Reconstitution medium for protein and peptide formulations
Patent Information
- Authority / Receiving Office
- US · United States
- Current Assignee / Owner
- THE RES FOUND OF STATE UNIV OF NEW YORK
- Publication Date
- 2005-03-31
- Estimated Expiration
- Not applicable · inactive patent
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Abstract
Description
FIELD OF THE INVENTION This invention relates to compositions for reconstitution of freeze-dried formulations and more particularly provides a composition and method for reconstitution of freeze-dried formulations comprising proteins and lipids. BACKGROUND OF THE INVENTION Advances in protein engineering and biotechnology, have led to large scale production of proteins and peptides for pharmaceutical purposes such as replacement therapies and vaccines. However, due to their complex structure and folding dynamics, proteins undergo physical and chemical instability. These instabilities present unique difficulties in the production, formulation, storage and administration of protein pharmaceuticals (1,2). Chemical instability is related to covalent modification of the protein that leads to loss of activity. One strategy to overcome this difficulty and to prolong the shelf life, is to freeze dry protein products and reconstitute them prior to the administration. The reconstitution buf...