US5217954A
Expired / Lapsed
US
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Formulations for stabilizing fibroblast growth factor
Assignee: Scios LLC
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Filing: 1990-04-04
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Granted: 1993-06-08
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Expires: 2010-04-04
Abstract
Abstract Pharmaceutical formulations and a method for their preparation are provided. These formulations provide a stabilized basic fibroblast growth factor (bFGF) which is less susceptible to oxidation or metal-induced aggregation by including an amount of a chelating agent effective to stabilize the bFGF.
Inventors
- 👤 Linda Foster
- 👤 Stewart A. Thompson
- 👤 S. Joseph Tarnowski
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 05:02
CPC Classifications
C; C07; C07K; C07K14/00; C07K14/435; C07K14/475; C07K14/50; C07K14/503; A; A61; A61K; A61K47/00; A61K47/06; A61K47/16; A61K47/18; A61K47/183; A61K47/20; A61K38/00
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
35 words
A stabilized basic fibroblast growth factor pharmaceutical formulation consisting essentially of a basic fibroblast growth factor (bFGF) and a chelating agent or a pharmaceutically acceptable salt thereof in an amount effective to stabilize said bFGF.
Claim 2
Dependent Claim
35 words
A stabilized basic fibroblast growth factor pharmaceutical formulation consisting essentially of a basic fibroblast growth factor (bFGF) and a chelating agent or a pharmaceutically acceptable salt thereof in an amount effective to stabilize said bFGF.
Claim 3
Dependent Claim
15 words
The stabilized bFGF formulation of claim 1 wherein the chelating agent is an aminopolycarboxylic acid.
Claim 4
Dependent Claim
32 words
The stabilized bFGF formulation of claim 1 wherein the chelating agent is selected from the group consisting of ethylenediaminetetraacetic acid (EDTA), diethylenetriaminepentaacetic acid (DTPA), nitrilotriacetic acid (NTA), glutamic acid, and aspartic acid.
Claim 5
Dependent Claim
13 words
The stabilized bFGF formulation of claim 3 wherein the chelating agent is EDTA.
Claim 6
Dependent Claim
13 words
The stabilized bFGF formulation of claim 3 wherein the chelating agent is DTPA.
Claim 7
Dependent Claim
21 words
The stabilized bFGF formulation of claim 1 wherein the pH range of the formulation is from about 4.5 to about 8.
Claim 8
Dependent Claim
17 words
The stabilized bFGF formulation of claim 6 wherein the pH range of the formulation is about 4.5-6.5.
Claim 9
Dependent Claim
25 words
The stabilized bFGF formulation of claim 1 wherein the pharmaceutically acceptable salts are a group consisting of the salts of sodium, potassium and calcium ions.
Claim 10
Dependent Claim
23 words
The stabilized bFGF formulation of claim 1 wherein said chelating agent has a binding strength for copper ion of about 7 to 15.
Claim 11
Dependent Claim
23 words
The stabilized bFGF formulation of claim 9 wherein said chelating agent has a binding strength for copper ion of about 10 to 15.
Claim 12
Dependent Claim
21 words
The stabilized bFGF formulation of claim 10 wherein said chelating agent has a binding strength for copper ion of about 15.
Claim 13
Dependent Claim
18 words
The stabilized bFGF formulation of claim 1 wherein said basic fibroblast growth factor is from a mammalian source.
Claim 14
Dependent Claim
14 words
The stabilized bFGF formulation of claim 10 which is human basic fibroblast growth factor.
Claim 15
Dependent Claim
17 words
The stabilized bFGF formulation of claim 1 wherein said basic fibroblast growth factor is a recombinant protein.
Claim 16
Dependent Claim
15 words
The stabilized bFGF formulation of claim 1 wherein said formulation is in a dry state.
Claim 17
Dependent Claim
16 words
The stabilized bFGF formulation of claim 1 wherein said formulation is dispersed in an aqueous solution.
Claim 18
Dependent Claim
16 words
The stabilized bFGF formulation of claim 13 wherein said formulation is dissolved in an aqueous solution.
Claim 19
Dependent Claim
16 words
The stabilized bFGF formulation of claim 1 which is formulated as a controlled, continuous release formulation.
Claim 20
Dependent Claim
32 words
The stabilized bFGF formulation of claim 14 wherein said chelating agent is present in amounts of from about 0.001 to about 2.0 percent by weight of the stabilized fibroblast growth factor formulation.
Claim 21
Dependent Claim
32 words
The stabilized bFGF formulation of claim 13 wherein said chelating agent is present in amounts of from about 0.01 to about 40 percent by weight of the stabilized fibroblast growth factor formulation.
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) | 1996-06-07 | 1996-12-07 | 1997-06-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-06-07 | 2000-12-07 | 2001-06-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-06-07 | 2004-12-07 | 2005-06-08 | $7700.00 | Window Closed / Lapsed |