# US 10,117,843 B2 · Levodopa and carbidopa intestinal gel and methods of use

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- Number: US 10,117,843 B2
- Document ID: US10117843B2
- Status: Granted
- Kind: B2
- Application number: 15/001,392
- Filed: 2016-01-20
- Published: 2016-07-21
- Granted: 2018-11-06
- Earliest claimed: 2015-01-20
- Assignees: AbbVie Inc.
- Applicants: AbbVie, Inc.
- Inventors: Rajkumar Conjeevaram; Alexandru Deac; Ye Huang; Sean E. Mackey; Randy A. Menges; Jayne Zimmerman
- Web page: https://patentgrep.com/patent/US10117843B2

## CPC

- A61K 31/198: 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)
- A61K 9/0019: {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)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/10: Dispersions; Emulsions
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 25/16: Anti-Parkinson drugs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 3)

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.

### Claim 5 (depends on 3)

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.

### Claim 6 (depends on 3)

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.

### Claim 7 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the pharmaceutical composition is present in a lower 02 permeable primary or secondary container.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 1)

A kit comprising the pharmaceutical composition of claim 1.

### Claim 11 (depends on 8)

A kit comprising the pharmaceutical dosage form of claim 8.