporated into a nasal spray delivery device and used to produce an efficacious nasal spray.

Abstract

According to the invention there is provided an aqueous composition for use in a nasal spray, wherein the aqueous composition comprises: 0.1-1.0% w/w iota carrageenan; 0.1-0.9% w/w NaCl; one or more acidic buffering agents or alkaline buffering agents to provide the aqueous composition with a pH of 4.0-4.4; and water present in an amount to make the aqueous composition up to 100% by weight.

Description

NASAL SPRAY
The present invention relates to nasal sprays, and particularly to nasal spray compositions comprising iota carrageenan. Such compositions may be for use as antibacterial, antiviral and/or antiallergenic medicaments.
BACKGROUND
Nasal sprays are used to deliver medicated and non-medicated compositions into the nasal cavity and may be used for the prevention and/or treatment of a range of conditions.
Carrageenans are sulphated polysaccharides that are extracted from red seaweeds, with the most industrially relevant carrangeenans being categorised into three different classes based on the number of sulphate groups per disaccharide unit: kappa carrageenan having one sulphate group per disaccharide, iota carrageenan having two and lambda carrageenan having three.
Carrageenans may be soluble in water, with their solubility being dependent on a number of factors, such as the number of hydrophilic sulphate groups per disaccharide unit, the presence of associated cations and the pH and temperature of the solution.
In the food, pharmaceutical, and biotechnology industries, carrageenans are used as gelling and thickening agents, with different types of carrageenans displaying differing rheological properties. For example, kappa carrageenan forms a stiff and brittle gel, while iota carrageenan forms a flexible, soft gel.
In pharmaceutical compositions, carrageenans may be used to provide formulations with improved drug delivery profiles, such as sustained release compositions. Furthermore, carrageenans are known to have anti-viral properties, and carrageenan-containing nasal spray compositions for use in preventing and treating the common cold, for example, are known. Carrageenan-containing nasal spray compositions may also be used in the prevention and treatment of allergies, enveloping and trapping the allergenic particles inhaled into the nasal cavity so that they can be cleared by ciliary action upon the mucous layer of the nasal cavity. Carrageenans are generally well tolerated. EP2178533 discloses the use of iota and/or kappa carrageenan in an antiviral pharmaceutical composition, which may be provided as a nasal spray. The composition may comprise NaCI as a preservative. The document discloses the effect of different concentrations of carrageenan on a range of viruses.
WO201 7/009351 discloses a composition for the treatment of respiratory viral infections and allergies. The composition comprises iota and/or kappa carrageenan with a non-ionic osmolality adjusting agent such as sorbitol and, optionally, an ionic osmolality adjusting agent, which may be NaCI, present in a quantity which is no more than 1.5% w/v. The pH of the composition may be 3.5-8.0.
WO201 7/069721 discloses an antiviral pharmaceutical composition which can be used in a nasal spray, the composition comprising iota carrageenan and beta glucan, the combination of which is said to enhance their stability and provide higher efficiency. The composition may comprise NaCI as an isotonic agent.
It is known that low-pH solutions have an inhibitory and/or a lethal effect on both viruses and bacteria, particularly those that are pathogens of the respiratory tract. However, as carrageenans are susceptible to acid hydrolysis, they may be unstable in low-pH solutions over time, which can lead to problems for the shelf-life of low-pH, carrageenan-containing compositions. In addition, for compositions that are delivered into the nasal cavity, the pH of the composition must be well tolerated by the nasal mucosa.
It is an object of the present invention to provide an improved iota carrageenan containing composition for use in a nasal spray.
For the avoidance of doubt, when reference is made herein to ‘open-ended’ terms such as ‘comprising’, ‘comprise’ and ‘comprises’, the invention is understood to relate also to embodiments in which the open-ended terms are replaced by ‘closed’ terms such as ‘consisting of and ‘consisting essentially of.
Also for the avoidance of doubt, the invention extends to ranges of a feature made up of any combination of upper limits, lower limits, specific values or endpoints disclosed in relation to specific ranges of the feature within the specification. For example, where ranges of 0.5-0.9% and 0.6-0.7% of a feature are explicitly disclosed, a range of 0.5-0.6% of the feature falls within the scope of the invention also.
SUMMARY OF INVENTION
In a first aspect of the invention there is provided an aqueous composition for use in a nasal spray, wherein the aqueous composition comprises:
0.1-1.0% w/w iota carrageenan;
0.1 -0.9% w/w NaCI; one or more acidic buffering agents or alkaline buffering agents to provide the aqueous composition with a pH of 4.0-4.4; and water present in an amount to make the aqueous composition up to 100% by weight.
The applicant has found that the concentrations of iota carrageenan, hydrogen ions and sodium cations of the invention provide a composition in an advantageous state, providing an equilibrium state in which the composition becomes a thixotropic semi gel with long-term stability at pH 4.0-4.4 and which can be readily broken into a free liquid for an optimal spray plume when a sheer stress is applied via activation of the nasal spray pump. The composition returns to a gel state or a semi-gel-like state in the nasal cavity, which improves the efficacy of the composition. As a result, a composition according to the invention is particularly well suited to use in a nasal spray as a medicament.
In some embodiments, the composition contains no further active antibacterial, antiviral or antiallergenic agents.
The composition may consist essentially of:
0.1-1.0% w/w iota carrageenan;
0.1 -0.9% w/w NaCI; one or more buffering agents to provide the aqueous composition with a pH of 4.0- 4.4; and water present in an amount to make the aqueous composition up to 100% by weight.
The composition can comprise 0.5-0.9% w/w iota carrageenan, optionally 0.6-0.8% w/w iota carrageenan. The composition can comprise 0.6-0.7% w/w iota carrageenan. The composition can comprise 0.7-0.8% w/w iota carrageenan.
The composition can comprise 0.3-0.9% w/w NaCI, optionally 0.4-0.6% w/w NaCI, and preferably about 0.5% w/w NaCI.
The one or more buffering agents can provide the aqueous composition with a pH of 4.1-4.3, optionally about 4.2. The buffering agents can comprise citric acid and sodium citrate, in which case the citric acid and/or the sodium citrate can be present in the aqueous solution in a concentration of 1 mM to 0.1 M, optionally about 0.01 M.
Alternatively, a range of organic and inorganic buffer solutions can be used as the one or more buffering agents including those derived from inorganic acids such as hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric or nitric acid and the like; and salts prepared from organic acids such as acetic, propionic, succinic, glycolic, stearic, lactic, malic, tartaric, citric, ascorbic, pamoic, maleic, hydroxymaleic, phenylacetic, aspartic, glutamic, benzoic, salicylic, sulfanilic, acetoxybenzoic, fumaric, toluenesulfonic, naphthyldisulfonic, methanesulfonic, ethane disulfonic, oxalic or isethionic acid, and the like. Additionally acceptable salts also include those derived from metal bases, including alkali metal bases, for example, alkali hydroxides such as sodium hydroxide, potassium hydroxide and lithium hydroxide in which the metal is a monovalent species, alkaline earth metal bases, for example, alkaline earth metal hydroxides such as magnesium hydroxide and calcium hydroxide in which the metal is a polyvalent species.
In a second aspect of the invention there is provided a nasal spray comprising the composition according to the first aspect of the invention in combination with a nasal spray delivery device charged with the composition. The nasal spray may be configured to deliver 0.1 mg to 3.0mg, optionally 0.5mg to 1.5mg, of iota carrageenan per spray. In a third aspect of the invention there is provided the composition according to the first aspect of the invention for use in a nasal spray as a medicament. The composition can be for use in a nasal spray as an antibacterial medicament, an antiviral medicament or an antiallergenic medicament.
Carrageenans including iota-carrageen have been demonstrated to have a broad spectrum antiviral activity against a wide range of viruses including those associated with respiratory tract infection, including Respiratory Syncytial Virus, Influenza and Parainfluenza viruses, Rhinoviruses, Coronaviruses and Adenoviruses, noting that in some cases these pathogens can lead to systemic diseases and damage to non- respiratory organs and even multi organ failure, though the route of entry is via the upper respiratory tract.
Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis are the most common bacterial pathogens in upper and lower respiratory tract infections. Streptococcus pyogenes is the predominant bacterial pathogen in pharyngitis and tonsillitis. Bacteria are adapted to their environment and thus respiratory bacterial pathogens are adapted to the respiratory tract pH of 6.6 and thus these respiratory bacteria are intolerant of an acidic pH environment, in particular when this pH is less than 4.4.
Pet allergies arise as an allergic reaction to proteins found in an animal's skin cells, saliva or urine. Signs of pet allergy include those common to hay fever, such as sneezing and runny nose. Some people may also experience signs of asthma, such as wheezing and difficulty breathing. Carrageenans have a high affinity to protein particles due to electrostatic forces causing the large scale carrageenan molecules to envelop and hence sequestrate the smaller proteins associated with pet allergy. In a fourth aspect of the invention there is provided a method of treating a condition comprising the steps of: providing a composition according to the first aspect of the invention in a nasal spray; and spraying the interior of the nose of a subject with the composition. The condition can be an antibacterial, antiviral medicament or antiallergenic condition.
In a fifth aspect of the invention there is provided a method of manufacturing a composition according to the first aspect of the invention comprising the steps of: dissolving one of more buffering agents in de-ionised water to provide a buffer solution having a pH of 4.0-4.4; dissolving NaCI in the buffer solution in an amount sufficient that the composition comprises 0.1 -0.9% w/w NaCI; and adding iota carrageenan to the buffer solution with sufficient agitation to ensure dissolution of the iota carrageenan without substantial gel clump formation, wherein the iota carrageenan is added in an amount sufficient that the composition comprises 0.1-1.0% w/w iota carrageenan.
A final filtering stage can be advantageous to remove any inadvertent gel clumps that may have formed during mixing of the iota carrageenan. A 400 micron mesh filter, or any other suitable filter grades, can be used.
The method of manufacturing the composition can be performed at a temperature between 20-25 degrees Celsius. In general, mixing below 18 degrees Celsius should be avoided to prevent excessive gel clump formation. While filtration will remove any gel clumps that form, this will adversely affect the iota-Carrageenan concentration present in the mixture.
Whilst the invention has been described above, it extends to any inventive combination of features set out above or in the following description. For example, features described in relation to one aspect of the invention are disclosed in relation to another aspect of the invention.
BRIEF DESCRIPTION OF DRAWINGS
Figure 1 is a cutaway drawing of a nasal spray delivery device containing a composition according to an embodiment of the invention.
DETAILED DESCRIPTION AND EXAMPLES Referring to Figure 1 there is illustrated a nasal spray delivery device 10 containing a composition 20 according to an embodiment of the present invention. The delivery device 10 comprises a bottle body 11 and a spray cap 12.
The composition is an aqueous composition, and comprises 0.1 -1.0% w/w carrageenan, 0.1 -0.9% w/w NaCI and one or more acidic buffering agents or alkaline buffering agents to maintain the composition within a pH range of 4.0-4.4. The composition comprises water in an amount to make the composition up to 100% by weight. In some embodiments, the composition consists essentially of carrageenan, NaCI, buffering agents and water.
While iota carrageenan is generally insoluble in cold water, the presence of suitable cations increases its solubility in cold water through the interaction of the cations with the carrageenan sulphate groups lota carrageenan comprises large, flexible molecules which can form a gel via carrageenan to carrageenan intermolecular linkages. In compositions according to the invention, the sulphate groups of the iota carrageenan interact with the sodium cations of the NaCI and the hydrogen ions from the citric acid buffer.
Availability of the negative sulphate groups to bond is also a function of the concentration of the iota carrageenan since there is an equilibrium between ‘free’ iota carrageenan and carrageenan to carrageenan intermolecular linkages. The concentrations of the iota carrageenan, hydrogen ions and sodium cations have been selected to ensure that the composition is an advantageous state, providing an equilibrium state so that the composition becomes a thixotropic gel. The composition provides a gel that has long-term stability at pH 4.0-4.4 and which can be readily broken into a free liquid for an optimal spray plume when a sheer stress is applied via activation of the spray pump. The composition returns to a gel state or a semi- gel-like state in the nasal cavity as a thin film once sprayed, which improves the efficacy of the composition. As a result, a composition is provided which is particularly well suited to use in a nasal spray as a medicament.
Citric acid and sodium citrate are preferred as buffering agents owing to their compatibility with the components of the composition and their suitability for use in pharmaceutical compositions for inhalation. The buffering agents are each present in a concentration of 1mM to 0.1M. However, other suitable buffering agents may be used, for example, but not limited to, those derived from hydrochloric, hydrobromic, nitric, phosphoric, sulfamic and/or sulfuric acid and salts prepared from acetic, acetoxybenzoic, ascorbic, aspartic, benzoic, citric, ethane disulfonic, fumaric, glutamic, glycolic, lactic, maleic, hydroxymaleic, isethionic, malic, methanesulfonic, naphthyldisulfonic, oxalic, pamoic, propionic, phenylacetic, salicylic, stearic, succinic, sulfanilic, tartartic and/or toluensulfonic acid.
In addition to contributing to the thixotropic state of the composition, the citric acid and sodium nitrate buffering agents maintain the pH of the composition once it has been administered into the nasal cavity, which also maintains its antimicrobial activity for a longer period than a solution that is not buffered. As such, the compound provides a broad spectrum of action on respiratory viruses, bacteria and allergens, including cat hair, dog hair and feather allergies.
The composition may be prepared by any suitable method, although a preferred method will now be described. The composition may be prepared by dissolving the required amount of buffering agents in de-ionised water in the desired concentration to obtain a pH of 4.0-4.4. The desired weight of NaCI is then dissolved in the buffer solution. The desired mass of carrageenan is slowly added to the buffered saline solution with continuous mixing to ensure complete dissolution of the iota carrageenan while avoiding the formation of gel clumps. Finally a filtration stage may be advantageous for example with a 400 micron mesh filter, noting other mesh grades of filter may be acceptable.
A controlled room temperature between 20-25 degrees Celsius is ideal and mixing below 18 degrees Celsius should generally be avoided to prevent excessive gel clump formation. While filtration will remove any gel clumps that form this will adversely affect the iota-Carrageenan concentration present in the mixture.
Example
To make 1000ml solution with iota-carrageenan at a concentration of 0.6%, NaCI at a concentration of 0.5%, pH buffered to 4.2 using Citric acid and Na Citrate, the following ingredients measured w/w, were combined as described in the preceding section. lota carrageenan: 6.0g NaCI: 5.0g
Citric acid: 2.32g, providing a 0.011 M solution of Citric acid Sodium citrate: 2.32g, providing a 0.009M solution of Na Citrate Water: 984.36g
The composition described in the Example was incorporated into a nasal spray delivery device and used to produce an efficacious nasal spray.

Claims

1. An aqueous composition for use in a nasal spray, wherein the aqueous composition comprises:
0.1-1.0% w/w iota carrageenan;
0.1 -0.9% w/w NaCI; one or more acidic buffering agents or alkaline buffering agents to provide the aqueous composition with a pH of 4.0-4.4; and water present in an amount to make the aqueous composition up to 100% by weight.
2. The composition according to claim 1 , wherein the composition contains no further active antibacterial, antiviral or antiallergenic agents.
3. The composition according to claim 1 wherein the composition consists essentially of:
0.1-1.0% w/w iota carrageenan;
0.1 -0.9% w/w NaCI; one or more buffering agents to provide the aqueous composition with a pH of 4.0-4.4; and water present in an amount to make the aqueous composition up to 100% by weight.
4. The composition according to any preceding claim comprising 0.5-0.9% w/w iota carrageenan.
5. The composition according to claim 4 comprising 0.6-0.7% w/w iota carrageenan.
6. The composition according to any preceding claim comprising 0.3-0.9% w/w NaCI.
7. The composition according to claim 6 comprising 0.4-0.6% w/w NaCI.
8. The composition according to claim 7 comprising about 0.5% w/w NaCI.
9. The composition according to any preceding claim wherein the one or more buffering agents provides the aqueous composition with a pH of 4.1-4.3.
10. The composition according to claim 9 wherein the one or more buffering agents provides the aqueous composition with a pH of about 4.2.
11. The composition according to any preceding claim wherein the buffering agents comprise citric acid and sodium citrate.
12. The composition according to claim 11 wherein the citric acid and/or the sodium citrate is present in the aqueous solution in a concentration of 1mM to 0.1M, optionally about 0.01 M.
13. A nasal spray comprising the composition according to any preceding claim in combination with a nasal spray delivery device charged with the composition.
14. A nasal spray according to claim 13 configured to deliver 0.1 mg to 3.0mg, optionally 0.5mg to 1.5mg, of iota carrageenan per spray.
15. The composition according to any one of claims 1 to 12 for use in a nasal spray as a medicament.
16. The composition according to any one of claims 1 to 12 for use in a nasal spray as an antibacterial medicament.
17. The composition according to any one of claims 1 to 12 for use in a nasal spray as an antiviral medicament.
18. The composition according to any one of claims 1 to 12 for use in a nasal spray as an antiallergenic medicament.
19. A method of treating a condition comprising the steps of: providing a composition according to any one of claims 1 to 12 in a nasal spray; and spraying the interior of the nose of a subject with the composition.
20. A method of manufacturing a composition according to any one of claims 1 to 12 comprising the steps of: dissolving one of more buffering agents in de-ionised water to provide a buffer solution having a pH of 4.0-4.4; dissolving NaCI in the buffer solution in an amount sufficient that the composition comprises 0.1 -0.9% w/w NaCI; and adding iota carrageenan to the buffer solution with sufficient agitation to ensure dissolution of the iota carrageenan without substantial gel clump formation, wherein the iota carrageenan is added in an amount sufficient that the composition comprises 0.1 -1.0% w/w iota carrageenan.
PCT/GB2022/051762 2021-07-08 2022-07-08 Nasal spray WO2023281272A1 (en)

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Citations (4)

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Publication number Priority date Publication date Assignee Title
EP2178533A1 (en) 2007-08-24 2010-04-28 Marinomed Biotechnologie GmbH Antiviral composition comprising a sulfated polysaccharide
WO2017009351A1 (en) 2015-07-14 2017-01-19 Marinomed Biotechnologie Gmbh Stuffy nose deblocking composition having antiviral activity
WO2017069721A1 (en) 2015-10-22 2017-04-27 Tolcheyev Yuriy Zakharovych Antiviral pharmaceutical composition
US11013687B1 (en) * 2020-06-08 2021-05-25 Amcyte Pharma, Inc. Preventive and therapeutic treatment for COVID 19 and any other disease caused by SARS CoV 2

Patent Citations (4)

* Cited by examiner, † Cited by third party
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