TTS containing an antioxidant
DC CAFC
First Claim
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1. A pharmaceutical composition comprising:
- (a) a therapeutically effective amount of (S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form (Compound A);
(b) about 0.01 to about 0.5 percent by weight of an antioxidant, based on the weight of the composition, and (c) a diluent or carrier.
1 Assignment
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Accused Products
Abstract
Pharmaceutical composition comprising (S)-N-ethyl-3-[1-dimethylamino)ethyl]-N-methyl-phenyl-carbamate in free base or acid addition salt form and an anti-oxidant. Said pharmaceutical compositions may be delivered to a patient using a transdermal delivery device.
17 Citations
20 Claims
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1. A pharmaceutical composition comprising:
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(a) a therapeutically effective amount of (S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form (Compound A);
(b) about 0.01 to about 0.5 percent by weight of an antioxidant, based on the weight of the composition, and (c) a diluent or carrier. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13, 14)
(a) Compound A in free base form in an amount of 20 to 40% by weight, (b) polymethacrylate in an amount of 10 to 30% by weight, (c) acrylate copolymer in an amount of 40 to 60% by weight, and (d) α - -tocopherol in an amount of between 0.05 and 0.3% by weight
wherein the total weight of the pharmaceutical composition is 100%.
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7. A transdermal device comprising a pharmaceutical composition as defined in claim 1, wherein the pharmaceutical composition is supported by a substrate.
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8. A transdermal device according to claim 7, wherein the pharmaceutical composition is located between an adhesive layer and the substrate.
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9. A transdermal device according to claim 8, wherein a release liner releasably contacts the adhesive layer.
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10. The pharmaceutical composition of claim 1, further comprising silicone oil.
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12. The transdermal device of claim 1, wherein the discrete layer of adhesive material also comprises silicone oil.
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13. The transdermal device of claim 1, wherein the antioxidant is tocopherol, esters thereof, ascorbic acid, butylhydroxytoluene, butylhydroxyanisole, or propyl gallate.
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14. The transdermal device of claim 1, wherein the antioxidant is α
- -tocopherol or ascorbyl palmitate.
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11. A transdermal device comprising a backing layer, a layer comprising a therapeutically effective amount of (S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate (Compound A) and an amount of antioxidant effective to stabilize Compound A from degradation in a polymer matrix, a release-liner and, disposed between the layer comprising Compound A in a polymer matrix and the release-liner, a discrete layer of adhesive material for releasably fixing said transdermal device to a patient'"'"'s skin.
- 15. A method of stabilizing (S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form (Compound A), wherein the method comprises forming a composition by combining Compound A with an amount of anti-oxidant effective to stabilize Compound A from degradation.
Specification
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Litigation Data
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Current AssigneeLTS Lohmann Therapie-Systeme GmbH, Novartis Ag
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Original AssigneeLTS Lohmann Therapie-Systeme GmbH, Novartis Ag
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InventorsKöpke, Kai, Tiemessen, Henricus L. G. M., Gargiulo, Paul M., Dinh, Steven Minh, Horstmann, Michael, Asmussen, Bodo
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Primary Examiner(s)Clardy, S. Mark
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Assistant Examiner(s)Williamson, Michael A.
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Application NumberUS09/291,498Time in Patent Office993 DaysField of Search424/449, 424/448, 602/57, 602/60, 604/290, 604/305, 604/307US Class Current424/449CPC Class CodesA61K 31/27 of carbamic or thiocarbamic...A61K 9/7061 PolyacrylatesA61P 25/28 for treating neurodegenerat...
