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Claims for Patent: 5,547,930

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Claims for Patent: 5,547,930

Title: Asp.sup.B28 insulin crystals
Abstract:The present invention relates to insulin crystals comprising ASP.sup.B28 and protamine, and pharmaceutical preparations containing same. The crystals and preparations exhibit rapid onset and prolonged activity when administered in vivo.
Inventor(s): Balschmidt; Per (Esper.ae butted.rde, DK)
Assignee: Novo Nordisk A/S (Basgsvaerd, DK)
Application Number:08/127,672
Patent Claims: 1. Crystals comprising Ash.sup.B28 human insulin and protamine.

2. Crystals, according to claim 1, comprising zinc.

3. Crystals according to claim 2, comprising from about 0.35 to about 1.5, preferably from about 0.5 to about 1, % (weight/weight) zinc.

4. Crystals according to claim 1, comprising from about 10 to about 15, preferably from about 12.5 to about 14, % (weight/weight) of protamine.

5. A preparation comprising crystals according to claim 1, suspended in an aqueous medium.

6. A preparation according to claim 5, comprising zinc.

7. A preparation according to claim 5, wherein the content of Asp.sup.B28 human insulin is in the range from about 10 through about 500 IU/ml, preferably in the range from about 20 through about 200 IU/ml, most preferred in the range from about 40 through about 100 IU/ml.

8. Protamine zinc insulin preparation according to claim 5, wherein the content of zinc is in the range from about 0.3 .mu.g through about 2 .mu.g zinc per IU of Asp.sup.B28 human insulin.

9. A preparation according to claim 5, having a pH value in the range from about 6.5 through about 8, preferably in the range from about 7 through about 7.5, most preferred in the range from about 7.2 through about 7.4.

10. A preparation according to claim 5 comprising dissolved Asp.sup.B28 human insulin.

11. A preparation according to claim 10, wherein the ratio between crystals comprising Asp.sup.B28 human insulin and protamine, on one hand, and dissolved Asp.sup.B28 human insulin, on the other hand, is in the range from about 90:10 to about 50:50, preferably about 70:30.
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