Compositions and Methods for Treatment of Symptoms in Parkinson's Disease Patients

Abstract

The invention provides dosage forms and methods utilizing nicotine to treat symptoms of a neurologic disorder. In some embodiments, the invention provides compositions for treatment of gait and balance problems associated with Parkinson's Disease.

Description

[0001]This application claims priority from U.S. Provisional Application 61 / 504,974, filed Jul. 6, 2011, the entire contents of each of which are hereby incorporated by reference in their entiretyBACKGROUND OF THE INVENTION[0002]Parkinson's disease (also known as Parkinson disease, Parkinson's, idiopathic parkinsonism, primary parkinsonism, PD, or paralysis agitans) is a degenerative disorder of the central nervous system. It results from the death of dopamine-containing cells in the substantia nigra, a region of the midbrain; the cause of cell-death is unknown. Early in the course of the disease, the most obvious symptoms are movement- and balance-related, including shaking, rigidity, slowness of movement and difficulty with walking and gait. The main motor symptoms are collectively called parkinsonism, or a “parkinsonian syndrome”. The pathology of the disease is characterized by the accumulation of a protein called alpha-synuclein into inclusions called Lewy bodies in neurons, an...

AI Technical Summary

Benefits of technology

The present patent provides a pulsatile or extended release dosage form of nicotine for treatment of symptoms of Parkinson's Disease or associated with dopaminergic treatment of Parkinson's Disease. The dosage form exhibits a first and second release peak, with the first peak occurring within two hours of administration and the second peak occurring between two and twelve hours after administration. The dosage form can be a capsule or tablet, and it can be administered once or twice a day. The dosage form can provide a therapeutic effect for at least six hours after administration. The invention also provides a delayed release dosage form that can be administered once or twice a day, with a hard gelatin outer surface. The delayed release dosage form can achieve a plasma level of nicotine metabolites of about 1 to about 500 ng / ml within four hours of administration. The dosage form can also include a dopaminergic agent such as levodopa or carbidopa.

Problems solved by technology

As the disease progresses and dopamine neurons continue to be lost, a point eventually arrives at which these drugs become ineffective at treating the symptoms and at the same time produce a complication called dyskinesia, marked by involuntary writhing movements.

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