Inhaler products and capsules for use therewith

Abstract

An inhaler article has a body including an upstream end and a downstream end, a bladder housing, and an airflow path extending from the bladder housing to an opening at the downstream end. A bladder is disposed within the bladder housing and has: a first end and a second end; a tubular sidewall extending between the first end and the second end; a single hole in the bladder extending through the tubular sidewall; and inhalable powder disposed within the bladder.

Description

[0001] This disclosure relates to a dry powder capsule with side perforations for use in an inhaler article, and to an inhaler article comprising said dry powder capsule.

[0002] Dry powder inhalers used to dispense powdered medications typically aim to deliver the full dose of dry powder in a single breath. These dry powder inhalers are often complex in design and may involve moving parts. Furthermore, these complex dry powder inhalers are difficult to manufacture and assemble at high speeds.

[0003] A dry powder inhaler configured to deliver dry powder particles to the lungs at an inhalation (airflow) rate within the range of a conventional smoking inhalation (airflow) rate can be designed to have a linear airflow path between the powder container and the outlet. The dry powder inhaler may contain inhalable powder in a capsule that can be punctured to access the powder. However, if the inhaler is inverted or otherwise manipulated in a non-upright position, loose powder may sometimes accidentally fall out of such an inhaler.

[0004] It is desirable to provide a dry powder inhaler that reduces accidental powder leakage from the inhaler. It is desirable to provide a dry powder inhaler that reduces accidental powder leakage from a dry powder sac disposed within the inhaler. It is desirable to provide a sac for the inhaler that is punctured when desired to allow dry powder to be inhaled, but reduces the amount of loose powder inside the inhaler (outside the sac) when the inhaler is not actively used. It is desirable to provide an inhaler with a simple design that is easy to manufacture and assemble and provides the benefit of reduced powder leakage.

[0005] According to embodiments of this disclosure, an inhaler article includes a body having an upstream end and a downstream end, a bladder housing, and an airflow path extending from the bladder housing to an opening at the downstream end. The downstream end is the mouthpiece end of the inhaler article. A bladder is disposed within the bladder housing. The bladder includes a first end and a second end, and a tubular sidewall extending between the first end and the second end. The bladder includes only a single orifice. The single orifice extends through the tubular sidewall of the bladder. The bladder also includes inhalable powder disposed within the bladder.

[0006] Advantageously, providing a single hole located on only one side of the capsule (opposite to one end) reduces accidental loss of dry powder from the capsule. It has been found that a single hole on one side of the capsule allows dry powder to be inhaled from within the capsule at an airflow rate within the normal smoking inhalation (airflow) rate. The capsule allows for a simple inhaler design while reducing powder loss from the inhaler. By using this technique to reduce powder leakage, the powder remains within the capsule until it is used or inhaled. Reducing powder leakage by placing the single hole on one side of the capsule requires no changes to the inhaler article itself. Placing the single hole on one side of the capsule requires no changes to the capsule during manufacturing. Forming the single hole on one side of the capsule can be performed by the user when the capsule and inhaler are ready for use.

[0007] The sac may include a first end cap at a first end and a second end cap at a second end. Each of the first and second end caps may include a hemisphere. The first end of the sac may be oriented towards an upstream end of the body. The second end may be oriented towards a downstream end of the body. In some embodiments, a single orifice extends through a tubular sidewall and is positioned closer to the first end than the second end. In some embodiments, a single orifice extends through a tubular sidewall and is positioned closer to the upstream end than the downstream end. According to an embodiment, the first and second end caps do not include any orifices.

[0008] Advantageously, positioning the orifice closer to the upstream end provides greater powder delivery compared to positioning it closer to the downstream end of the capsule. Surprisingly, it has been found that positioning the orifice closer to the upstream end on the side provides the same or nearly the same amount of powder delivered per aspiration (draw-off) compared to positioning it at the upstream end of the capsule. Advantageously, positioning a single orifice on the sidewall reduces accidental loss of dry powder from the capsule.

[0009] The location of the hole can be determined by measuring along the longitudinal axis of the bladder from its midpoint. The midpoint can be determined by dividing the length of the bladder sidewall in half. The distance from the hole to the midpoint can be determined as an actual measured distance or as a percentage of the length toward one end or the other (e.g., "% toward the first end"), calculated by dividing the distance from the hole to the midpoint by half the length of the bladder sidewall. The individual hole can be positioned from 0% to 100% toward the first end. A single hole can be positioned at 10% or more, 25% or more, 50% or more, or 75% or more toward the first end. The actual distance from the hole to the midpoint can be selected based on the size of the bladder. In some cases, the bladder is a size 1, size 2, size 3, size 4, or size 5 bladder, preferably size 3. The bladder can have a length of about 11 mm, about 14 mm, about 16 mm, about 18 mm, or about 19 mm. The bladder sidewall can have a length of about 8 mm, about 10 mm, about 11 mm, about 12 mm, or about 14 mm. A single hole can be positioned (measured from the midpoint) 1 mm or more, 3 mm or more, or 5 mm or more toward the first end of the sac. A single hole can be positioned (measured from the midpoint) 7 mm or less, 6 mm or less, or 5 mm or less toward the first end of the sac. If measured along the longitudinal axis of the sac from the first end, a single hole can be within 2 mm, 4 mm, 6 mm, or 10 mm of the first end. If measured along the longitudinal axis of the sac from the upstream end of the sidewall, a single hole can be within 1 mm, 2 mm, 4 mm, 6 mm, or 10 mm of the first end cap.

[0010] Preferably, the bladder-receiving portion has dimensions that maintain the orientation of the bladder within the bladder-receiving portion. For example, the bladder-receiving portion may have a width that keeps the bladder oriented such that the first end of the bladder points towards the upstream end of the body. A suitable width can be selected based on the width and length of the bladder so that the bladder has some space to move (e.g., vibrate or rotate) within the bladder-receiving portion but not enough space to flip over. For example, the bladder may have a length and the bladder-receiving portion may have a width less than the length of the bladder. The width of the bladder-receiving portion may also be determined based on the width or diameter of the bladder. For example, the width (diameter) of the bladder-receiving portion may be 5% to 25% larger than the width (diameter) of the bladder. The diameter of the bladder-receiving portion may be 8% to 22%, or 10% to 20%, larger than the diameter of the bladder. The bladder may be a two-piece bladder, with one part having a diameter slightly larger than the other part, allowing the two parts to fit together telescopically. A single hole may be provided along the sidewall of the bladder in an area where the diameter of the bladder-receiving portion is only 20% or 15% larger than the diameter of the bladder. If the sac is positioned at the center of the sac receiving portion, a space of less than 2 mm, less than 1.5 mm, less than 1.2 mm, less than 1 mm, less than 0.8 mm, or less than 0.5 mm may exist between the sac sidewall and the wall of the sac receiving portion. In some cases, the sac receiving portion is sized for a size 3 sac and may have an inner diameter ranging from about 6 mm to about 7 mm or from about 6.5 mm to about 6.7 mm. The sac receiving portion may have a length ranging from about 15 mm to about 30 mm or from about 18 mm to about 25 mm. The sac receiving portion may define a cylindrical or substantially cylindrical space configured to contain the sac. The sac receiving portion may have a substantially uniform or uniform diameter along its length.

[0011] Individual pores may have a suitable size to allow a desired amount of powder to exit the capsule upon inhalation. For example, an individual pore may have a diameter of 0.5 mm or larger, 0.6 mm or larger, or 0.7 mm or larger. An individual pore may have a diameter of 1.5 mm or smaller, 1.2 mm or smaller, or 1.0 mm or smaller. An individual pore may have a diameter from 0.5 mm to 1.2 mm, from 0.7 mm to 1.0 mm, or about 0.8 mm. An individual pore may have a diameter of 0.2 mm. 2 Or larger, 0.3mm 2 Or larger, or 0.4mm 2 Or a larger area. A single hole can be 1.8mm. 2 Or smaller, 1.5mm 2 Or smaller, 1.2mm 2 Or smaller, 1.0mm 2 Or smaller, or 0.8mm 2 Or even smaller areas. A single hole can be 0.2mm in size. 2 Up to 1.5mm 2 or 0.4mm 2up to 0.8mm 2 The area.

[0012] Inhaler articles can be used to inhale any desired dry powder. According to embodiments, the capsule contains a dry powder comprising particles containing one or more pharmaceutically active agents. Examples of pharmaceutically active agents include: nicotine, neonicotinoids, antiviral compounds such as acyclovir; anti-inflammatory compounds such as salicylic acid, aceclofenac, or ketoprofen; antidiabetic compounds such as metformin or glipizide; antihypertensive compounds such as oxprenolol; antiemetic compounds such as promethazine; antidepressant compounds such as seroxetine; anticoagulant compounds such as picotamide; bronchodilators such as clenbuterol; or anticancer compounds such as β-lapaquinone. Pharmaceutically active agents may include pharmaceutically acceptable salts of pharmaceutically active agents. Suitable salts include, for example, salts of lactic acid (“lactates”), salts of tartaric acid (“tartrates” or “bitartrates”), salts of aspartic acid (“aspartate”), salts of pyruvic acid (“pyruvate”), salts of citric acid (“citricate”), salts of salicylic acid (“salicylate”), salts of glutamic acid (“glutamate”), salts of gentianic acid (“gentianate”), salts of benzoic acid (“benzoate”), salts of fumaric acid (“fumarate”), salts of hydrochloric acid (“hydrochloride”), salts of α-dihydroxybenzoic acid (“α-dihydroxybenzoate”), salts of β-dihydroxybenzoic acid (“β-dihydroxybenzoate”), salts of oxalic acid (“oxalate”), salts of p-anisinic acid (“anisate”), salts of glutaric acid (“glutarate”), etc. In some cases, the capsule contains nicotine powder. For example, the capsule may contain a dry powder comprising nicotine salts. The dry powder may also contain other components, such as sugars or sugar alcohols, amino acids, flavorings, cough suppressants, or other pharmaceutically acceptable ingredients suitable for use in inhalable powders. In one embodiment, the capsule contains nicotine powder comprising nicotine particles, wherein the nicotine particles comprise nicotine salts, sugars or sugar alcohols, and amino acids. The capsule may also comprise flavoring particles, cough suppressant particles, or both flavoring particles and cough suppressant particles. Flavorings and cough suppressant particles are collectively referred to herein as flavoring particles. The capsule may contain inhalable powder comprising particles having an MMAD particle size in the range of 0.5 μm to 10 μm or 0.5 μm to 5 μm. In one embodiment, the capsule contains nicotine powder comprising nicotine particles, wherein the nicotine particles have an MMAD particle size in the range of 0.5 μm to 10 μm or 0.5 μm to 5 μm. The capsule may also contain flavoring particles having an MMAD particle size of 10 μm or larger, 20 μm or larger, or 40 μm or larger. Fragrance particles may have an MMAD particle size of 200 μm or smaller, 150 μm or smaller, or 120 μm or smaller. Fragrance particles may have an MMAD particle size of 20 μm to 200 μm or from 40 μm to 120 μm.In some embodiments, the capsule contains nicotine particles having an MMAD particle size in the range of 0.5 μm to 10 μm or 0.5 μm to 5 μm and flavor particles having an MMAD particle size in the range of 20 μm to 200 μm or 50 μm to 150 μm.

[0013] The capsule may contain a predetermined amount of nicotine particles and optional flavoring particles. The capsule may contain enough nicotine particles to provide at least 2 inhalations or "puffs," or at least 5 inhalations or "puffs," or at least 10 inhalations or "puffs." The capsule may contain enough nicotine particles to provide 5 to 50 inhalations or "puffs," or 10 to 30 inhalations or "puffs." Each inhalation or "puff" delivers 0.1 mg to 3 mg of nicotine particles, 0.2 mg to 2 mg of nicotine particles, or approximately 1 mg of nicotine particles to the user's lungs.

[0014] Depending on the specific formulation used, nicotine granules may have any useful concentration of nicotine. Nicotine granules may have at least about 1 wt% of nicotine to about 30 wt% of nicotine, or about 2 wt% to about 25 wt% of nicotine, or about 3 wt% to about 20 wt% of nicotine, or about 4 wt% to about 15 wt% of nicotine, or about 5 wt% to about 13 wt% of nicotine.

[0015] The capsule may hold or contain 5 mg or more, or 10 mg or more of nicotine particles. The capsule may hold or contain 900 mg or less, 600 mg or less, 300 mg or less, or 150 mg or less of nicotine particles. The capsule may hold or contain 5 mg to 300 mg or 10 mg to 200 mg of nicotine particles. When flavoring particles are mixed or combined with the nicotine particles in the capsule, the flavoring particles may be present in an amount that provides the desired flavor to each inhalation or "vape" delivered to the user. The capsule may hold or contain 5 mg or more or 10 mg or more of dry powder (also known as a powder system). The capsule may hold or contain 900 mg or less, 600 mg or less, 300 mg or less, or 150 mg or less of dry powder. The capsule may hold or contain 5 mg to 300 mg, 10 mg to 200 mg, or 25 mg to 100 mg of dry powder. Nicotine granules may constitute 40 wt% or more, 60 wt% or more, or 80 wt% or more of the dry powder.

[0016] The dry powder (powder system) may have an average diameter of 60 μm or less, or in the range of 1 μm to 40 μm or 1.5 μm to 25 μm. The average diameter refers to the average diameter per unit mass, as measured by laser diffraction, laser diffusion, or electron microscopy, preferably by laser diffraction.

[0017] The nicotine or nicotine particles in the powder system can be pharmaceutically acceptable free nicotine, or nicotine salts or nicotine salt hydrates. Useful nicotine salts or nicotine salt hydrates include, for example, nicotine pyruvate, nicotine citrate, nicotine aspartate, nicotine lactate, nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate, or nicotine hydrochloride. The nicotine particles preferably include amino acids. Preferably, the amino acid can be leucine, such as L-leucine. Providing nicotine-containing particles with an amino acid such as L-leucine reduces the adhesive force of the particles and the attraction between nicotine particles, thereby reducing the clumping of nicotine particles and adhesion of nicotine particles to surfaces. Similarly, the adhesive force to particles including flavorings can also be reduced. The powder system can be a free-flowing material and has a stable relative particle size for each powder component, even when nicotine particles are combined with flavoring particles.

[0018] The particles containing fragrance may include compounds used to reduce adhesive forces or surface energy and the resulting agglomeration. The fragrance particles can be surface-modified with adhesive-reducing compounds to form coated fragrance particles. A preferred adhesive-reducing compound is magnesium stearate. Providing the fragrance particles with an adhesive-reducing compound, such as magnesium stearate, particularly coating the fragrance particles, reduces the adhesive forces of the fragrance-containing particles and reduces the attractive forces between the fragrance particles, and thus reduces agglomeration of the fragrance particles. Agglomeration of the fragrance particles and nicotine particles can also be reduced. The powder system described herein can therefore have a stable relative particle size between the nicotine-containing particles and the fragrance-containing particles, even when the nicotine particles and fragrance particles are combined. The powder system is preferably free-flowing.

[0019] Because the active particles may be too small to be affected by the simple airflow through the inhaler, conventional formulations for dry powder inhalation include carrier particles to increase the fluidity of the active particles. The powder system may include carrier particles. These carrier particles may be sugars such as lactose or mannitol and may have a particle size greater than 50 μm. By acting as a diluent or loosening agent in the formulation, carrier particles can be used to improve dosage uniformity. In some embodiments, the capsule comprises a powder system that has no carrier or is substantially free of sugar particles such as lactose or mannitol. "No carrier" means that the powder system contains no separated carrier particles (e.g., sugar particles) other than nicotine particles (which may contain sugars or sugar alcohols) and optional flavoring particles. The absence of a carrier or the substantial absence of sugars such as lactose or mannitol allows nicotine to be inhaled and delivered to the user's lungs at an inhalation or airflow rate similar to that of typical smoking.

[0020] The capsule can be made of any suitable material. For example, the capsule can be made of a polymeric material, gelatin, or any other suitable material used to manufacture fillable rigid capsules. In one embodiment, the capsule is made of a polymeric material, preferably hydroxypropyl methylcellulose (“HPMC”). For example, the capsule can be a size 1 HPMC capsule. The capsule can be a size 2 HPMC capsule. The capsule can be a size 3 HPMC capsule. The capsule can be a size 4 HPMC capsule. The capsule can be a size 1 capsule. The capsule can be a size 2 capsule. The capsule can be a size 3 capsule. The capsule can be a size 4 capsule.

[0021] The inhaler article of this disclosure allows powder to be inhaled at an inhalation (airflow) rate within the range of conventional smoking inhalation (airflow) rates. According to one aspect of this disclosure, the inhaler article includes an inhaler body having tubular sidewalls defining an interior and a longitudinal central axis. The interior forms a receiving portion for receiving a capsule containing inhalable powder. The inhaler article also includes a mouthpiece element. The inhaler body and mouthpiece have a simple design that is easy to manufacture and easy to assemble into the inhaler article. According to an embodiment, the mouthpiece can be simply inserted into the tubular inhaler body. The mouthpiece element extends from an upstream end to a downstream end along the longitudinal central axis. The upstream end of the mouthpiece element is received within the interior of the inhaler body. The mouthpiece element includes an airflow passage extending through the mouthpiece element. The downstream end of the mouthpiece element may form the mouth end of the inhaler article or be disposed at the mouth end of the inhaler article. The upstream end of the mouthpiece element is inserted into or disposed within the inhaler body. The upstream end of the mouthpiece element may form the downstream end of the capsule receiving portion. The receiving portion may extend from the upstream end of the inhaler body to the upstream end of the mouthpiece element. The inhaler body may have a closed upstream end. The upstream end of the inhaler body may be folded closed. For example, the upstream end of the inhaler body may be folded closed by a fan-shaped folding member. The upstream end of the inhaler body may form the upstream end of the receiving portion. The upstream end of the inhaler body may be opened before use, for example by an inhaler retainer. The inhaler article may be designed to exhibit a desired inhalation resistance (“RTD”). The inhaler article may have an RTD ranging from 30 to 200 mmWG.

[0022] The inhaler article includes a body defining a capsule containment and an airflow path extending from the capsule containment to an opening or outlet. The inhaler article body can be constructed of any suitable material. For example, the inhaler article body can be constructed of cellulose material, polymer material, metal, or a combination thereof. According to an embodiment, the body is constructed of cellulose material, preferably of paper, cardboard, or stiffboard. In a preferred embodiment, the inhaler article includes a tubular body made of paper, cardboard, or stiffboard. The upstream end of the tubular body made of paper, cardboard, or stiffboard can be folded closed, preferably by a fan-shaped folding member. The closed end can be opened before use of the inhaler.

[0023] The inhaler article may also include packaging that wraps around at least a portion of the inhaler body. The packaging may also wrap around at least a portion of the mouthpiece element. In some embodiments, the packaging does not cover the entire length of the mouthpiece element, such that a portion of the mouthpiece element's length is uncovered. The packaging may be paper packaging, such as cigarette packaging or tipping paper.

[0024] Advantageously, inhaler products made from cellulose materials are easy and inexpensive to manufacture, and are environmentally friendly and biodegradable.

[0025] The sac may be sealed within the inhaler article before consumption. The sac may be pre-loaded into the inhaler. The inhaler article containing the sac within the sac housing may be contained within a sealed or airtight container or bag. The inhaler article may include one or more peelable or removable seals to cover one or more air inlet passages or air outlets or mouthpieces of the inhaler article.

[0026] Inhaler articles can be used with retainers. For example, an inhaler article can be configured for use with a retainer capable of opening a closed upstream end of the inhaler article. An inhaler article can be configured for use with a retainer capable of puncturing a dry powder capsule contained in a receiving portion. An inhaler article can be configured for use with a retainer that provides an air inlet to the inhaler article. A retainer can be configured to activate the inhaler article by opening a closed end of the inhaler article. A retainer can be configured to activate the inhaler article by puncturing a capsule with a puncturing element. A retainer can be configured to release particles contained within the capsule and enable the article to deliver particles to a consumer. Multiple inhaler articles can be combined with retainers to form a system or kit. A user can activate and use one inhaler article and capsule at a time. A single retainer can be used for 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler articles to activate (puncture or puncture) the capsule contained within each inhaler article and inhale the powder contained within the capsule.

[0027] According to an embodiment, a method of preparing an inhaler article for use includes piercing a single hole in a tubular sidewall of a capsule using a piercing element. The capsule includes a first end and a second end, and a tubular sidewall extending between the first end and the second end. The capsule may be disposed within a capsule receiving portion of the inhaler article such that the first end points towards an upstream end of the inhaler article. The capsule includes inhalable powder disposed within the capsule. The method includes forming a single hole through the sidewall of the capsule. The method may include forming a single hole closer to the first end than the second end. The single hole may be formed (measured from the midpoint of the capsule) toward the first end by 10% or more, 25% or more, 50% or more, or 75% or more. The actual distance of the hole from the midpoint may be selected based on the size of the capsule. In some cases, the capsule is a size 1, size 2, size 3, size 4, or size 5 capsule, preferably size 3. The capsule may have a length of about 11 mm, about 14 mm, about 16 mm, about 18 mm, or about 19 mm. The sac sidewalls may have a length of approximately 8 mm, 10 mm, 11 mm, 12 mm, or 14 mm. Individual holes may be positioned (measured from the midpoint) 1 mm or more, 3 mm or more, or 5 mm or more toward the first end of the sac. Individual holes may also be positioned (measured from the midpoint) 7 mm or less, 6 mm or less, or 5 mm or less toward the first end of the sac. When measured along the longitudinal axis of the sac, individual holes may be within 2 mm, 4 mm, 6 mm, or 10 mm of the first end.

[0028] The method may include forming a single pore in the sidewall of the capsule, the single pore having a diameter of 0.5 mm or greater, 0.6 mm or greater, or 0.7 mm or greater. The single pore may have a diameter of 1.5 mm or less, 1.2 mm or less, or 1.0 mm or less. The single pore may have a diameter of 0.5 mm to 1.2 mm, 0.7 mm to 1.0 mm, or about 0.8 mm. The single pore may have a diameter of 0.2 mm. 2 Or larger, 0.3mm 2 Or larger, or 0.4mm 2 Or a larger area. A single hole can be 1.8mm. 2 Or smaller, 1.5mm 2 Or smaller, 1.2mm 2 Or smaller, 1.0mm 2 Or smaller, or 0.8mm 2 Or even smaller areas. A single hole can be 0.2mm in size. 2 Up to 1.5mm 2 or 0.4mm 2 up to 0.8mm 2 The area.

[0029] Compared to conventional dry powder inhalers, this inhaler may be less complex and have a simplified airflow path. The inhaler can be configured to provide a vortex airflow that causes the capsule to rotate about its longitudinal axis upon inhalation. Advantageously, the rotation of the capsule within the inhaler more effectively atomizes the dry powder and helps maintain free-flowing powder. Therefore, the inhaler may not require the increased inhalation rate typically used in conventional inhalers to deliver the aforementioned nicotine particles deep into the lungs.

[0030] Inhaler articles and capsules may use flow rates of 5 L / min or less, 3 L / min or less, 2 L / min or less, or 1.6 L / min or less. Preferably, the flow rate may be in the range of 1 L / min to 3 L / min or 1.5 L / min to 2.5 L / min. Preferably, the inhalation rate or flow rate may be similar to the inhalation rate or flow rate of Health Canada smoking status, i.e., 1.6 L / min.

[0031] Consumers can use the inhaler and capsule in a manner similar to smoking a regular cigarette or vaping. This type of smoking or vaping is characterized by two steps: a first step in which a small amount containing the consumer's desired amount of nicotine is inhaled into the mouth; followed by a second step in which the small amount containing the aerosol containing the desired amount of nicotine is further diluted with fresh air and inhaled more deeply into the lungs. Both steps are controlled by the consumer. During the first inhalation step, the consumer can determine the amount of nicotine to be inhaled. During the second step, the consumer can determine the amount used to dilute the first amount for deeper inhalation into the lungs, thereby maximizing the concentration of the active agent delivered to the surface of the respiratory epithelium. This smoking mechanism is sometimes referred to as "inhale-exhale."

[0032] All scientific and technical terms used herein have their common meanings in the art, unless otherwise indicated. The definitions provided herein are for ease of understanding of certain terms used frequently and are not intended to limit the scope of this disclosure.

[0033] The term "nicotine" refers to nicotine and nicotine derivatives, such as free nicotine base and nicotine salts.

[0034] The term "fragrance" or "flavoring" refers to a sensory compound, composition, or material that alters or is intended to alter the taste or aroma properties of nicotine during its consumption or inhalation.

[0035] The terms “upstream” and “downstream” refer to the relative positions of the components of the described retainer, inhaler article, and inhaler system with respect to the direction of the inhaled airflow as the inhaled airflow passes over the retainer body, inhaler article, and inhaler system.

[0036] Unless otherwise stated, the term "grain size" as used herein refers to the mass median aerodynamic diameter (MMAD). MMAD is preferably measured using a cascade impactor.

[0037] As used herein, the term “basically” has the same meaning as “roughly” and can be understood to modify the following term by at least about 90%, at least about 95%, or at least about 98%.

[0038] The term “not substantially” as used in this article has the same meaning as “not substantially” and can be understood to have the opposite meaning to “substantially”, that is, to modify the following term with no more than 25%, no more than 10%, no more than 5%, or no more than 2%.

[0039] For the purposes of this specification and the appended claims, unless otherwise stated elsewhere, all figures representing quantities, quantities, percentages, etc., shall be understood to be modified by the term "about" in all cases. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein. Thus, in this context, the numeral A shall be understood as A ± 5%. Within this context, the numeral A may be considered as a value included within the general standard error of the measurement of the characteristic modified by the numeral A. In some instances as used in the appended claims, the numeral A may deviate from the percentages listed above, provided that the amount of deviation from A does not significantly affect the fundamental and novel features of the claimed invention. Moreover, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein.

[0040] For example, the terms “a,” “an,” and “the” are not intended to refer to a single entity, but rather to include general categories that can be described by specific examples.

[0041] The terms “a,” “an,” and “the” are used interchangeably with the term “at least one.” The phrases “at least one” and “including at least one” followed by a list refer to any one of the items in the list and any combination of two or more items in the list.

[0042] As used herein, unless otherwise clearly specified, the term "or" is generally used in its common meaning, including "and / or". The term "and / or" means one or all of the listed elements or any combination of two or more of the listed elements.

[0043] As used herein, the terms "have," "having," "include," "including," "comprise," "comprising," etc., are used in their open sense and generally mean "including but not limited to." It should be understood that phrases such as "consistently composed of," "comprise," etc., fall under the category of "including." As used herein, when referring to compositions, products, methods, etc., "consistently composed of" means that the components of the composition, product, method, etc., are limited to the listed components and any other components that do not substantially affect the essential and novel features of the composition, product, method, etc.

[0044] The terms "preferred" and "ideally" refer to embodiments that provide certain benefits in certain circumstances. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are useless, nor is it intended to exclude other embodiments from the scope of this disclosure, which includes the claims.

[0045] The invention is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more features of these examples may be combined with any one or more features of another example, embodiment, or aspect described herein.

[0046] Example Ex.1. is an inhaler article comprising: a body including an upstream end and a downstream end, a sac receiving portion, and an airflow path extending from the sac receiving portion to an opening at the downstream end; a sac disposed within the sac receiving portion, the sac including: a first end and a second end; a tubular sidewall extending between the first end and the second end; a single hole in the sac extending through the tubular sidewall; and inhalable powder disposed within the sac.

[0047] Example Ex.2. The inhaler article according to Example 1, wherein each of the first end and the second end comprises a hemisphere.

[0048] Example Ex. 3. An inhaler article according to any one of Examples 1 to 2, wherein the first end of the sac is oriented toward the upstream end of the body, and wherein the single hole is configured to be closer to the first end than to the second end.

[0049] Example Ex. 4. An inhaler article according to any one of Examples 1 to 3, wherein the bladder has a diameter, and the diameter of the bladder receiving portion is 5% to 25%, 8% to 22%, or 10% to 20% larger than the diameter of the bladder.

[0050] Example Ex.5. An inhaler article according to any one of Examples 1 to 4, wherein, when measured along the longitudinal axis of the capsule, the single hole is within 2 mm, 4 mm, 6 mm or 10 mm of the first end.

[0051] Example Ex. 6. An inhaler article according to any one of Examples 1 to 5, wherein the single hole is positioned toward the first end at 10% or more, 25% or more, 50% or more, or 75% or more.

[0052] Example Ex. 7. An inhaler article according to any one of Examples 1 to 6, wherein the single hole has a diameter of 0.2 mm. 2 Or larger, 0.3mm 2 Or larger, or 0.4mm 2 Or a larger area. The individual hole can be 1.8 mm in diameter. 2 Or smaller, 1.5mm 2 Or smaller, 1.2mm 2 Or smaller, 1.0mm 2 Or smaller, or 0.8mm 2 Or even smaller. Each hole can have a diameter of 0.2 mm. 2 Up to 1.5mm 2 or 0.4mm 2 up to 0.8mm 2 The area.

[0053] Example Ex. 8. An inhaler article according to any one of Examples 1 to 7, wherein the inhalable powder comprises nicotine particles comprising nicotine salts. The dry powder may also comprise sugars or sugar alcohols, amino acids, flavorings, cough suppressants, or other pharmaceutically acceptable ingredients. The dry powder may comprise nicotine powder comprising nicotine particles, wherein the nicotine particles comprise nicotine salts, sugars or sugar alcohols, and amino acids. The dry powder may also comprise flavoring particles, cough suppressant particles, or both flavoring particles and cough suppressant particles.

[0054] Example Ex. 9. An inhaler article according to any one of Examples 1 to 8, wherein the inhalable powder comprises nicotine particles having an MMAD particle size in the range of 0.5 μm to 10 μm or 0.5 μm to 5 μm.

[0055] Example Ex. 10. An inhaler article according to any one of Examples 1 to 9, wherein the inhalable powder comprises flavor particles. The flavor particles may have an MMAD particle size of 10 μm or larger, 20 μm or larger, or 40 μm or larger. The flavor particles may have an MMAD particle size of 200 μm or smaller, 150 μm or smaller, or 120 μm or smaller. The flavor particles may have an MMAD particle size of 20 μm to 200 μm or 40 μm to 120 μm.

[0056] Example Ex. 11. An inhaler article according to any one of Examples 1 to 10, wherein the inhalable powder comprises nicotine particles having an MMAD particle size in the range of 0.5 μm to 10 μm or 0.5 μm to 5 μm and flavor particles having an MMAD particle size of 20 μm to 200 μm or 50 μm to 150 μm.

[0057] Example Ex. 12. An inhaler article according to any one of Examples 1 to 11, wherein the capsule is a polymer capsule or a clear capsule, preferably an HPMC capsule.

[0058] Example Ex. 13. An inhaler article according to any one of Examples 1 to 12, wherein the bladder is a bladder of size 1, size 2, size 3, size 4 or size 5, or a bladder of size 1 to size 4, or a bladder of size 2 to size 3, preferably a bladder of size 3.

[0059] Example Ex. 14. An inhaler article according to any one of Examples 1 to 13, wherein the body is constructed of a cellulose material, preferably of paper, cardboard, or hardboard, and most preferably of paper.

[0060] Example Ex. 15. An inhaler article according to any one of Examples 1 to 14, wherein the body comprises a tubular member constructed of a cellulose material, preferably of paper, cardboard, or hardboard, and most preferably of paper.

[0061] Example Ex. 16. An inhaler article according to any one of Examples 1 to 15, wherein the upstream end of the body is folded closed, preferably by a fan-shaped folding member. The upstream end of the inhaler body can be opened before use, for example by an inhaler retainer.

[0062] Example Ex. 17. An inhaler article according to any one of Examples 1 to 16, wherein the upstream end of the tubular body forms the upstream end of the bladder receiving portion.

[0063] Example Ex. 18. An inhaler article according to any one of Examples 1 to 17, wherein the inhaler article includes a mouthpiece element received at the downstream end of the body.

[0064] Example Ex. 19. An inhaler article according to any one of Examples 1 to 18, wherein the mouthpiece element defines the downstream end of the bladder receiving portion.

[0065] Example Ex. 20. An inhaler article according to any one of Examples 1 to 19, wherein the inhaler article is coupled to a retainer. The retainer may be capable of opening the closed upstream end of the inhaler article. The retainer may be configured to puncture the capsule received in the receiving portion.

[0066] Several examples will now be described further with reference to the accompanying drawings, in which:

[0067] Figure 1A This is a side view of the capsule according to an embodiment.

[0068] Figure 1B This is a schematic side view of a capsule with a single hole according to an embodiment.

[0069] Figure 2A This is a perspective view of an inhaler article according to an embodiment.

[0070] Figure 2B The settings according to the embodiment Figure 2A A cross-sectional side view of the capsule in an inhaler product.

[0071] Figure 3 It is used with a retainer. Figure 2B A cross-sectional side view of the inhaler product and capsule.

[0072] Figure 4 yes Figure 2B A partial cross-sectional side view of the inhaler product and capsule.

[0073] Capsule 20 containing inhalable powder 50 Figure 1A and 1B The sac 20 is shown in the figure. The sac 20 includes a first end 21 and a second end 22. The sac 20 may include a first end cap 23 at the first end 21 and a second end cap 24 at the second end 22. The sac 20 includes a tubular sidewall 25 extending between the first end 21 and the second end 22 or between the first end cap 23 and the second end cap 24. As shown, each of the first end cap 23 and the second end cap 24 of the sac may be shaped as a hemisphere. The sac 20 includes only a single hole 30. The single hole 30 extends through the tubular sidewall 25 of the sac 20.

[0074] In some embodiments, a single hole 30 is positioned closer to the first end 21 than the second end 22. The distance of the hole 30 can be determined by measuring from the midpoint 26 of the sac along the longitudinal axis A20 of the sac 20. The sac sidewall 25 has a length 25, and the midpoint 26 defines half a length L26. The first end cap 23 and the second end cap 24 have lengths L23 and L24, respectively. The total length L20 of the sac 20 is the sidewall length L25 plus the length L23 of the first end cap 23 and the length L24 of the second end cap.

[0075] The distance D30 from the hole 30 to the midpoint 26 can be determined as an actual measured distance or as a percentage of the length toward one end or the other (e.g., "% toward the first end"), the percentage of length calculated as D30 / L26. A single hole 30 can be positioned from 0% to 100% toward the first end 21. A single hole 30 can be positioned at 10% or more, 25% or more, 50% or more, or 75% or more toward the first end 21. The actual distance D30 from the hole 30 to the midpoint 26 can be selected based on the size of the bladder 20. In some cases, the bladder 20 is a size 1, size 2, size 3, size 4, or size 5 bladder, preferably size 3. The bladder 20 can have a length of about 11 mm, about 14 mm, about 16 mm, about 18 mm, or about 19 mm. The bladder sidewall 25 can have a length of about 8 mm, about 10 mm, about 11 mm, about 12 mm, or about 14 mm. A single hole 30 can be positioned (measured from midpoint 26) 1 mm or more, 3 mm or more, or 5 mm or more toward the first end 21 of the bladder 20. A single hole 30 can be positioned (measured from midpoint 26) 7 mm or less, 6 mm or less, or 5 mm or less toward the first end 21 of the bladder 20. If measured along the longitudinal axis A20 of the bladder 20 from the first end 21, a single hole 30 can be within 2 mm, 4 mm, 6 mm, or 10 mm of the first end 21.

[0076] Inhaler article 10 containing capsule 20 Figure 2A and 2B The inhaler article 10 is schematically shown. It has a first downstream end 11 and an opposing second upstream end 12. A mouthpiece element 200 is disposed at the downstream end 11 of the inhaler article 10. The outer surface of the inhaler article 10 may be at least partially formed by a packaging material 13. The inhaler article 10 includes an inhaler body 100 having tubular sidewalls 101. The inhaler body 100 defines an interior forming a receiving portion 102 for receiving a sac 20. The inhaler body 100 also defines a longitudinal central axis A. The mouthpiece element 200 extends along the longitudinal central axis A. The mouthpiece element 200 may be at least partially inserted into the inhaler body 100. The mouthpiece element 200 has a downstream end 201 and an upstream end 202. The upstream end 202 of the mouthpiece element 200 is received within the interior of the inhaler body 100 and forms the downstream end of the sac receiving portion 102.

[0077] The first end 21 of the capsule 20 may be oriented toward the upstream end 12 of the body. The second end 22 may be oriented toward the downstream end 11 of the body. In some embodiments, a single hole 30 extends through the tubular sidewall 20 and is positioned closer to the first end 21 of the capsule 20 and the upstream end 12 of the inhaler article 10 than the second end 22 and the downstream end 11.

[0078] like Figure 3As shown, the inhaler article 10 can be used with a retainer 400. The retainer 400 can be configured to open the upstream end 12 of the inhaler article 10. The retainer 400 can be configured to provide an air inlet 401 to the inhaler article 10. The retainer 400 can also be configured to puncture the sac 20. The retainer 400 can be configured to create a single hole 30 in the sidewall 25 of the sac 20. When the user inhales air through the inhaler article to use the inhaler, air can flow from the air inlet 401 through the receiving portion 102, carrying dry powder particles from inside the sac 20, and through the mouthpiece element 200, and out of the outlet 211. According to an embodiment, the dry powder can be inhaled from the sac 20 at an airflow rate of 5 mL / min or less, or 2 mL / min or less.

[0079] The bladder housing 102 may have a width (diameter) W102 smaller than the length L20 of the bladder 20, such that the bladder 20 maintains its orientation within the bladder housing 102. The first end 21 of the bladder 20 is oriented towards the upstream end 12, and the second end 22 of the bladder 20 is oriented towards the downstream end 11 of the inhaler 10. Figure 4 As shown, the sac 20 may have space for slight movement (e.g., vibration and rotation) but not enough to flip over. The sac has a width (diameter) W20. The width (diameter) W102 of the sac receiving portion 102 may be 5% to 25%, 8% to 22%, or 10% to 20% larger than the width (diameter) W20 of the sac 20.

[0080] Example

[0081] The powder delivery performance of capsules with a single pore at different locations was tested. Each capsule was a 3HPMC capsule (total length 15.9 ± 0.3 mm) and contained 50 mg of powder containing nicotine salt and flavoring particles. The pore was made using a needle with a diameter of 0.8 mm.

[0082] Sample 1 is a capsule with a single pore at the center of the first (upstream) end.

[0083] Sample 2 is a capsule with a single hole in its sidewall, the single hole being positioned closer to the first (upstream) end. The hole in Sample 2 is 13.6 mm from the downstream end of the capsule, or 2.3 mm from the upstream end of the capsule.

[0084] Sample 3 is a capsule with a single hole in its sidewall, the single hole being positioned closer to the second (downstream) end. The hole in Sample 3 is 2.5 mm from the downstream end of the capsule.

[0085] The samples were tested by placing the capsule in the capsule housing of the inhaler and inhaling air through the inhaler. The air-drawing pattern mimicked smoking, with 80 mL of air drawn in for 2 seconds (single draw), repeated 12 times. The amount of powder delivered during the 12 draws was measured. The results are shown in Table 1 below.

[0086] Table 1. Powder delivery.

[0087] Hole position Powder delivery, 12 suctions Sample 1 Upstream end, center 34.1mg Sample 2 Sidewall, near the upstream end 31.5mg Sample 3 Sidewall, near the downstream end 11.7mg

[0088] It was observed that a single hole in the sidewall near the upstream end delivered almost the same amount of powder as a hole located at the center of the upstream end. The difference in powder delivery between Sample 1 and Sample 2 was not statistically significant. Surprisingly, a single hole in the sidewall near the upstream end delivered powder much more efficiently than a single hole in the sidewall near the downstream end.

Claims

1. An inhaler article, comprising: The main body includes an upstream end and a downstream end, a bladder-containing portion, and an airflow path extending from the bladder-containing portion to an opening at the downstream end; as well as A sac disposed within the sac receiving portion, the sac comprising: First end and second end; A tubular sidewall extending between the first end and the second end; The capsule contains only a single opening, which extends through the tubular sidewall; and Inhalable powder contained within the capsule The first end of the bladder is oriented toward the upstream end of the body, and the single hole is configured to be closer to the first end than the second end.

2. The inhaler article of claim 1, wherein each of the first end and the second end comprises a hemisphere.

3. The inhaler article according to any one of claims 1 to 2, wherein the bladder has a diameter, and the diameter of the bladder receiving portion is 5% to 25% larger than the diameter of the bladder.

4. The inhaler article according to any one of claims 1 to 2, wherein, Measured along the longitudinal axis of the bladder, the single hole is located at a distance of 2 mm to 10 mm from the first end.

5. The inhaler article according to any one of claims 1 to 2, wherein the single orifice has a diameter of 0.2 mm. 2 Up to 1.5mm 2 The area.

6. The inhaler article according to any one of claims 1 to 2, wherein the inhalable powder comprises nicotine.

7. The inhaler article according to any one of claims 1 to 2, wherein the inhalable powder comprises nicotine particles having a mass median aerodynamic diameter particle size in the range of 0.5 µm to 10 µm.

8. The inhaler article according to any one of claims 1 to 2, wherein the inhalable powder comprises flavor particles.

9. The inhaler article according to any one of claims 1 to 2, wherein the capsule is a polymer capsule.

10. The inhaler article according to any one of claims 1 to 2, wherein the capsule is a capsule of size 1 to size 4.

11. The inhaler article according to any one of claims 1 to 2, wherein the body is constructed of a cellulose material.

12. The inhaler article according to any one of claims 1 to 2, wherein the body comprises a tubular member constructed of a cellulose material.

13. The inhaler article according to any one of claims 1 to 2, wherein the upstream end of the tubular body forms the distal end of the sac-receiving portion.

14. The inhaler article according to any one of claims 1 to 2, wherein the inhaler article includes a mouthpiece element received at the downstream end of the body.

15. The inhaler article of claim 14, wherein the mouthpiece element defines the downstream end of the bladder receiving portion.

16. The inhaler article of claim 6, wherein the inhalable powder comprises nicotine salt.

17. The inhaler article of claim 9, wherein the polymer capsule comprises hydroxypropyl methylcellulose.

18. The inhaler article of claim 10, wherein the capsule is a capsule of size 2 to size 3.

19. The inhaler article of claim 10, wherein the bladder is a bladder of size 3.

20. The inhaler article of claim 11, wherein the body is constructed of paper.

21. The inhaler article of claim 12, wherein the tubular member is constructed of paper.

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