Lamellar gels and methods for making and using

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Liposomes

Reexamination Certificate

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C424S121000, C424S009321, C424S009510, C424S417000, C264S004100, C264S004300

Reexamination Certificate

active

06207186

ABSTRACT:

Throughout this application various publications are referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains.
BACKGROUND OF THE INVENTION
The field of the invention is lamellar gels and methods for making and using thereof.
Gels are viscoelastic materials that normally consist of a solid component dispersed in a liquid, water in the case of hydrogels. Polymer gels, either natural such as gelatin, or synthetic, contain a polymer network that serves as the solid component and can resist shear. For many biological applications, gels based on high molecular weight polyethylene glycol have been used because of their low immunogenicity. In this context these gels coat more immunogenic tissues, proteins and other materials and thereby provide protection from immune response.
Conventional polymer gels incorporate solid phase components, a characteristic that places constraints on their manipulation and use in a variety of settings. Polymer gels that incorporate solid phase components (e.g., poly(vinyl alcohol) based gels) (1) are severely limited in their ability to provide flexible means for making reagents accessible to or directing such reagents towards different targets.
Gels that can function without solid phase components such as those that utilize a lamellar hydrogel phase for regulating their viscosity and elasticity would overcome many of the problems observed in the field of conventional gels. Unlike polymer gels that incorporate a primarily covalently-linked network with no fluid component, a bioactive gel such as the gel of the invention, based on fluid membranes could incorporate membrane-imbedded proteins or other biologically active molecules, thus providing a way to deliver such molecules in a stable gel.
The state of the current art in the field of gels (polymer gels) and their compositions and methods for making and using in a manner that facilitates drug targeting and delivery or other applications for molecule delivery in related contexts, is limited by the inability to imbed molecules into the linked network.
The present invention is directed to overcoming the limitations associated with polymer gels.
SUMMARY OF THE INVENTION
The invention provides novel compositions involving lamellar gel complexes and methods for making them. This new class of fluid membrane based compositions and methods of the manipulating them are significant improvements in the field of gel complex synthesis, macromolecule targeting and delivery to various biological systems.
The disclosed invention utilizes novel compositions of materials and identifies critical material parameters in the method of controlling lamellar gel formation and component parameters, e.g., controlling the characteristics of the gel superstructure. In addition, the invention disclosed means to manipulate the phase structure of the lamellar gel compositions in order to facilitate their use in molecule targeting and delivery.
By utilizing these new compositions and the methods for making, using and manipulating this new class of gels, an extremely versatile molecular targeting and delivery system can be developed for a variety of applications. The invention has applications in the numerous protocols, which would benefit from the utilization gels such as bioactive hydrogels partnered with various macromolecules. Such protocols include tissue healing as well as the molecular delivery of various molecules including drugs, peptide and proteins. The disclosed invention also has applications in the field of the so-called “smart” hydrogels (e.g., gels for therapeutic or cosmetic applications) of polymer networks that respond by altering their configurations to external stimuli such as temperature, solvent or pH changes.


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