Readily dissolvable lyophilized fibrinogen formulation

• US 4,650,678 A
• Filed: 08/10/1984
• Issued: 03/17/1987
• Est. Priority Date: 02/04/1982
• Status: Expired due to Term

• Current Assignee: AVENTIS BEHRING GMBH (CSL Limited)
• Original Assignee: Behringwerke Aktiengesellschaft (Sanofi )
• Inventors: Burk, Wolfgang, Stohr, Hans-Arnold, Heimburger, Norbert, Fuhge, Peter
• Primary Examiner(s): Moyer, Donald B.
• Assistant Examiner(s): Stone, Jacqueline M.
• Application Number:
  US06/639,617
• Time in Patent Office: 949 Days
• Field of Search: 424/177, 424/101, 514/2
• US Class Current: 530/382
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen
• CPC Class Codes: C07K 14/75 Fibrinogen

Abstract

A solid fibrinogen formulation is described, which formulation contains, in addition to fibrinogen, a substance containing the urea or guanidine radical, and a process for its preparation. This formulation is used for the preparation of a fibrinogen solution which is suitable as an adhesive for human and animal tissue and as a fibrinogen concentrate for intravenous administration.

Claims

1. A lyophilized fibrinogen formulation consisting essentially of fibrinogen and from 0.05 to 5 percent by weight of a substance selected from the group consisting of arginine, creatine, creatinine, glycocyamine, urea and citrulline, said substance enabling the fibrinogen to be readily dissolved in an aqueous solution to a concentration of 2 to 14 percent by weight.

2. A formulation as claimed in claim 1 which further comprises at least 0.1 to 5 percent by weight of either an amino acid having a hydrophobic side chain or a water-soluble fatty acid.

3. The lyophilized formulation of claim 1 consisting essentially of fibrinogen and arginine.

4. A formulation as claimed in claim 3 which further comprises at least 0.1 to 5 percent by weight of either an amino acid having a hydrophobic side chain or a water-soluble fatty acid.

5. A formulation as claimed in one of claims 2, 3 or 4 which further comprises factor XIII and aprotinin.