Reservoir system with closed membrane
A dermal or transdermal therapeutic system comprising a reservoir that contains at least one active substance, an active substance-permeable membrane which delimits the active-substance reservoir, and a closing layer. The closing layer is impermeable to the active substance at a temperature lying below the skin temperature while being permeable at skin temperature and above.
1. A dermal or transdermal therapeutic system prepared for applying to the skin of a patient, said therapeutic system comprising:
an active substance reservoir;
an active substance-permeable membrane which delimits the active substance reservoir on one side; and
a temperature dependent closing layer overlaying said membrane, said closing layer being impermeable to an active substance in said reservoir at a temperature lying below a skin temperature of the patient while being permeable to the active substance at or above the patient's skin temperature, said closing layer functioning as a switch, to be in the impermeable condition at temperatures below skin temperature, and switching to the permeable condition when said closing layer is applied to the skin of the patient, said closing layer consisting of a homogeneous mixture of materials consisting of beeswax and carnauba wax, with the proportion of beeswax being in the range of about 40 to 95% by weight and the proportion of carnauba wax being in the range of about 5 to 60% by weight.
2. The dermal or transdermal therapeutic system according to claim 1 , wherein the closing layer has permeation-enhancing properties at skin temperature and above.
3. The dermal or transdennal therapeutic system according to claim 1 , wherein the closing layer has pressure-sensitive adhesive properties.
4. The dermal or transdermal therapeutic system according to claim 1 , wherein the thickness of the closing layer lies in the range of 50 μm to 600 μm.
5. The dermal or transdermal therapeutic system according to claim 1 , wherein the thickness of the closing layer lies in the range of 100 μm to 500 μm.
6. The dermal or transdermal therapeutic system according to claim 1 , wherein the thickness of the closing layer lies in the range of 200 μm to 400 μm.
7. The dermal or transdermal therapeutic system according to claim 1 , wherein the active substance reservoir is formed as a solid, semi-solid, or liquid reservoir.
8. A dermal or transdermal therapeutic system comprising:
an active substance reservoir;
an active substance-permeable membrane which delimits the active substance reservoir; and
a closing layer, the closing layer being impermeable to an active substance at a temperature lying below a skin temperature while being permeable to the active substance at skin temperature or above, wherein the closing layer comprises 0.1 to 10% by weight of antioxidants, wherein the antioxidants are polyethylene glycol derivatives of tocopherol.
9. The dermal or transdermal therapeutic system according to claim 8 , wherein the closing layer comprises a material selected from the group consisting of vegetable fats and animal fats and mixtures thereof.
10. The dermal or transdermal therapeutic system according to claim 8 , wherein the closing layer comprises a material selected from the group consisting of cocoa butter, cupuacu butter, carnauba wax, candelilla wax, shea butter, lanolin, beeswax, hard fat, neutral oil, colophony, and mixtures thereof.
11. The dermal or transdermal therapeutic system according to claim 8 , wherein the closing layer comprises a material selected from the group consisting of mixtures of vegetable fats and animal fats and mixtures of vegetable fats and animal fats in combination with resins.
12. A dermal or transdermal therapeutic system prepared for applying to the skin of a patient, said therapeutic system comprising:
an active substance reservoir;
an active substance-permeable membrane which delimits the active substance reservoir on one side; and
a temperature dependent closing layer overlaying said membrane, said closing layer being impermeable to an active substance in said reservoir at a temperature lying below a skin temperature of the patient while being permeable to the active substance at or above the patient's skin temperature, said closing layer functioning as a switch, to be in the impermeable condition at temperatures below skin temperature, and switching to the permeable condition when said closing layer is applied to the skin of the patient, said closing layer comprising 0.1 to 10% by weight of antioxidants, said antioxidants being polyethylene glycol derivatives of tocopherol.