US5385887A
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Formulations for delivery of osteogenic proteins
Assignee: Genetics Institute LLC
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Filing: 1993-09-10
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Granted: 1995-01-31
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Expires: 2013-09-10
Abstract
Abstract A composition is disclosed comprising a pharmaceutically acceptable admixture of an osteogenic protein; a porous particulate polymer matrix; an osteogenic protein-sequestering amount of blood clot; and a calcium sulfate hemihydrate-containing substance. Also disclosed are formulations of bone morphogenetic proteins with improved solubility and/or stability characteristics.
Inventors
- 👤 Kalvin W. K. Yim
- 👤 Michael C. Huberty
- 👤 Richard P. Northey, Jr.
- 👤 Jay A. Schrier
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 13:20
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/14; A61L27/22; A61L27/227; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/18; A61K38/1875; A61L27/26; A61P; A61P19/00; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/84
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
42 words
A composition comprising an osteogenic protein, about 0.1 to about 5.0% (w/v) of a sugar, about 1.0 to about 10.0% (w/v) glycine, and about 1 to about 20 mM of glutamic acid hydrochloride, wherein such composition has a pH of about 4.5.
Claim 2
Dependent Claim
42 words
A composition comprising an osteogenic protein, about 0.1 to about 5.0% (w/v) of a sugar, about 1.0 to about 10.0% (w/v) glycine, and about 1 to about 20 mM of glutamic acid hydrochloride, wherein such composition has a pH of about 4.5.
Claim 3
Dependent Claim
17 words
The composition of claim 1, further comprising about 0.01 to about 0.1% (w/v) of a non-ionic surfactant.
Claim 4
Dependent Claim
48 words
A composition comprising an osteogenic protein, about 1 to about 10% (w/v) glycine, about 0.1 to about 5.0% (w/v) sucrose, about 0.01 to about 0.1% (w/v) non-ionic surfactant and about 5 to about 10 mM glutamic acid hydrochloride, wherein such composition has a pH less than about 6.0.
Claim 5
Dependent Claim
48 words
A composition comprising an osteogenic protein, about 1 to about 10% (w/v) glycine, about 0.1 to about 5.0% (w/v) sucrose, about 0.01 to about 0.1% (w/v) non-ionic surfactant and about 5 to about 10 mM glutamic acid hydrochloride, wherein such composition has a pH less than about 6.0.
Claim 6
Dependent Claim
35 words
A composition comprising an osteogenic protein, about 2.5% (w/v) glycine, about 0.5% (w/v) sucrose, about 5 mM glutamic acid hydrochloride, and about 0.01% (w/v) polysorbate 80, wherein such composition has a pH of about 4.5.
Claim 7
Dependent Claim
35 words
A composition comprising an osteogenic protein, about 2.5% (w/v) glycine, about 0.5% (w/v) sucrose, about 5 mM glutamic acid hydrochloride, and about 0.01% (w/v) polysorbate 80, wherein such composition has a pH of about 4.5.
Claim 8
Dependent Claim
47 words
A composition comprising a lyophilized formulation of about 3.12% to about 24.38% (w/w) BMP; about 0.52% to about 10.27% (w/w) glutamic acid hydrochloride; about 38.4% to about 75.7% (w/w) glycine; about 14.28% to about 47.15% (w/w) sucrose; and optionally about 0.15% to about 2.94% (w/w) polysorbate 80.
Claim 9
Dependent Claim
47 words
A composition comprising a lyophilized formulation of about 3.12% to about 24.38% (w/w) BMP; about 0.52% to about 10.27% (w/w) glutamic acid hydrochloride; about 38.4% to about 75.7% (w/w) glycine; about 14.28% to about 47.15% (w/w) sucrose; and optionally about 0.15% to about 2.94% (w/w) polysorbate 80.
Claim 10
Dependent Claim
45 words
A composition according to claim 5 wherein the lyophilized formulation comprises relative weight amounts of about 4.0 mg/ml of BMP-2; about 0.918 mg/ml of glutamic acid hydrochloride; about 25 mg/ml of glycine; about 5 mg/ml of sucrose; and optionally about 0.1 mg/ml of polysorbate 80.
Claim 11
Dependent Claim
45 words
A composition according to claim 5 wherein the lyophilized formulation comprises relative weight amounts of about 2.0 mg/ml of BMP-2; about 0.918 mg/ml of glutamic acid hydrochloride; about 25 mg/ml of glycine; about 5 mg/ml of sucrose; and optionally about 0.1 mg/ml of polysorbate 80.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1998-01-30 | 1998-08-01 | 1999-01-31 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-01-30 | 2002-08-01 | 2003-01-31 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-01-30 | 2006-08-01 | 2007-01-31 | $7700.00 | Window Closed / Lapsed |