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Last Updated: March 28, 2024

Claims for Patent: 4,859,604


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Summary for Patent: 4,859,604
Title: Composition for stabilization of diagnostic reagents
Abstract:Disclosed herein is a composition useful for stabilizing diagnostic reagent which functions to react with a specimen to determine the presence or absence of a biological condition comprising about 0.01 to 35 parts by weight protein or peptide and either (A) about 1 to 90 parts by weight of a saccharide polyol selected from the group consisting of corn syrup and dextrose and optionally up to about 25 parts by weight of a pyrrol, or (B) about 1 to 90 parts by weight of a saccharide polyol and about 0.01 to 25 parts by weight of a pyrrol. Also disclosed is a method of stabilizing such diagnostic reagents comprising using the stabilizing composition, and a diagnositc device comprising a non-absorbent base carrying at least one deposition area in which is carried the evaporative residue of such diagnostic reagent and the stabilizing composition.
Inventor(s): Gould; Martin (Gibbstown, NJ), Vulimiri; Sudhakar (West Deptford, NJ)
Assignee: Ampor, Inc. (Bridgeport, NJ)
Application Number:07/089,840
Patent Claims:1. A diagnostic device comprising a non-absorbent base carrying at least one deposition area in which is carried an evaporative residue of a mixture of combination of (a) a normally unstable at room temperature diagnostic reagent which functions to react with a specimen to determine the presence or absence of a biological condition, and (b) a stabilizing composition comprising abou 0.01 to 35 parts by weight of non-diagnostic protein selected from the group consisting of bovine serum albumin, human serum albumin, and egg albumin, and about 1 to 90 parts by weight of a material selected from the group consisting of corn syrup and dextrose.

2. Device of claim 1 wherein said stabilizing composition further includes up to abou 25 parts by weight of pyrrol.

3. Device of claim 2 whereins aid pyrrol is 2-pyrrolidinone.

4. Device of claim 1 wherein said stabilizing composition further includes about 0.01 to 30 parts of a conditioning agent selected from the group consisting of polyvinyl alcohol, polyvinyl alcohol/acetate, polyethylene glycol, hydroxyalkyl cellulose, and polyalkene acrylamides.

5. Device ofo claim 1 wherein said stabilizing composition comprises corn syrup, 2-pyrrlidinone, bovine serum albumin, and polyvinyl alcohol/acetate.

6. Device of claim 1 wherein said evaporative residue is the evaporative residue of an aqueous solution of said diagnostic reagent and said stabilizing composition.

7. Device of claim 6 wherein said evaporative residue is the evaporative residue of an aqueous-alcohol solutionn of said diagnostic reagent and said stabilizing composition.

8. Device of claim 1 wherein said non-absorbent base is a substrate which has a surface selected from the group consisting of glass and plastic.

9. Device of claim 8 wherein said surface is a plastic selected from the group consisting of polystyrene, polyacrylate, polymethacrylate, polyethylene, and polyvinyl chloride.

10. Device of claim 1 wherein said diagnostic reagent is selected from the group consisting of gamma globulin responsive to rheumatoid factor, cellular stroma responsive to infectious mononucleosis, HCG and anti-HCG antiserum responsive to pregnancy, toluidine red unheated serum test antigen responsive to syphilis, and beta hemalitic strep responsive to throat infections.

11. Device of claim 1 wherein said non-diagnostic protein is bovine serum albumin and said material is corn syrup.

Details for Patent 4,859,604

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2040-01-28
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2040-01-28
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2040-01-28
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2040-01-28
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 02/17/1995 ⤷  Try a Trial 2040-01-28
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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