Reconstitution medium for protein and peptide formulations

a technology of protein and peptide, which is applied in the direction of peptide/protein ingredients, drug compositions, pharmaceutical delivery mechanisms, etc., can solve the problems of protein product safety, loss of activity, physical and chemical instability of proteins, etc., and achieve the effects of promoting protein-lipid interaction, preventing physical instability, and stabilizing intermediate structures
US20050069578A1Inactive Publication Date: 2005-03-31THE RES FOUND OF STATE UNIV OF NEW YORK

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

Compositions useful for reconstitution of concentrated formulations containing protein / peptide pharmaceuticals are provided. The composition generally includes one or more lipids, as well as one or more alcohols that promote and stabilize the formation of (a) lipid molecular assemblies with greater protein encapsulation; (b) protein-lipid complexes and (c) protein and lipid solutions. The reconstitution medium improves the protein-lipid association that in turn alters the pharmaceutical properties.
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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...

Claims

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