Patent US4769028A successfully refreshed from Google Patents.
US4769028A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Pharmaceutical product, in medical bandage form
Assignee: Sanol Schwarz GmbH
•
Filing: 1986-07-17
•
Granted: 1988-09-06
•
Expires: 2006-07-17
Abstract
Abstract The present invention is related to a pharmaceutical product preferably in medical bandage form, for the controlled release of a therapeutically active agent or several such agents to the skin. The pharmaceutical product of the invention consists of an impermeable backing layer, a particularly composed supersaturated reservoir layer for the therapeutically active agent connected therewith and comprising a polymer matrix wherein the therapeutically active agent is soluble and which is permeable to the active agent, an adhesive layer connected with the reservoir layer and permeable to the active agent, and a cover layer covering and adhering to said adhesive layer and removable therefrom for the use of the pharmaceutical product as transdermal therapeutic system, said reservoir layer for the therapeutically active agent consisting of a multitude of layers wherein the concentration of the therapeutically active agent increases from layer to layer with increasing distance from the adhesive layer, and process for producing such a pharmaceutical product.
Inventors
- 👤 Hans R. Hoffmann
- 👤 Reinhold Meconi
- 👤 Michael Wolff
- 👤 Horst Zerbe
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-27 15:53
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084; A61K9/7092
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
179 words
In a pharmaceutical product, in medical bandage form, for the controlled release of one or several therapeutically active agents to the skin comprising: (a) an impermeable backing layer, (b) a reservior layer adjacent to and in close contact with said backing layer, said reservior layer comprising a polymer matrix wherein said therapeutically active agent or agents are soluble and which is permeable to said agent or agents, (c) an adhesive layer adjacent to, and in close contact with, said reservoir layer and permeable to said therapeutically active agent or agents, and (d) a cover layer covering and adhering to said adhesive layer and removable therefrom for the use of said pharmaceutical product as a transdermal therapeutic system, the improvement wherein said reservoir layer for the therapeutically active agent or agents consists of a multitude of individual layers, each layer having a concentration of said therapeutically active agent or agents above saturation and the concentration of the therapeutically active agent or agents in said individual layers increasing from individual layer to individual layer with increasing distance from said adhesive layer.
Claim 2
Dependent Claim
179 words
In a pharmaceutical product, in medical bandage form, for the controlled release of one or several therapeutically active agents to the skin comprising: (a) an impermeable backing layer, (b) a reservior layer adjacent to and in close contact with said backing layer, said reservior layer comprising a polymer matrix wherein said therapeutically active agent or agents are soluble and which is permeable to said agent or agents, (c) an adhesive layer adjacent to, and in close contact with, said reservoir layer and permeable to said therapeutically active agent or agents, and (d) a cover layer covering and adhering to said adhesive layer and removable therefrom for the use of said pharmaceutical product as a transdermal therapeutic system, the improvement wherein said reservoir layer for the therapeutically active agent or agents consists of a multitude of individual layers, each layer having a concentration of said therapeutically active agent or agents above saturation and the concentration of the therapeutically active agent or agents in said individual layers increasing from individual layer to individual layer with increasing distance from said adhesive layer.
Claim 3
Dependent Claim
22 words
The pharmaceutical product as claimed in claim 1, additionally having an adhesive layer between said impermeable backing layer and said reservoir layer.
Claim 4
Dependent Claim
19 words
The pharmaceutical product as claimed in claim 1, wherein said reservoir layer consists of 2 to 12 individual layers.
Claim 5
Dependent Claim
19 words
The pharmaceutical product as claimed in claim 1 wherein said reservoir layer consists of 2 to 6 individual layers.
Claim 6
Dependent Claim
36 words
The pharmaceutical product as claimed in claim 1 wherein said individual layers are equal or different in their individual thickness, the thickness of each individual layer being in the range of from 0.005 to 5.0 mm.
Claim 7
Dependent Claim
40 words
The pharmaceutical product as claimed in claim 2 wherein said individual layers of the reservoir layer are equal or different in their individual thickness, the thickness of each individual layer being in the range of from 0.005 to 5.0 mm.
Claim 8
Dependent Claim
36 words
The pharmaceutical product as claimed in claim 4 wherein said individual layers are equal or different in their individual thickness, the thickness of each individual layer being in the range of from 0.01 to 0.5 mm.
Claim 9
Dependent Claim
24 words
The pharmaceutical product as claimed in claim 5 wherein said adhesive layer has a thickness in the range of from 0.005 to 3.0 mm.
Claim 10
Dependent Claim
24 words
The pharmaceutical product as claimed in claim 6 wherein said adhesive layer has a thickness in the range of from 0.005 to 3.0 mm.
Claim 11
Dependent Claim
24 words
The pharmaceutical product as claimed in claim 7 wherein said adhesive layer has a thickness in the range of from 0.01 to 0.5 mm.
Claim 12
Dependent Claim
42 words
The pharmaceutical product as claimed in claim 1 wherein the polymer matrix comprises one or several usual additives selected from the group consisting of the plasticizers, the adhesive agents, the resorption improving agents, the carrier materials, the stabilizing agents, and the fillers.
Claim 13
Dependent Claim
24 words
The pharmaceutical product as claimed in claim 1 wherein the individual layers forming the reservoir layer are equal or different in polymer matrix material.
Claim 14
Dependent Claim
60 words
The pharmaceutical product as claimed in claim 1 wherein the amount of therapeutically active agent or agents in the reservoir layer is up to the tenfold of the therapeutically necessary amount which is determined by the type of therapeutically active agent or agents, the intended duration of administration and the intended field of pharmaceutical use for the therapeutically active agent.
Claim 15
Dependent Claim
76 words
The pharmaceutical product as claimed in claim 1 or claim 2 wherein the proportion between the concentration of the therapeutically active agent or agents in g per cm 3 in the individual layer of said reservoir layer adjacent to said adhesive layer and the concentration of the therapeutically active agent or agents in the individual layer adjacent to said backing layer or, respectively, said additional adhesive layer, is in the range of from 1:1.1 to 1:20.
Claim 16
Dependent Claim
20 words
The pharmaceutical products as claimed in claim 14 wherein said proportion is in the range of from 1:2% to 1:20.
Claim 17
Dependent Claim
126 words
Process for the production of a pharmaceutical product as claimed in claim 1 or claim 2 wherein there is coated onto a removable cover layer said adhesive layer permeable to the therapeutically active agent or agents to be incorporated into the pharmaceutical product, there then are coated consecutively onto said adhesive layer the various individual layers of said reservoir layer, first the individual layer with the lowest concentration in therapeutically active agent or agents and thereafter the individual layers with increasing concentration in therapeutically active agent or agents, if desired, there thereafter is coated the additional adhesive layer and finally said lacking layer, or wherein the coating procedure is effected in the contrary sequence starting with said backing layer and finalizing with said removable cover layer.
Claim 18
Dependent Claim
100 words
Process as claimed in claim 16 wherein there are used individual coating layer materials for building up said reservoir layer the concentration of the therapeutically active agent or agents in said individual layer materials being such that the proportion between the concentration of the therapeutically agent or agents in g per cm 3 in the individual layer of said reservoir layer adjacent to said adhesive layer and the concentration of the therapeutically active agent or agents in the individual layer adjacent to said backing layer or, respectively, said additional adhesive layer is in the range of from 1:1.1 to 1:2.
Claim 19
Dependent Claim
56 words
Process as claimed in claim 16 or claim 17 wherein the material for the adhesive and/or the reservoir layers comprises solvent or, respectively, dispersion agent when being used in the coating step, said solvent or dispersion agent is substantially completely removed from said coating material in each coating step before the next coating step is effected.
Claim 20
Dependent Claim
18 words
Process as claimed in claim 16 wherein one or several of the various coatings is applied by lining.
Claim 21
Dependent Claim
24 words
Process as claimed in claim 16 wherein all of the individual layers are produced from a melt of the layer material in each instance.
References Cited (Backward Citations)
US3598122A
Cited
US3598122B1
Cited
US4289795A
Cited
US4341759A
Cited
US4286592A
Cited
US4314557A
Cited
US4297995A
Cited
JPS5984817A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1991-09-06 | 1992-03-07 | 1992-09-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-09-06 | 1996-03-07 | 1996-09-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-09-06 | 2000-03-07 | 2000-09-06 | $7700.00 | Window Closed / Lapsed |