Stabilizers for fibroblast growth factors

• US 5,348,941 A
• Filed: 04/01/1992
• Issued: 09/20/1994
• Est. Priority Date: 04/01/1992
• Status: Expired due to Term

• Current Assignee: Merck Sharp & Dohme Corporation (Merck & Co., Inc.)
• Original Assignee: Merck & Co., Inc.
• Inventors: Tsai, Pei-Kuo, Volkin, David B., Middaugh, C. Russell
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/861,060
• Time in Patent Office: 902 Days
• Field of Search: 514/12, 514/21, 514/970, 530/397, 530/399, 536/26.21, 536/26.23, 536/26.26
• US Class Current: 514/9.1
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/40 Cyclodextrins; Derivatives thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00

Abstract

Medicinal compositions containing fibroblast growth factor are stabilized against loss of biological activity by including in said composition a stabilizing amount of phytic add, phosvitin, phosphate buffer, (NH₄)₆ P₄ O₁₃, Na₅ P₃ O₁₀, Na₄ P₂ O₇ and Na₃ P₃ O₉, adenosine tetra, tri, di and mono phosphate and related diadenosine compounds plus other single and multi-phosphorylated mono and di-nucleotides, poly-aspartic acid, poly-adenylic-guanylic add and related compounds, double stranded deoxyribonucleic add, single stranded deoxyfibonucleic acid and poly-glutamic acid. Medicinal compositions for topical use are combined with a viscous excipient such as a water soluble polysaccharide with said combination with a second stabilizier.

Claims

1. A stable aqueous medicinal composition comprising acidic fibroblast growth factor combined with a stabilizing amount of a compound selected from the group consisting of ATP, AT4P, Ap₃ A, Ap₄ A, Ap₅ A and Ap₆ A said compound stabilizing acidic fibroblast growth factor against loss of biological activity.