Transdermal therapeutic system for Parkinson's Disease
OwnerHans-Michael Wolffinventor
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Abstract
The invention provides a transdermal therapeutic system (TTS) containing rotigotine as the active ingredient. The TTS is useful in the treatment of Parkinson's Disease because it induces a pharmacokinetic profile where the rotigotine plasma level is high and stable.
Claims120
A method for treating Parkinson's Disease in a human patient, comprising administering to the patient a rotigotine formulation capable of providing a plasma concentration effective to alleviate the symptoms of Parkinson's Disease, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and wherein the mean area under the curve (AUCo-t) is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method for treating Parkinson's Disease in a human patient, comprising administering to the patient a rotigotine formulation capable of maintaining a plasma concentration effective to alleviate the symptoms of Parkinson's Disease, wherein the Cmax is sustained at a level from about 0.14 ng/mL to about 1.54 ng/mL and wherein the mean area under the curve (AUCo-t) is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method of treating Parkinson's Disease in a human patient, comprising applying a transdermal therapeutic system (TTS) comprising rotigotine, wherein the TTS is capable of providing a plasma concentration effective to alleviate the symptoms of Parkinson's Disease, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and wherein the mean area under the curve (AUCo-t) is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method for treating Parkinson's Disease in a human patient, comprising administering to the patient over a 24 hr period a rotigotine formulation capable of providing a plasma concentration effective to alleviate the symptoms of Parkinson's Disease, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and the AUCO-t is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method of treating Parkinson's Disease in a human patient comprising applying one or more transdermal patches comprising an amount of rotigotine from 4 mg to 20 mg to the patient to provide a plasma concentration effective to alleviate the symptoms of Parkinson's Disease in the human patient, wherein the Cmax is sustained at a level from about 0.14 ng/mL to about 1.54 ng/mL and the mean area under the curve (AUCo-t) in the patient is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method of treating Parkinson's Disease in a human patient comprising
- a) applying one or more transdermal patches comprising an amount of rotigotine from 4 mg to 20 mg to the patient;
- b) removing the patch or patches of step a) and applying another patch or patches comprising an amount of rotigotine from 4 mg to 20 mg to the patient at an interval providing a plasma concentration effective to alleviate the symptoms of Parkinson's Disease in the patient;
- and
- c) repeating step b) as required to sustain the Cmax at a level effective to alleviate the symptoms of Parkinson's Disease in the human patient,
- wherein the Cmax is sustained at a level from about 0.14 ng/mL to about 1. 54 ng/mL.
A method for treating Parkinson's Disease in a human patient, comprising administering over a 24 hour period a rotigotine formulation capable of providing a plasma concentration effective to alleviate the symptoms of Parkinson's Disease, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and the AUCO-t is from about 3.3 ng/mL *h to about 32.2 ng/mL *h, regardless of where the rotigotine is administered to the body of the human patient.
A controlled release rotigotine formulation for transdermal administration to a human patient, comprising from about 4 mg to about 20 mg of rotigotine, wherein the formulation provides a plasma concentration wherein the (Cmax) of rotigotine is from about 0.14 ng/mL to about 1.54 ng/mL and a mean area under the curve up to the last quantifiable concentration (AUCo-t) from about 3.3 ng/mL *h to about 32.2 ng/mL *h, regardless of where the rotigotine formulation is applied on the body of the human patient.
A method for inducing treating Restless Legs Syndrome in a human patient, comprising administering a rotigotine formulation capable of providing a plasma concentration effective to alleviate symptoms of Restless Legs Syndrome, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and the AUCO-t is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method for treating Restless Legs Syndrome in a human patient, comprising administering to the patient over a 24 hr period a rotigotine formulation capable of providing a plasma concentration effective to alleviate the symptoms of Restless Legs Syndrome, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and the AUCO-t is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method for treating a disease related to the dopaminergic system in a human patient, comprising administering to the patient over a 24 hr period a rotigotine formulation capable of providing a plasma concentration effective to alleviate the symptoms of the disease related to the dopaminergic system, wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and the AUCO-t is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
A method for treating a disease related to the dopaminergic system in a human patient, comprising administering rotigotine to the patient wherein the Cmax is from about 0.14 ng/mL to about 1.54 ng/mL and wherein the AUCO-t is from about 3.3 ng/mL *h to about 32.2 ng/mL *h.
Dependencies are inferred from the claim text.