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EP-4391840-B1 - MEDICAL LIQUID COMPOSITION FOR AERIAL ADMINISTRATION

EP4391840B1EP 4391840 B1EP4391840 B1EP 4391840B1EP-4391840-B1

Inventors

  • FERRI, Emanuele
  • DELL'AGLI, Mario
  • Ferri, Nicola

Dates

Publication Date
20260506
Application Date
20220805

Claims (11)

  1. A composition for aerial administration comprising or consisting of the following components: a) water 10-50% or 20-50% by weight b) a diol 20-65% or 20-60% by weight c) glycerol 10-40% or 10-30% by weight d) ethanol 0-10% by weight e) one or more protective substances selected from linear or branched dextrins, cyclodextrins and cellulose derivatives; f) one or more antioxidants; g) optionally, a preservative, wherein the sum of the weight percentages of components e), f) and g) is between 0.1% and 5% by weight.
  2. The composition for aerial administration according to claim 1, comprising or consisting of the following components: a) water 10-50% or 20-50% by weight b) 1,3-propanediol 20-65% or 20-60% by weight c) glycerol 10-40% or 10-30% by weight d) ethanol 0-10% by weight e) one or more protective substances selected from linear or branched dextrins, cyclodextrins and cellulose derivatives; f) one or more antioxidants; g) optionally, a preservative, wherein the sum of the weight percentages of components e), f) and g) is between 0.1% and 5% by weight.
  3. The composition for aerial administration according to claim 2, which does not contain propylene glycol and comprises or consists of the following components: a) water 10-50% or 20-50% by weight b) 1,3-propanediol 20-65% or 20-60% by weight c) glycerol 10-40% or 10-30% by weight d) ethanol 0-10% by weight e) one or more protective substances selected from linear or branched dextrins, cyclodextrins and cellulose derivatives; f) one or more antioxidants; g) optionally, a preservative, wherein the sum of the weight percentages of components e), f) and g) is between 0.1% and 5% by weight.
  4. The composition according to claim 2 or 3, comprising or consisting of the following components: a) water 10-40%, or 30-40%, or 32-38% by weight b) 1,3-propanediol 30-65%, or 30-50%, or 40-48% by weight c) glycerol 15-40%, or 15-25% by weight d) ethanol 0-10% by weight e) one or more protective substances selected from linear or branched dextrins and cyclodextrins; f) one or more antioxidants; g) optionally, a preservative, wherein the sum of the weight percentages of components e), f) and g) is between 0.2% and 0.7%, or between 0.3 and 0.6% by weight.
  5. The composition according to any one of claims 1 to 4, wherein the one or more protective substances of component e) are selected from cyclodextrins, carboxymethyl cellulose and microcrystalline cellulose.
  6. The composition according to any one of claims 1 to 5, wherein the one or more antioxidants of component f) are selected from hydroxytyrosol, curcumin, gallic acid, stilbenes including resveratrol and piceid, ellagic acid, caffeic acid derivatives including caffeic acid, chlorogenic and rosmarinic acid, secoiridoids such as oleuropein and ligstroside and glycoside derivatives, flavonoid derivatives including epigallocatechin gallate, quercetin, luteolin, apigenin, catechin and glycoside derivatives thereof.
  7. The composition according to any one of claims 1 to 6, wherein the preservative is sodium benzoate or sodium ascorbate.
  8. The composition according to any one of claims 1 to 7, comprising flavors preferably selected from fruit, tobacco, mentholated flavors, or mixtures thereof.
  9. The composition according to any one of claims 1 to 8, comprising: water <40% by weight 1,3-propanediol >40% by weight glycerol ≤40% by weight.
  10. The composition according to any one of claims 1 to 9, comprising nicotine.
  11. A device for aerial administration containing one or more doses of one or more compositions according to any one of claims 1 to 10, wherein said device is selected from a personal vaporizer, an electronic cigarette and an aerosol atomizer.

Description

Field of application of the invention The present invention relates to a medical liquid composition with protective and antioxidant properties, which is usable for aerial administration, for example with personal vaporizers and aerosol devices and to devices for aerial administration containing such composition. Background art The damage to health caused by tobacco smoke is universally known. It is well known that cigarette smoking causes serious damage to health, not so much due to nicotine, which is also a highly toxic substance, but due to the combustion by-products, such as polycyclic aromatic hydrocarbons, tar and carbon monoxide, some of which have a pronounced carcinogenic effect. Alternative smoking is now a widespread practice all over the world, at least partially replacing cigarette smoking. There are two types of alternative smoking on the market. A first type is the so-called heat-not-burn systems which include heating tobacco at a controlled temperature (generally no higher than 350°C), so as to avoid the harmful effects of high-temperature combustion. The second type is so-called "electronic cigarettes" which vaporize a liquid comprising, in addition to a base adapted to provide a sufficiently dense body to the vapor released, also a controlled amount of nicotine and various types of flavorings. The first type, with heated tobacco, is more similar to traditional smoking, but some toxic substances contained in tobacco in addition to nicotine are still released despite the lower combustion temperatures. A typical example is nitrosamines. Electronic cigarettes are safer, since they do not contain such toxic or carcinogenic substances, apart from a controlled amount of nicotine, which can be added to the composition to provide the smoker with the desired nicotinic receptor stimulating effect. The possibility of flavoring the composition in various manners is a further attraction. However, electronic cigarettes too are not free of toxicity. In fact, the basic composition mostly consists of a mixture of propylene glycol and glycerol which cause, especially the former, damage to the cells of the oropharyngeal mucosa and respiratory tract. Smokers of both traditional cigarettes and alternative products generally have two different smoking modes: the so-called "cheek draw" and the "lung draw". In the first case the smoke is not ingested but remains in the oral cavity, while in the second case it is inhaled up to the respiratory tract. The damage of the smoke can thus be visible at the level of both the latter and the oropharyngeal cavity. Therefore, it is the problem addressed by the present invention to provide a composition for aerial administration which can counteract and alleviate the damage caused by the chronic use of cigarettes, heated tobacco and electronic cigarettes at the level of both the oral cavity and pulmonary respiratory tract. Document WO2015/148649 discloses a composition comprising a nicotine-containing material and an anti-cancer agent dissolved in a solvent suitable to be administered with an inhalation device. Summary of the invention The aforesaid technical problem is substantially solved by a composition comprising the technical features set out in one or more of the appended claims, the definitions of which form an integral part of the present description for the purpose of sufficiency of description. Therefore, the present invention relates to a composition for aerial administration comprising or consisting of the following components: a) water20-50% by weightb) a diol20-60% by weightc) glycerol10-30% by weightd) ethanol0-10% by weighte) one or more protective substances preferably selected from cyclodextrins and cellulose derivatives;f) one or more antioxidants;g) optionally, a preservative, in which the sum of the weight percentages of components e), f) and g) is between 0.1% and 5% by weight. Further features and advantages of the present invention will become more apparent from the indicative and thus non-limiting description of preferred, but not exclusive embodiments of the invention. Brief description of the drawings Figure 1 depicts a diagram comparing a composition according to the invention (MEDICAL MIXTURE) and two compositions of the prior art (80PG/20VG and 20PG/80VG), depicting the variation of the average size of the vapor droplets as a function of the electrical power applied by dispensing the compositions with a common electronic cigarette. Detailed description of the invention The present invention relates to a composition for aerial administration comprising or consisting of the following components: a) water10-50% or 20-50% by weightb) a diol20-65% or 20-60% by weightc) glycerol10-40% or 10-30% by weightd) ethanol0-10% by weighte) one or more protective substances selected from linear or branched dextrins, cyclodextrins and cellulosederivatives;f) one or more antioxidants;g) optionally, a preservative, in which the sum of the weight percentages of compon