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US-20260124163-A1 - SOFT GUMMY

US20260124163A1US 20260124163 A1US20260124163 A1US 20260124163A1US-20260124163-A1

Abstract

The current invention relates to a soft gummy for therapeutic oral use, said soft gummy comprising an outer shell encapsulating an inner liquid, wherein said outer shell comprises: (i) a pectin; and (ii) honey in an amount of at least 25 wt. % relative to the weight of the outer shell; wherein said inner liquid has a moisture content of at least 10 wt. % as measured by ISO 760:1978 and a viscosity of at most 50.0 Pa s measured at 20° C. and wherein the soft gummy comprises a hydrolysable tannin or source of hydrolysable tannin. The invention also relates to a use of a soft gummy.

Inventors

  • Bart Rossel
  • André Antunes
  • Laurens DE SCHEPPER
  • Mike VAN GANSE

Assignees

  • OYSTERSHELL NV

Dates

Publication Date
20260507
Application Date
20230929
Priority Date
20220929

Claims (15)

  1. 1 . A soft gummy for therapeutic oral use, said soft gummy comprising an outer shell encapsulating an inner liquid, wherein said outer shell comprises: a pectin; and honey in an amount of at least 25 wt. % relative to the weight of the outer shell; wherein said inner liquid has a moisture content of at least 10 wt. % as measured by ISO 760:1978 and a viscosity of at most 50.0 Pa s measured at 20° C., and wherein the soft gummy comprises a hydrolysable tannin or source of hydrolysable tannin.
  2. 2 . The soft gummy according to claim 1 , wherein said pectin is chosen from high methoxyl (HM) pectin, low methoxyl (LM) pectin or low methoxyl amidated (LMA) pectin.
  3. 3 . The soft gummy according to claim 1 , wherein said pectin is high methoxyl (HM) pectin, said high methoxyl (HM) pectin having a degree of methoxylation (DM) of at least 50.
  4. 4 . The soft gummy according to claim 1 , wherein said pectin is high methoxyl (HM) pectin, said high methoxyl (HM) pectin having a degree of esterification (DE) of at least 60.
  5. 5 . The soft gummy according to claim 1 , wherein said pectin is high methoxyl (HM) pectin, said high methoxyl (HM) pectin is at least partially crosslinked.
  6. 6 . The soft gummy according to claim 1 , wherein said outer shell further comprises a dicarboxylic acid or a tricarboxylic acid.
  7. 7 . The soft gummy according to claim 1 , wherein said inner liquid comprises the honey.
  8. 8 . The soft gummy according to claim 1 , wherein said outer shell comprises 1-10 wt. % of pectin relative to the weight of the outer shell; and 50-90 wt. % of honey relative to the weight of the outer shell.
  9. 9 . The soft gummy according to claim 1 , wherein said inner liquid comprises said hydrolysable tannin or source of hydrolysable tannin, wherein said hydrolysable tannin is present in an amount of at least 0.5 wt. % relative to the weight of the inner liquid.
  10. 10 . The soft gummy according to claim 1 , wherein said outer shell comprises said hydrolysable tannin or source of hydrolysable tannin, wherein said hydrolysable tannin is present in an amount of at least 0.5 wt. % relative to the weight of the outer shell.
  11. 11 . The soft gummy according to claim 1 , wherein said inner liquid comprises a hydrolysable tannin or a source of hydrolysable tannin in an amount of at least 0.5 wt. % relative to the weight of the inner liquid.
  12. 12 . The soft gummy according to claim 1 , wherein said inner liquid comprises menthol or a mint extract.
  13. 13 . The soft gummy according to claim 1 , wherein said outer shell comprises at least 50 wt. % honey relative to the total weight of said outer shell, and wherein said inner liquid comprises at least 50 wt. % honey relative to the total weight of said inner liquid.
  14. 14 . A method for treatment, said method comprising administering the soft gummy according to claim 1 , as an oral therapeutic.
  15. 15 . A method for treatment or prevention of a cough or cold, said method comprising administering the gummy according to claim 1 .

Description

FIELD OF THE INVENTION The present invention relates, in a first aspect, to a soft gummy for therapeutic oral use. In a second aspect, the present invention also relates to a use of a soft gummy for therapeutic oral use. BACKGROUND A cough medicine or a cough and cold medicine, is a medicinal drug used in those with coughing and related conditions, particularly associated with inflammation of the respiratory system. This could also include liquid medicine for daytime or nighttime relief of cold, flu, allergies, or sleeplessness. Cough medicines typically comprise drugs with painkilling and fever-reducing properties, like for example ibuprofen (IBU) or dextromethorphan (DXM) this is a cough suppressant in quantities of up to 5% b.w. but also actives of natural origin like for example dry extracts of ivy willow is more common for this medical purpose. The medicines are offered in liquid or solid form, as for example syrups, sprays, tablets, pills, capsules, pastilles or hard candies, starch cast strips. Individuals may find it difficult to swallow tablets and capsules, particularly if they are large. Avoidance of taking medications can lead to low levels of drug efficacy, resulting in prolonged or worsening symptoms and/or failure to treat or cure the indicated malady. Cough syrups do not have these difficulties with swallowing. Cough syrups furthermore provide a mechanical method of action; by providing a sweet and soothing layer to the throat thereby providing immediate relief to dry cough and/or sore throat. However, cough syrups are generally sticky liquids which are difficult to use, difficult to dose accurately and cannot be used discretely. Hydrophilic cellulose polymers are commonly used as the excipient base in tableted slowly eroding matrix systems. The effectiveness of these erodible hydrophilic matrix systems is due to a successive physic-chemical process of hydration of the cellulosic polymers. U.S. Pat. No. 9,877,971 describes oral, slow releasing pharmaceutical compositions suitable for chewing or sucking comprising non-systemic corticosteroid soft lozenges. Said composition comprises gelatins, plasticizers, sweeteners, corticosteroids, release modifiers, pH modifiers and water. The composition orally disintegrates within about 30-45 minutes upon oral administration to a subject in need thereof. It is known that gelatin-based gels are not suited to encapsulate high moisture content fillings. Water could migrate and destroy the gelatin structure. Another problem relates to APIs which lose their active properties or are completely lost as a result of the physical conditions (e.g. temperature, humidity, flow, etc.) that are present during the development and/or production phase of the formulation. Exposure to extreme temperatures and humidity causes structural degradation and changes in chemical behavior of an API. For example, certain APIs have shown that they are not suitable for hot melt extrusion, a general production method for polymers. In addition, certain APIs also exhibit chemical interaction with residual solvents commonly used for polymer processing, or in certain cases the APIs may even react with the polymer itself when coupled together. All these situations lead to impurities in the API formulation that have no therapeutic value and may even be harmful (i.e., genotoxic). The present invention aims to resolve at least some of the problems and disadvantages mentioned above. SUMMARY OF THE INVENTION The present invention and embodiments thereof serve to provide a solution to one or more of above-mentioned disadvantages. To this end, the present invention relates, in a first aspect, to a soft gummy according to claim 1. The soft gummy according to claim 1 provides an easy-to-use dosage form. There is no requirement to handle or dose sticky liquids nor swallow large pills or capsules. The soft gummy combines the advantages of a solid dosage form, i.e. ease of use, reduced chance of spilling, improved dosage control and single dosage packaging with the advantages of a syrup, i.e. application of a sweet syrup which may provide relief cough symptoms. The soft gummy according to claim 1 is designed to disintegrate in the oral cavity. Soft gummies can be chewed or allowed to dissolve slowly in the mouth. Upon breakage of the outer shell, the inner liquid is immediately released into the oral cavity, providing immediate relief as customary with cough syrups. These dosage forms can be flavored and thus are administrable to both pediatric and geriatric patients. Advantageously, the outer shell shows excellent chemical and physical properties. In particular, the outer shell forms a strong capsule which allows the storage of a relatively large amount of liquid with a high moisture content. Where center-filled gels are known, the amount of liquid and their moisture content is typically too limited. Said outer shell shows excellent chemical and physical properties. The outer shell provides a strong c