1. A transdermal patch, comprising
a release liner film,
a polymer layer containing a non-crystalline active substance, and
a carrier layer,
wherein the active substance layer is between the release liner film and the carrier layer,
the release liner film andor the carrier layer comprising at least one peripheral separating edge with none of the polymer layer therebetween,
wherein the release liner film and the carrier layer are thermally and detachably directly connected to each other over a length of at least 70% of the peripheral separating edge, such that the polymer layer is sealed by said thermally and detachably connected peripheral separating edge.
2. The transdermal patch according to claim 1, wherein the detachable connection of the peripheral edge is created by a thermal process selected from the group consisting of welding, thermal caulking andor thermal joining.
3. The transdermal patch according to claim 1, wherein the active substance is selected from the group consisting of rotigotine, a pharmacologically acceptable salt of rotigotine, and the free base of rotigotine.
4. The transdermal patch according to claim 1, wherein the polymer layer comprises a silicone-based adhesive.
5. The transdermal patch according to claim 1, in which at least the release liner film comprises a weakened andor breakable region, which weakened andor breakable region can be used as an opening aid for the patch.
6. The transdermal patch according to claim 1, in which the release liner film and carrier layer are made from the same material.
7. The transdermal patch according to claim 1, in which the release liner film has a thickness in the range of about 50-150 \u03bcm.
8. The transdermal patch according to claim 3, wherein rotigotine is present in the active substance layer essentially in the form of the free base and in 5-20 wt %, relative to the weight of the active substance layer.
9. The transdermal patch according to claim 1 for treatment of a disease selected from the group consisting of Parkinson’s disease, Restless Leg Syndrome, Parkinson-Plus, depression and fibromyalgia.
10. The transdermal patch of claim 3 in which no crystals of rotigotine form II can be detected.
11. The transdermal patch of claim 1 wherein said at least one peripheral separating edge is a peripheral edge of said patch.
12. A method for the treatment of a disease, selected from the group consisting of Parkinson-Plus, depression, fibromyalgia, as well as Parkinson’s disease and Restless Leg Syndrome, the method comprising the application to a patient in need thereof of a transdermal patch according to claim 1,
wherein the release liner film and the carrier layer are thermally and detachably connected to each other over a length of at least 70% of the peripheral separating edge, such that the polymer layer is sealed by said thermally and detachably connected peripheral separating edge.
13. A process for manufacturing a transdermal patch according to claim 1, the process comprising
a) providing a release liner film and a carrier layer;
b) providing an active substance layer comprising an active substance selected from rotigotine, rotigotine free base, andor one of its pharmacologically acceptable salts, said active substance layer being disposed between said release liner film and said carrier layer, wherein the release liner film andor the carrier layer of the patch is provided with at least one thermally effected peripheral separating edge,
thermally and detachably bonding the release liner film and the carrier layer directly to each other along at least 70% of the peripheral separating edge, such that the active substance layer is sealed by the thermally bonded peripheral separating edge.
14. The process according to claim 13, wherein the release liner film is thermally weakened andor at least partly broken in a region of a predetermined breaking edge, which predetermined breaking edge can be used as an opening aid for the patch.
15. The process according to claim 13, wherein the thermal bonding is carried out above a melting temperature of an active substance.
16. The process according to claim 13, wherein the thermal bonding is accomplished by means of a pair of heatable opposing rollers.
17. The process according to claim 13, wherein the release liner film and the carrier layer are electrically discharged directly before the release liner film andor the carrier layer are provided with a thermally effected separating edge.
18. The process according to claim 13, wherein the active substance is in amorphous form.
19. The process of claim 18 wherein the appearance of rotigotine crystals in the patch is eliminated.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A condensate removal system for removing condensate from a fluid reservoir, said condensate removal system including:
a fluid conduit including a discharge leg having a first end and a second end, said first end adapted to be connected in fluid communication with the fluid reservoir, said second end including an outlet port, said discharge leg including a first segment extending from said first end toward said second end and a second segment located between said second end and said first segment, said first segment including a first bore having a first cross-sectional area and said second segment including a second bore having a second cross-sectional area, said second cross-sectional area being smaller than said first cross sectional area to inhibit evaporation of fluid within said discharge leg through said outlet port.
2. The condensate removal system of claim 1 wherein said second segment of said discharge leg includes said outlet port, said second segment being slidably attached to said first segment such that the position of the outlet port can be selectively adjusted.
3. The condensate removal system of claim 1 wherein said second segment of said discharge leg includes a seal mechanism, said seal mechanism including a seat and a seal member, said seal member adapted to engage said seat and create a seal therewith to inhibit evaporation of fluid within said discharge leg through said outlet port, said seal member adapted to disengage from said seat to allow fluid within said discharge leg to flow through said outlet port.
4. The condensate removal system of claim 3 wherein said seat is generally annular and said seal member is generally spherical.
5. The condensate removal system of claim 3 wherein said seal member comprises a flap pivotally attached to said discharge leg.
6. The condensate removal system of claim 1 wherein said second end of said discharge leg includes a spout, said spout including said outlet port.
7. The condensate removal system of claim 1 wherein said fluid conduit includes a collection leg, said collection leg including a first end adapted to be connected in fluid communication with the fluid reservoir and a second end adapted to be connected in fluid communication with said first end of said discharge leg.
8. A condensate removal system for removing condensate from a fluid reservoir containing a primary fluid, said condensate removal system including:
a fluid conduit adapted to be connected in fluid communication with the fluid reservoir, said fluid conduit adapted to receive primary fluid and condensate from the fluid reservoir, said fluid conduit including a discharge leg having a first end, a second end and a seal mechanism, said first end adapted to be connected in fluid communication with the fluid reservoir, said second end including an outlet port, said seal mechanism including a seat and a seal member, said seal member adapted to engage said seat to create a seal therewith to inhibit evaporation of condensate within said discharge leg through said outlet port, said seal member adapted to disengage from said seat to allow condensate within said discharge leg to flow through said outlet port to maintain a substantially constant level of primary fluid in the fluid reservoir.
9. The condensate removal system of claim 8 wherein said seat is generally annular and said seal member is generally spherical.
10. The condensate removal system of claim 8 wherein said seal member comprises a flap pivotally attached to said discharge leg.
11. The condensate removal system of claim 8 wherein said outlet port is in fluid communication with the atmosphere.
12. A condensate removal system for removing condensate from a fluid reservoir, said condensate removal system including:
a fluid conduit including a discharge leg having a first end and a second end, said first end adapted to be connected in fluid communication with the fluid reservoir, said second end including an outlet port, said discharge leg including a first segment including said first end and a second segment including said outlet port, said second segment being slidably attached to said first segment such that the position of said outlet port can be selectively adjusted.
13. The condensate removal system of claim 12 wherein said discharge leg includes a seal mechanism, said seal mechanism including a seat and a seal member, said seal member adapted to engage said seat to create a seal therewith to inhibit evaporation of fluid within the discharge leg through said outlet port, said seal member adapted to disengage from said seat to allow fluid within said discharge leg to flow through said outlet port.
14. The condensate removal system of claim 12 including a seal member slidably sealing said second segment to said first segment.
15. The condensate removal system of claim 12 wherein said first segment includes a first bore having a first cross-sectional area and said second segment includes a second bore having a second cross-sectional area, said second cross-sectional area being smaller than said first cross-sectional area.
16. A method of controlling a condensate removal system for removing condensate from a fluid reservoir containing a primary fluid, said method comprising the steps of:
providing a fluid conduit having a discharge leg including a first segment and a second segment, said first segment adapted to be connected in fluid communication with the fluid reservoir, said second segment including an outlet port, said second segment being slidably connected to said first segment;
moving said second segment with respect to said first segment to thereby adjust the elevation of said outlet port to a desired elevation with respect to the fluid reservoir as determined by the specific gravity of the primary fluid.
17. A method of controlling a condensate removal system for removing condensate from a fluid reservoir containing a primary fluid, said method comprising the steps of:
providing a fluid reservoir adapted to contain a primary fluid, and a fluid conduit having a discharge leg including a first end adapted to be connected in fluid communication with the fluid reservoir and a second end including a seat and a seal member adapted to selectively create a seal with said seat, said discharge leg adapted to contain condensate;
sealing said seat of said discharge leg with said seal member to inhibit evaporation of condensate within said discharge leg through said seat; collecting condensate from said fluid reservoir in said fluid conduit; and
breaking said seal between said seat of said discharge leg and said seal member to allow condensate within said discharge leg to flow through said seat to maintain a substantially constant level of primary fluid in said reservoir.
18. The method of claim 17 wherein the primary fluid has a first specific gravity and the condensate has a second specific gravity, said second specific gravity being greater than said first specific gravity.
19. A method of controlling a condensate removal system for removing condensate from a fluid reservoir containing a primary fluid, said method comprising the steps of:
providing a fluid conduit having a discharge leg including a bore extending from a first end to a second end of said discharge leg, said first end adapted to be connected in fluid communication with the reservoir, said second end including an outlet port;
decreasing the cross-sectional area of said bore from a first cross-sectional area at said first end of said discharge leg to a second cross-sectional area adjacent said outlet port to inhibit evaporation of fluid with said discharge leg through said outlet port.