System for Dermal Application of a Pharmaceutical and/or Cosmetic Composition
20220193382 · 2022-06-23
Inventors
Cpc classification
A45D2200/055
HUMAN NECESSITIES
B05B11/0032
PERFORMING OPERATIONS; TRANSPORTING
A45D34/04
HUMAN NECESSITIES
A61K31/40
HUMAN NECESSITIES
A61M35/003
HUMAN NECESSITIES
International classification
A61M35/00
HUMAN NECESSITIES
A45D34/04
HUMAN NECESSITIES
A45D40/28
HUMAN NECESSITIES
Abstract
The present invention relates to a system for applying and/or spreading a pharmaceutical and/or cosmetic composition on the skin. The system (100) comprises a container (110) for receiving a pharmaceutical and/or cosmetic composition (140); a dosing unit (120) mechanically coupled with the container (100) for dispensing a predetermined amount (141) of the composition (140) from the container (110) through an opening (121) of the dosing unit (120); and an applicator (130). The applicator (130) is configured to be temporarily coated or loaded with the predetermined amount (141) of the composition (140). Moreover, the applicator (130) is configured for spreading the predetermined amount (141) of the composition (140) on a skin area of a user. The applicator (130) is detachably connectable with the container (110) or the dosing unit (120).
Claims
1. A system comprising: a container configured to store a pharmaceutical and/or cosmetic composition; a dosing unit mechanically coupled with the container and configured to dispense a predetermined amount of the composition from the container through an opening of the dosing unit; and an applicator; wherein the applicator is configured to be temporarily loaded with the predetermined amount of the composition; wherein the applicator is configured to apply and/or spread the predetermined amount of the composition on a skin area of a user; and wherein the applicator is detachably connectable with the container or the dosing unit.
2. The system according to claim 1, wherein the applicator is configured to be a closure for the container such that the dosing unit is disposed in an inner space of the applicator, when the applicator is connected at a first location of the container or at a first location of the dosing unit.
3. The system according to claim 1, wherein the applicator, when connected at the first location of the container or at the first location of the dosing unit, is configured to seal the opening of the dosing unit.
4. The system according to claim 1, wherein the applicator is detachably connectible to the container at a second location of the container such that the container forms an extension handle of the applicator.
5. The system according to claim 1, wherein the applicator comprises: a gripping part configured to be gripped by the user, and an application part configured to receive the composition dispensed through the opening of the dosing unit and to apply and/or spread on the skin of the user the composition so received, wherein the application part has one of convex shape, a flat shape and a concave shape.
6. The system according to claim 5, wherein the applicator is detachably connectable with the container or the dosing unit by connecting the gripping part of the applicator to the container or the dosing unit.
7. The system according to claim 6, wherein an outer surface of the gripping part of the applicator is configured to be flush with the container when the gripping part of the applicator is connected to the container or the dosing unit.
8. The system according to claim 5, wherein the applicator comprises flow-arresting means configured to arrest a flow of the composition flowing in a direction from the application part towards the gripping part.
9. The system according to claim 5, wherein the gripping part comprises grip-enhancing means configured to enhance a grip of the user at the gripping part.
10. The system according to claim 1, wherein a ratio of a width (W1) and a height (H) of the applicator is equal to or less than 3:5.
11. The system according to claim 1, wherein the applicator is configured for spreading the predetermined amount of the composition on the skin area of the user in a connected state of the applicator and the container or the dosing unit.
12. The system according to claim 1, wherein an outer surface of the applicator, which faces away from the dosing unit in a connected state of the applicator and the dosing unit or the container, is configured for being temporarily loaded with the predetermined dose.
13. The system according to claim 1, wherein an inner surface of the applicator, which faces the dosing unit in a connected state of the applicator and the dosing unit or the container, is configured for being temporarily loaded with the predetermined dose.
14. The system according to claim 1, wherein the composition is a pharmaceutical and/or cosmetic composition in the form of an oil-in-water emulsion comprising a glycopyrronium salt and an emulsifier system.
15. A method for using a system according to claim 1, the method comprising: detaching, from the container or the dosing unit, the applicator connected with the container or the dosing unit to expose the dosing unit; dispensing, onto the applicator, a predetermined amount of the composition from the container through an opening of the dosing unit by actuating the dosing unit, to load the applicator with the predetermined amount of the composition; applying and/or spreading the predetermined amount of the composition loaded on the applicator, from the applicator directly onto a skin area of a user by contacting the applicator directly with the skin area of the user; and connecting the applicator with the container or the dosing unit such that the dosing unit is disposed in an inner space of the applicator.
Description
[0045] The foregoing and other objects, features, and advantages of the invention are apparent through the following detailed description taking in conjunction with the accompanying drawings in which:
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[0058] As shown in
[0059] The dosing unit 120 is mechanically coupled with the container 110. The dosing unit 120 may be mechanically coupled with the container 110 specially when the composition 140 is in the container 110. Once the composition 140 is inside the container 110, the dosing unit 120 may be fixedly attached to the container 110 or may be detachably attached to the container 110. When fixedly attached to the container 110, a user may not be able to separate the dosing unit 120 from the container 110 thereby obviating unintended spillage of the composition 140. When detachably attached to the container 110, the dosing unit 120 may be separated from the container 110, for example to fill or refill the container 110 with the composition 140 or with another product or composition.
[0060] In particular, the dosing unit 120 may close an opening of the container 110 such that the pharmaceutical and/or cosmetic composition 140 is confined within the container 110, unless purposively expelled or dispensed by a user by operation of the dosing unit 120. A joint between the container 110 and the dosing unit 120 may be sealed such that the composition 140 does not spill or seep out of the container 110 when the system 100 or the container 110 are tilted or laid laterally on a surface, or even when positioned in upside down orientation. The container 110 with the dosing unit 120 may generally be configured as an airless dispenser that allows the storage and dispensing of a viscous composition, for example a gel-based composition or a paste.
[0061] The dosing unit 120 includes an opening 121 through which the composition 140 is dispensed, when the dosing unit 120 is operated by a user. The dosing unit 120 may be operated by a user in variety of ways, for example by pressing an actuation surface 124 of the dosing unit 120, for example in a downward direction shown in
[0062] The applicator 130 is configured to be temporarily coated or wetted with the predetermined amount of the composition 140 and then used for applying and/or spreading the predetermined amount of the composition on a skin area of a user. The user can grip or hold the applicator 130 and manipulate the applicator 130 to apply and/or spread the composition 140 at a desired skin area of the user.
[0063] The applicator 130 may be configured to be mechanically coupled with the container 110 as shown in
[0064] Alternatively, as shown in
[0065] According to the first, the second and the third embodiments of the system 100 shown in
[0066] The applicator 130 may be detachably connectible to the container 110 at a first location 112 of the container 110 or at a first location 122 of the dosing unit 120, as explained hereinabove with reference to
[0067] When connected at the first location 112 of the container 110 or at the first location 122 of the dosing unit 120, the applicator 130 may also function to spread the predetermined amount 141 of the composition 140 on the skin area of a user. For using the applicator 130 to spread the predetermined amount 141 of the composition 140 on the skin area while being connected at the first location 112 of the container 110 or at the first location 122 of the dosing unit 120, the predetermined amount of the composition 140 is dispensed from the opening 121, by actuation of the dosing unit 120, and disposed (i.e. temporarily coated) on the applicator 130 while the applicator 130 is detached from the container 110 and/or the dosing unit 120. Once the predetermined amount 141 of the composition 140 is temporarily coated on the applicator 130, the applicator 130 is connected (i.e. reconnected) at the first location 112, 122 and can be used to spread and/or spread the predetermined amount 141 of the composition 140 on the skin area, while remaining connected at the first location 112, 122.
[0068] In another embodiment, the applicator 130 may be detachably connectible to the container 110 at a second location 114 of the container 110, independent of being connectible at the first locations 112, 122, i.e. the applicator 130 may or may not be configured to be detachably connectible to the first locations 112, 122.
[0069] Optionally, the applicator 130 may be detachably connectible to the container 110 at the second location 114 of the container 110, in addition to being detachably connectible at the first location 112 of the container 110 or at the first location 122 of the dosing unit 120, for example as shown in
[0070] Generally, the second coupling may be, but not limited to, a plug-in connection, a snap-on connection, a screw and thread connection, a friction-fit connection and a combination thereof.
[0071] When connected at the second location 114 of the container 110, the applicator 130 may function to spread the predetermined amount 141 of the composition 140 on the skin area of a subject or user. For using the applicator 130 to spread the predetermined amount 141 of the composition 140 on the skin area while being connected at the second location 114 of the container 110, the predetermined amount of the composition 140 is dispensed from the opening 121, by actuation of the dosing unit 120, and disposed (i.e. temporarily coated) on the applicator 130 while the applicator 130 is detached from the container 110 and/or the dosing unit 120. Once the predetermined amount of the composition 140 is temporarily coated on the applicator 130, the applicator 130 is connected at the second location 114 and can be used to spread the predetermined amount 141 of the composition 140 on the skin area, while remaining connected at the second location 114.
[0072] When the applicator 130 is used to spread the predetermined amount 141 of the composition 140 on the skin area, while being at the first location 112, 122 or while being connected at the second location 114, the container 110 acts as an extension handle for the applicator 130. Thus, a larger separation is realized between the composition 140 temporarily coated on the applicator 130 and the fingers of the user gripping the extension handle. Furthermore, due to the extension handle hard to reach parts of the body, such as back of the user, may be reached more easily.
[0073] It may be noted that the applicator 130 can be used to apply and/or spread the composition 140 onto the skin area while being unattached or disconnected from the container 110 or the dosing unit 120.
[0074] The dosing unit 120 is configured for dispensing the predetermined amount 141 (shown in
[0075] The predetermined amount 141 of the pharmaceutical composition may be used to coat a part or a region of an outer surface 131 and/or a part or a region of an inner surface 132 of the applicator 130. In case of a liquid pharmaceutical composition, the region of the inner and/or the outer surface 131, 132 of the applicator 130 may in particular be wetted with the predetermined amount 141 of the composition 140. The region of the inner and/or the outer surface 131, 132 of the applicator 130 coated or wetted with the composition 140 is configured to receive the composition 140 dispensed from the opening 121 of the dosing unit 120, when the dosing unit 120 is actuated.
[0076] Hereinafter, further detail of the applicator 130 have been described with reference to
[0077] The applicator 130 comprises an application part 131a and a gripping part 131b. The application part 131a is configured to receive the composition 140, preferably predetermined amount 141 of the composition 140, from the opening 121, when the dosing unit 120 is actuated. The application part 131a, on receiving the composition 140, gets temporarily coated by the composition 140. The gripping part 131b is configured to be gripped or held by a user. The gripping part 131b is not intended for receiving the composition 140 from the dosing unit 120. The application part 131a and the gripping part 131b may be formed monolithically, or alternatively the application part 131a and the gripping part 131b may be formed separately and then assembled with each other to realize the applicator 130.
[0078] The application part 131a and the gripping part 131b may be formed of same material, for example both parts i.e. the application part 131a and gripping part 131b may be formed of a polymer such as polypropylene (PP). Alternatively, the application part 131a and the gripping part 131b may be formed of different materials, for example the application part 131a may be formed of a polymer such as polypropylene (PP), whereas the gripping part 131b may be formed of another polymer such as rubber.
[0079] In an embodiment, the application part 131a is non-deformable. The phrase ‘non-deformable’ as used in the present technique means a structure that does not get deformed by intended usage or that does need to be deformed for intended usage. For example, the application part 131a is non-deformable as opposed to conventionally known brush or foam applicator devices. In addition to or as an alternative to the non-deformable application part 131a, in another embodiment of the system 100, the application part 131a is non-porous. The phrase ‘non-porous’ as used in the present technique means a structure such that the composition 140 does not penetrate or impregnate the application part 131a when the composition 140 is dispensed by the dosing unit 120 onto the application part 131a, simply put the composition 140 stays atop the surface of the application part 131a before being transferred to the skin area of the user.
[0080] The application part 131a of the applicator 130 is configured to come into contact with the skin area of the user where the composition 140 is applied and/or spread and thus the application part 131a may be formed devoid of sharp edges or surface structures that may irritate or affect the user's skin. The gripping part 131b of the applicator 130 is configured to come into contact with fingers of the user for purpose of holding and manipulating the applicator 130.
[0081] As shown in
[0082] Alternatively, in another embodiment as shown in
[0083] In yet another embodiment as shown in
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[0085] The surface of the applicator 130 in the application part 131a may be different from the surface of the applicator 130 in the gripping part 131b, as shown in
[0086] Optionally, as shown in
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[0089] In another embodiment, the applicator 130 may include grip-enhancing means 131e, independent of the flow-arresting means 131d, i.e. flow-arresting means 131d may or may not be present when the grip-enhancing means 131e is present in the applicator 130.
[0090] In yet another embodiment, in addition to the flow-arresting structure 131d, the applicator 130 includes, in the gripping part 131b, the grip-enhancing means 131e that may be realized as one or more grip-enhancing structures 131e.
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[0092] In one embodiment, for any of the applicators 130 of
[0093] In another embodiment of the system 100, the applicator or a part of the applicator is formed of a flexible material, and in this embodiment an inner surface 132 may be used for spreading the composition 140 onto the skin area of the user or another subject. The flexible material allows everting the applicator so that the predetermined amount 141 of the pharmaceutical composition 140 can be applied and/or spread onto the skin area. In other words, the inner surface with the predetermined amount 141 of the pharmaceutical composition is reverted inside-out allowing an application of the composition on the user's skin.
[0094] In particular, parts of the outer surface 131 and/or the inner surface 132 of the applicator 130 that are comprised in the application part 131a may be free of edges and/or corners to avoid any irritation of the skin area coming in contact with such edges and/or corners of the outer surface 131 and/or the inner surface 132 of the applicator.
[0095] The outer surface 131 and/or the inner surface 132 of the applicator 130 may be hydrophobic or hydrophilic depending on the pharmaceutical and/or cosmetic composition. Preferably the surface of the applicator 130 used for receiving the composition is hydrophobic. A suitable material of the applicator 130 is polypropylene (PP), however, also other polymeric materials known to the skilled person in the technical field of applicator systems can be used. The quality most preferably complies with Ph. Eur. § 3.1.3 Polyolefins and § 3.1.6 Polypropylenes for containers and closures for parenteral and ophthalmic preparations.
[0096] The outer surface 131 and/or the inner surface 132 of the applicator 130 more preferably is roughened in order to avoid a slipping or gliding of the composition 140. A slipping or gliding is particularly problematic if the composition is an oil-in-water emulsion.
[0097] The pharmaceutical and/or cosmetic composition 140 may be an oil-in-water emulsion (O/W) comprising a glycopyrronium salt (GP salt) and an emulsifier system. Preferably the emulsifier system comprises at least one macrogol glycerol fatty acid ester, at least one glycerol fatty acid ester and at least one fatty alcohol. Such an emulsion may be used as a medicament, in particular for treating and preventing diseases in conjunction with excessive sweating (hyperhidrosis). In a non-therapeutic (cosmetic) use, such an oil-in-water emulsion for topical application may be used on the skin of a mammal in order to reduce sweating. The composition 140 may contain pharmaceutically and cosmetically acceptable excipients known to the skilled person. The form of the composition 140 is not particularly limited, however, it preferably is a lotion or cream. Particularly preferred embodiments of the composition 140 are disclosed in the co-pending applications EP 17 181 684 and PCT/EP2018/069273 being incorporated herein by reference. For glycopyrronium salts (GP salts) the application to the skin of the user in a well-defined way is particularly important. The anticholinergic effect of GP may result in a toxicity or undesired pharmacological effects, such as skin irritation or blotching, for the user if administered in high amounts or to unwanted areas of the body. Thus, the system 100 of the invention allows to significantly minimize the risk of a toxic or undesired effect such as an unintended oral administration, accidental ingestion, accidental contamination of body parts such as eyes or ear canal, accidental insufflation, pulmonary aspiration, etc. through composition contaminated hands.
[0098] In one embodiment the system 100 includes the composition 140, for example a composition comprising a glycopyrronium salt (GP salt) and an emulsifier system is stored or filled within the container 110.
[0099] The system 100 is useful for a topical dermal composition. In one embodiment the system 100 is used for storing, dispensing, and applying and/or spreading of a topical composition for medicinal and/or cosmetic use.
[0100] In one embodiment of the system 100, the applicator 130 is configured to be temporarily coated with the predetermined amount 141 of the composition 140, and further configured for spreading the predetermined amount 141 of the composition 140 on a skin area of a user, and also configured to be used as a closure for the container 110 and/or the dosing unit 120, by being mechanically coupled, at the first location 112, 122 of the container 110 and/or the dosing unit 120, respectively. Thus, the applicator 130 may be used as a closure for the container 110 and/or the dosing unit 120 and used for being temporarily coated with the predetermined amount 141 of the composition 140 and for spreading the predetermined amount 141 of the composition 140 on a skin area of a user.
[0101] The present technique envisages the applicator 130 used in the system 100, wherein the system is as explained hereinabove with reference to
LIST OF REFERENCE SIGNS
[0102] 100 system [0103] 110 container [0104] 112 first location of the container [0105] 114 second location of the container [0106] 120 dosing unit [0107] 121 opening [0108] 122 first location of the dosing unit [0109] 124 actuation surface of the dosing unit [0110] 130 applicator [0111] 131 outer surface of the applicator [0112] 131a application part [0113] 131b gripping part [0114] 131c boundary region [0115] 131d flow-arresting means [0116] 131e grip-enhancing means [0117] 132 inner surface of the applicator [0118] 133 opening of the applicator [0119] 135 inner space of the applicator [0120] 140 pharmaceutical and/or cosmetic composition [0121] 141 predetermined amount of the composition [0122] 150 snap-on connection