Claims
- 1. An applicator for applying a spreadable composition to the skin or other exterior region of a human or animal body, comprising receiving means for receiving and carrying a unit or measured dose of the composition and a grip for enabling a user to grip and manipulate the applicator, wherein the grip and receiving means are arranged such that a user gripping the applicator by the grip is protected from inadvertent contact with a composition, a unit or measured dose of which is carried by the receiving means.
- 2. An applicator as claimed in claim 1, shaped to shield the grip, or a zone in the vicinity of the grip, from contact with a composition, a unit or measured dose of which is carried by the receiving means.
- 3. An applicator as claimed in claim 1 or claim 2, comprising a shroud around at least a portion of the grip, or a zone in the vicinity of the grip, wherein the shroud is arranged to shield said zone or portion of the grip from a composition, a unit or measured dose of which is carried by the receiving means.
- 4. An applicator as claimed in any of the proceeding claims, wherein the grip is arranged to be held between a finger and thumb of a user's hand.
- 5. An applicator as claimed in claim 4, shaped to shroud the tips of a finger and thumb holding the grip.
- 6. An applicator as claimed in any of claims 1-3, wherein the grip is in the form of a sheath arranged to engage and accommodate a user's finger or thumb.
- 7. An applicator as claimed in any of the proceeding claims, wherein the receiving means forms a portion of a spreading means for facilitating the spreading of a composition, a unit or measured dose of which is carried by the receiving means, on the skin or other exterior region of a human or animal body.
- 8. An applicator as claimed in claim 7, wherein the receiving and spreading means are integrally formed.
- 9. An applicator as claimed in claim 7 or 8, comprising a combined spreading and receiving means, wherein said combined spreading and receiving means also serves to shield the grip, or a zone in the vicinity of the grip, from contact with a composition, a unit or measured dose of which is carried by the receiving means.
- 10. An applicator as claimed in any of the proceeding claims in the form of a single piece moulding.
- 11. An applicator as claimed in any of the proceeding claims, wherein the grip is foldable or collapsible from a position where is it extended for use into a storage position.
- 12. An applicator as claimed in claim 11, further comprising means for releasably retaining the grip in said storage position.
- 13. An applicator as claimed in any of the proceeding claims, wherein the receiving means are arranged to define a recess that can accommodate a unit dose of the spreadable composition with a face of the unit dose exposed for application to the skin and at least a portion of the unit dose within the recess, wherein the depth of the recess adjusts automatically and sufficiently to allow substantially all of a unit dose accommodated in the recess to be applied through skin contact induced erosion at said exposed face of the unit dose.
- 14. An applicator as claimed in claim 13, wherein the recess is configured to confine at least an uneroded portion of the unit dose.
- 15. An applicator as claimed in claim 14, wherein the recess is configured to resist displacement of said portion of the unit dose from the recess other than as a result of skin contact induced erosion at said exposed face of the unit dose.
- 16. An applicator as claimed in any of claims 13-15, wherein a first recess defining portion of the receiving means is resiliently mounted with respect to a second recess defining portion of the receiving means to provide said automatic depth adjustment.
- 17. An applicator as claimed in any of claims 13-16, wherein the first and second recess defining portions of the receiving means form a platform, a first portion of which is recessable relative to a second to provide said recess.
- 18. An applicator as claimed in claim 17, wherein the first portion of the platform is surrounded by the second portion of the platform.
- 19. An applicator as claimed in claim 17 or 18, wherein the first portion of the platform is variably recessable relative to the second.
- 20. An applicator as claimed in any of claims 17-19, wherein the first and/or second portion(s) of the platform is or are resiliently mounted.
- 21. An applicator as claimed in any of claims 17-20, wherein the first recess defining portion of the receiving means is embodied by the second portion of the platform and the second recess defining portion of the receiving means is embodied by the first portion of the platform.
- 22. An applicator as claimed in any of claims 17-20, wherein the first recess defining portion of the receiving means is embodied by the first portion of the platform and the second recess defining portion of the receiving means is embodied by the second portion of the platform.
- 23. An applicator as claimed in any of claims 17-21, wherein the first portion of the platform comprises a pad in a fixed relationship with the grip, said pad being surrounded by the second portion of the platform, and said second portion of the platform is retractable relative to the pad and grip against resilient pressure.
- 24. An applicator as claimed in any of the proceeding claims, wherein the grip, or a zone in the vicinity of the grip, is protected or shielded from contact with the spreadable composition during application of the latter.
- 25. An applicator as claimed in any of the proceeding claims further comprising a unit or measured dose of a spreadable composition carried on or coupled to the receiving means.
- 26. An applicator as claimed in any of the proceeding claims, wherein the unit or measured dose of the spreadable composition is, at ambient or room temperatures, a solid unit dosage form.
- 27. An applicator as claimed in claim 26, wherein the solid unit dosage form is a solid tablet.
- 28. An applicator as claimed in claim 26 or 27, wherein the receiving means comprises a surface adapted to retain a solid unit dosage form or tablet.
- 29. An applicator as claimed in any of the proceeding claims, wherein the spreadable composition is solid at ambient or room temperatures, but softens sufficiently to be spreadable on contact with the skin of a live human or animal body.
- 30. An applicator as claimed in any of the proceeding claims, wherein the solid composition or unit dosage form remains solid when heated to temperatures of up to 25, 26, 27 or 28° C., but softens sufficiently to be spreadable, or has a softening point, when heated to a temperature no higher than 37, 35, 34, 33 or preferably 32° C.
- 31. An applicator as claimed in claim 30, wherein the softening point of the solid composition or unit dosage form is the temperature at which its viscosity is reduced to 100,000 and preferably 50,000 centipoise, or below.
- 32. An applicator as claimed in any of the preceding claims, wherein the solid composition or unit dosage form becomes substantially liquid when heated to a physiological temperature, or to a temperature of at least 37, 35, 33, or 33° C.
- 34. An applicator as claimed in any of the preceding claims, wherein, when placed in continuous contact with the skin of a living human or animal body, the solid unit dosage form will soften to a consistency to effect substantial application of the unit dosage form onto the contacted skin within a time period of less than 10, 5 and, preferably, 2 minutes.
- 35. An applicator as claimed in any of the preceding claims, wherein the spreadable composition is a pharmaceutical composition or formulation.
- 36. An applicator as claimed in claim 35, wherein the pharmaceutical composition or formulation comprises a unit dose or a measured dose of a pharmaceutically active agent and, optionally, a pharmaceutically acceptable carrier.
- 37. An applicator as claimed in claim 36, wherein when placed in continuous contact with the skin of a living human or animal body the pharmaceutical composition or formulation will soften to a consistency to effect substantial application of the unit dose of said pharmaceutically active agent onto the contacted skin within a time period of less than 10, 5 and, preferably, 2 minutes.
- 38. An applicator as claimed in any of the proceeding claims packaged in a sealed container.
- 39. An applicator as claimed in claim 38, wherein said applicator is one of a plurality of applicators, each packaged in one of a plurality of sealed containers and said containers form part of an array of such containers.
- 40. A method of treating a human or animal body, comprising applying a spreadable composition to the skin or other external part of said body with an applicator as claimed in any of the proceeding claims.
- 41. A kit comprising an applicator as claimed in any of claims 1-24 and at least one separately packaged unit dosage form.
- 42. A kit as claimed in claim 41, wherein said unit dosage form is a unit dosage form as defined in any one of claims 26-37.
- 43. A method of coupling a solid unit dosage form to an applicator as claimed in any of claims 1-24, comprising heating and melting or softening a surface of the dosage from, contacting that surface with the receiving means and cooling the resulting assembly to harden the melted or softened portion of the dosage form and cause it to become bonded to the receiving means.
- 44. An applicator as claimed in any of claims 1-24 including a surface having indicia of measurement thereon, the surface configured to receive a measured dosage of a pharmaceutical formulation in extruded form.
- 45. A device for topically treating a desired skin region of a living being comprising, an applicator member including a surface having indicia of measurement thereon, the surface configured to receive a measured dosage of a pharmaceutical formulation in extruded form, and a grip extending from the applicator member, the grip configured to be held by a user and to enable the user to move the applicator member with respect to the desired skin region so as to apply and spread the measured dosage over the desired skin region.
- 46. An applicator or device as claimed in claim 44 or 45, further comprising a measured dose of the pharmaceutical formulation.
- 47. An applicator or device as claimed in any of claims 44-46, wherein the desired skin region is larger than the surface carrying the indicia.
- 48. An applicator or device as claimed in any of claims 44-47, wherein the surface carrying the indicia is substantially planar, or at least partially convex.
- 49. An applicator or device as claimed in any of claims 44-48, wherein the pharmaceutical formulation includes a therapeutically effective amount of a therapeutic agent and a pharmaceutically acceptable carrier medium therefor.
- 50. An applicator or device as claimed in any of claims 44-49, wherein the pharmaceutical formulation is in the form of an ointment or a gel.
- 51. An applicator or device as claimed in any of claims 44-50, wherein the applicator member and the grip are of integral construction.
- 52. An applicator or device as claimed in any of claims 44-51, wherein the applicator includes a non-absorptive material.
- 53. An applicator or device as claimed in any of claims 44-52, wherein the applicator member and the grip are configured to enable the application and the spreading without contacting the pharmaceutical formulation with a skin region outside the desired skin region.
- 54. An applicator or device as claimed in any of claims 44-53, wherein the indicia of measurement include spaced markings, preferably in the form of raised ridges, indented ridges, or printed lines.
- 55. A method for applying a pharmaceutical formulation to a desired skin region of a living being, the method comprising extruding an amount of the pharmaceutical formulation onto a surface of an applicator member of a spreading device, the surface including indicia of measurement, the extruding being performed so as to obtain a measured dosage of the pharmaceutical formulation using the indicia of measurement, gripping a grip of the spreading device, the grip extending from the applicator member, and moving the grip with respect to the desired skin region so as to apply and spread the measured dosage over the desired skin region.
- 56. A method as claimed in claim 55, wherein the spreading device is an applicator or device as claimed in any of claims 44, 45 and 47-54.
- 57. A device for topically treating a desired skin region of a living being, the device comprising:
a unit dose of a pharmaceutical formulation including a therapeutically effective amount of a therapeutic agent and a pharmaceutically acceptable carrier medium therefore, the formulation being solid at ambient temperature and having a softening point of not higher than 35, 34, 33, or 32° C., such that when the formulation is placed in a continuous contact with the desired skin region, it is softened to a consistency to effect substantial application of the unit dose onto the desired skin region within a time period of less than 10, 5 or 2 minutes; and an applicator member having a first portion coupled to the unit dose and a second portion configured for being held by a user.
- 58. A device as claimed in claim 57, wherein the user is the living being.
- 59. A device as claimed in claim 57, wherein the user is a second living being.
- 60. A device as claimed in claim 57, further comprising an intermediate member attached to the unit dose, and wherein the first portion of the applicator member is configured to be removably attachable to the intermediate member.
- 61. A device as claimed in claim 57, wherein the first portion of the applicator is removably attachable to the unit dose.
- 62. A device as claimed in claim 57, wherein the unit dose is tablet-shaped.
- 63. A device as claimed in claim 57, wherein the unit dose has an aspect ratio (wall:face) of less than 1:1.
- 64. A device as claimed in claim 57, further comprising a protective layer adhering to the applicator and sealing the unit dose form an outside environment.
- 65. A device as claimed in claim 57, wherein the applicator includes a flange between the first and second portions.
- 66. A device as claimed in claim 57, wherein the second portion includes a hollow cylindrical portion configured to surround a fingertip of the user.
- 67. A device as claimed in claim 57, further comprising a protective wrapper surrounding the applicator and unit dose and sealing the unit dose from an outside environment.
- 68. A device as claimed in claim 57, wherein the second portion includes an elongated tab configured to be gripped by the user.
- 69. A device as claimed in claim 57, further comprising a protective shield removably attached to the applicator and configured to protect the unit dose from an outside atmosphere.
- 70. A device as claimed in claim 69, wherein the protective shield is configured to be attachable to the second portion of the applicator so as to aid the user in holding the applicator.
- 71. A device as claimed in claim 57, wherein the pharmaceutical formulation has a softening point of not higher than the skin temperature of the desired skin region.
- 72. A device as claimed in claim 57, wherein the pharmaceutical formulation, upon being placed into continuous contact with the desired skin region, is softened to a consistency to effect substantial application of the unit dose within a time period of less than 10 minutes.
- 73. A device as claimed in claim 57, wherein the living being is a mammalian patient.
- 74. A device as claimed in claim 57, wherein the mammalian patient is a human.
- 75. A device as claimed in any of claims 57-74, comprising an applicator or a device as claimed in any of claims 1-39 and 44-54.
- 76. A method for topically treating a desired skin region of a living being, the method comprising:
coupling a unit dose of a pharmaceutical formulation to a first portion of an applicator, the formulation including a therapeutically effective amount of a therapeutic agent and a pharmaceutically acceptable carried medium therefore, the formulation being solid at ambient temperature and having a softening point of not higher than 35, 34, 33, or 32° C., such that when the formulation is placed in continuous contact with the desired skin region, it is softened to a consistency to effect substantial application of the unit dose onto the desired skin region within a time period of less than 10, 5 or, preferably, 2 minutes; holding a second portion of the applicator; spreading the unit dose with a skin region outside the desired skin region.
- 77. A method as claimed in claim 76, wherein the applicator is an applicator or device as claimed in any of claims 1-39, 44-54 and 57-75.
Parent Case Info
[0001] This application claims priority from U.S. Provisional Application Serial No. 60/380,030 filed May 6, 2002 and U.S. Provisional Application Serial No. 60/409,264, filed on Sep. 9, 2002, the disclosures of which are incorporated by reference in their entirety.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60380030 |
May 2002 |
US |
|
60409264 |
Sep 2002 |
US |