Abstract: A method of preparing polysaccharide glassy microparticles which are less than 10 ?um in diameter and contain structurally delicate agents, such as proteins, peptides, gene materials, vaccines, antibodies, viruses and liposomes using low-temperature aqueous-aqueous emulsification (free of polyelectrolytes) and freezing-induced phase separation. When delicate agents are added to a polysaccharide-PEG two phase system followed by homogenization (or other shear adding process), the agents partition into the polysaccharide dispersed phase preferentially. These processes help to avoid aggregation of proteins caused by interaction with charged polyelectrolytes used for stabilizing the polysaccharide dispersed phase in our previously reported aqueous-aqueous emulsion. When this system is frozen and lyophilized, glassy particles less than 10 ?m in diameter containing delicate agents can be formed.

Abstract: This invention provides method for sustained release delivery of structurally delicate agents such as proteins and peptides. Using a unique emulsion system (Stable polymer aqueous-aqueous emulsion), proteins and peptides can be microencapsulated in polysacchride glassy particles under a condition free of any chemical or physical hazard such as organic solvents, strong interfacial tension, strong shears, elevated temperature, large amount of surfactants, and cross-linking agents. Proteins loaded in these glassy particles showed strong resistance to organic solvents, prolonged activity in hydrated state, and an excellent sustained release profile with minimal burst and incomplete release when being further loaded in degradable polymer microspheres. This invention provides a simple yet effective approach to address all the technical challenges raised in sustained release delivery of proteins.

Abstract: This invention provides a stable aqueous/aqueous emulsion system which is prepared with a hydrophilic polymer. This invention also provides the method of preparing a stable aqueous/aqueous emulsion. Finally, this invention provides an encapsulation comprising the emulsion system which is prepared with a hydrophilic polymer.

Abstract: This invention provides a cochleate and nano-cochleate systems wherein the agents bridging lipid bilayer are organic multi-valent cations. This invention also provides a method for preparing the cochleate system comprising direct cochleation and hydrogel-isolated procedure. The preparation method comprises using the charge ration between the bridging agents and lipids to control the particle sizes. This cochleate or nano-cochleate system may be used for microencapsulation and delivery of therapeutics wherein the therapeutic agents are loaded in the cochleate structure as the bridging agents between lipid bilayers. Finally, this invention provides other uses of these new cochleate and nano-cochleate systems.

Abstract: This invention demonstrated novel pharmaceutical compositions that improve dissolution, water dispersion and/or oral absorption of insoluble or poorly soluble drugs without increase in formulation complicity and patient appliance as compared with conventional solid-dosage form. The compositions of the present invention comprise a lipid or mixed lipids that dissolve the insoluble or poorly soluble drugs and forms solution, micelles, microemulsion or emulsion with the drugs in aqueous media. The compositions further comprise a porous powder or mixed porous powder that absorb the drug-lipid melts in a considerable amount (>than their own mass) while remaining free flowing and compressible in nature. Due to their excellent effectiveness-simplicity ratio, the compositions of this invention have a wide applicability to therapeutic compounds whose efficacy is limited by poor solubility, low dissolution rate and less absorption.