Claims for Patent: 6,905,886

Summary for Patent: 6,905,886

Title:	Preservative solutions
Abstract:	This invention relates to preservative solutions for peptides, for example, parathyroid hormone, insulin-like growth factor binding protein 3 (IGFBP3), adrenocorticotropic hormone (ACTH) and mixtures thereof. Preferably, the peptides preserved by the solutions are non-reconstituted. In one embodiment, the preservative solutions comprise a polyvinyl alcohol, EDTA component and molybdic component.
Inventor(s):	Sundaram; Lata (Laguna Niguel, CA), Hoang; Ann (Lake Forest, CA), Shimizu; Stan (Trabuco Canyon, CA), Umelo-Njaka; Elizabeth R. (Trabuco Canyon, CA), Thomas; Darcy A. (Lake Forest, CA)
Assignee:	Quest Diagnostics Investments Incorporated (Wilmington, DE)
Application Number:	10/099,498
Patent Claims:	1. A solution of a diagnostic system, comprising a non-reconstituted peptide, a polyvinyl alcohol, an EDTA water soluble salt, and a water soluble salt of molybdenum, wherein the peptide remains stable in the solution for at least six months. 2. The solution of claim 1 wherein the EDTA water soluble salt is an EDTA disodium salt, and wherein the water soluble salt of molybdenum is sodium molybdate. 3. The solution of claim 1 wherein the preservative comprises about 0.10% to about 1% (% v/v) polyvinyl alcohol, about 0.10% to about 0.50% (% w/v) of a dissolved EDTA di-sodium salt and about 0.10% to about 1.00% (% w/v) of a dissolved molybdate salt. 4. The solution of claim 1 wherein the preservative comprises about 0.5% (% v/v) polyvinyl alcohol, about 0.17% (% w/v) dissolved EDTA di-sodium salt, and about 0.7% (% w/v) dissolved molybdate salt. 5. The solution of claim 1 further comprising a non-binding reducer. 6. The solution of claim 1 further comprising approximately 0.5% t-octylphenoxypolyethoxyethanol (TX-100). 7. The solution of claim 1 further comprising at least one of bovine serum albumin and fish skin gelatin. 8. The solution of claim 1 further comprising about 2.0% of at least one of bovine serum albumin and fish skin gelatin. 9. The solution of claim 1 having a pH of about 5 to about 8. 10. The solution of claim 1 having a pH of about 6. 11. The solution of claim 1 wherein the peptide is selected from the group consisting of parathyroid hormone, insulin-like growth factor binding protein 3 (IGFBP3), and adrenocorticotropic hormone (ACTH). 12. A diagnostic test system comprising: a. a plurality of standards of known percentages of a non-reconstituted peptide in a solution comprising a preservative, wherein the standards have a useful shelf life of at least six months, the preservative comprises a polyvinyl alcohol, an EDTA water soluble salt, and a water soluble salt of molybdenum; b. a solid phase coated with anti-peptide antibody; and c. a composition of labeled antibody of the peptide. 13. The system of claim 12 wherein the EDTA water soluble salt comprises a dissolved EDTA di-sodium salt and the water soluble salt of molybdenum comprises a dissolved sodium molybdate. 14. The system of claim 12 wherein the preservative comprises about 0.10% to about 1% (% v/v) polyvinyl alcohol, about 0.10% to about 0.50% (% w/v) dissolved EDTA di-sodium salt and about 0.10% to about 1.00% (% w/v) dissolved molybdate. 15. The system of claim 12, wherein the solution further comprises a non-binding reducer. 16. The system of claim 12, wherein the solution further comprises approximately 0.5% t-octylphenoxypolyethoxyethanol (TX-100). 17. The system of claim 12, wherein the solution further comprises a protein selected from the group consisting of bovine serum albumin, and fish skin gelatin. 18. The system of claim 12, wherein the solution has a pH of about 5 to about 8. 19. The system of claim 12, wherein the solution has a pH of about 6. 20. The system of claim 12 wherein the peptide is selected from the group consisting of parathyroid hormone, insulin-like growth factor binding protein 3 (IGFBP3), and adrenocorticotropic hormone (ACTH).

Details for Patent 6,905,886

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2020-08-11