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Claims for Patent: 6,152,897

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Claims for Patent: 6,152,897

Title: Syringe
Abstract:The invention relates to a one-dose syringe comprising a first chamber with a freeze-dried composition comprising a protein in an amount of less than 1.4 mg, amino acid and stabilizer where the weight ratio between protein and amino acid versus stabilizer is less than 1.5 and in which the ratio of the weight of the dry component versus the cake volume in the first chamber is above 12 mg/ml, and a second chamber with an aqueous reconstitution solution with an injectable volume of less than 0.5 ml.
Inventor(s): Limrell; Karin (Sollentuna, SE), Florin-Robertsson; Ebba (Stockholm, SE), Hokby; Elvy (Enskede, SE), Nilsson; Ulf (Ekero, SE), Strom; Anders (Enskede, SE)
Assignee: Pharmacia & Upjohn AB (Stockholm, SE)
Application Number:09/196,514
Patent Claims: 1. One-dose syringe, comprising:

i) a first chamber containing a freeze-dried composition comprising growth hormone in an amount of less than 1.4 mg, mannitol and amino acid wherein the weight ratio between protein and amino acid versus stabilizer is less than 1.5 and the ratio of the weight of the freeze dried component versus the cake volume is above 12 mg/ml; and

ii) a second chamber containing an aqueous reconstitution solution with an injectable volume of less than 0.5 ml.

2. Syringe according to claim 1 in which the ratio of the weight of the freeze dried component versus the cake volume in the first chamber is above 15 mg/ml.

3. Syringe according to claim 1, wherein the amino acid is glycine.

4. Syringe according to claim 1, wherein the amino acid is alanine.

5. Syringe according to claim 1, wherein the first chamber comprises a buffer.

6. Syringe according to claim 5, wherein the buffer comprises sodium phosphate.

7. Syringe according to claim 1, wherein the second chamber comprises isotonic agent.

8. Syringe according to claim 1, wherein the growth hormone is human growth hormone.

9. Syringe according to claim 8, wherein the amino acid is glycine.

10. Syringe according to claim 8, wherein the second chamber comprises isotonic agent.

11. Syringe according to claim 1, wherein the amino acid is glycine or alanine.
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