Transdermal therapeutic system containing asenapine
AssigneeLTS Lohmann Therapie-Systeme AG
InventorsPatrick Mohr, René Rietscher, René Eifler, Olga Bourquain
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Abstract
The present invention relates to transdermal therapeutic systems (TTS) for the transdermal administration of asenapine comprising a self-adhesive layer structure containing a therapeutically effective amount of asenapine, such asenapine TTS for use in a method of treatment, processes of manufacture of such TTS as well as asenapine and transdermal therapeutic systems containing asenapine for use in a method of treatment and to a method of treating a human patient by transdermal administration of asenapine.
Claims20
A transdermal therapeutic system for the transdermal administration of asenapine comprising a self-adhesive layer structure containing asenapine, said self-adhesive layer structure comprising an asenapine-containing matrix layer comprising asenapine and a polymer,
- wherein
- the transdermal therapeutic system has an area of release of from 10 to 80 cm2;
- the amount of asenapine in the asenapine-containing matrix layer ranges from 2% to 20% by weight;
- the asenapine-containing matrix layer has an area weight ranging from 90 to 230 g/m2;
- and
- further wherein, the transdermal therapeutic system provides:
- a mean transdermal asenapine release rate of 0.5 to 20 mg/day;
- an asenapine Cmax value of from 0.5 to 10 ng/ml following administration of the transdermal system to the skin of a subject in need thereof;
- and
- a skin permeation rate of asenapine as measured in a Franz diffusion cell with dermatomed human skin of
- 0 μg/(cm2 h) to 10 μg/(cm2 h) in the first 8 hours,
- 2 μg/(cm2 h) to 20 μg/(cm2 h) from hour 8 to hour 24,
- 3 μg/(cm2 h) to 20 μg/(cm2 h) from hour 24 to hour 32,
- 3 μg/(cm2 h) to 20 μg/(cm2 h) from hour 32 to hour 48, and
- 2 μg/(cm2 h) to 15 μg/(cm2 h) from hour 48 to hour 72.
Dependencies are inferred from the claim text.