Flavoured nicotine powder
Abstract
The nicotine powder inhaler 10 includes a body portion extending between the mouthpiece portion 12 and the distal end 14 , an airflow channel 15 extending between the mouthpiece portion and the distal end, and a nicotine powder disposed along the airflow channel. a receptacle 20, and a powder system disposed within the nicotine powder receptacle. The powder system includes a first plurality of particles having a particle size of about 10 μm or less and comprising nicotine and a second plurality of particles having a particle size of about 20 μm or greater and comprising a flavor. The first plurality of particles comprises nicotine or an amino acid selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate and nicotine lactate.

Term
10.2 yearsto projected expiry
Projected expiry 8 December 2036, counted from filing; an application has no term until it is granted.
- Priority
- Filed
- Published
- Today
- Projected expiry
18 claims: 11 independent, 7 dependent
- 1분말 시스템으로서, 약 10㎛ 이하의 입자 크기를 가지고 니코틴 및 아미노산을 포함하는 제1 복수의 입자;및 약 20㎛ 이상의 입자 크기를 가지고 향미를 포함하는 제2 복수의 입자를 포함하는 분말 시스템.
- 2분말 시스템으로서, 약 10㎛ 이하의 입자 크기를 가지고 니코틴 피루빈산염, 니코틴 모노-피루빈산염, 니코틴 아스파르트산염 및 니코틴 젖산염으로 이루어지는 군에서 선택된 니코틴을 포함하는 제1 복수의 입자;및 약 20㎛ 이상의 입자 크기를 가지고 향미를 포함하는 제2 복수의 입자를 포함하는 분말 시스템.
- 3제1항 또는 제2항에 있어서, 상기 분말 시스템의 상기 니코틴의 적어도 약 60wt%는 약 10㎛ 이하의 입자 크기를 가지는 입자에 포함되는, 분말 시스템.
- 4제1항 내지 제3항 중 어느 한 항에 있어서, 상기 분말 시스템의 상기 향미의 적어도 약 60wt%는 약 20㎛ 이상의 입자 크기를 가지는 입자에 포함되는, 분말 시스템.
- 5제1항 내지 제4항 중 어느 한 항에 있어서, 상기 제1 복수의 입자는 약 5㎛ 이하, 약 3㎛ 이하, 또는 약 1㎛ 내지 약 3㎛ 범위의 질량 중앙 공기역학적 직경을 가지고, 상기 제2 복수의 입자는 약 50㎛ 이상, 또는 약 50㎛ 내지 약 150㎛ 범위의 질량 중앙 공기역학적 직경을 가지는 분말 시스템.
- 6제1항 내지 제5항 중 어느 한 항에 있어서, 상기 니코틴은 니코틴 염 또는 니코틴 염 수화물을 포함하는 분말 시스템.
- 7제1항 및 제3항 내지 제6항 중 어느 한 항에 있어서, 상기 아미노산은 니코틴 상에 배치되는 분말 시스템.
- 8제1항 및 제3항 내지 제7항 중 어느 한 항에 있어서, 상기 아미노산은 류신을 포함하는 분말 시스템.
- 9제1항 내지 제8항 중 어느 한 항에 있어서, 상기 제1 복수의 입자 및 상기 제2 복수의 입자는 단일 캡슐에 담기는 분말 시스템.
- 10제1항 내지 제8항 중 어느 한 항에 있어서, 상기 제1 복수의 입자는 제1 캡슐에 담기고, 상기 제2 복수의 입자는 제2 캡슐에 담기는 분말 시스템.
- 11제1항 내지 제10항 중 어느 한 항에 있어서, 상기 제1 복수의 입자는 상기 분말 시스템 총 중량의 약 50wt% 내지 약 99wt%이고, 상기 제2 복수의 입자는 상기 분말 시스템 총 중량의 약 50wt% 내지 약 1wt%인 분말 시스템.
- 12제1항 내지 제11항 중 어느 한 항에 있어서, 상기 제2 복수의 입자는 스테아린산 마그네슘(magnesium stearate)을 포함하는 분말 시스템.
- 13니코틴 분말 흡입기로서, 마우스피스부와 원위 단부 사이에서 연장되는 바디부;상기 마우스피스부와 상기 원위 단부 사이에서 연장되는 기류 채널;및 상기 기류 채널을 따라 배치된 니코틴 분말 수용부 및 상기 니코틴 분말 수용부 내에 배치된 제1항 내지 제12항 중 어느 한 항의 상기 분말 시스템을 포함하는 니코틴 분말 흡입기.
- 14제13항에 있어서, 상기 제1 복수의 입자 및 상기 제2 복수의 입자는 단일 캡슐 내에 담기고, 상기 캡슐은 상기 니코틴 분말 수용부 내에 배치되며, 상기 제1 복수의 입자 및 상기 제2 복수의 입자는 상기 단일 캡슐로부터 상기 기류 채널 내에 방출되는 니코틴 분말 흡입기.
- 15제13항에 있어서, 상기 제1 복수의 입자는 제1 캡슐 내에 담기고, 상기 제2 복수의 입자는 제2 캡슐 내에 담기며, 상기 제2 캡슐은 상기 제1 캡슐의 상류 또는 하류에 있으며 상기 기류 채널 내에 있는 니코틴 분말 흡입기.
- 16제13항에 있어서, 상기 니코틴 분말 수용부와 평행한 기류 관계에 있는 제2 기류 채널을 더 포함하되, 상기 제1 복수의 입자는 상기 니코틴 분말 수용부 내의 제1 캡슐에 담기고, 상기 제2 복수의 입자는 상기 제2 기류 채널 내의 제2 캡슐에 담기는 니코틴 분말 흡입기.
- 17제13항 내지 제16항 중 어느 한 항에 있어서, 상기 제1 복수의 입자는 분당 약 5리터 미만의 흡입 속도로 사용자에 폐에 흡입되는 니코틴 분말 흡입기.
- 18니코틴을 사용자의 폐에 흡입시키는 방법으로서, 상기 제1 복수의 입자를 사용자의 폐에 전달하기 위해 제12항 내지 제17항 중 어느 한 항의 상기 니코틴 분말 흡입기를 통해 분당 약 2리터 미만의 유속으로 공기를 흡입하는 단계를 포함하되, 상기 제2 복수의 입자는 상기 사용자의 폐에 전달되지 않는 방법.
Independent claims18
62 paragraphs, as filed
flavored nicotine powder
The present disclosure relates to a powder system comprising particles comprising nicotine and particles comprising flavor, wherein the flavor particles are larger than the nicotine particles.
Dry powder inhalers (DPI) are known and used to treat respiratory diseases by inhaling and delivering a dry powder containing a medicament into the respiratory tract of a patient in the form of an aerosol. For delivery into the lungs, particles in the range of 1 μm to 5 μm are preferred. In dry pharmaceutical powders, the active pharmaceutical ingredient (API) may agglomerate on the surface of large carrier particles such as lactose. DPI works as a complex mechanism that causes the API to disperse, break up, or break down these clumps before they are inhaled into the lungs. The dry pharmaceutical powder containing lactose as a carrier may range from 20 μm to 100 μm.
DPI relies on the patient's suction power to entrain the powder from the device and break it down into particles small enough to enter the lungs. A sufficiently high inhalation rate is required to ensure that the powder is administered correctly and completely disintegrated. Generally, due to incomplete disintegration of the powder, large amounts of API remain attached to the surface of the carrier and are deposited in the upper respiratory tract. Inhalation rates of conventional DPIs are typically in the range of 20 to 100 liters/min (L/min). Thus, existing DPIs are only suitable for delivering dry powder to a user in a manner different from the inhalation rate associated with smoking articles.
It would be desirable to provide a stable powder system that supplies nicotine particles to a user's lungs and flavor particles, preferably in or oral cavity of a user. It is desirable that the relative particle sizes of nicotine and flavor remain stable even when they are combined with each other. It is desirable to deliver such a stable powder system to a user at an inhalation rate or airflow rate that is less than or equal to the inhalation rate or airflow rate of a conventional smoking system.
The powder system includes a first plurality of particles having a particle size of about 10 μm or less and a second plurality of particles having a particle size of about 20 μm or greater and comprising a flavor. The first plurality of particles comprises nicotine or an amino acid selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate and nicotine lactate. The particles of the powder system are preferably free flowing.
The powder system may have about 40 wt% or more of nicotine of the powder system included in the particles having a particle size of about 10 μm or less. The powder system may have 60 wt% or more of nicotine in the powder system included in the particles having a particle size of about 10 μm or less. The powder system may have about 80 wt% or more of nicotine of the powder system included in the particles having a particle size of about 10 μm or less. The powder system may have about 90 wt% or more of nicotine of the powder system included in the particles having a particle size of about 10 μm or less.
The powder system may have about 40 wt% or more of nicotine of the powder system included in the particles having a particle size of about 5 μm or less. The powder system may have about 60 wt% or more of nicotine of the powder system included in the particles having a particle size of about 5 μm or less. The powder system may have about 80 wt% or more of nicotine of the powder system included in the particles having a particle size of about 5 μm or less. The powder system may have about 90 wt% or more of nicotine of the powder system included in the particles having a particle size of about 5 μm or less.
The powder system may have about 40 wt% or more of nicotine in the powder system contained in particles having a particle size of about 1 μm to about 3 μm or less. The powder system may have about 60 wt% or more of nicotine in the powder system included in the particles having a particle size of about 1 μm to about 3 μm or less. The powder system may have about 80 wt% or more of nicotine in the powder system contained in particles having a particle size of about 1 μm to about 3 μm or less. The powder system may have about 90 wt% or more of nicotine of the powder system included in the particles having a particle size of about 1 μm to about 3 μm or less.
The powder system may have a flavor of about 60 wt% or more or 80 wt% or more of the powder system contained in particles having a particle size of about 20 μm or less. The powder system may have a flavor of about 60 wt% or more or 80 wt% or more of the powder system contained in particles having a particle size of about 50 μm or more. The powder system may have a flavor of about 60 wt% or more or 80 wt% or more of the powder system contained in particles having a particle size of about 150 μm or less.
The powder system may comprise from about 50 wt % to about 99 wt % of the first plurality of particles. The powder system may comprise from about 1 wt % to about 50 wt % of the first plurality of particles.
The size of a particle specified herein preferably refers to the aerodynamic diameter of the particle. The aerodynamic diameter of the powder system is preferably measured with a cascade impactor.
Advantageously, the powder system described herein provides a stable, free-flowing powder system that selectively delivers nicotine to the user's lungs and selectively flavor to the user's mouth. Advantageously, the powder system described herein preferably has a stable relative particle size of each powder component even when the nicotine particles and flavor particles are combined. Advantageously, an inhaler using such a powder system may not need to reduce the size of the powder particles and may deliver the powder system at an inhalation rate or airflow rate that is less than or equal to the inhalation rate or airflow rate of a conventional smoking system.
The term "nicotine" refers to nicotine and nicotine derivatives such as free-base nicotine, nicotine salts, and the like.
The term "flavor" or "flavor" refers to an organoleptic compound, composition, or material intended to modify and modify the taste or aroma properties of nicotine while it is consumed or inhaled. The term "flavor" or "flavor" is preferably used in the Flavor & Extract Manufacturers Association (FEMA) Flavor Ingredient Library and, in particular in the GRAS Flavoring Substances Documents 3 to 27. disclosed compounds. These FEMA flavor ingredient library references include: GRAS Flavoring Substances 3, Hall, RL & Oser, BL, Food Technology, February 1965 pg 151-197; GRAS Flavoring Substances 4, Hall, RL & Oser, BL, Food Technology, Vol. 24, No. 5 pg 25-34; GRAS Substances 5, Hall, RL & Oser, BL, Food Technology, 1972 pg 25-37; GRAS Substances 6, Oser, BL & RA Ford, Food Technology, Vol. 27, No. 1, 1973 pg 64-67; GRAS Substances 7, Oser, BL & RA Ford, Food Technology, Vol. 27, No. 11, 1973 pg 56-57; GRAS Substances 8, Oser, BL & RA Ford, Food Technology, September 1974 pg 76-80; GRAS Substances 9, Oser, BL & RA Ford, Food Technology, August 1975 pg 70-72; GRAS Substances 10, Oser, BL & RA Ford, Food Technology, January 1977 pg 65-74; GRAS Substances 11, Oser, BL & RA Ford, Food Technology, February 1978 pg 60-70; GRAS Substances 12, Oser, BL & RA Ford, Food Technology, July 1979 pg 65-73; GRAS Substances 13, Oser, BL, et al., Food Technology, October 1984 pg 66-89; GRAS Substances 14, Oser, BL, et al., Food Technology, November 1985 pg 108-117; GRAS Substances 15, Oser, BL, et al., Food Technology, February 1990 pg 78-86; GRAS Substances 16, Smith, RL & Ford, RA, Food Technology, June 1993 pg 104-117; GRAS Flavoring Substances 17, Smith, et al., Food Technology, October 1996 pg 72-81; GRAS Flavoring Substances 18, Newberne, P., et al., Food Technology, Vol. 52, No. 9, September 1998 pg 68-92; GRAS Flavoring Substances 19, Newberne, P., et al., Food Technology, Vol. 54, No. 6, June 2000 pg 66-84; GRAS Flavoring Substances 20, Smith, RL, et al., Food Technology, Vol. 55, No. 12, December 2001 pg 34-55; GRAS Flavoring Substances 21, Smith, RL, et al., Food Technology, Vol. 57, No. 5, May 2003 pg 46-59; GRAS Flavoring Substances 22, Smith, RL, et al., Food Technology, August 2005 pg 24-62; GRAS Flavoring Substances 23, Waddell, WJ, et al., Food Technology, August 2007 pg 22-48; GRAS Flavoring Substances 24, Smith, RL, et al., Food Technology, June 2009 pg 46-105; GRAS Flavoring Substances 25, Smith, RL, et al., Food Technology, July 2011 pg 44-75; GRAS Flavoring Substances 26, Marnett, SM, et al., Food Technology, August 2013 pg 38-56; and GRAS flavoring substances 27 SM Cohen et al., Food Technology Aug. 2015 pg. 40-59. For the purposes of this disclosure, nicotine is not considered a flavoring agent or flavoring agent.
The present disclosure relates to a powder system comprising particles comprising nicotine and particles comprising a flavor. The powder system preferentially supplies nicotine particles to the user's lungs and preferentially supplies flavor particles to the user's mouth or oral cavity. The particles comprising nicotine further comprise nicotine or an amino acid selected from the group consisting of nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate and nicotine lactate. The relative particle sizes of the particles comprising nicotine and particles comprising flavor remain stable even when they are combined with each other.
The particles comprising nicotine may have any useful size distribution for preferential inhalation delivery into the lungs of a user. The powder system may have about 40 wt% or more, 60 wt% or more, or about 80 wt% or more of the nicotine of the powder system included in the particles having a particle size of about 10 μm or less. The powder system may have about 40 wt% or more, 60 wt% or more, or about 80 wt% or more of the nicotine of the powder system included in the particles having a particle size of about 5 μm or less. The powder system may have at least about 40 wt %, at least 60 wt %, or at least about 80 wt % of the nicotine of the powder system included in particles having a particle size in the range of about 1 μm to about 3 μm.
Preferably, the nicotine may be a pharmaceutically acceptable free base nicotine, nicotine salt or nicotine salt hydrate. Useful nicotine salts or nicotine salt hydrates are, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate ( nicotine fumarate, nicotine mono-pyruvate, nicotine glutamate or nicotine hydrochloride. Preferred nicotine salts or nicotine salt hydrates include nicotine pyruvate, nicotine mono-pyruvate, nicotine aspartate or nicotine lactate.
Compounds that combine with nicotine to form salts or salt hydrates can be selected based on the expected pharmacological effect. For example: nicotine salicylate may be administered for fever relief as an anti-inflammatory or analgesic; Nicotine fumarate may be administered to treat multiple sclerosis; Nicotine mono-pyruvate may be administered to treat chronic obstructive pulmonary disease (COPD) or to lose weight.
Particles comprising nicotine may comprise amino acids. The amino acid may be disposed on or coated on at least a portion of a particle comprising nicotine. Preferably, the amino acid may be a leucine such as L-leucine. When particles containing nicotine are provided to amino acids such as L-leucine, in particular, when nicotine is coated with amino acids, the adhesion of the particles containing nicotine can be reduced, and the attraction between the nicotine particles can be reduced, so nicotine can be reduced. Agglomeration of particles can be reduced. Likewise, agglomeration of the nicotine particles with the flavor particles is also reduced as the adhesion of the flavor-containing particles can also be reduced. The powder system described herein may be a free flowing material and may have a stable relative particle size of each powder component even when the nicotine particles and flavor particles are combined.
Preferably, the nicotine may be a surface modified nicotine salt in which the nicotine salt particles are coated particles. A preferred coating material is L-leucine. Particularly useful particles comprising nicotine are L-leucine coated nicotine bitartrate or L-leucine coated nicotine pyruvate or L-leucine coated nicotine mono-pyruvate or L-leucine coated nicotine aspartate or L - At least one of the leucine coated nicotine lactate salts.
Particles having a particle size of about 10 μm or less may have at least about 20 wt% of nicotine, at least about 30 wt% of nicotine, at least about 40 wt% of nicotine, or at least about 50 wt% of nicotine. Particles having a particle size of about 10 μm or less may comprise nicotine in the range of about 20 wt% to about 100 wt% of nicotine, or in the range of about 30 wt% to about 90 wt%.
Particles having a particle size of about 5 μm or less may have at least about 20 wt%, at least about 30 wt%, at least about 40 wt%, or at least about 50 wt% nicotine. Particles having a particle size of about 5 μm or less may comprise nicotine in the range of about 20 wt% to about 100 wt% of nicotine, or in the range of about 30 wt% to about 90 wt%.
The flavor-comprising particles may have any useful size distribution for preferential inhalation delivery to the mouth or oral cavity of a user.
The powder system may have at least about 40 wt %, at least about 60 wt %, or at least about 80 wt % of the flavor of the powder system included in particles having a particle size of about 20 μm or greater. The powder system may have at least about 40 wt %, at least about 60 wt %, or at least about 80 wt % of the flavor of the powder system included in particles having a particle size of about 50 μm or greater. The powder system may have at least about 40 wt %, at least about 60 wt %, or at least about 80 wt % of the flavor of the powder system included in particles having a particle size in the range of about 50 μm to about 150 μm.
The flavor or flavor may be provided as a solid flavor (at room temperature of about 22° C. and 1 atmosphere) and may include flavor agents, flavor containing materials, and flavor precursors. The flavoring agent may include one or more natural flavoring agents, one or more synthetic flavoring agents, or a combination of natural and synthetic flavoring agents. A flavoring agent described herein is a sensory stimulating compound, composition, or material that is selected, used, or intended to change the taste or aroma properties of nicotine while nicotine is consumed or inhaled.
Flavoring agent or flavoring refers to various flavoring materials of natural or synthetic origin. These include single compounds and mixtures. Preferably, the flavor or flavoring agent has flavor properties that enhance the experience with nicotine while the nicotine is consumed. The flavor may be selected to provide an experience similar to that obtained by smoking a combustible smoking article. For example, a flavor or flavoring agent may enhance flavor properties such as complexity and mouthfeel. Complexity is generally known as the overall balance of richer flavors without dominating a single sensory attribute. Mouth fullness is described as the consumer's perception of fullness and volume in the mouth and throat.
Suitable flavors include tobacco, smoke, menthol (such as peppermint and spearmint), mint, chocolate, licorice, citrus and other fruit flavors, gamma octalactone, vanillin, ethyl vanillin, mouthwash flavors, and spices such as cinnamon flavor, methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, ginger oil, and the like.
Other suitable flavors may include flavor compounds selected from the group consisting of acids, alcohols, esters, aldehydes, ketones, pyrazines, combinations or blends thereof, and the like. Suitable flavor compounds are, for example, phenylacetic acid, solanone, megastigmatrienone, 2-heptanone, benzyl alcohol, cis-3-hexenyl acetate (cis- 3-hexenyl acetate), valeric acid, valeraldehyde, ester, terpene, sesquiterpene, nootkatone, maltol, damascenone, pyrazine, lactone, anetol, It may be selected from the group consisting of iso-s valeric acid, combinations thereof, and the like.
Additional specific examples of flavor can be found in the current literature and are known to those skilled in the art of flavoring to impart an odor or taste to a product.
A flavoring agent may be a high potency flavoring agent and may be used to detect levels of less than 200 ppm in the inhalation airflow. Examples of such flavoring agents include major tobacco aroma compounds, such as beta-damascenone, 2-ethyl-3,5-dimethylpyrazine, phenylacetaldehyde ( phenylacetaldehyde), guaiacol, and furaneol. Other flavors can only be perceived by humans at higher concentration levels. Such flavoring agents, referred to herein as lower potency flavoring agents, are generally used at levels that are much higher than the amount of flavoring agent released into the inhalation airflow. Examples of suitable lower potency flavoring agents include natural or synthetic menthol, peppermint, spearmint, coffee, tea, spices (such as cinnamon, cloves, ginger), cocoa, vanilla, fruit flavors, chocolate, eucalyptus, geranium, eugenol and including but not limited to linalool.
Particles comprising flavor may include compounds to reduce adhesion or surface energy and agglomeration. The flavor particles may be surface modified with a tack reducing compound to form coated flavor particles. One preferred tack reducing compound may be magnesium stearate. Providing flavor particles to an adhesion reducing compound such as magnesium stearate, particularly coating the flavor compound, can reduce the adhesion of the flavor-containing particles and reduce the agglomeration of the flavor particles by reducing the attraction between the flavor particles. . Accordingly, agglomeration of flavor particles with nicotine particles can also be reduced. Thus, the powder system described herein can have a stable relative particle size of the particles comprising nicotine and particles comprising flavor even when nicotine particles and flavor particles are combined. The powder system is preferably free flowing.
The flavor particles may have at least about 10 wt % of the flavor, or at least about 20 wt % of the flavor, or at least about 30 wt % of the flavor, or at least about 40 wt % of the flavor. The flavor particles may include flavor in the range of about 10 wt % to about 100 wt % of the flavor, or in the range of about 30 wt % to about 90 wt % of the flavor.
Conventional formulations for dry powder inhalation generally contain carrier particles that serve to increase the fluidization of the active particles, as the active particles may be too small to be affected by a simple airflow through the inhaler. These carrier particles are generally sugars such as lactose or mannitol having a particle size greater than about 50 μm. Carrier particles are used to improve dosage uniformity by acting as a diluent or bulking agent in the formulation. Carrier particles such as lactose or mannitol are not considered flavoring agents or flavoring materials in this disclosure.
The powder systems described herein may be carrier-free or substantially free of sugars such as lactose or mannitol. The absence of a carrier or substantially free of sugars such as lactose or mannitol may allow nicotine to be inhaled and delivered to the user's lungs at an inhalation rate or airflow rate similar to that of a typical smoking system. Further, since nicotine is free of carriers or substantially free of sugars such as lactose or mannitol, the airflow path of the inhaler may have a simple geometry or a simple configuration.
The powder system includes particles comprising nicotine and particles comprising flavor. The nicotine particles and flavor particles may be combined in one capsule. As described above, the nicotine particles and flavor particles can each have reduced adhesion, resulting in a stable powder formulation whose particle size does not substantially change when the nicotine particles and flavor particles are combined. The powder system is preferably free flowing.
Alternatively, the powder system may comprise particles comprising nicotine contained in a nicotine capsule or a first capsule and particles comprising flavor contained in a flavor capsule or a second capsule. The nicotine capsules and the separate flavor capsules may be placed in parallel arrangement or fluidly connected in parallel during the airflow, or may be placed in series or in series fluidic connection during the airflow.
The particles comprising nicotine and the particles comprising flavor may be combined in any useful relative amounts such that a flavor is detected by a user when the flavor is consumed with nicotine. The first plurality of particles comprising nicotine may be from about 50 wt % to about 99 wt % of the total weight of the powder system and the second plurality of particles comprising flavor may be from about 50 wt % to about 1 wt % of the total weight of the powder system have. Preferably, the nicotine particles and flavor particles form at least about 90 wt%, or at least about 95 wt%, or at least about 99 wt%, or 100 wt% of the total weight of the powder system.
The airflow path or airflow channel through the body portion of the inhaler may be a simple path or channel. Preferably, the airflow path or airflow channel through the inhaler body may be parallel to the longitudinal axis of the inhaler and may extend linearly along the entire length of the inhaler body. The inhaler may have only one main airflow channel with one capsule receptacle disposed therein. Alternatively, the inhaler may comprise two or three airflow channels that are collinear or parallel. One, two, or all three of the airflow channels may include a capsule receiver disposed therein. The inhaler may be configured to deliver nicotine particles and flavor particles simultaneously.
Preferably, the particles comprising nicotine and the particles comprising flavor may be a dry powder mixed with each other and in one capsule. Alternatively, the flavor comprising particles may be separated from the nicotine comprising particles prior to being inhaled or delivered through an airflow channel of the inhaler. The particles comprising nicotine and the particles comprising flavor may be disposed in series in an airflow to be disposed in a single airflow channel, and the particles comprising flavor may be upstream or downstream of particles comprising nicotine. Alternatively, the particles comprising nicotine and the particles comprising flavor may be placed in parallel in the airflow, and the particles comprising nicotine and particles comprising flavor are combined downstream of both the nicotine receptacle and the flavor receptacle. It may be disposed within a pair of airflow channels forming a mixture.
The nicotine receptacle can contain a capsule containing nicotine and optionally flavor (when combined in a capsule). Capsules may contain a predetermined amount or dosage of nicotine and optionally flavor. The capsule contains sufficient nicotine to enable inhalation or "puffing" of nicotine at least twice, inhalation or "puffing" of nicotine at least about 5 times, or inhalation or "puffing" of nicotine at least about 10 times. This can be included Preferably, the capsule may contain enough nicotine to enable about 5 to 50 inhalations or "puffs" of nicotine, or about 10 to 30 inhalations or "puffs" of nicotine. Each time nicotine is inhaled or "puffed" about 0.1 mg to about 3 mg of the particles comprising nicotine are delivered to the user's lungs, from about 0.2 mg to about 2 mg nicotine to the user's lungs, or about 1 mg nicotine It can be delivered to the user's lungs. Preferably, about 50 μg to about 150 μg of nicotine is delivered to the user's lungs with each "puff".
The capsule may hold or contain at least about 5 mg of nicotine or at least about 10 mg of nicotine. The capsule may hold or contain less than about 30 mg of nicotine, or less than about 25 mg of nicotine, or less than about 20 mg of nicotine. Preferably, the capsule holds or contains about 5 mg to about 30 mg of nicotine or about 10 mg to about 20 mg of nicotine.
When the flavor-containing particles are blended or combined in capsules with the nicotine-comprising particles, the flavor is present in an amount that provides the desired flavor for each inhalation or "puff" delivered to the user.
The capsule may be formed of an airtight material that may be pierced or pierced by an inhaler. The capsule serves to remove contaminants from the capsule, but may be formed of a metallic or polymeric material that can be pierced or pierced by the inhaler during use.
The nicotine powder inhaler includes a body portion extending between the mouthpiece and a distal end and an airflow channel extending between the mouthpiece portion and the distal end. The nicotine powder receptacle is disposed along the airflow channel and the powder system described herein is disposed within the nicotine powder receptacle.
The powder system can be delivered through a simple inhaler construction at an inhalation rate or airflow rate that is less than or equal to the inhalation rate or airflow rate of a conventional smoking system.
A method of inhaling nicotine into the lungs of a user comprises inhaling air through a nicotine powder inhaler described herein at a flow rate of less than 2 liters per minute to deliver the nicotine to the lungs of the user. The flavor may not be delivered to the user's lungs.
The inhaler may include a puncturing element configured to puncture the capsule or a pair of opposing puncturing elements. The puncturing element or a pair of opposing piercing elements may load the flavor powder capsule into the nicotine powder receiver or engage the capsule of nicotine powder according to the demands of an actuator on the inhaler body portion.
The flavor-containing particles may be separated from the nicotine-containing particles, and the flavor-containing particles may be contained in separate capsules. The capsule may be formed of an airtight material that can be pierced or pierced by an inhaler. The capsule serves to remove contaminants from the capsule, but may be formed of a metallic or polymeric material that can be pierced or pierced by the inhaler during use.
A nicotine inhaler according to the present invention may be operated using a flow rate of less than about 5 L/min or less than about 3 L/min or less than about 2 L/min or less than about 1.6 L/min. Preferably, the flow rate ranges from about 1 L/min to about 3 L/min, or from about 1.5 L/min to about 2.5 L/min. More preferably, the inhalation rate or flow rate is about 1.6 L/min similar to the Health Canada smoking regime. Conversely, conventional DPIs operate at flow rates of about 20-100 L/min or greater, and often require an energy source or propellant to facilitate airflow to achieve these airflow rates.
The nicotine inhaler described herein can be used by a consumer just like smoking a conventional cigarette or vaping an e-cigarette. This smoking or vaping is characterized by two stages: a first stage, during which a small volume containing the total amount of nicotine desired by the consumer is drawn into the oral cavity, and this small volume containing nicotine is further diluted by fresh air and A second phase is followed, during which aspiration is further deep into the lungs. All steps are controlled by the consumer. During the first inhalation phase the consumer can determine the amount of nicotine to inhale. During the second phase, the consumer can determine the volume to dilute the first volume to be aspirated deep into the lungs, thereby maximizing the concentration of active agent delivered to the airway epithelial surface. This smoking mechanism is sometimes referred to as "puff-intake-exhaust".
All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. Definitions provided herein are intended to facilitate understanding of certain terms frequently used herein.
The terms "upstream" and "downstream" refer to the relative positions of the described inhaler elements with respect to the direction of the inhalation airflow as it is drawn from the distal end through the body portion of the inhaler to the mouthpiece portion.
As used herein, the singular forms "a", "an", and "the" include embodiments with plural objects unless the content clearly dictates otherwise.
As used herein, "or" is generally used in its sense including "and/or" unless the content clearly dictates otherwise. The term "and/or" means one or all of the listed elements, or a combination of any two or more of the listed elements.
As used herein, "have, having," "include, including, comprise, comprising," etc. are used in an open sense and generally mean "including but not limited to". do. It will be understood that "consisting essentially of," "consisting of," and the like are encompassed by "comprising," and the like.
The words "preferred" and "preferably" refer to embodiments of the invention that may provide certain advantages under certain circumstances. However, other embodiments may be preferred under the same or different circumstances. Further, the description of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure, including the claims.
1-5 are schematic diagrams of an exemplary nicotine powder inhaler 10 . The schematic drawings are not necessarily to scale and are provided for purposes of illustration and not limitation. The drawings illustrate one or more aspects described in this disclosure. However, it will be understood that other aspects not shown in the drawings fall within the scope and spirit of the present invention.
Referring now to FIGS. 1 and 2 , a nicotine powder inhaler 10 includes a mouthpiece portion 12 and a distal end 14 and a nicotine capsule 20 disposed therebetween. The puncturing elements 11a and 11b are configured to puncture the capsule 20 to fluidly connect the airflow channel 13 of the mouthpiece portion 12 with the airflow channel 15 of the distal end 14 . The airflow channels extend linearly along the length of the nicotine powder inhaler 10 . 2 further shows the capsule 20 in the reusable receptacle 25 .
3 to 5 show schematic views of the inhaler 10 . 3 shows a nicotine inhaler 10 with one capsule 120 containing both nicotine particles and flavor particles and one airflow path. The airflow path includes an upstream portion 15 and a downstream portion 13 .
4 shows a nicotine inhaler 10 with a single airflow path, and a flavor capsule 100 containing flavor particles and a nicotine capsule 20 containing nicotine particles disposed in series in an airflow. The flavor capsule 100 may be punctured as described above for the nicotine capsule 20 . The airflow path includes an upstream portion 15 and a downstream portion 13 .
5 shows a nicotine inhaler 10 with parallel airflow paths, and a flavor capsule 100 containing flavor particles and a nicotine capsule 20 containing nicotine particles disposed in parallel in an airflow. The flavor capsule 100 may be punctured as described above for the nicotine capsule 20 . The airflow path includes an upstream portion 15 and a downstream portion 13 .
6 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| WO2024090890A1 | Cited by | World Intellectual Property Organization (WIPO) | International search |
35 members in 20 offices
Priority claims9
| Document | Office | Kind | Date |
|---|---|---|---|
| 15202728 | European Patent Office (EPO) | A | |
| 15202728 | European Patent Office (EPO) | A | |
| 152027280 | European Patent Office (EPO) | – | |
| 2016057452 | International Bureau of the World Intellectual Property Organization (WIPO) | W | |
| 2016057452 | International Bureau of the World Intellectual Property Organization (WIPO) | W | |
| 152027280 | – | – | – |
| EP20150202728 | – | – | – |
| PCTIB2016057452 | – | – | – |
| WO2016IB57452 | – | – | – |
Members35
| Document | Office | Kind | |
|---|---|---|---|
| CA3008208A1 | Canada | A1 | |
| WO2017109625A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2016376027A1 | Australia | A1 | |
| CN108289841A | China | A | |
| SG11201804598RA | Singapore | A | |
| IL259936A | Israel | A | |
| MX2018007507A | Mexico | A | |
| KR20180098247AThis record | Republic of Korea | A | |
| EP3393451A1 | European Patent Office (EPO) | A1 | |
| BR112018010685A2 | Brazil | A2 | |
| US2018369225A1 | United States of America | A1 | |
| PH12018501142A1 | Philippines | A1 | |
| BR112018010685A8 | Brazil | A8 | |
| JP2019505479A | Japan | A | |
| ZA201803584B | South Africa | B | |
| RU2018126872A | Russian Federation | A | |
| RU2018126872A3 | Russian Federation | A3 | |
| US10751336B2 | United States of America | B2 | |
| US2020375972A1 | United States of America | A1 | |
| UA122699C2 | Ukraine | C2 | |
| MY186270A | Malaysia | A | |
| RU2762084C2 | Russian Federation | C2 | |
| AU2016376027B2 | Australia | B2 | |
| IL259936B | Israel | B | |
| IL259936B2 | Israel | B2 | |
| EP3393451B1 | European Patent Office (EPO) | B1 | |
| JP2023113755A | Japan | A | |
| ES2952674T3 | Spain | T3 | |
| PL3393451T3 | Poland | T3 | |
| HUE063028T2 | Hungary | T2 | |
| CN117695207A | China | A | |
| MX386252B | Mexico | B | |
| KR20250058060A | Republic of Korea | A | |
| JP2025126285A | Japan | A | |
| US12414946B2 | United States of America | B2 |
3 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Decision of rejection after re-examinationX601 | X601 | |
| Notification of reason for refusalE902 | E902 | |
| Request for examinationA201 | A201 |
Numbers
- Publication
- 1020180098247
- Publication, DOCDB
- 20180098247
- Publication, EPODOC
- KR20180098247
- Application
- 1020187016365
- Application, DOCDB
- 20187016365
- Application, EPODOC
- KR20187016365
Titles4
- Korean
- 가향된 니코틴 분말
- English
- flavored nicotine powder
- Unlabeled
- 가향된 니코틴 분말
- Unlabeled
- flavored nicotine powder
Classification
- CPC, 19
- A61K9/00
- A61K9/0075
- A61K31/465
- A61K47/183
- A61K9/14
- A61K9/145
- A61M15/003
- A61M15/0035
- A61M15/0063
- A61M15/06
- A61M2202/064
- A61K47/18
- A61M15/0011
- A61K9/5015
- A61K47/12
- A61M15/0021
- A61M15/002
- A61M2205/3331
- A61M2210/1039
- IPC, 6
- A61K9 00
- A61K31 465
- A61K47 18
- A61K9 14
- A61M15 00
- A61M15 06