Source: http://www.google.com/patents/US6469227?dq=5319712
Timestamp: 2017-08-22 19:50:28
Document Index: 265125714

Matched Legal Cases: ['§341', '§348', '§348', '§348', '§348', '§348', '§348']

Patent US6469227 - Antipruritic patch - Google Patents
The present invention provides a non-occlusive adhesive skin patch. The patch includes a woven or nonwoven porous backing having a front side and a back side. The patch also includes a therapeutic formulation located on the front side of the backing. The backing includes a flexible sheet of water insoluble...http://www.google.com/patents/US6469227?utm_source=gb-gplus-sharePatent US6469227 - Antipruritic patch
Publication number US6469227 B1
Application number US 09/569,783
Also published as WO2001041745A1, WO2001041746A1
Publication number 09569783, 569783, US 6469227 B1, US 6469227B1, US-B1-6469227, US6469227 B1, US6469227B1
Inventors Dede Cooke, David Rolf
Patent Citations (59), Non-Patent Citations (2), Referenced by (57), Classifications (14), Legal Events (13)
US 6469227 B1
1. An adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side; wherein the therapeutic formulation comprises:
camphor present up to about 3.0 wt. % of the therapeutic formulation;
menthol present up to about 1.0 wt. % of the therapeutic formulation; and
2. The patch of claim 1 wherein the therapeutic formulation is positioned on the entire front side of the backing.
a pressure sensitive adhesive; wherein the adhesive patch can effectively cover the entire surface of skin inflicted with a topical disorder.
29. An adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and an ointment wherein the ointment comprises:
30. The adhesive patch of claim 29 wherein the pressure sensitive adhesive is a hot melt adhesive, a solvent based adhesive, a petroleum based adhesive, a water based adhesive, or a combination thereof.
applying to the area of the skin inflicted with the topical disorder an adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and a therapeutic formulation positioned on the front side of the backing; wherein the therapeutic formulation comprises:
camphor present up to about 3.0 wt. % of the therapeutic formulation,
32. The method of claim 31 wherein the adhesive patch can effectively cover the entire skin surface that is inflicted with the topical disorder.
applying to the area of the skin inflicted with the topical disorder an adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side; wherein the therapeutic formulation comprises:
camphor present up to about 3.0 wt. % of the therapeutic formulation:
36. The method of claim 35 wherein the non-occlusive adhesive patch can effectively cover the entire skin surface that is inflicted with the topical disorder.
applying to the entire skin surface inflicted with the topical disorder an adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side; wherein the therapeutic formulation comprises:
43. A method for protecting skin inflicted with a topical disorder or for facilitating the healing process of skin inflicted with a topical disorder comprising:
44. A method for alleviating topical discomfort comprising:
applying to the area of the skin inflicted with the topical disorder an adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and an ointment positioned on the front side of the backing; wherein the ointment comprises:
45. An adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side; wherein the therapeutic formulation comprises:
menthol present up to about 1.0 wt. % of the therapeutic formulation;
46. An adhesive patch comprising a backing of a flexible sheet of water insoluble porous material, the backing having a front side and a back side and a therapeutic formulation positioned on at least a portion of the front side; wherein the therapeutic formulation comprises:
a medicament useful for relieving topical discomfort, wherein the medicament is at least one of camphor, menthol, benzocaine, butamben picrate, dibucaine, dibucaine hydrochloride, dimethisoquin hydrochloride, dyclonine hydrochloride, lidocaine, lidocaine hydrochloride, pramoxine hydrochloride, tetracaine, tetracaine hydrochloride, benzyl alcohol, camphorated metacresol, juniper tar, phenol, phenolate sodium, resorcinol, diphenhydramine hydrochloride, tripelennamine hydrochloride, hydrocortisone, a corticosteroid, and hydrocortisone acetate; and
wherein the camphor is present up to about 3.0 wt. % of the therapeutic formulation and menthol is present up to about 1.0 wt. % of the therapeutic formulation; benzocaine is present in above about 5.0 wt. % to about 20.0 wt. % of the therapeutic formulation; butamben picrate is present in about 0.5 wt. % to about 1.5 wt. % of the therapeutic formulation; dibucaine is present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation; dibucaine hydrochloride is present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation; dimethisoquin hydrochloride is present in about 0.3 wt. % to about 0.5 wt. % of the therapeutic formulation; dyclonine hydrochloride is present in about 0.5 wt. % to about 1.0 wt. % of the therapeutic formulation; lidocaine is present in about 0.5 wt. % to about 4.0 wt. % of the therapeutic formulation; lidocaine hydrochloride is present in about 0.5 wt. % to about 4.0 wt. % of the therapeutic formulation; pramoxine hydrochloride is present in about 0.5 wt. % to about 1.0 wt. % of the therapeutic formulation; tetracaine is present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation; tetracaine hydrochloride is present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation; benzyl alcohol is present in about 10.0 wt. % to about 33.0 wt. % of the therapeutic formulation; camphor is present in about 0.1 wt. % to about 3.0 wt. % of the therapeutic formulation; juniper tar is present in about 1.0 wt. % to about 5.0 wt. % of the therapeutic formulation; phenolate sodium is present in about 0.5 wt. % to about 1.5 wt. % of the therapeutic formulation; resorcinol is present in about 0.5 wt. % to about 3.0 wt. % of the therapeutic formulation; diphenhydramine hydrochloride is present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation; tripelennamine hydrochloride is present in about 0.5 wt. % to about 2.0 wt. % of the therapeutic formulation; hydrocortisone is present in about 0.25 wt. % to less than about 1.0 wt. % of the therapeutic formulation; corticosteroid is present in about 0.25 to about 5.0 wt. % of the therapeutic formulation; camphor is present in about 3 wt. % to about 10.8 wt. % of the therapeutic formulation with phenol; camphor is present in about 3 wt. % to about 10.8 wt. % of the therapeutic formulation with metacresol in about 1 wt. % to about 3.6 wt. % of the therapeutic formulation, as camphorated metacresol; or hydrocortisone acetate is present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation.
FDA regulations (e.g., Federal Register, Vol. 48, No. 27, §341) regulate what components (i.e., “active ingredients”), in a specified amount, may be described as relieving itching (i.e., contains a topical antipruritic). In order to follow FDA regulations, therefore, only a select number of active ingredients that are able to relieve itching, in a specified amount, may be included in an adhesive patch when the patch is described as a relieving itching. Consequently, it is difficult to manufacture a vapor permeable adhesive patch that includes a topical antipruritic, while at the same time maintaining (a) the solubility and stability of the active ingredients in the therapeutic formulation, (b) the pressure sensitive adhesive properties of the therapeutic formulation, and (c) following FDA regulations.
The patch should be able to maintain the solubility and stability of the medicament (e.g., topical antipruritic) during the manufacturing, packaging, shipping, and/or storage of the patch, while maintaining the pressure sensitive adhesive properties of the therapeutic formulation. In addition, the patch should adhere to FDA regulations (e.g., Federal Register, Vol. 48, No. 27, §348).
As used herein, “topical discomfort” is the discomfort associated with an insect bite, rash, skin irritation, poison ivy, poison sumac, or poison oak. As such, the medicament can be an analgesic, an anesthetic, or an antipruritic; as disclosed in Federal Register, Vol. 48, No. 27, §348, and references cited therein. As used herein, an “external analgesic” is a topically (i.e., externally) applied agent that relieves pain by altering perception of nociceptive stimuli without producing anesthesia or loss of consciousness; an “external antipruritic” is a topically (i.e., externally) applied agent that prevents or relieves itching; and an “external anesthetic” is a topically (i.e., externally) applied agent that can reversibly depress neuronal function, producing loss of ability to perceive pain and/or other sensations (see, Stedman's Medical Dictionary, 25th Ed., Ill., 1990, p.65, p.77, and p.99).
The medicament can be present in any appropriate and suitable amount. Specifically, the medicament can be present in about 0.01 wt. % to about 99.9 wt. % of the therapeutic formulation 5. More specifically, the amount of medicament present in the therapeutic formulation 5 can depend upon the specific compound or compounds employed as the medicament. Preferably, the amount of medicament will comply with Federal Register, Vol. 48, No. 27, §348, and references cited therein.
For example, as disclosed in Federal Register, Vol. 48, No. 27, §348, camphor can be present up to about 3.0 wt. % of the therapeutic formulation and menthol can be present up to about 1.0 wt. % of the therapeutic formulation. In addition, benzocaine can be present in about 5.0 wt. % to about 20.0 wt. % of the therapeutic formulation. Butamben picrate can be present in about 0.5 wt. % to about 1.5 wt. % of the therapeutic formulation. Dibucaine can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation. Dibucaine hydrochloride can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation. Dimethisoquin hydrochloride can be present in about 0.3 wt. % to about 0.5 wt. % of the therapeutic formulation. Dyclonine hydrochloride can be present in about 0.5 wt. % to about 1.0 wt. % of the therapeutic formulation. Lidocaine can be present in about 0.5 wt. % to about 4.0 wt. % of the therapeutic formulation. Lidocaine hydrochloride can be present in about 0.5 wt. % to about 4.0 wt. % of the therapeutic formulation. Pramoxine hydrochloride can be present in about 0.5 wt. % to about 1.0 wt. % of the therapeutic formulation. Tetracaine can be present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation. Tetracaine hydrochloride can be present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation. Benzyl alcohol can be present in about 10.0 wt. % to about 33.0 wt. % of the therapeutic formulation. Camphor can be present in about 0.1 wt. % to about 3.0 wt. % of the therapeutic formulation. Juniper tar can be present in about 1.0 wt. % to about 5.0 wt. % of the therapeutic formulation. Phenolate sodium can be present in about 0.5 wt. % to about 1.5 wt. % of the therapeutic formulation. Resorcinol can be present in about 0.5 wt. % to about 3.0 wt. % of the therapeutic formulation. Diphenhydramine hydrochloride can be present in about 1.0 wt. % to about 2.0 wt. % of the therapeutic formulation. Tripelennamine hydrochloride can be present in about 0.5 wt. % to about 2.0 wt. % of the therapeutic formulation. Hydrocortisone can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation. A corticosteroid can be present in about 0.25 to about 5.0 wt. % of the therapeutic formulation. Camphor can be present in about 3 wt. % to about 10.8 wt. % of the therapeutic formulation with phenol in accordance with Federal Register, Vol. 48, No. 27, §348.20(a)(4). Camphor can be present in about 3 wt. % to about 10.8 wt. % of the therapeutic formulation with metacresol in about 1 wt. % to about 3.6 wt. % of the therapeutic formulation, as caphorated metacresol. In addition, hydrocortisone acetate can be present in about 0.25 wt. % to about 1.0 wt. % of the therapeutic formulation. See, e.g., Federal Register, Vol. 48, No. 27, §348.
Preferably, the topical moisturizer can be aloe. Aloe is commercially available as Aloe Vera Gel from Terry Laboratories (Melbourne, Fla.). Aloe Vera Gel is commercially available as Aloe Vera Gel 40×(20.0 wt. % solution in water), Aloe Vera Gel 1×(0.5 wt. % solution in water), Aloe Vera Gel 10×(5.0 wt. % solution in water), or solid Aloe Vera. The solid Aloe Vera can be dissolved in a carrier, such as water, to the desired concentration. In addition, the commercially available forms of Aloe Vera are optionally available as decolorized Aloe Vera.
For example, the topical moisturizer can include Aloe Vera Gel, 1×up to about 40.0 wt. % of the therapeutic formulation 5, up to about 5.0 wt. % of the therapeutic formulation 5, or up to about 1.0 wt. % of the therapeutic formulation 5.
EXAMPLES Example 1: Therapeutic Formulation (in wt. %)
Menthol 1.000
Camphor 3.000
Propylene Glycol 8.100
Glycerin 45.400
Calamine 1.200
Aloe Vera Decolorized 1X 1.000
Karaya 22.300
Acrylic Ester Copolymer Adhesive 17.700
Example 2: Therapeutic Formulation (in wt. %)
Lidocaine 4.000
Glycerin 42.600
Polyacrylamide 17.700
Deionized Water 5.500
Acrylic Ester Copolymer Adhesive 24.200
Example 3: Therapeutic Formulation (in wt. %)
Propylene Glycol 7.100
Polyethylene Glycol 0.400
Glycerin 43.400
Aloe Vera Decolorized 1X 0.500
Calamine 1.000
Polyacrylamide 23.000
Acrylic Ester Copolymer Adhesive 21.100
Example 4: Therapeutic Formulation (in wt. %)
Menthol 0.700
Camphor 2.600
Propylene Glycol 10.300
Fragrance 5.500
Glycerin 38.100
Aloe Vera Decolorized 1X 0.800
Algin 18.500
Acrylic Ester Copolymer Adhesive 23.500
Example 5: Therapeutic Formulation (in wt. %)
Propylene Glycol 2.300
Fragrance 4.500
Glycerin 39.600
Aloe Vera Decolorized 1X 0.700
Karaya 28.300
Deionized Water 4.600
Acrylic Ester Copolymer Adhesive 15.000
Example 6: Therapeutic Formulation (in wt. %)
Example 7: Therapeutic Formulation (in wt. %)
Camphor 2.000
Propylene Glycol 6.100
Fragrance 1.100
Glycerin 40.600
Calamine 1.300
Aloe Vera Decolorized 1X 0.200
Polyacrylamide 24.100
Acrylic Ester Copolymer Adhesive 13.200
Example 8: Therapeutic Formulation (in wt. %)
Lidocaine 2.500
Propylene Glycol 8.400
Polyethylene Glycol 0.700
Glycerin 42.400
Algin 22.500
Deionized Water 4.000
Example 9: Therapeutic Formulation (in wt. %)
Camphor 2.300
Propylene Glycol 9.100
Polyethylene Glycol 0.500
Glycerin 40.300
Calamine 1.100
Aloe Vera Decolorized 1X 0.900
Karaya 26.500
Deionized Water 1.400
Acrylic Ester Copolymer Adhesive 16.600
Example 10: Therapeutic Formulation (in wt. %)
Menthol 0.500
Lidocaine 3.200
Propylene Glycol 8.600
Fragrance 1.200
Glycerin 40.400
Polyacrylamide 18.900
Acrylic Ester Copolymer Adhesive 18.000
Example 11: Therapeutic Formulation (in wt. %)
Lidocaine 3.500
Polyethylene Glycol 7.000
Fragrance 3.400
Glycerin 42.100
Karaya 24.500
Deionized Water 2.500
Acrylic Ester Copolymer Adhesive 13.000
Propylene Glycol 12.300
Fragrance 2.300
Glycerin 44.500
Polyacrylamide 19.250
Deionized Water 3.250
Acrylic Ester Copolymer Adhesive 14.500
Propylene Glycol 5.500
Polyethylene Glycol 1.000
Fragrance 0.700
Glycerin 38.500
Calamine 0.800
Algin 26.500
Acrylic Ester Copolymer Adhesive 25.000
Propylene Glycol 9.200
Polyethylene Glycol 0.800
Glycerin 44.000
Karaya 25.100
Acrylic Ester Copolymer Adhesive 13.500
Glycerin 42.300
Polyacrylamide 17.500
Acrylic Ester Copolymer Adhesive 23.000
Camphor 2.500
Calamine 3.000
Aloe Vera Decolorized 1X 1.500
Deionized Water 7.000
Acrylic Ester Copolymer Adhesive 17.000
Hydrocortisone 0.500
Fragrance 3.600
Glycerin 38.900
Calamine 0.500
Karaya 24.000
Deionized Water 10.500
Polyethylene Glycol 0.200
Glycerin 40.200
Calamine 0.900
Karaya 24.200
Acrylic Ester Copolymer Adhesive 19.000
Lidocaine 3.000
Propylene Glycol 5.200
Polyethylene Glycol 3.200
Glycerin 41.000
Polyacrylamide 25.200
Deionized Water 5.400
Algin 25.900
Deionized Water 4.200
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U.S. Classification 602/48, 602/54, 604/307, 604/304, 424/447, 424/445, 424/448, 424/443
International Classification A61P17/04, A61K9/70
Cooperative Classification A61K9/7061, A61K9/70
European Classification A61K9/70, A61K9/70E2B6B2
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:COOKE, DEDE;ROLF, DAVID;REEL/FRAME:011214/0291
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BUSEMAN, TERI;REEL/FRAME:013035/0557