# US 8,772,309 B2 · Pharmaceutical formulation of apomorphine for buccal administration

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- Number: US 8,772,309 B2
- Document ID: US8772309B2
- Status: Granted
- Kind: B2
- Application number: 13/669,148
- Filed: 2012-11-05
- Published: 2013-05-23
- Granted: 2014-07-08
- Earliest claimed: 2005-05-06
- Assignees: Amarin Pharmaceuticals Ireland Limited
- Applicants: Amarin Pharmaceuticals Ireland Limited
- Inventors: Anthony Clarke
- Web page: https://patentgrep.com/patent/US8772309B2

## CPC

- A61K 31/435: having six-membered rings with one nitrogen as the only ring hetero atom
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/473: ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/10: for impotence
- A61P 25/00: Drugs for disorders of the nervous system
- 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 invention provides a kit comprising, in separate compartments of a container, the following components (a) and (b): (a) a combination of apomorphine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable excipient or carrier; and (b) a solution which comprises a diluent and a pH modifying agent; the components being presented such that they can be combined at the point of use into a formulation which is adjusted to a pH ranging from mildly acidic to alkaline and which is suitable for buccal administration. The formulation is useful in treating Parkinson's disease and in promoting sexual function.

## Claims

### Claim 1

A method of buccally administering an apomorphine composition to a patient in need thereof, comprising:
(a) at the time of administration, adding a diluent and a pH modifying agent to an apomorphine composition to form a liquid composition comprising a pharmaceutically effective amount of apomorphine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable excipient or carrier and to adjust the pH of the liquid composition to a pH ranging from mildly acidic to alkaline, thereby forming a pH adjusted liquid composition; and then
(b) introducing the resulting pH adjusted liquid composition to the mouth of a patient in need thereof, thereby buccally administering a pharmaceutically effective amount of apomorphine or a pharmaceutically acceptable acid salt thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the diluent comprises water.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pH modifying agent comprises a buffer effective for buffering the composition to a pH ranging from mildly acidic to alkaline.

### Claim 4 (depends on 1)

The method of claim 1, wherein composition is administered to treat Parkinson's disease.

### Claim 5 (depends on 1)

The method of claim 1, wherein the composition is administered to promote function, treat sexual dysfunction, enhance libido, reduce impotence, or a combination thereof.