CONTAINER WITH PARTICLES FOR USE WITH INHALER

Abstract

A container containing a powder system including a first plurality of particles having a particle size of about 10 micrometers or less, and a second plurality of particles having a particle size of about 20 micrometers or greater, and a single aperture extending through the container. A system including an inhaler article and the container is disclosed also.

Claims

1.-17. (canceled)

18. A container containing a powder system comprising: a first plurality of particles having a particle size of about 10 micrometers or less; a second plurality of particles having a particle size of about 20 micrometers or greater; wherein the powder system comprises a weight ratio of the first plurality of particles to second plurality of particles of about 1:1 to about 10:1, a single aperture extending through the container, wherein the single aperture has a diameter of about 0.5 mm to about 1.5 mm, or an open surface area of the single aperture is in a range from about 0.1% to about 0.5% of the total surface area of the container.

19. The container according to claim 18, wherein the container is a capsule.

20. The container according to claim 18, wherein the first plurality of particles comprises nicotine or a nicotine salt.

21. The container according to claim 18, wherein the first plurality of particles comprises an amino acid comprising leucine.

22. The container according to claim 18, wherein at least 90%, of the first plurality of particles have a particle size of about 5 micrometers or less.

23. The container according to claim 18, wherein at least 90%, of the second plurality of particles have a particle size of about 50 micrometers or greater.

24. The container according to claim 18, wherein the single aperture has an open surface area from about 0.5 mm.sup.2 to about 1 mm.sup.2, and the container is a capsule having a volume from about 0.2 mL to about 0.5 mL.

25. The container according to claim 18, wherein the first plurality of particles comprises nicotine lactate, leucine, and a sugar comprising trehalose, and has a nicotine content of about 1 wt % to about 10 wt %.

26. The container according to claim 18, wherein the container is a size 2 to size 4 capsule and contains from about 20 mg to about 80 mg of powder system.

27. The container according to claim 18, wherein the second plurality of particles comprises a flavour, the flavour comprises menthol.

28. A system comprising: an inhaler article comprising a cavity for receiving a container according to claim 18; and a piercing element for forming an aperture in a single side or end of the container.

29. The system according to claim 28, wherein the cavity is bounded on an upstream end by an end cap providing inhalation airflow that rotates the container within the cavity, and the cavity is bounded on a downstream end by porous element that contains the container and transmits particles entrained within the inhalation air to a mouthpiece of the inhaler.

30. The system according to claim 28, wherein the piercing element pierces the end cap and only one wall of the container to form the aperture.

31. The system according to claim 28, wherein the container is a capsule.

32. The system according to claim 28, wherein the inhaler delivers a substantially uniform dose of the powder system over each of at least about 20 inhalation puffs.

33. The container according to claim 18, wherein at least 90% of the first plurality of particles have a particle size of about 3 micrometers or less, and at least 90% of the second plurality of particles have a particle size in a range from 75 to 200 micrometers, and the powder system comprises a weight ratio of the first plurality of particles to second plurality of particles of about 2:1 to about 6:1.

34. The container according to claim 33, wherein the first plurality of particles comprises nicotine lactate, leucine, and a sugar comprising trehalose, and has a nicotine content of about 1 wt % to about 10 wt %.

35. The container according to claim 34, wherein the first plurality of particles comprises nicotine lactate, 5 to 15 wt % leucine, and 75 to 85 wt % sugar comprising trehalose, and has a nicotine content of about 1 wt % to about 10 wt %.

36. The container according to claim 33, wherein the second plurality of particles comprise menthol.

37. The container according to claim 33, wherein the single aperture has an open surface area in a range from about 0.2% to about 0.5% of the total surface area of the container and the container is a size 3 capsule containing 40 to 60 mg of powder system.

Description

[0108] The words preferred and preferably refer to embodiments of the invention that may afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation 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 disclosure, including the claims.

[0109] FIG. 1 is a perspective view of an illustrative inhaler article.

[0110] FIG. 2 is a cross-sectional schematic diagram of the illustrative inhaler article of FIG. 1 along the longitudinal axis.

[0111] FIG. 3A and FIG. 3B are perspective views of an illustrative end cap.

[0112] FIG. 4A and FIG. 4B are perspective views of another illustrative end cap.

[0113] FIG. 5 is a cross-sectional schematic diagram of another illustrative end cap.

[0114] FIG. 6 is cross-sectional schematic diagram of another illustrative end cap.

[0115] FIG. 7 is a schematic diagram end view of a capsule with the single aperture

[0116] The schematic drawings are not necessarily to scale and are presented for purposes of illustration and not limitation. The drawings depict one or more aspects described in this disclosure. However, it will be understood that other aspects not depicted in the drawing fall within the scope and spirit of this disclosure.

[0117] FIG. 1 and FIG. 2 illustrate an example of an inhaler article 100. FIG. 2 is a cross-sectional schematic diagram of the illustrative inhaler article of FIG. 1 along the longitudinal axis. The inhaler article 100 includes a body 110 extending along a longitudinal axis L.sub.A from a mouthpiece end 112 to a distal end 114 and a capsule cavity 116 defined within the body 110. A mouthpiece air channel 111 extends from the capsule cavity 116 to the mouthpiece end 112. An end cap 120 is disposed within the distal end 112 and extends to the capsule cavity 116. The end cap 120 extends from an end cap distal end 124 to an end cap inner end 122 an end cap length. The end cap 120 includes an air channel 113 extending from the end cap distal end 124 to the end cap inner end 122. The air channel 113 is non-parallel with the longitudinal axis L.sub.A.

[0118] The end cap inner end 122 and a porous support element 140 bound the capsule cavity 116. A capsule 130 is disposed within the cavity 116. The capsule 130 contains the powder system. The end cap 120 and the porous support element 140 cooperate to contain the capsule 130 longitudinally within the capsule cavity 116. The mouthpiece end 112 is illustrated having a recessed end where the body 110 bounds an open space at the mouthpiece end 112. Alternatively, the porous support element 140 can extend to the mouthpiece end 112 to fill the entire mouthpiece end 112.

[0119] The capsule cavity 116 has a cavity length L.sub.1 extending along the longitudinal axis L.sub.A. The capsule 130 has a capsule length L.sub.2. The capsule cavity has a cavity inner diameter D.sub.1. The capsule 130 has a capsule outer diameter D.sub.2. The capsule 130 axis of rotation may be coextensive with the longitudinal axis L.sub.A.

[0120] FIG. 3A to FIG. 4B illustrate opposing curved, or helical air channels 113 rotating about the circumference as a function of a location along the length of the end cap 120. The end cap 120 may include a collar element 125 having a larger diameter than the remaining body 123 of the end cap 120.

[0121] FIG. 3A, FIG. 4A, FIG. 5 and FIG. 6 illustrate a linear piercing channel 121 extending through the length of the end cap 120. The linear piercing channel 121 may extend along a central axis of the end cap 120.

[0122] FIG. 4B, FIG. 5 and FIG. 6 illustrate a resealable element 129 disposed on or within the linear piercing channel 121. FIG. 4B and FIG. 5 illustrate a resealable element 129 disposed on the end cap inner end 122 and sealing the linear piercing channel 121. FIG. 6 illustrates a resealable element 129 disposed on the end cap distal end 124 and sealing the linear piercing channel 121.

[0123] FIG. 7 is a schematic diagram end view of a capsule 130 with only a single aperture 220. The single aperture 220 may extend though the capsule body 210 at an end portion 212 of the capsule body 210. The single aperture 220 may be incident with a longitudinal axis of the capsule 130 and incident with the longitudinal axis L.sub.A of the inhaler body 110.

[0124] A separate piercing element 300 (FIG. 2) may be utilized by a consumer to pierce the capsule 130 and form the single aperture 220 through the piercing channel shown in FIG. 1 in the end cap 120 along the longitudinal axis L.sub.A. The piercing element may be withdrawn from the single aperture 220. A consumer may then utilize the capsule 130 in an inhaler device 100.

EXAMPLES

[0125] The following non-limiting examples provide examples of nicotine powder formulations in accordance with various aspects of the present disclosure and illustrate properties, including size and nicotine delivery, associated with the formulations.

Nicotine Delivery Example

[0126] The impact on nicotine delivery of mixing the first plurality of particles (nicotine powder) with the second plurality of particles having a larger particle size is tested. The test sample (Example 7) includes both the first plurality of particles (40 mg) and the second plurality of particles (10 mg). The control sample (Example 7C) includes only the first plurality of particles (40 mg). Nicotine delivery is tested for varying numbers of puffs. The results are shown in Table 9 below.

Sample Preparation:

[0127] The first plurality of particles is prepared with nicotine lactate, trehalose, and leucine, and includes 5 wt % nicotine (based on the total weight of nicotine in the nicotine lactate). The powder is prepared by spray drying, and has a particle size X.sub.50 of 2.250.2 micrometres.

[0128] The second plurality of particles has a particle size X.sub.50 of 100 micrometres and includes no more than 5% of the particles with a particle size of 20 micrometres or less. The powder includes 4.3 wt % menthol.

[0129] The powder system or mixture of Example 7 is prepared by mixing the first plurality of particles (40 mg) with the second plurality of particles (10 mg) at a weight ratio of 4:1, the total weight of the powder mixture is 50 mg.

[0130] Samples are prepared for testing by packing 40 mg of the first plurality of particles (control, Example 7C) and 50 mg of powder system (test sample, Example 7) into size #3 HPMC capsules. Four replicates of each sample are prepared and tested. The capsules are inserted into inhalers and pierced once with a 1 mm diameter needle forming only a single aperture.

Testing:

[0131] The samples are smoked at a suction rate of 80 mL/2 sec with a 30 sec interval between puffs, and the powder delivered from the inhaler is collected in groups of 4 puffs from the first 20 puffs, and in groups of 10 puffs thereafter. The amount of nicotine in the collected puffs is tested by gas chromatography. The results for nicotine delivered in the first 12 puffs, the first 20 puffs, and the first 50 puffs is shown in Table 9 below. The amount of nicotine is averaged for the four replicates and normalized for the quantity of nicotine present in the powder.

TABLE-US-00001 TABLE 9 Nicotine Delivery Example 1-12 Puffs 1-20 Puffs 1-50 Puffs 7C (control) 0.20 0.36 0.61 7 0.51 0.68 1.08

[0132] The content of a container according to the invention comprising a powder system according to the invention is more fully delivered over a series of inhalations.