Claims for Patent: 11,033,521

Summary for Patent: 11,033,521

Title:	Levodopa fractionated dose composition and use
Abstract:	There is provided a convenient new treatment of Parkinson disease by a frequent administration of optimal levodopa doses mimicking a continuous intravenous or infusion treatment, thus mitigating motor complications; and a new carbidopa/levodopa pharmaceutical unit form providing said new treatment.
Inventor(s):	Chase; Thomas N (Washington, DC), Clarence-Smith; Kathleen E. (Washington, DC)
Assignee:	AVION PHARMACEUTICALS, LLC (Alpharetta, GA)
Application Number:	16/719,203
Patent Claims:	1. A method for the treatment of Parkinson's disease or related levodopa (LD)-responsive disorders, comprising orally administering to a patient in need thereof, carbidopa/levodopa (CD/LD) at an effective dose selected from the group consisting of carbidopa--6.25 mg/levodopa--25 mg and carbidopa--12.5 mg/levodopa--50 mg, to simulate continuous intravenous administration of LD, up to 9 times per day; wherein the CD/LD are present in a total carbidopa--25 mg/levodopa--100 mg amount in a multiscore, bilayered tablet formed by a fully scored top layer, and divided by three scores providing four sections; that is adjoined to an inert, bottom layer comprising a pharmaceutical carrier without active ingredients; wherein each score of the fully scored top layer partially penetrates the inert, bottom layer; and wherein each of the four sections of the fully scored top layer comprises carbidopa--6.25 mg and levodopa--25 mg. 2. The method of claim 1, wherein the patient is administered from one to six unit doses as the effective dose, each unit dose comprising a carbidopa--6.25 mg/levodopa--25 mg and the effective dose is administered from 5 times to 9 times per day. 3. The method of claim 1, wherein said patient is a newly diagnosed patient at the initial stage of Parkinson's disease. 4. The method of claim 1, wherein said patient is a parkinsonian patient previously administered a standard treatment with carbidopa/levodopa (CD/LD). 5. The method of claim 4, wherein said patient suffers from Motor Response Complications. 6. The method of claim 2, wherein said unit dose is carbidopa--6.25 mg/levodopa--25 mg, as a section of a three-score/four-section of the multiscore, bilayered tablet formed by the fully scored top layer comprising carbidopa, in a total amount of 25 mg, and levodopa, in a total amount of 100 mg, in admixture with a pharmaceutical carrier for immediate release. 7. The method of claim 1, wherein one or more section is administered as a single unit dose from 5 to 9 times per day. 8. The method of claim 7, wherein one or more section is administered as a single unit dose from 5 to 6 times per day. 9. The method of claim 1, wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with no motor response complications. 10. A multiscore, bilayered tablet formed by a fully scored top layer containing a carbidopa (CD)-25 mg/levodopa (LD)-100 mg amount, in admixture with a pharmaceutical carrier for immediate release, and divided by three scores providing four sections; that is adjoined to an inert, bottom layer comprising a pharmaceutical carrier without active ingredients; wherein each score of the fully scored top layer partially penetrates the bottom inert layer; and wherein each of the four sections of the fully scored top layer contains carbidopa--6.25 mg and levodopa--25 mg. 11. The multiscore, bilayered tablet of claim 10, wherein the carbidopa and levodopa are formulated in an orally disintegrable formulation. 12. A method for the treatment of Parkinson's disease or levodopa (LD)-responsive disorders in a patient who is hypersensitive to LD, comprising orally administering to the patient, carbidopa/levodopa (CD/LD) at an effective dose selected from the group consisting of carbidopa--6.25 mg/levodopa--25 mg and carbidopa--12.5 mg/levodopa--50 mg to simulate continuous intravenous administration of LD, up to 9 times per day, wherein the CD/LD are present in a total carbidopa--25 mg/levodopa--100 mg amount in a multiscore, bilayered tablet formed by a fully scored top layer, in admixture with a pharmaceutical carrier, and divided by three scores providing four sections; that is adjoined to an inert, bottom layer comprising a pharmaceutical carrier without active ingredients; wherein each score of the fully scored top layer partially penetrates the inert, bottom layer; wherein each of the four sections of the fully scored top layer comprises carbidopa--6.25 mg and levodopa--25 mg. 13. The method of claim 12, wherein the patient is a minor child. 14. The method of claim 12, wherein the LD-responsive disorder is generalized dystonia. 15. The method of claim 12, wherein the carbidopa/levodopa is administered two times a day (b.i.d.) or three times a day (t.i.d.). 16. The method of claim 12, wherein the effective dose of carbidopa--12.5 mg/levodopa--50 mg is administered two times a day (b.i.d.). 17. A method of treating or alleviating motor response complications related to Parkinson's disease or related levodopa (LD)-responsive disorder, comprising orally administering to a patient in need thereof, carbidopa/levodopa (CD/LD) at an effective dose selected from the group consisting of carbidopa--6.25 mg/levodopa--25 mg and carbidopa--12.5 mg/levodopa--50 mg, to simulate continuous intravenous administration of LD, up to 9 times per day, wherein the CD/LD are present in a total carbidopa--25 mg/levodopa--100 mg amount in a multiscore, bilayered tablet formed by a fully scored top layer, and divided by three scores providing four sections; that is adjoined to an inert, bottom layer comprising a pharmaceutical carrier without active ingredients; wherein each score of the top, fully scored layer partially penetrates the inert, bottom layer; and wherein each of the four sections of the fully scored top layer comprises carbidopa--6.25 mg and levodopa--25 mg. 18. The method of claim 17, wherein one or more section is administered as a single unit dose from 5 to 9 times per day. 19. The method of claim 18, wherein one or more section is administered as a single unit dose from 5 to 6 times per day. 20. The method of claim 17, wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with no motor response complications.