Claims
- 1. A stable, albumin-free, lyophilized rFVIII preparation comprising, when reconstituted in water, about
- 65 to 400 mM glycine,
- up to 50 mM histidine,
- 15 to 60 mM sucrose,
- about 50 to about 100 mM NaCl,
- up to 5 mM CaCl.sub.2, and
- 50 to 1500 lU rFVIII/ml.
- 2. A stable, albumin-free lyophilized rFVIII preparation comprising, when reconstituted with water, about
- 290 mM glycine,
- 20 mM histidine,
- 30 mM sucrose,
- 100 mM NaCl,
- 2.5 mM CaCl.sub.2, and
- 50 to 1500 lU rFVIII/ml.
- 3. The lyophilized preparation of claim 1 wherein the residual water content is about 1 to 3% by weight.
- 4. The lyophilized preparation of claim 2 wherein the residual water content is about 1% by weight.
- 5. A stable, albumin-free, lyophilized rFVIII preparation comprising, when reconstituted in water, about
- 65 to 400 mM glycine,
- up to 50 mM histidine,
- 15 to 60 mM sucrose,
- about 50 mM NaCl to about 100 mM,
- up to 5 mM CaCl.sub.2, and
- 50 to 1500 lU rFVIII/ml
- the preparation being crystalline with an amorphous component and including a residual water content of about 1 to 3% by weight,and having the property of being rapidly reconstituted in water.
- 6. The product of claim 5 wherein the preparation reconstitutes in water within 30 seconds.
- 7. The product of claim 5 wherein the preparation is substantially amorphous.
Parent Case Info
This is a Continuation-in-Part of patent application Ser. No. 08/678,492, filed Jul. 12, 1996, now U.S. Pat. No. 5,763,401.
US Referenced Citations (10)
Continuation in Parts (1)
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Number |
Date |
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678492 |
Jul 1996 |
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