EP0284249A1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Lyophilized lymphokine composition
Assignee: Interferon Sciences Inc
•
Filing: 1988-03-10
•
Granted: —
•
Expires: 2008-03-10
Abstract
Abstract An exceptionally stable lyophilized lymphokine composition for therapeutic administration upon reconstitution is disclosed which comprises: a) a therapeutically effective amount of a lymphokine, for example, an interferon such as recombinant alpha-2 interferon; b) a bulking agent such as mannitol or human serum albumin; c) a stabilizer for the lymphokine such as glycine or human serum albumin; d) a dispersant such as polysorbate 20; e) an isotonic agent such as sodium chloride; and, f) a buffer such as a combination of succinic acid and sodium succinate to maintain the pH of the composition within a range which is conducive to the stability of the lymphokine component thereof.
Inventors
- 👤 John A. Bontempo
- 👤 Sean A. Evans
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-05 21:16
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K38/00; A61K38/16; A61K38/17; A61K38/19; A61K38/21; A61K38/212; A61K9/14; A61K9/19
Claims Analysis
Total Claims: 20
Claim 1
Independent Claim
59 words
A lyophilized lymphokine composition for therapeutic administration which comprises: a) a therapeutically effective amount of a lymphokine; b) a bulking agent; c) a stabilizer for the lymphokine; d) a dispersant; e) an isotonic agent; and f) a buffer to maintaining the pH of the composition within a range which is conductive to the stability of the lymphokine component thereof.
Claim 2
Dependent Claim
59 words
A lyophilized lymphokine composition for therapeutic administration which comprises: a) a therapeutically effective amount of a lymphokine; b) a bulking agent; c) a stabilizer for the lymphokine; d) a dispersant; e) an isotonic agent; and f) a buffer to maintaining the pH of the composition within a range which is conductive to the stability of the lymphokine component thereof.
Claim 3
Dependent Claim
12 words
The lyophilized composition of claim 1 where the lymphokine is an interferon.
Claim 4
Dependent Claim
15 words
The lyophilized composition of claim 1 wherein the bulking agent is a polyhydric sugar alcohol.
Claim 5
Dependent Claim
19 words
The lyophilized composition of claim 1 wherein the stabilizer is selected from the group consisting of glycine and alanine.
Claim 6
Dependent Claim
15 words
The lyophilized composition of claim 1 wherein the dispersant is a nonionic surface active agent.
Claim 7
Dependent Claim
24 words
The lyophilized composition of claim 1 wherein the buffer is a combination of an organic acid and an acid salt of an organic acid.
Claim 8
Dependent Claim
98 words
A lyophilized composition for therapeutic administration which comprises: a) a therapeutically effective amount of an interferon; b) a bulking agent selected from the group consisting of polyhydric sugar alcohol and human serum albumin; c) a stabilizer for the interferon selected from the group consisting of glycine, alanine and human serum albumin; d) a nonionic surface active agent as dispersant; e) an inorganic salt as isotonic agent; and, f) a buffer based on an organic acid and an acid organic acid salt to maintain the pH of the composition within a range of from about 4.0 to about 8.0.
Claim 9
Dependent Claim
98 words
A lyophilized composition for therapeutic administration which comprises: a) a therapeutically effective amount of an interferon; b) a bulking agent selected from the group consisting of polyhydric sugar alcohol and human serum albumin; c) a stabilizer for the interferon selected from the group consisting of glycine, alanine and human serum albumin; d) a nonionic surface active agent as dispersant; e) an inorganic salt as isotonic agent; and, f) a buffer based on an organic acid and an acid organic acid salt to maintain the pH of the composition within a range of from about 4.0 to about 8.0.
Claim 10
Dependent Claim
13 words
The lyophilized composition of claim 7 wherein the interferon is an alpha interferon.
Claim 11
Dependent Claim
16 words
The lyophilized composition of claim 2 or 7 wherein the interferon is a recombinant alpha interferon.
Claim 12
Dependent Claim
29 words
The lyophilized composition of claim 1 or 7 wherein the polyhydric sugar alcohol bulking agent is selected from the group consisting of glycerine, erythritol, arabitol, xylitol, sorbitol and mannitol.
Claim 13
Dependent Claim
20 words
The lyophilized composition of claim 1 or 7 wherein both the bulking agent and the stabilizer is human serum albumin.
Claim 14
Dependent Claim
20 words
The lyophilized composition of claim 1 or 7 wherein the nonionic surface active agent dispersant is a polyoxyethylene sorbitan monolaurate.
Claim 15
Dependent Claim
26 words
The lyophilized composition of claim 1 or 7 wherein the inorganic salt isotonic agent is selected from the group consisting of sodium chloride and potassium chloride.
Claim 16
Dependent Claim
22 words
The lyophilized composition of claim 1 or 7 wherein the buffer is a combination of succinic acid and an alkali metal succinate.
Claim 17
Dependent Claim
32 words
The lyophilized composition of claim 1 or 7 further comprising at least one additional pharmaceutically acceptable component selected from the group consisting of mild reducing agent, chelating agent, acid sugar and saccharide.
Claim 18
Dependent Claim
14 words
The lyophilized composition of claim 1 or 7 suitable for parenteral administration upon reconstitution.
Claim 19
Dependent Claim
30 words
A two-component syringe wherein one component is the lyophilized composition of claim 1 and the other component is an amount of water sufficient for the reconstitution of the lyophilized composition.
Claim 20
Dependent Claim
30 words
A two-component kit wherein one component is the lyophilized composition of claim 1 and the other component is a vial containing preserved sterile water for reconstitution of the lyophilized composition.
References Cited (Backward Citations)
EP0089245A2
Cited
EP0123291A2
Cited
US4469228A
Cited
WO1985004328A1
Cited
EP0196203A2
Cited
EP0229016A2
Cited
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.