权利要求：
1. An applicator for applying a pharmaceutical preparation to a skin surface of a patient in
need thereof, said applicator comprising one or more substantially rigid side walls
bounding a cavity which is open at a bottom end and closed at a top end by a top wall
substantially perpendicular to said one or more side wall to form a cap which fits over and
encloses a top portion of a container and dispenser for the pharmaceutical preparation, the
side walls being configured to detachably engage with a top portion of the container or
dispenser, said closed top end of the cap having an outer surface comprising
a central flat and continuous face which is solid and non-porous such that liquid
cannot pass through said face, the flat outer face being useful for receiving one or more
doses of the pharmaceutical preparation dispensed thereon from the pharmaceutical
preparation container, and
a peripheral ridge bounding the flat face and forming a reservoir area for retaining
the pharmaceutical preparation within said reservoir area on the flat face when the
pharmaceutical preparation is dispensed thereon.
The applicator of claim I wherein the one or more substantially rigid side walls flexibly
engage with and detachably affix to the top portion of the container or dispenser.
3. The applicator of claim 1 wherein the substantially rigid side walls comprise a ridge or
protrusion formed thereon to matingly engage the top portion of the container or the
dispenser.
4. The applicator of claim 3 wherein the substantially rigid side walls matingly engage the
top portion of the container or the dispenser to form a substantially airtight seal.
5. The applicator of claim 3 wherein the side wall ridge or protrusion is formed as threads to
threadingly engage the top portion of the container or the dispenser.
6, The applicator of claim 1 comprising a single side wall forming a. cross-sectionally
circular or oval shaped applicator.
7. The applicator of claim 6 wherein the outer top surface of the top end of the applicator
comprises a circular or oval ridge circumferentially hounding the central flat face of the
cap.
8, The applicator of claim 1 comprising four side walls forming a cross-sectionally
rectangular shaped applicator.
9. The applicator of claim 1 wherein the peripheral ridge has a top surface which is rounded.
10. The applicator of claim 1 wherein the one or more side walls of the cap comprise
indentations to facilitate gripping and handling or attaching or detaching the cap.
11. The applicator of claim 1, wherein the applicator further comprises an overcap which
covers at least the central flat surface of the applicator.
12. The applicator of claim 1 wherein the central flat continuous face of the outer surface of
the cap provides for application of the dispensed dose or doses of pharmaceutical
preparation to the skin surface of the patient and the peripheral ridge serves to retain the
dispensed pharmaceutical preparation within the reservoir area formed in the central flat
face during administration of the pharmaceutical preparation.
13. The applicator of claim I wherein the skin surface is on an axilla of xe patient.
14. The applicator of claim 1 wherein the preparation comprises an active pharmaceutical
ingredient useful to treat or ameliorate excessive sweating or hyperhidrosis.
15. The applicator of claim 14, wherein the active pharmaceutical ingredient is sofpironiuni
bromide.
16, The applicator of claim 1 wherein the pharmaceutical preparation is a gel.
17. A system for applying a pharmaceutically acceptable preparation to a skin surface of a
patient in need thereof, said system comprising
- a container for housing and storing a plurality of doses of the pharmaceutical
preparation, the container having an opening at a top end for receiving and engaging a
dispenser for dispensing a metered dose of the pharmaceutical preparation, and
- a cap covering the dispenser and detachably engaging the top portion of the container
or a portion of the dispenser, said cap comprising one or more substantially rigid side
walls bounding a cavity which is open at a bottom end and closed at a top end by a
top wall perpendicular to said one or more side wall, said closed top end of the cap
having au outer surface comp-rising a central flat, continuous face, which is solid and
non-porous such that liquid cannot pass through said face, and a peripheral ridge
bounding the flat face and defining a reservoir area for retaining the pharmaceutical
preparation within said reservoir area on the flat face when the pharmaceutical
preparation is dispensed thereon,
wherein the cap further serves as an applicator for receiving and retaining the
dispensed pharmaceutical preparation within the reservoir area of said flat face and
allowing the pharmaceutical preparation to be administered to the patient from the flat
face when applied to the skin surface of said patient.
18. The system of claim 17 further comprising an overcap which engages with the cap and
covers at least the central flat surface of the applicator.
19. The system of claim 17 wherein the container further comprises a bottom end which is
open or in open communication with ambient air outside the container to allow
equilibration of pressure within the container following dispensing of the pharmaceutical
preparation from the container.
20. The system of claim 17 wherein the container further comprises a piston within the
container which reduces storage volume of contents within the container upon each dose
dispensation and compresses the contents for ultimately dispensing substantially all the
pharmaceutical preparation from the container.
1. The system of claim 17 wherein the container further comprises a collapsible inner liner
disposed within the container whiCh reduces storage volume of contents within the
container upon each dose dispensation and compresses the contents for ultimately
dispensing substantially all the pharmaceutical preparation from the container.
22. The system of claim 17 wherein tine container includes a bottom cap forming a base of the
container.
23. The system of claim 17 wherein the dispenser is a pump dispenser.
24. The system of claim 23 wherein the pump dispenser is a metered-dose pump dispenser.
25. A method for treating or ameliorating excessive sweating or hyperhidrosis in a patient in
need thereof, said method comprising the steps of:
a) providing a container having a contents comprising a pharmaceutical preparation
effective for treating or ameliorating excessive sweating or hyperhidrosis, and a
dispenser engaged with said container for dispensing the pharmaceutical preparation
from said container, said container including a detachable applicator fitting over a top
portion of said container and dispenser, said applicator comprising one or more
substantially rigid side walls bounding a cavity which is open at a bottom end and
closed at a top end substantially perpendicular to said one or more side wall, said
Closed top end of the applicator having an outer surface comprising a central flat and
continuous face whiCh is solid and non-porous, and a peripheral ridge bounding the
flat face and forming a reservoir area for retaining the pharmaceutical preparation
within said reservoir area on the flat face when the pharmaceutical preparation is
dispensed thereon from the container; the applicator optionally comprising an overcap
which covers at least the reservoir area on the flat face of the cap;
b) removing the cap from the container and, if present, removing the overcap from the
applicator;
c) dispensing one or more doses of the pharmaceutical preparation into the reservoir area
on the outer flat face of the applicator; and
d) applying the dispensed dose or doses onto the skin surface of the patient.
26. The method of claim 25 wherein the pharmaceutical preparation is in the form of a
solution, suspension, lotion, cream, light ointment, foam or gel.
27. The method of claim 25 wherein the pharmaceutical preparation is dispensed from the
container by a metered dose dispenser as a single dose.
28. The method of claim 25 wherein the pharmaceutical preparation comprises an active
pharmaceutical ingredient which is effective for treating or ameliorating excessive
sweating or hyperhidrosis.
29. The method of claim 25 wherein the active pharmaceutical ingredient is sofpironium
bromide.
30. The method of claim 25 wherein the pharmaceutical preparation comprises one or more
carriers or excipients selected from the group consisting of a solvent, a co-solvent, a
penetration enhancer, a pH-modifying agent, and a viscosity modulating agent.
31. The method of claim 30 wherein the pharmaceutical preparation further comprises
isopropyl myristate.
32. The method of claim 25 wherein the skin surface is on an axilla of the patient.
33. The method of claim 25 wherein the pharmaceutical preparation is dispensed and applied
to the skin surface at least one time per day.
34. The method of claim 25 wherein the pharmaceutical preparation is dispensed and applied
to the skin surface one to four times daily.
35. The method of claim 25 wherein the pharmaceutical preparation is dispensed and applied
to the skin surface before the patient's sleep period.
36. The method of claim 25 wherein the patient is a human.
37, The method of claim 25 wherein the patient is suffering from hyperhidrosis or excessive
sweating.
38. An applicator system used for applying a pharmaceutical preparation for topical or
transdermal administration on a body surface, the pharmaceutical preparation having
viscosity in a range from 100 to 2000 centipoise at 25°C, the applicator system including:
a container configured to accommodate the pharmaceutical preparation; and an applicator
detachably attached to the container, the applicator including an therapeutic surface
capable of receiving a single dose of the pharmaceutical preparation to be applied on a
body surface, the therapeutic surface being formed by a rigid, non-elastic material, and
forming a single recess.
39. The applicator system described in Claim 38, in which the pharmaceutical preparation is
selected from the group consisting of a gel, a lotion, a cream and a liquid preparation,
each having viscosity in a range from 100 to 1100 centipoise at 25°C.
40. The applicator system described in Claim 39, in which the pharmaceutical preparation has
viscosity in a range from 100 to 900 centipoise at 25°C.
41. The applicator system described in any one of Claim 38 to 40, in which the
pharmaceutical preparation is a preparation containing 40w/w% or more of one or a
plurality of C I -C4 alcohols.
42. The applicator system described in any one of Claim 38 to Claim 41, in which the single
dose is in a range from 0,1 mI, to 1 mL.
43. The applicator system described in any one of Claim 38 to Claim 42, in which the
therapeutic surface includes only an outer peripheral ridge portion merging into a side
surface of the applicator and a top outer surface surrounded by the outer peripheral ridge
portion.
44. The applicator system described in Claim 43, in which the top outer surface forms a
single flat portion and the single flat portion occupies 5?/ or more of a surface area of the
therapeutic surface.
45. The applicator system described in Claim 44, in which the single flat portion occupies
60% or more of the surface area of the therapeutic surface.
46. The applicator system described in any one of Claim 38 to Claim 45, in which a
difference in height between an uppermost portion of the therapeutic surface and a
lowermost portion of the therapeutic surface is in a range from 0.1 mm to 4.0 mm.
47. The applicator system described in Claim 46, in which the difference in height between
the uppermost portion of the therapeutic surface and the lowermost portion of the
therapeutic surface is in a range from 0.1 mm to 1.5 mm.
48. An applicator system described in any one of Claim 38 to Claim 47, in which the
therapeutic surface has a substantially circular shape having a diameter in a range from
20 mm to 45 mm or a substantially oval shape having a. long or short diameter in a. range
from 20 mm to 45 mm as viewed from above.
49. The applicator system described in any one of Claim 38 to Claim 48, in which the
container includes a bottle portion configured to accommodate the pharmaceutical
preparation and a pump portion attached to a mouth portion of the bottle portion.
50. The applicator system described in Claim 49, in which the therapeutic surface is
configured to be capable of receiving the single dose of the pharmaceutical preparation
dispensed from the pump portion.
51. The applicator system described in any one of Claim 38 to Claim 50, in which the
pharmaceutical preparation includes sofpironium bromide used for treatment of
hyperhidrosis.
52. The applicator system described in any one of Claim 38 to Claim 51 in which the
applicator is configured to be applied to an axilla.
53. An applicator used for applying a pharmaceutical preparation for topical or
transdermal administration on a body surface, the pharmaceutical preparation having a
viscosity in a range from about 100 to 3000 centipoise at 25°C, the applicator including a
therapeutic surface capable of receiving a single dose of the pharmaceutical preparation to
be applied on a body surface, the therapeutic surface being formed by a rigid, non-elastic
material, and forming a single recessed reservoir area.
54. The applicator described in Claim 53, in which the pharmaceutical preparation is
selected from the group consisting of a gel agent, a lotion agent, a cream agent and a liquid
agent, each having viscosity in a range from 100 to 1500 centipoise at 25°C.
55. The applicator described in Claim 54, in which the pharmaceutical preparation has
viscosity in a range from 100 to 1000 centipoise at 25°C.
56. The applicator described in any one of Claim 53 to Claim 55, in which the
pharmaceutical formulation is a preparation containing 40w/w%= or more of one or a
plurality of C1-C4 alcohols.
57. The applicator described in any one of Claim 53 to Claim 56, in which the single
dose is in a range from 0.1 mL, to 1 mL.
58. The applicator described in any one of Claim 53 to Claim 57, in which the
therapeutic surface includes only an outer peripheral ridge portion merging into a side wall
of the applicator and a top surface, including the therapeutic surface surrounded by the
outer peripheral ridge portion.
59. The applicator described in Claim 58, in which the top outer surface forms a single
flat portion and the single flat portion includes a therapeutic surface that occupies 5% or
more of a surface area of the applicator top surface.
60. The applicator described in Claim 59. in which the single flat portion occupies 60%
or more of the surface area of the applicator top surface.
61. The applicator described in any one of Claim 53 to Claim 60, in which a difference in
height between an uppermost portion of the outer ridge and the therapeutic surface of the
applicator is in a range from 0.1 mm to 4.0 mm.
62. The applicator described in Claim 61, in which the difference in height between the
uppermost portion of outer ridge and the therapeutic surface of the outer ridge is in a range
from 0.1 mm to 1.5 mm.
63. The applicator described in any one of Claim 53 to Claim 62, in which the
therapeutic surface has a substantially circular shape having a diameter in a range from
20 mm to 45 mm or a substantially oval shape having a long or short diameter in a range
from 20 mm to 45 mm as viewed from above.
64. The applicator described in any one of Claim 53 to Claim 63, in which the
pharmaceutical preparation includes sofpironium bromide used for treatment of
hyperhidrosis.
65. The applicator described in any one of Claim 53 to Claim 64 in which the applicator
is configured to be applied to an axilla.