US4082737A
Expired / Lapsed
US
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Stabilized thymosin composition and method
Assignee: Hoffmann La Roche Inc
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Filing: 1977-02-22
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Granted: 1978-04-04
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Expires: 1997-02-22
Abstract
Abstract Thymosin fraction 5 has been widely employed recently in the clinical investigation of this thymic hormone. This material is a hormonally active proteinaceous composition which is involved in the regulation of cell-mediated immunity. The present disclosure provides a solid, stable, endotoxin and pyrogen free thymosin fraction 5 composition suitable for reconstitution for injection.
Inventors
- 👤 Weldon Courtney McGregor
- 👤 Harold Leon Newmark
- 👤 Armin Hermann Ramel
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 22:45
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/045; A61K31/05; A61K31/21; A61K31/215; A61K31/235; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/2292; A61K45/00; A61K45/06; A61P; A61P37/00
Claims Analysis
Total Claims: 9
Claim 1
Independent Claim
69 words
A solid stable endotoxin and pyrogen free form of thymosin fraction 5 comprising in combination: A. a major amount of thymosin fraction 5; and minor, effective amounts each of B. a phenolic type antimicrobial agent, selected from the group consisting phenol cresols and the pharmaceutically acceptable esters of para hydroxy benzoic acids and C. a buffering agent in an amount sufficient to provide a pH of 7-8 on reconstitution.
Claim 2
Dependent Claim
69 words
A solid stable endotoxin and pyrogen free form of thymosin fraction 5 comprising in combination: A. a major amount of thymosin fraction 5; and minor, effective amounts each of B. a phenolic type antimicrobial agent, selected from the group consisting phenol cresols and the pharmaceutically acceptable esters of para hydroxy benzoic acids and C. a buffering agent in an amount sufficient to provide a pH of 7-8 on reconstitution.
Claim 3
Dependent Claim
11 words
The composition of claim 1 wherein said antimicrobial agent is phenol.
Claim 4
Dependent Claim
12 words
The composition of claim 1 wherein the buffer agent is sodium bicarbonate.
Claim 5
Independent Claim
124 words
A method for preparing a solid, stable endotoxin and pyrogen free form of thymosin fraction 5 which method comprises in combination: A. ultrafiltering an aqueous solution of thymosin fraction 5 buffered with a volatile weakly basic buffer to a pH of 7 to 8 through a membrane having a cut off of about molecular weight 10,000 whereby any endotoxins or pyrogen in said solution is retained in the concentrate and the thymosin fraction 5 is passed into the permeate; B. adding a phenolic type antimicrobial agent selected from the group consisting phenol cresols and the pharmaceutically acceptable esters of para hydroxy benzoic acids to said permeate; and C. lyophilizing said permeate, said phenolic type antimicrobial agent being retained with the lyophilized thymosin fraction 5.
Claim 6
Independent Claim
124 words
A method for preparing a solid, stable endotoxin and pyrogen free form of thymosin fraction 5 which method comprises in combination: A. ultrafiltering an aqueous solution of thymosin fraction 5 buffered with a volatile weakly basic buffer to a pH of 7 to 8 through a membrane having a cut off of about molecular weight 10,000 whereby any endotoxins or pyrogen in said solution is retained in the concentrate and the thymosin fraction 5 is passed into the permeate; B. adding a phenolic type antimicrobial agent selected from the group consisting phenol cresols and the pharmaceutically acceptable esters of para hydroxy benzoic acids to said permeate; and C. lyophilizing said permeate, said phenolic type antimicrobial agent being retained with the lyophilized thymosin fraction 5.
Claim 7
Dependent Claim
18 words
The method of claim 4 wherein said aqueous solution of thymosin fraction 5 is buffered with ammonium bicarbonate.
Claim 8
Dependent Claim
19 words
The method of claim 5 wherein ammonium bicarbonate of a concentration in the range of about 0.1-0.5M is used.
Claim 9
Dependent Claim
13 words
The method of claim 4 wherein said phenolic type antimicrobial agent is phenol.
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) | 1981-04-03 | 1981-10-03 | 1982-04-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1985-04-03 | 1985-10-03 | 1986-04-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1989-04-03 | 1989-10-03 | 1990-04-04 | $7700.00 | Window Closed / Lapsed |