Abstract: Pharmaceutical compositions that include a poorly water-soluble therapeutic compound, an aqueous solvent, an chelator/antioxidant, a buffer or buffer component, and a bulking agent. The pharmaceutical compositions can be orally ingested or administered parenterally. The pharmaceutical compositions can further be lyophilized to form a pharmaceutically acceptable cake that can be administered orally, e.g., as a solid oral dosage form; or reconstituted and administered parenterally, e.g. as a single i.v. bolus or iv infusion, or administered orally, e.g. as a drink solution.

Abstract: The present invention relates to pharmaceutical formulations of benzodiazepine compounds which are active against Respiratory Syncytial Virus (RSV) suitable for parenteral administration.

Abstract: A method of liposome-based therapy for a mammalian subject is disclosed. The method uses liposomes and/or liposomes with outer surfaces that contain an affinity moiety effective to bind specifically to a biological surface at which the therapy is aimed, and a hydrophilic polymer coating. The hydrophilic polymer coating is made up of polymer chains covalently linked to surface lipid components. After a desired liposome biodistribution is achieved, the affinity agent binds to the target surface and helps internalize the liposomes.

Abstract: Methods for reducing or inhibiting the irreversible inactivation of water-soluble biologically active agents in biodegradable polymeric delivery systems which are designed to release such agents over a prolonged period of time, such as PLGA delivery systems are provided. The method comprises preparing PLGA delivery systems whose microclimate, i.e. the pores where the active agent resides, uniformly or homogenously maintain a pH of between 3 and 9, preferably between 4 and 8, more preferably between 5 and 7.5 during biodegradation.

Abstract: Methods for reducing or inhibiting the irreversible inactivation of water-soluble biologically active agents in biodegradable polymeric delivery systems which are designed to release such agents over a prolonged period of time, such as PLGA delivery systems are provided. The method comprises preparing a PLGA delivery systems whose microclimate, i.e. the pores where the active agent resides, uniformly or homogenously maintain a pH of between 3 and 9, preferably between 4 and 8, more preferably between 5 and 7.5 during biodegradation.

Abstract: Methods for reducing or inhibiting the irreversible inactivation of water-soluble biologically active agents in biodegradable polymeric delivery systems which are designed to release such agents over a prolonged period of time, such as PLGA delivery systems are provided. The method comprises preparing a PLGA delivery systems whose microclimate, i.e. the pores where the active agent resides, uniformly or homogenously maintain a pH of between 3 and 9, preferably between 4 and 8, more preferably between 5 and 7.5 during biodegradation.

Abstract: A delivery system and a method for sustained release of formaldehyde-treated vaccine antigens wherein the antigens are stabilized by stabilizing agents mixed with the formaldehyde-treated antigens and then dispersed within a biocompatible polymer matrix. The stabilizing agents inhibit formaldehyde mediated aggregation of formaldehyde-treated vaccine antigens by greater than 60% compared to antigens incubated without stabilizing agents. Stabilizing agents may be selected from formaldehyde-interacting amino acids, basic additives, and mono, di-, or polysaccharides. The delivery system may be biodegradable. The formaldehyde-treated vaccine antigens my be tetanus toxoid, diphtheria toxoid, or both tetanus toxoid and diphtheria toxoid.

Abstract: Methods for reducing or inhibiting the irreversible inactivation of water-soluble biologically active agents in biodegradable polymeric delivery systems which are designed to release such agents over a prolonged period of time, such as PLGA delivery systems are provided. The method comprises preparing a PLGA delivery systems whose microclimate, i.e. the pores where the active agent resides, uniformly or homogenously maintain a pH of between 3 and 9, preferably between 4 and 8, more preferably between 5 and 7.5 during biodegradation.