Patent US2658139A successfully refreshed from Google Patents.
US4604377A
Expired / Lapsed
US
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Pharmaceutical compositions of microbially produced interleukin-2
Assignee: Novartis Vaccines and Diagnostics Inc
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Filing: 1985-03-21
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Granted: 1986-08-05
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Expires: 2005-03-21
Abstract
Abstract A sterile, stable lyophilized formulation of selectively oxidized microbially produced recombinant IL-2 in which the recombinant IL-2 is admixed with a water soluble carrier such as mannitol that provides bulk, and a sufficient amount of sodium dodecyl sulfate to ensure the solubility of the recombinant IL-2 in water. The formulation is suitable for reconstitution in aqueous injections for parenteral administration and it is stable and well tolerated in human patients. FIG. 1 illustrates a preferred method of purifying recombinant IL-2 suitable for use in preparing the formulations of the present invention.
Inventors
- 👤 Pete M. Fernandes
- 👤 Terrance A. Taforo
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 02:15
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/14; A61K9/19; C; C07; C07K; C07K14/00; C07K14/435; C07K14/52; C07K14/54; C07K14/55; A61K47/00; A61K47/06; A61K47/20; A61K47/26; A61K47/28; Y; Y10; Y10S; Y10S435/00; Y10S435/8215; Y10S435/948
Claims Analysis
Total Claims: 16
Claim 1
Independent Claim
117 words
A recombinant IL-2 composition suitable for reconstituting in a pharmaceutically acceptable aqueous vehicle for parenteral administration to a patient to provide IL-2 therapy comprising a sterile lyophilized mixture of: (a) a therapeutically effective amount of a selectively oxidized microbially produced recombinant IL-2 that is substantially free of non-IL-2 protein, and it is at least 95% pure recombinant IL-2, and contains less than about 5 ng endotoxin per 100,000 units of IL-2 activity; (b) a physiologically acceptable water soluble carrier that does not affect the stability of the selectively oxidized microbially produced IL-2 adversely; and (c) a sufficient amount of a surface active agent to ensure the water solubility of the selectively oxidized, microbially produced hydrophobic recombinant IL-2.
Claim 2
Dependent Claim
117 words
A recombinant IL-2 composition suitable for reconstituting in a pharmaceutically acceptable aqueous vehicle for parenteral administration to a patient to provide IL-2 therapy comprising a sterile lyophilized mixture of: (a) a therapeutically effective amount of a selectively oxidized microbially produced recombinant IL-2 that is substantially free of non-IL-2 protein, and it is at least 95% pure recombinant IL-2, and contains less than about 5 ng endotoxin per 100,000 units of IL-2 activity; (b) a physiologically acceptable water soluble carrier that does not affect the stability of the selectively oxidized microbially produced IL-2 adversely; and (c) a sufficient amount of a surface active agent to ensure the water solubility of the selectively oxidized, microbially produced hydrophobic recombinant IL-2.
Claim 3
Dependent Claim
34 words
The composition of claim 1 wherein the oxidized microbially produced recombinant IL-2 includes less than about 5% by weight non-IL-2 protein and the surface active agent is sodium dodecyl sulfate (SDS) or sodium deoxycholate.
Claim 4
Dependent Claim
21 words
The composition of claim 1 wherein the oxidized microbially produced IL-2 constitutes about 0.02% to 3.85% by weight of the mixture.
Claim 5
Dependent Claim
15 words
The composition of claim 1 wherein the recombinant IL-2 is des ala IL-2 ser125 .
Claim 6
Dependent Claim
12 words
The composition of claim 1 wherein the water soluble carrier is mannitol.
Claim 7
Dependent Claim
23 words
The composition of claim 2 wherein the sodium dodecyl sulfate is present at about 100 to about 250 μg per mg of IL-2.
Claim 8
Dependent Claim
64 words
The composition of claim 2 wherein the recombinant IL-2 is des ala IL-2 ser125 , the recombinant IL-2 protein includes less than about 5% by weight non-IL-2 protein, the IL-2 constitutes about 0.015% to 3.85% by weight of the mixture, the water soluble carrier is mannitol, and the sodium dodecyl sulfate is present at about 100 to about 250 μg per mg of IL-2.
Claim 9
Dependent Claim
52 words
A pharmaceutical composition for providing therapy to a patient comprising a sterile solution of: (a) the mixture of claim 1 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 mg to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 ml.
Claim 10
Dependent Claim
53 words
A pharmaceutical composition for providing IL-2 therapy to a patient comprising a sterile solution of: (a) the mixture of claim 2 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 mg to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 ml.
Claim 11
Dependent Claim
54 words
A pharmaceutical composition for providing IL-2 therapy to a patient comprising a sterile solution of: (a) the mixture of claim 3 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 mg to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 per ml.
Claim 12
Dependent Claim
54 words
A pharmaceutical composition for providing IL-2 therapy to a patient comprising a sterile solution of: (a) a mixture of claim 4 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 mg to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 per ml.
Claim 13
Dependent Claim
53 words
A pharmaceutical composition for providing IL-2 therapy to a patient comprising a sterile solution of: (a) the mixture of claim 5 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 per ml.
Claim 14
Dependent Claim
54 words
A pharmaceutical composition for providing IL-2 therapy to a patient comprising a sterile solution of: (a) the mixture of claim 6 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 mg to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 per ml.
Claim 15
Dependent Claim
53 words
A pharmaceutical composition for providing therapy to a patient comprising a sterile solution of: (a) the mixture of claim 7 dissolved in (b) a pharmaceutically acceptable aqueous parenteral injection, said solution containing in the range of about 0.01 mg to about 2 mg of the selectively oxidized microbially produced recombinant IL-2 per ml.
Claim 16
Dependent Claim
15 words
The pharmaceutical composition of claim 8 wherein the aqueous parenteral vehicle is water for injection.
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) | 1989-08-04 | 1990-02-03 | 1990-08-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-08-04 | 1994-02-03 | 1994-08-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1997-08-04 | 1998-02-03 | 1998-08-05 | $7700.00 | Window Closed / Lapsed |