US5122367A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Polyanhydride bioerodible controlled release implants for administration of stabilized growth hormone
Assignee: Massachusetts Institute of Technology
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Filing: 1989-03-31
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Granted: 1992-06-16
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Expires: 2009-03-31
Abstract
Abstract A controlled release device for the administration of biologically active growth hormone proteins or peptide fragments, and method of preparation thereof, wherein biologically active growth hormone is stabilized and release rate modulated by incorporation of a stabilizing compound. The controlled release devices are prepared by mixing a stabilizer, such as sucrose, with a biologically active growth hormone, such as bovine somatotropic hormone, in solution, lyophilizing, then incorporating the dried powder into a surface erodible, biocompatible polymeric matrix, such as a poly(anhydride) or poly(orthoester) matrix.
Inventors
- 👤 Eyal Ron
- 👤 Mark Chasin
- 👤 Tom Turek
- 👤 Robert S. Langer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 11:04
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/27; A61K47/00; A61K47/06; A61K47/26; A61K9/00; A61K9/20; A61K9/2004; A61K9/2013; A61K9/2018; A61K9/2022; A61K9/2031
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
101 words
A controlled release system for a protein comprising: a protein having physical, chemical and biological activity equivalent to that of somatotrophin; a simple polysaccharide; and a biocompatible, surface erodible, hydrophobic polymeric matrix selected from the group consisting of polyanhydrides, poly(orthoesters), copolymers and combinations thereof, wherein the polysaccharide and protein are incorporated within and released from the polymeric matrix, the ratio of polysaccharide to protein in the matrix is greater than 1:1, and the rate of release of the protein in combination with the polysaccharide is more linear than the rate or release of the protein in the absence of the polysaccharide.
Claim 2
Dependent Claim
101 words
A controlled release system for a protein comprising: a protein having physical, chemical and biological activity equivalent to that of somatotrophin; a simple polysaccharide; and a biocompatible, surface erodible, hydrophobic polymeric matrix selected from the group consisting of polyanhydrides, poly(orthoesters), copolymers and combinations thereof, wherein the polysaccharide and protein are incorporated within and released from the polymeric matrix, the ratio of polysaccharide to protein in the matrix is greater than 1:1, and the rate of release of the protein in combination with the polysaccharide is more linear than the rate or release of the protein in the absence of the polysaccharide.
Claim 3
Dependent Claim
32 words
The controlled release system of claim 1 wherein the protein is elected from the group consisting of polypeptides, peptide fragments and natural, recombinant and synthetic analogs thereof of somatotrophin, having somatotrophin activity.
Claim 4
Dependent Claim
21 words
The controlled release system of claim 1 wherein the polysaccharide is selected from the group consisting of sucrose, glucose, and fructose.
Claim 5
Dependent Claim
30 words
The controlled release system of claim 1 wherein the polysaccharide is sucrose, the growth hormone like protein is biologically active growth hormone, and the polymeric matrix is formed from poly(anhydrides).
Claim 6
Independent Claim
109 words
A method for making a delivery system for a protein comprising providing a protein having physical, chemical and biological activity equivalent to that of somatotrophin in combination with a simple polysaccharide and incorporating the combination within a biocompatible, surface erodible, hydrophobic polymeric matrix selected from the group consisting of polyanhydrides, poly(orthoesters), copolymers and combinations thereof, wherein the polysaccharide and protein are incorporated within and released from the polymeric matrix, the ratio of polysaccharide to protein is greater than 1:1 and the rate of release of the protein in combination with the polysaccharide is more linear than the rate of release of the protein in the absence of the polysaccharide.
Claim 7
Independent Claim
109 words
A method for making a delivery system for a protein comprising providing a protein having physical, chemical and biological activity equivalent to that of somatotrophin in combination with a simple polysaccharide and incorporating the combination within a biocompatible, surface erodible, hydrophobic polymeric matrix selected from the group consisting of polyanhydrides, poly(orthoesters), copolymers and combinations thereof, wherein the polysaccharide and protein are incorporated within and released from the polymeric matrix, the ratio of polysaccharide to protein is greater than 1:1 and the rate of release of the protein in combination with the polysaccharide is more linear than the rate of release of the protein in the absence of the polysaccharide.
Claim 8
Dependent Claim
21 words
The method of claim 5 further comprising lyophilizing a solution containing the protein and polysaccharide before incorporation into the polymer matrix.
Claim 9
Dependent Claim
19 words
The method of claim 5 wherein the polysaccharide is selected from the group consisting of sucrose, glucose, and fructose.
Claim 10
Dependent Claim
30 words
The method of claim 5 wherein the protein is selected from the group consisting of polypeptides, peptide fragments and natural, recombinant and synthetic analogs thereof of somatotrophin, having somatotrophin activity.
Claim 11
Dependent Claim
27 words
The method of claim 5 wherein the polysaccharide is sucrose, the growth hormone-like protein is biologically active growth hormone, and the polymeric matrix is formed from poly(anhydrides).
Claim 12
Dependent Claim
18 words
The delivery system of claim 1 wherein the polysaccharide to protein ratio is between approximately 2:1 and 8:1.
Claim 13
Dependent Claim
17 words
The method of claim 5 wherein the polysaccharide to protein ratio is between approximately 2:1 and 8:1.
References Cited (Backward Citations)
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-06-16 | 1995-12-16 | 1996-06-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-06-16 | 1999-12-16 | 2000-06-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-06-16 | 2003-12-16 | 2004-06-16 | $7700.00 | Window Closed / Lapsed |