Accordion pill comprising levodopa for an improved treatment of Parkinson's Disease symptoms
Inventors
Navon, Nadav • Kirmayer, David • Shvetz, Julia • Kluev, Elena • Abramov, Eva • Weiss, Zeev • Carni, Giora
Assignees
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Publication Number
US-9801826-B2
Publication Date
2017-10-31
Expiration Date
Abstract
The invention provides for the use of an accordion pill comprising levodopa for the treatment of symptoms of Parkinson's disease in a subject in need thereof over a 24 hour period, to be administered to the subject in a twice daily administration regimen, with an interval of about 8 to about 10 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose and the first dose of the following day. The twice daily administration regimen provides a stable blood plasma level of levodopa in the subject after multiple administrations and is effective in treating the symptoms of Parkinson's disease over a 24 hour period.
Core Innovation
The invention provides an accordion pill comprising levodopa for the treatment of symptoms of Parkinson’s disease in a subject in need thereof over a 24 hour period. The accordion pill is administered as a twice daily administration regimen with two doses in a day, including a first dose of the day and a second dose of the same day.
The regimen specifies an interval of about 8 to about 10 hours between the first dose and the second dose, and an interval of about 14 to about 16 hours between the second dose of the day and the first dose of the following consecutive day over a period of more than one week. The accordion pill is a multilayered gastroretentive dosage form, folded into a capsule in undulated form, and unfolds upon contact with gastric fluids.
This unfolding is used to achieve stable levodopa exposure over the 24 hour period after multiple administrations. The disclosed approach targets maintenance of stable levodopa blood plasma levels over 24 hours, reduced peak-to-trough fluctuations, improved morning levodopa levels, alleviation of OFF time during waking hours, improved ON timing, and alleviation or elimination of nocturnal sleep disturbances and daytime sleepiness or drowsiness.
Claims Coverage
The independent claim is directed to a method for treating Parkinson’s disease symptoms over a 24 hour period using a twice-daily regimen with specified inter-dose intervals and an accordion pill that is a multilayered gastroretentive, undulated capsule that unfolds upon contact with gastric fluids. The claim set emphasizes two inventive features.
Accordion pill multilayered gastroretentive undulated unfolding in gastric fluids
The accordion pill comprising levodopa is a multilayered gastroretentive dosage form, folded into a capsule in undulated form, which unfolds upon contact with gastric fluids.
Twice-daily administration with defined inter-dose intervals over more than one week
The accordion pill comprising levodopa is administered in a twice daily administration regimen of two doses in a day, with an interval of about 8 to about 10 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose of the day and the first dose of the following consecutive day over a period of more than one week.
Overall, the independent claim coverage centers on administering levodopa via an accordion pill characterized as a multilayered gastroretentive, undulated capsule that unfolds upon contact with gastric fluids, together with a twice-daily regimen defined by an about 8 to 10 hour interval and an about 14 to 16 hour interval across consecutive days for more than one week to treat symptoms over a 24 hour period.
Stated Advantages
Maintains stable levodopa blood plasma levels over 24 hours after multiple administrations.
Reduces peak-to-trough fluctuations in levodopa blood plasma levels.
Improves morning levodopa levels.
Alleviates or reduces total OFF time during waking hours and improves ON timing.
Alleviates nocturnal sleep disturbances.
Eliminates or alleviates daytime sleepiness or drowsiness.
Documented Applications
Treatment of symptoms of Parkinson’s disease in a subject in need thereof over a 24 hour period using a twice-daily administration regimen with specified inter-dose intervals and an accordion pill that unfolds upon contact with gastric fluids.
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