WO2022146909A1

WO2022146909A1 - Container with permeable inlay or chamber

Info

Publication number: WO2022146909A1
Application number: PCT/US2021/065192
Authority: WO
Inventors: Gudrun SPEIDEL; Klaus Freitag; Claudia Reitz; Elke Wagner
Original assignee: Elanco Us Inc.
Priority date: 2020-12-29
Filing date: 2021-12-27
Publication date: 2022-07-07

Abstract

The disclosed embodiments include a container for administration of a medicament to an animal. The container may include an adsorption compartment, a release compartment, and a divider. The adsorption compartment is configured to store a first ingestible material including the medicament. The release compartment is configured to store a second ingestible material. The divider is selectively openable between the adsorption compartment and the release compartment. The selectively openable divider includes a plurality of openings configured to allow at least one agent of the second ingestible material to be provided to the first ingestible material

Description

CONTAINER WITH PERMEABLE INLAY OR CHAMBER

FIELD

[0001] The present disclosure relates to a container with an inlay or chamber configured to facilitate permeation of a dosing unit.

BACKGROUND

[0002] Veterinary products can be administered to animals using a variety of techniques. The spectrum ranges from topical shampoos, showers, dips, baths, sprays, to medicated collars. However, the most effective administration may be when the animal's body takes up the product orally, parenterally, or transdermally. Examples include injection, tablet, capsule, drink, feed additive and similar products. Each of these administration forms can have advantages or disadvantages depending on the actual situation and the animal that is in need of such a treatment. Treatment of herd animals, like horses, cattle, sheep, or poultry usually requires different administration methods than for the treatment of single animals, such as pets like dogs and cats.

[0003] While humans easily manage the administration of oral uptake for medicaments, animals may be less cooperative. Often the animal owner or veterinarian faces challenges in the natural behavior of the animals so the administration of oral medicaments is challenging.

SUMMARY

[0004] One implementation of the present disclosure is an apparatus including a container for administration of a medicament to an animal. The container includes at least an adsorption compartment, a release compartment, and, optionally, a selectively openable divider. The adsorption compartment is configured to store a first ingestible material including the medicament. The release compartment configured to store a second ingestible material. The selectively openable divider is between the adsorption compartment and the release compartment and includes a plurality of openings configured to allow at least one agent of the second ingestible material to be provided to the first ingestible material.

[0005] One implementation of the present disclosure is a method for administering a medicament to an animal. The method includes loading a first ingestible material, including the medicament, into an adsorption compartment of a container, loading a second ingestible material into a release compartment of the container such that the at least one agent of the second ingestible material is provided to the first ingestible material, and removing the first ingestible material from the adsorption compartment.

[0006] One implementation of the present disclosure is a container for administration of a medicament to an animal. The container includes an adsorption compartment configured to store a first material including the medicament, a release compartment configured to store a second material, and, optionally, a selectively openable divider between the adsorption compartment and the release compartment. The selectively openable divider includes a plurality of openings configured to allow at least one odorous particle of the second material to be provided to the first material.

[0007] BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Exemplary embodiments are described herein with reference to the following drawings, according to an exemplary embodiment. [0009] FIGS. 1A-B illustrate example forms of dosing units.

[0010] FIGS. 1C-D illustrate example forms of palatable units.

[0011] FIG. 2 illustrates a first embodiment of a container with a permeable divider to separate the dosing units and the palatable units.

[0012] FIG. 3 illustrates a second embodiment of a container with a permeable divider to separate the dosing units and the palatable units.

[0013] FIG. 4 illustrates an exploded view of the example of FIG. 3.

[0014] FIG. 5 illustrates an example permeable divider of FIGS. 3-4.

[0015] FIG. 6 illustrates a third embodiment of a container with a permeable divider to separate the dosing units and the palatable units.

[0016] FIG. 7 illustrates an example permeable divider of FIG. 6.

[0017] FIG. 8 illustrates a fourth embodiment of a container with a permeable divider to separate the dosing units and the palatable units.

[0018] FIG. 9 illustrates a flowchart for an example implementation of the container of FIGS. 1-8.

[0019] FIG. 10 illustrates a fifth embodiment of a container with a divider to separate the dosing units and the palatable units and a moisture collection chamber.

DETAILED DESCRIPTION

[0020] Ideally, an effective and easy administration treatment for animals, especially pets, is the oral uptake of a medicament. The field of veterinary medicine has long sought a solution to overcome the natural behavior of the animal to resist oral treatment, specifically to take and swallow medicament. The following embodiments include one or more medicaments in various forms that may be externally modified to adsorb or otherwise accept odor, taste, or both from another material, which may be referred to as an odor releasing material. In the disclosed embodiments, when the term "odor" is used, it may be substituted with taste or odor and taste. The medicament may be a tablet or capsule, as illustrated, and may also be a powder, liquid, gel, jelly or paste. In the disclosed embodiments, the term "tablet" may be substitute with any one or more of powder, liquid, gel, jelly or paste. Table 1 includes examples oral pharmaceutical dosage forms: buccal tablet, cachet, capsule, chewable tablet, coated tablet, concentrate for gargle, dispersible tablet, effervescent granules, effervescent powder, effervescent tablet, film-coated tablet, gargle, gastro-resistant capsule, gastro- resistant capsule, gastro-resistant granules, gastro-resistant tablet, gingival gel, gingival paste, gingival solution, granules, granules for oral solution, granules for oral suspension, granules for syrup, lozenge, modified-release capsule, modified-release granules, modified-release tablet, mouth wash, muco-adhesive buccal tablet, oral drops, oral drops (emulsion), oral drops (solution), oral drops (suspension), oral emulsion, oral gel, oral gum, oral liquid, oral lyophilisate, oral paste, oral powder, oral solution, oral suspension, orodispersible tablet, oromucosal capsule, oromucosal drops, oromucosal gel, oromucosal liquid, oromucosal paste, oromucosal solution, oromucosal spray, oromucosal suspension, pillules, powder, powder and solvent for oral solution, powder and solvent for oral suspension, powder for oral solution, powder for oral suspension, powder for syrup, prolonged-release capsule, prolonged-release granules, prolonged- release tablet, soluble tablet, sublingual spray, sublingual tablet, syrup, tablet, powder and solvent for dental gel, premix for medicated feeding stuff, compressed lozenge, pastille, soft capsule, chewable capsule, soft chew, lyophilisate for suspension, thin film, and/or oromucosal cream.

[0021] The odor releasing material is a substance that releases substances (e.g., volatilized chemical compounds such as organic compounds) into the ambient environment (e.g., into the air). Example volatile compounds may include alcohols, aldehydes, ketones, esters, sulfur compounds, pyrazines, furans, alkanes, benzene derivatives, and terpenes. The volatile compounds may be detected by an olfactory nerve, for example, in the nose of an animal. The odor releasing material may emit at least a number of particles or molecules that may be detected by the olfactory nerve of animals. The taste of the material may be detected by taste buds or microvilli hairs. The type and intensity of the odor and/or taste sensation may depend on the kind of substances emitted and their concentration or quantity.

[0022] The tablet or capsule is an odor absorbing material or an odor adsorbing material. The material is configured to take up the substances emitted from the odor releasing material. Through adsorption, the odor causing molecules may attach to the surface or pores of the adsorbent, the tablet or capsule. In some instances, the odor causing molecules may attach to the surface and in others the odors causing molecules may penetrate the tablet. The surface attachment and/or surface penetration may occur as a function of an ambient variable. Examples for the ambient variable include exposure time and temperature.

[0023] The following embodiments include a container or dispenser with an inlay or compartment that is divided from a main compartment by a permeable divider. The tablets may be contained in the main compartment and the odor releasing material may be contained in the inlay. The opposite arrangement may be used; that is, the odor or taste releasing material may be contained in the main compartment and the tablets may be contained in the inlay. In either case, the permeable divider provides a path for volatilized chemical compounds from the odor releasing material to reach the tablets. Thus, the tablets take up the odors of the odor releasing material.

[0024] The intended recipient of the medicament of the tablets may be an animal such as a pet. The odor releasing material may be a flavor, treat or food that the animal is accustomed. Because the tablets have taken up the odors of the odor releasing material, the tablets carry the same odor. When the animal is presented with the tablets, the animal is reminded of the familiar flavor, treat or food. Thus, the animal is more likely to accept and consume the tablet.

[0025] FIGS. 1A-B illustrate example forms of dosing units. FIG. 1A illustrates a dosage unit 100 having a tablet form or shape. The tablet shape may be cylindrical. The faces of the tablet shape may be convex. The tablet may be formed from a tablet press, which may be automatically driven or manually driven. Alternatively, the tablet or capsule may be formed from extrusion or another process. In addition to the one or more active ingredient for the medicament, the dosage unit 100 may include a tablet blend and a colorant. In some examples, the dosage unit 100 may include an adsorbent material configured to adsorb the odor particles.

[0026] FIG. IB illustrates a dosage unit 100 having a capsule form or shape. The capsule may include an outer covering that encloses the composition of the dosage unit 100. The covering may be formed of gelatin, starch, and/or protein. The covering may be formed from a water-based or solvent-based solution to which a gelling agent is added. The capsule may be a hard shell including two components such as a body and a cap.

The body may be filled with the composition and then enclosed, encapsulated, or otherwise sealed by the cap. Other example shapes may be heart shaped, triangular, arc triangle, rounded square, rounded rectangle, pillow, cushion, diamond, pentagon, hexagon, octagon, half moon, almond, or spherical.

[0027] Any tabletting equipment can be used to form the dosage unit 100. The table press may be an eccentric tablet press or a rotary tablet presses. There is no limitation to the shape of the dosage form. In one example, the tablet press is configured for 200 mg tablets with oblong punches. A manual press that is hand operated may be used. Alternatively, an automatic press including a motor is used. The motor may operate a drive mechanism that actuates the press in response to a user input (e.g., button or computer controller control). In one example, the tablet includes one or more diluents, fillers, binders, disintegrants, lubricants, flowability enhancers, flavors, coloring agents or preservatives.

[0028] Other examples of a manufacturing device include an extruder and a three-dimensional (3D) printer or additive device. The extruder may include at least one screw that is configured to mix and propel the mixture through one or more openings. As the mixture protrudes through the opening, portions may be measured and cut to form the dosage unit 100. The dosing unit 100 may be removed from the manufacturing device. The dosing unit 100 may be removed by hand, using a knife, or through a robotic arm.

[0029] The 3D printer may include a hopper to receive the mixture. The 3D printer may electronically receive or store a pattern for the dosage unit 100 according to any of the examples herein. The 3D printer may place layers of the mixture on top of one another until the desired size and shape of the dosage unit 100 is formed.

[0030] FIGS. 1C-D illustrate example forms of palatable units 102 (e.g., odor releasing materials). FIG. 1C includes a packet (e.g., flavor packet or odor packet) that is configured to release odor. The packet may include a porous sheet wrapped around the odor releasing material (e.g., for materials that are in powder form). FIG. ID illustrates a palatable unit 102 shaped in a shape associated with the intended recipient. The shape may be associated with a type of food for the intended recipient. For example, when the intended recipient is a domestic cat or another type of feline, the shape may be a fish shape, as illustrated. Another example shape associated with the intended recipient is a bone shape for a dog. Other food imitating shapes may include bacon, steak, hot dogs, and others. The shape may be associated with a toy or prey of the intended recipient.

For example, when the intended recipient is a domestic cat or another type of feline, the shape may be a mouse shape or a ball.

[0031] FIG. 2 illustrates a first embodiment of a container 101 with a permeable divider to separate the dosing units 100 and the palatable units 102. The container 101 is for administration of a medicament in the dosing unit 100 to an animal that responds to the odor of the palatable units 102. The container 101 includes an adsorption compartment 110, a release compartment 112, and a divider between the adsorption compartment 110 and the release compartment 112. At least one component of the container 101 may be formed from an example rigid material or flexible material. For example, one or more of the adsorption compartment 110, the release compartment 112, and the divider may be formed from plastic, metal, glass, wood and/or a composite. In some examples, the walls of the container 101 (e.g., the walls of the adsorption compartment 110 and/or the release compartment 112) may provide a predetermined level of protection from light (i.e., the walls may be at least partially opaque from light). The opacity may be selected in response to the type, category, or quantity of the dosing units 100 and/or the palatable units 102. Additional, different, or fewer components may be used.

[0032] The adsorption compartment 110 is configured to store a first ingestible material (e.g., dosing units 100) including the medicament. The container 101 may be sealed by cap 109 with the dosing units 100 in the adsorption compartment. In one example, when the cap 109 is removed from the container 101 a safety seal is broken. The cap 109 is placed over an opening that allows the dosing units 100 to be removed from the adsorption compartment 110.

[0033] The release compartment 112 is configured to store a second ingestible material (e.g., palatable units 102). The release compartment 112 may be connected and disconnected from the adsorption compartment 110. In one example, the adsorption compartment 110 includes a threaded extension collar 105 that extends around the circumference of the adsorption compartment 110 and extends from the bottom of the adsorption compartment 110.

[0034] Various techniques may be used to couple the release compartment 112 to the adsorption compartment 110. The release compartment 112 may include a threaded portion 107 on the inside surface of the release compartment 112. The threaded portion 107 is configured to mate with the threaded extension collar 105. That is, the release compartment 112 is secured to the adsorption compartment 110 by screwing the release compartment 112 into the adsorption compartment 110 by way of the extension collar 105 and the threaded portion 107. The adsorption compartment 110 and the release compartment 112 are removable from the container 101. Alternatively, the release compartment 112 to the adsorption compartment 110 and be press fit or coupled together by another type of connection. Finally, the release compartment 112 to the adsorption compartment 110 may not be coupled together. That is, the adsorption compartment 110 may be placed inside the release compartment 112. In this example, the divider 114 may be omitted and instead the adsorption compartment 110 may be a permeable compartment, having a designated area or entire surface formed of a permeable or porous membrane or other material, that permits the volatile compounds to travel from the release compartment 112 to the adsorption compartment 110. In this instance, the adsorption compartment 110 may rest inside the release compartment 112.

[0035] The divider 114 is a selectively openable divider between the adsorption compartment 110 and the release compartment 112. The selectively openable divider 114 may be a membrane. The selectively openable divider 114 may include a plurality of openings 115 configured to allow at least one agent of the second ingestible material to be provided to the first ingestible material. The second ingestible material may be palatable and the at least one agent may provide the palatable features of the second ingestible material. The at least one agent may include an odorous molecule sized to flow through the plurality of openings 115.

[0036] Rather than distinct openings, the divider 114 may be of a uniform material configured to allow the odorous sized molecules to flow through the divider 114 uninhibited or substantially uninhibited. The term "substantially uninhibited" may be defined as sufficient to transfer the odor or smell from the release compartment 112 to the adsorption compartment 110. The uniform material may also prevent water or other liquids from traveling from the release compartment 112 to the adsorption compartment 110. The uniform material may substantially prevent water or other liquids from traveling from the release compartment 112 to the adsorption compartment 110. The term "substantially prohibit" may be defined as sufficient to prevent measurable amounts of liquid from traveling from release compartment 112 to the adsorption compartment 110. Examples of materials that are both substantially uninhibited with respect to odor transfer and also substantially prohibit moisture transfer may include paper or a non-woven material or film.

[0037] In one example, the container 101 may include a switch 106 configured to open and close the plurality of openings in the divider 114. In one example, the release compartment 112 presses the switch 106 in response to the threaded portion 107 being screwed into the threaded extension collar 105. Thus, tightening the release compartment 112 into the adsorption compartment 110 may press the switch and open the divider 114 so that odor molecules may flow freely from the second ingestible material to the first ingestible material.

[0038] The size of the adsorption compartment 110 or the release compartment 112 may be adjustable. For example, the position of the divider 114 may be movable to increase the size of one compartment or decrease the size of the other compartment. One or more sections may be added or removed from the adsorption compartment 110 or the release compartment 112. [0039] FIG. 3 illustrates a second embodiment of a container 101 with an inlay.

The container 101 includes a permeable divider 114 to separate the dosing units 100 and the palatable units 102. FIG. 4 illustrates an exploded view of the example of FIG. 3. FIG. 5 illustrates an example permeable divider of FIGS. 3-4. The container 101 includes an adsorption compartment 110 and a release compartment 112. In the second embodiment, the adsorption compartment 110 may fit inside the release compartment 112. The release compartment 112 may be sized to accept the adsorption compartment 110. Thus, the release compartment 112 is slightly larger than thee adsorption compartment 110. The fit may be a snug fit or friction fit so that the release compartment 112 grips the adsorption compartment 110. The adsorption compartment 110 screw into the release compartment 112. An arrow A illustrates the relative movement between the release compartment 112 and the adsorption compartment 110. Additional, different, or fewer components may be used.

[0040] FIG. 6 illustrates a third embodiment of a container 101 with a permeable divider 114 to separate the dosing units and the palatable units. FIG. 7 illustrates an example permeable divider 114 of FIG. 6. In this example, a user input, such as lever 121 is coupled to or extends from the permeable divider 114. The permeable divider 114 is configured to rotate under actuation of the lever 121. The permeable divider 114 may be spring loaded (e.g., spring 122) to a default position of the permeable divider 114 in which openings 115 are blocked. FIG. 7 illustrates covers 125 that are moved in front of or adjacent to the openings 115. When the lever 121 is moved, the permeable divider 114 is moved against the force of the spring 122 to open the openings 115. A locking mechanism may lock the permeable divider 114 in the open position. When released, the permeable divider 114 returns to the closed position.

[0041] FIG. 8 illustrates a fourth embodiment of a container 101 with a permeable divider 114 to separate the dosing units 100 and the palatable units 102. The adsorption compartment 110 and the release compartment 112 may include a coupling mechanism. A first component of the coupling mechanism may be integrated with or attached to the adsorption compartment 110, and a second component of the coupling mechanism may be integrated with or attached to the release compartment 112.

[0042] In an example embodiment, the adsorption compartment 110 includes a slider 131 and the release compartment 112 includes a sliding track 132. The slider 131 and sliding track 132 form a path for the adsorption compartment 110 or the release compartment 112 to move from a first position to a second position. The adsorption compartment 110 may be moved into the first position in order to load the adsorption compartment 110 with dosing units 100 then moved into the second position in order to place the dosing units 100 close to the palatable units 102. A lever for opening and closing the divider 114 may be triggered by the slider 131.

[0043] FIG. 9 illustrates a flowchart for an example implementation of the container of FIGS. 1-8 in order to administer a medicament to an animal. Additional, different, or fewer acts may be included.

[0044] At act S101, a first ingestible material is loaded into an adsorption compartment of a container. The first ingestible material is a dosing unit including at least one medicine or medicament. The first ingestible material may be a tablet including at least one active ingredient and at least one adsorbing material. [0045] At act S103, a second ingestible material is loaded into a release compartment of the container. The second ingestible material is a palatable material. At least one agent (e.g., particle, molecule, etc.) of the second ingestible material is provided to the first ingestible material. In some examples, a switch may be actuated to open a divider between the release compartment and the adsorption compartment. [0046] At act S105, a delay may be used to allow odors from the release compartment to be adsorbed by the adsorption compartment. The time period may range from a few minutes to a few days. In some examples, the delay period is selected by the user. The delay period may be selected through trial and error. The user may determine when the first ingestible material has adsorbed sufficient odor based on the behavior of the animal. The user may determine when the first ingestible material has adsorbed sufficient odor based on inspection of odor from the first ingestible material. [0047] In other examples, the container may include an electronic or mechanical mechanism that provides thee delay time period. For example, a delay circuit may include a timer, a power source (e.g., a battery), and a switch. The delay circuit may count down the timer period in response to actuation of the switch. The switch to turn on the time may be actuated by connection of the release compartment and the adsorption compartment. For example, a mechanical lever or button where the release compartment and the adsorption compartment connect may complete a circuit or move the switch to start the timer. When the time period has elapsed, the delay circuit may generate an indication to the user. The indication may be a sound produced by a speaker (e.g., piezoelectric) or an image produced by a display (e.g., light emitting diode

LED). [0048] Other time based indicators may be used that are based on chemical reactions, fading ink, exposure to oxygen or other particles. For example, a chemical timer may include a barrier layer and a colorant. Initially, the barrier layer blocks visibility of the colorant to an observer. Over time, a predetermined amount of the colorant is permitted to migrate through the barrier layer and become visible to the observer.

[0049] At act S107, the first ingestible material is removed from the adsorption compartment. At act S109, the first ingestible material may be administered to an animal. The animal may be motivated to take up and consume the first ingestible material because of the odor received from the second ingestible material.

[0050] FIG. 10 illustrates a fifth embodiment of a container with a divider 114 to separate the dosing units 100 and the palatable units 102 and a moisture collection chamber 301 including desiccant 302. Additional, different or fewer components may be included.

[0051] The moisture collection chamber 301 may be separated from the release compartment 112 by a divider 303 (e.g., second divider). The divider 303 may include one or more openings or open areas so that moisture from the palatable units 102 absorbs into desiccant 302. The desiccant 302 may include beads or another form. The desiccant 302 may be configured to eliminate humidity from the air and sustain a moisture free or moisture reduced environment within the container. The desiccant 302 may include silica gel or another inert material. The desiccant 302 may include activated charcoal and/or one or more molecular sieves. [0052] The desiccant 302 may include a humidity indicator to show whether the desiccant 302 has absorbed a predetermined amount of water and should be replaced. One example humidity indicator is cobalt chloride, which may turn from blue to purple as it becomes substantially saturated with water. The user may observer the color change, and in response, open/remove the moisture collection chamber 301 in order to replace the desiccant 302. As an alternative to the desiccant 302, a humectant may be used.

[0053] In summary, the embodiments described herein include improvements to oral medicines administered to animals. An animal may not have a natural willingness to take medicine orally, which leads to pet owners or medical professionals to force the animals to take the medicament, by making it swallow or by injecting it. Some animals may tend to bite or scratch if these circumstances. The described embodiments improve this procedure by introducing an odor emitting agent to the medicament. In one example, the odor is provided by a treat or other palatable substance that the animal is already familiar with.

Claims

WHAT IS CLAIMED IS:

1. A container for administration of a medicament to an animal, the container comprising: an adsorption compartment configured to store a first ingestible material including the medicament; a release compartment configured to store a second ingestible material; and a divider between the adsorption compartment and the release compartment, wherein the divider includes a plurality of openings configured to allow at least one agent of the second ingestible material to be provided to the first ingestible material.

2. The container of claim 1, further comprising: a switch configured to open and close the plurality of openings.

3. The container of claim 1, wherein the adsorption compartment, the release compartment, or both the adsorption compartment and the release compartment, are removable from the container.

4. The container of claim 1, further comprising: a coupling mechanism including a path for the adsorption compartment or the release compartment to move from a first position to a second position.

5. The container of claim 1, wherein a size of the adsorption compartment or the release compartment is adjustable.

6. The container of claim 1, wherein the first ingestible material is a dosing unit.

7. The container of claim 1, wherein the first ingestible material is a tablet including at least one active ingredient and at least one adsorbent material.

8. The container of claim 1, further comprising: a moisture collection chamber including a desiccant.

9. The container of claim 1, wherein the second ingestible material includes one or more palatable ingredients.

10. The container of claim 1, wherein the at least one agent of the second ingestible material includes an odorous molecule.

11. A method for administering a medicament to an animal, the method comprising: loading a first ingestible material, including the medicament, into an adsorption compartment of a container; loading a second ingestible material into a release compartment of the container; wherein at least one agent of the second ingestible material is provided to the first ingestible material; and removing the first ingestible material from the adsorption compartment.

12. The method of claim 11, further comprising: providing the first ingestible material to the animal.

13. The method of claim 11, further comprising: actuating a switch configured to open and close at least one opening between the adsorption compartment and the release compartment.

14. The method of claim 11, wherein the first ingestible material is a dosing unit.

15. The method of claim 11, wherein the first ingestible material is a tablet.

16. The method of claim 15, wherein the tablet includes at least one active ingredient and at least one adsorbing material and the second ingestible material includes one or more palatable ingredients.

17. A container for administration of a medicament to an animal, the container comprising: an adsorption compartment configured to store a first material including the medicament; a release compartment configured to store a second material; and

19 a selectively openable divider between the adsorption compartment and the release compartment, wherein the selectively openable divider includes a plurality of openings configured to allow at least one odorous particle of the second material to be provided to the first material.

18. The container of claim 17, wherein the first material is an ingestible tablet for the animal.

19. The container of claim 18, wherein the second material is one or more palatable treats for the animal.

20. The container of claim 17, further comprising: a switch configured to move the selectively open divider between a first position and a second position; and a spring configured to bias the selectively open divider into the first position.

20