Device for the transdermal administration of a rotigotine base
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Accused Products
Abstract
The invention relates to a polymer matrix suitable for the transdermal administration of rotigotine [(−)-5, 6, 7, 8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino)-1-naphtol], containing a matrix for the transdermal administration of rotigotine [(−)-5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1naphtol], containing a matrix polymer which is supersaturated with a rotigotine base. Said polymer matrix is characterised in that the part of the rotigotine which is not dissolved in the matrix polymer is dispersed in the matrix polymer as amorphous particles having a maximum mean diameter of 30 ?m, and the matrix is free of solubilisers, crystallisation inhibitors and dispersants. The invention also relates to a flat device for the transdermal administration of rotigotine, containing the above-mentioned, preferably silicon-based polymer matrix which is supersaturated with rotigutine, and a rear layer which is impermeable to the active ingredient.
158 Citations
28 Claims
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1-11. -11. (canceled)
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12. A matrix for transdermal administering of rotigotine containing a matrix polymer supersaturated with rotigotine base,
wherein a portion of the rotigotine not dissolved in the matrix polymer is dispersed in the matrix polymer as amphorous particles with a maximum mean diameter of 30 μ - m and
the matrix is free of solvents, crystallization inhibitors and dispergents. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
- m and
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13. A matrix for transdermal administering of rotigotine, consisting of:
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(a) matrix polymer, (b) rotigotine base in a concentration above the solubility limit of the matrix polymer, wherein a portion of the rotigotine not dissolved in the matrix polymer is dispersed in matrix polymer as amphorous particles with a maximum mean diameter of 30 μ
m and(c) optionally one or more antioxidants.
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26. A method for producing a pharmaceutical matrix for transdermal administering of rotigotine, comprising:
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(a) dissolving matrix polymer in one or more solvents;
(b) adding rotigotine base in crystalline form in a quantity above the solubility limit of the matrix polymer;
(c) removing solvent and heating the matrix produced in (b) to at least about 74°
C. for a time sufficient to melt rotigotine;
(d) cooling the matrix. - View Dependent Claims (27, 28)
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Specification