Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Matrices
Reexamination Certificate
2005-04-26
2005-04-26
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Matrices
C424S486000, C424S485000, C424S484000, C424S448000, C424S449000
Reexamination Certificate
active
06884434
ABSTRACT:
A transdermal therapeutic system, comprising a backing layer inert to the components of the matrix, a self-adhesive matrix layer containing (−)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]amino]-1-naphthalenol in an effective amount and a protective foil or sheet to be removed prior to use, is characterised by a matrix that is based on a non-aqueous, acrylate-based or silicone-based polymer adhesive system having a solubility of ≧5% (w/w) for (−)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]-amino]-1-naphthalenol, and said matrix is substantially free of inorganic silicate particulates.
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Chiang C.M. et al. “A two-phase matrix for the delivery of N-0923, a dopamine agonist”, Proc. Int. Symp. Controlled Release Bioact. Mater. 1995 22 nd 710-711.*
Izaak den Daas et al., “Transdermal administeration of the dopamine agonist N-0437 and seven ester prodrugs:comparison with oral administeration in the 6-OHDA turning model”, Naunyn-Schmiedegerg's pharmacol (1990) 342: 655-659.*
Swart, P. J. et al., “The influence of azone on the transdermal penetration of the dopamine D agonist N-0923 in freely moving rats”, Int. J. Pharm. 1992 88 (1-3) 165-170.*
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Mar. 14, 1989 Abstract of “Microdialysis and Striatal dopamine release: stereoselective actions of the enantiomers of N-0437” W. Timmerman et al. Eur J. Pharmacol 143-150.
Aug. 18, 1995 Abstract of “Development and validation of a gradient reversed-phase high-performance liquid chromatographic assay for S(-)-2-(N-propyl-N-2-thienylethylamino)-5-hydroxytetralin (n-0923) from a transdermal delivery system” D.L. Walters et al. J. Chromatogr. B. Biomed Appl. 299-307.
Dec. 1990 Abstract of “Transdermal administration of the dopamine agonist N-0437 and seven ester prodrugs: comparison with oral administration in the 6-OHDA turning model” Tepper P.G. den Daas I et al. Naunyn Schmiedebergs Arch Pharmacol 655-659.
Aug. 3, 1989 Abstract of “Stereoselective reversal of MPTP-induced parkinsonism in the marmoset after dermal application of N-0437” P.A. Loschmann et al. Eur J. Pharmacol 373-380.
Muller Walter
Peck James V.
Aderis Pharmaceuticals, Inc.
Ghali Isis
Jordan and Hamburg LLP
LTS Lohmann Therapie-Systeme AG
Page Thurman K.
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