# US 9,040,575 B2 · Combination for the treatment of osteoarthritis

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- Number: US 9,040,575 B2
- Document ID: US9040575B2
- Status: Granted
- Kind: B2
- Application number: 13/947,538
- Filed: 2013-07-22
- Published: 2013-11-21
- Granted: 2015-05-26
- Earliest claimed: 2009-12-21
- Assignees: Professional Dietetics S.R.L.
- Applicants: Professional Dietetics, S.R.L.
- Inventors: Franco Conti; Francesco Saverio Dioguardi
- Web page: https://patentgrep.com/patent/US9040575B2

## CPC

- A61K 31/401: Proline; Derivatives thereof, e.g. captopril
- 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 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 31/717: Celluloses
- A61K 31/728: Hyaluronic acid
- A61K 31/79: Polymers of vinyl pyrrolidone
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61L 2300/40: characterised by a specific therapeutic activity or mode of action
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to the use of a combination of glycine, proline, and optionally a natural or synthetic viscosity-controlling polymer, and/or lysine and/or leucine, to prepare a composition for the treatment of osteoarthritis.

## Claims

### Claim 1

A method of treating osteoarthritis in patients in need thereof, said method comprising
administering to said patients an effective amount of an intra-articular formulation consisting of:
a) glycine,
b) proline,
c) a natural or synthetic viscosity-controlling polymer;
d) lysine,
e) leucine; and
f) suitable excipients; and
treating said osteoarthritis in said patients.

### Claim 2 (depends on 1)

The method as claimed in claim 1, wherein osteoarthritis is patellofemoral or femorotibial knee osteoarthritis, hip osteoarthritis and shoulder osteoarthritis.

### Claim 3 (depends on 1)

The method as claimed in claim 1, wherein the natural or synthetic viscosity-controlling polymer is selected from hyaluronic acid or a salt thereof, polyvinylpyrrolidone and cellulose derivatives.

### Claim 4 (depends on 3)

The method as claimed in claim 3, wherein the natural or synthetic viscosity-controlling polymer is hyaluronic acid or a salt thereof.

### Claim 5 (depends on 1)

The method as claimed in claim 1, wherein the amino acids are in L form.

### Claim 6 (depends on 1)

The method as claimed in claim 1, wherein said formulation is in the form of powders for reconstitution or viscous solutions in biocompatible solvents.

### Claim 7

A method of treating osteoarthritis in patients in need thereof, said method comprising
administering to said patients an effective amount of an intra-articular formulation consisting of
the following ranges by weight:
a) 25 to 500 mg of glycine,
b) 40 to 300 mg of proline,
c) 5 to 50 mg of hyaluronic acid or a salt thereof,
d) 5 to 100 mg of lysine,
e) 5 to 50 mg of leucine; and
f) suitable excipients.