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Last Updated: August 11, 2020

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Claims for Patent: 5,866,538

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Summary for Patent: 5,866,538
Title: Insulin preparations containing NaCl
Abstract:Insulin preparations of superior chemical stability, comprising human insulin or an analogue or derivative thereof, glycerol and/or mannitol, and 5 to 100 mM of a halogenide are disclosed.
Inventor(s): Norup; Elsebeth (Jyllinge, DK), Langkj.ae butted.r; Liselotte (Klampenborg, DK), Havelund; Svend (Bagsvaerd, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:08/879,991
Patent Claims:1. A pharmaceutical formulation comprising:

a polypeptide selected from the group consisting of human insulin, an analogue thereof, a derivative thereof, and combinations of any of the foregoing;

glycerol, mannitol, or glycerol and mannitol; and

5 to 100 mM of a halogenide.

2. A pharmaceutical formulation according to claim 1, wherein the halogenide is an alkali or alkaline earth halogenide.

3. A pharmaceutical formulation according to claim 1, wherein said glycerol or mannitol is present at a concentration of 100 to 250 mM.

4. A pharmaceutical formulation according to claim 1, wherein said polypeptide is an analogue of human insulin selected from the group consisting of: (i) an analogue wherein position B28 is Asp, Lys, Leu, Val or Ala and position B29 is Lys or Pro; and (ii) des(B28-B30), des(B27) or des(B30) human insulin.

5. A pharmaceutical formulation according to claim 4, wherein said polypeptide is an analogue of human insulin wherein position B28 is Asp or Lys, and position B29 is Lys or Pro.

6. A pharmaceutical formulation according to claim 4, wherein said polypeptide is des(B30) human insulin.

7. A pharmaceutical formulation according to claim 1, wherein said halogenide is present at a concentration of 5 to 60 mM.

8. A pharmaceutical formulation according to claim 1, wherein said polypeptide is a derivative of human insulin having one or more lipophilic substituents.

9. A pharmaceutical formulation according to claim 8, wherein the insulin derivative is selected from the group consisting of B29-N.sup..epsilon. -myristoyl-des(B30) human insulin, B29-N.sup..epsilon. -palmitoyl-des(B30) human insulin, B29-N.sup..epsilon. -myristoyl human insulin, B29-N.sup..epsilon. -palmitoyl human insulin, B28-N.sup..epsilon. -myristoyl Lys.sup.B28 Pro.sup.B29 human insulin, B28-N.sup..epsilon. -palmitoyl-Lys.sup.B28 Pro.sup.B29 human insulin, B30-N.sup..epsilon. -myristoyl-Thr.sup.B29 Lys.sup.B30 human insulin, B30-N.sup..epsilon. -palmitoyl-Thr.sup.B29 Lys.sup.B30 human insulin, B29-N.sup..epsilon. -(N-palmitoyl-.gamma.-glutamyl)-des(B30) human insulin, B29-N.sup..epsilon. (N-lithocholyl-.gamma.-glutamyl)-des(B30) human insulin, B29-N.sup..epsilon. -(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and B29-N.sup..epsilon. -(.omega.-carboxyheptadecanoyl) human insulin.

10. A pharmaceutical formulation according to claim 9, wherein the insulin derivative is B29-N.sup..epsilon. -myristoyl-des(B30) human insulin.

11. A pharmaceutical formulation according to claim 8, wherein said halogenide is present at a concentration of 10 to 100 mM.

12. A pharmaceutical formulation according to claim 1, comprising an insulin analogue as well as an insulin derivative.

13. A pharmaceutical formulation according to claim 1, wherein said polypeptide is present at a concentration of 60 to 3000 nmol/ml.

14. A pharmaceutical formulation according to claim 1, further comprising:

10 to 40 ug Zn/100 U insulin.

15. A pharmaceutical formulation according to claim 1, further comprising:

0 to 5 mg/ml of a phenolic compound.

16. A pharmaceutical formulation according to claim 15, comprising:

0. 5 to 4.0 mg/ml of m-cresol or 0.5 to 4.0 mg/ml of phenol, or a mixture thereof.

17. A pharmaceutical formulation according to claim 1, wherein the halogenide is sodium chloride.

Summary for Patent:   Start Trial

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark685/96Jun 20, 1996

Details for Patent 5,866,538

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Novo Nordisk Inc NOVOLOG MIX 50/50 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021810 001 2017-11-21   Start Trial Novo Nordisk A/S (Bagsvaerd, DK) 2016-06-20 DISCN company
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313 001 2016-03-07   Start Trial Novo Nordisk A/S (Bagsvaerd, DK) 2016-06-20 DISCN company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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