Levodopa and carbidopa intestinal gel and methods of use

Patent metadata

Field	Value
Publication number	US-10117843-B2
Application number	US-201615001392-A
Country	US
Kind code	B2
Filing date	Jan 20, 2016
Priority date	Jan 20, 2015
Publication date	Nov 6, 2018
Grant date	Nov 6, 2018

Abstract

The present disclosure relates to (a) an improved pharmaceutical composition comprising a levodopa active agent and a carbidopa active agent (b) methods of producing the pharmaceutical composition and (c) methods of treating Parkinson's disease and associated conditions comprising administering the pharmaceutical composition to a subject with Parkinson's disease.

First claim

What is claimed is:

1. A pharmaceutical composition for intraduodenal administration comprising:
(a) a levodopa active agent in an amount of about 4.0 weight/weight percent of the total composition;
(b) a carbidopa monohydrate active agent in an amount of about 1.0 weight/weight percent of the total composition;
(c) one or more polymer-based suspending agents selected from the group consisting of hydroxypropylcellulose, hydroxymethylcellulose, and sodium carboxymethyl cellulose; and
(d) water,
wherein the pharmaceutical composition has:
(i) a high shear viscosity of no more than about 4500 cps at 22° C. and 24.1 s −1 ;
(ii) a low shear viscosity of no less than about 45000 cps at 5° C. and 1 s −1 ; and
(iii) a ratio of low shear viscosity to high shear viscosity of not less than 10.

2. The pharmaceutical composition according to claim 1 , wherein the one or more polymer-based suspending agents is sodium carboxymethyl cellulose.

3. The pharmaceutical composition according to claim 2 , wherein the concentration of water is in an amount of from about zero percent to about 95 weight/weight percent of the total composition.

4. The pharmaceutical composition according to claim 3 , wherein the pharmaceutical composition does not experience degradation into DHPA at a rate faster than 0.06 w/w% per week.

5. The pharmaceutical composition according to claim 3 , wherein the pharmaceutical composition does not experience degradation into DHPPA at a rate faster than 0.06 w/w% per week.

6. The pharmaceutical composition according to claim 3 , wherein the pharmaceutical composition does not experience degradation producing hydrazine at a rate faster than 0.75 μg/g per week.

7. The pharmaceutical composition according to claim 3 , wherein the pharmaceutical composition is present in a lower 0 2 permeable primary or secondary container.

8. A pharmaceutical dosage form comprising the pharmaceutical composition of claim 1 in a disposable drug reservoir having an oxygen impermeable enclosure disposed therein, wherein the oxygen impermeable enclosure is purged with an inert gas and an oxygen scavenger is added.

9. The pharmaceutical dosage form according to claim 8 , wherein the pharmaceutical dosage form is suitable for use in a continuous infusion pump capable of delivering the composition in a therapeutically effective manner.

10. A kit comprising the pharmaceutical composition of claim 1 .

11. A kit comprising the pharmaceutical dosage form of claim 8 .

Assignees

• Abbvie Inc
• Abbvie Inc

Inventors

• Conjeevaram Rajkumar
• Deac Alexandru
• Huang Ye
• Mackey Sean E
• Menges Randy A
• Zimmerman Jayne

Classifications

• A61P25/16

  Anti-Parkinson drugs · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K47/38

  Cellulose; Derivatives thereof · CPC title

• A61K31/198 Primary

  Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title