Novel Antihemophilic (AHF) Formulations: Surface Coated Dispersion Systems as a Delivery Vehicle for AHF and its Fragments

Liposome technologies were developed to circumvent the problems associated with delivering therapeutic proteins into the human body. By encapsulating the protein of interest, the liposome allows the protein to remain in the circulation long enough t o have a pharmacological effect. While liposomes can increase the protein’s half-life, improve its stability and minimize its immunogenicity, they are not without limitations. A remaining problem in the liposome field is that there is a limitation to the amount of protein that can be encapsulated while still maintaining a workable size.

This invention encompasses a novel protein formulation system and a method capable of stabilizing hydrophobic domains of the selected protein and shieldin g specific regions to alter therapeutic responses, such as immunogenicity and antigenicity. Further, this invention allows for an increase in the association (up to 90%) of the protein with the liposome by taking into account the thermodynamical par ameters governing the protein’s folding characteristics. In essence, the method increases the amount of protein in a liposome and provides for homogeneous size distribution of the delivery particles. This has resulted in a lipo-protein complex that overcomes problems of physical and chemical instability such as denaturation, aggregation, and precipitation thereby leading to improvements in the production, formulation, and storage of protein pharmaceuticals. The technology has been demonstrate d with a variety of proteins including but not limited to anti-hemolytic factor, also known as factor VIII or AHF.

Type of Offer: Licensing



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