The present disclosure relates to 5,6,7,8-tetrahydro-6-[N,N-bis[(2-thienyl)ethyl]]amino-1-naphthol, a method for preparing the same, and use of 5,6,7,8-tetrahydro-6-[N,N-bis[(2-thienyl)ethyl]]amino-1-naphthol as a reference compound for determining an impurity in rotigotine or a preparation thereof.

The present invention relates to a method for preparing a preparation for percutaneous absorption, which comprises rotigotine as an active ingredient, and more specifically, to a method for preparing a preparation for percutaneous absorption comprising a step of mixing rotigotine and an ethylene-vinyl acetate adhesive so as to have a weight ratio of 1:0.1 to 20, a preparation for percutaneous absorption manufactured by the method, and a percutaneous treatment system. The preparation and the syst...

The present invention relates to a method for preventing the formation of rotigotine crystals. More particularly, the present invention relates to a method for preventing the precipitation of rotigotine crystals, comprising a step of mixing rotigotine and one or more crystallization prevention agents selected from the group consisting of fatty alcohols, fatty acids, fatty acid esters, fatty acid amides, and the derivatives thereof, and to a transdermally absorbable preparation that contains roti...

An improved Transdermal Delivery System (TDS) comprising a backing layer inert to the components of the matrix a self-adhesive matrix containing rotigotine and a protective foil or sheet to be removed prior to use characterized in that the self-adhesive matrix consists of a solid or semi-solid semi-permeable polymer (1) wherein rotigotine in its free base form has been incorporated (2) which is saturated with rotigotine and contains said rotigotine as a multitude of microreservoirs within the ma...

A process for the preparation of Rotigotine (1) and of pharmaceutically acceptable salts thereof, which comprises the reductive amination of an amine of formula 6 with the 2-thienylacetic acid-sodium boron hydride complex and which makes use of hydrobromide 5 as an intermediate The process is advantageous from the industrial point of view in that it allows to obtain Rotigotine with high enantiomeric purity starting from optically active 5,6,7, 8-tetrahydro-6-(S)-N-propylamino-1-methoxy-naphthale...

A process for the preparation of Rotigotine (1) and of pharmaceutically acceptable salts thereof which comprises the reductive amination of an amine of formula 6 with the 2-thienylacetic acid-sodium boron hydride complex and which makes use of hydrobromide 5 as an intermediate The process is advantageous from the industrial point of view in that it allows to obtain Rotigotine with high enantiomeric purity starting from optically active 567 8-tetrahydro-6-(S)-N-propylamino-1-methoxy-naphthalene (...

The chiral compound S-5-substituted-N-2'-(thienyl-2-yl-)ethyl-tetralin-2-amine or its chiral acid salts and preparation method thereof are disclosed and the method for preparing Rotigotine by using the chiral compound is also disclosed. Racemic 5-substituted-N-2'-(thien-2-yl-)ethyl-tetralin-2-amine (compound 1) is resolved by using a conventional chiral acid to obtain an optically pure chiral acid salt of S-5-substituted-N-2'-(thien-2-yl-)ethyl-tetralin-2-amine which is then dissociated to obtai...