COMPOSITIONS AND METHODS FOR TREATMENT IN PARKINSON'S DISEASE PATIENTS

摘要

The invention provides dosage forms and methods for treating Parkinson's Disease, symptoms resulting from Parkinson's Disease, side effects resulting from treatment of Parkinson's Disease with other pharmaceutical agents, and reducing the progress of Parkinson's Disease. In various embodiments, the dosage forms and methods utilize nicotine and/or salts thereof for once daily administration resulting in four pulsatile releases following administration.

主权项

1. An oral pulsatile release dosage form for once-daily oral administration, said form comprising an effective amount of nicotine or a salt thereof for treatment of symptoms of Parkinson's Disease or symptoms associated with dopaminergic treatment of Parkinson's Disease or for delay in progression of Parkinson's Disease, wherein said form exhibits first, second, third, and fourth pulsatile releases of nicotine or salt thereof;
wherein said first pulsatile release occurs with a maximum release within two hours of administration, said second pulsatile release occurs with a maximum release between five and seven hours following administration, said third pulsatile release occurs with a maximum release between eleven and thirteen hours following administration, and said fourth pulsatile release occurs with a maximum release between sixteen and twenty hours following administration; or wherein said first pulsatile release occurs with a maximum release between about two to four hours of administration, said second pulsatile release occurs with a maximum release between seven and nine hours following administration, said third pulsatile release occurs with a maximum release between thirteen and fifteen hours following administration, and said fourth pulsatile release occurs with a maximum release between eighteen and twenty-two hours following administration; or wherein said first pulsatile release occurs with a maximum release within two hours of entering the small intestine, said second pulsatile release occurs with a maximum release between seven and nine hours following administration, said third pulsatile release occurs with a maximum release between thirteen and fifteen hours following administration, and said fourth pulsatile release occurs with a maximum release between eighteen and twenty-two hours following administration.