# US 2013/0157955 A1 · Method of drug delivery for bone anabolic protein

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- Number: US 2013/0157955 A1
- Document ID: US20130157955A1
- Status: Published application
- Kind: A1
- Application number: 13/438,086
- Filed: 2012-04-03
- Published: 2013-06-20
- Earliest claimed: 2006-10-03
- Assignees: Ipsen Pharma S.A.S.; Radius Health, Inc.
- Inventors: Michael J. Dey; Nathalie Mondoly; Benedicte Rigaud; Bart Henderson; C. Richard Lyttle
- Web page: https://patentgrep.com/patent/US20130157955A1

## CPC

- A61K 38/29: Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
- 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 9/08: Solutions {(composition of solutions A61K47/00)}
- A61P 19/10: for osteoporosis
- 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 storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.

## Claims

### Claim at position 1

-2. (canceled)

### Claim 3

A method of stimulating bone growth in a subject in need thereof comprising administering to said subject a storage stable composition comprising:
a) a PTHrP having the sequence [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 (SEQ ID NO.: 2); and
b) an effective amount of buffer to maintain the pH in a range of about 4.5 to about 5.6.

### Claim 4 (depends on 3)

The method of claim 3, wherein said subject is administered the storage stable composition by subcutaneous injection of an amount of said composition containing from about 40 to about 45 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 (SEQ ID NO.2).

### Claim 5 (depends on 4)

The method of claim 4, wherein said storage-stable composition further comprises phenol in a concentration from about 0.25 to about 5 mg/mL.

### Claim 6 (depends on 5)

The method of claim 5, wherein said pH buffer is an acetate buffer.

### Claim 7 (depends on 3)

The method of claim 3, wherein said subject is administered the storage stable composition by subcutaneous injection of an amount of said composition containing from about 75 to about 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 (SEQ ID NO.2).

### Claim 8 (depends on 7)

The method of claim 7, wherein said storage-stable composition further comprises phenol in a concentration from about 0.25 to about 5 mg/mL.

### Claim 9 (depends on 8)

The method of claim 8, wherein said pH buffer is an acetate buffer.

### Claim 10 (depends on 3)

The method of claim 3, wherein said subject has a bone fracture.

### Claim 11 (depends on 4)

The method of claim 4, wherein the subcutaneous injection is once per day, once every other day, twice per week, once per week, once every two weeks or once per month.

### Claim 12 (depends on 4)

The method of claim 4, wherein the subcutaneous injection is single daily subcutaneous injection.

### Claim 13 (depends on 7)

The method of claim 7, wherein the subcutaneous injection is once per day, once every other day, twice per week, once per week, once every two weeks or once per month.

### Claim 14 (depends on 7)

The method of claim 7, wherein the subcutaneous injection is single daily subcutaneous injection.