Abstract: This invention relates to proliposomal powder dispersions of testosterone undecanoate (TU) and phospholipids, including dispersions of TU and palmitoylphosphatidylcholine (DPPC), wherein the weight/weight (w/w) ratio of TU:DPPC in the proliposomal powder dispersion is about 1:2; or TU and 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC), wherein the weight/weight (w/w) ratio of TU:DMPC in the proliposomal powder dispersion is about 1:3; or TU and a 1-myristoyl-2-palmitoyl-sn-glycero 3-phosphocholine (MPPC), wherein the weight/weight (w/w) ratio of TU:MPPC in the proliposomal powder dispersion is about 1:3.

Abstract: Compositions and methods for making and using proliposomal and liposomal formulations of chemotherapeutic agents are disclosed. The proliposomal and liposomal formulations of chemotherapeutics, as well as medicaments and dosage forms that include such formulations, can be used with treatment regimens for bladder cancer and urothelial cancer. Hence, the formulations, medicaments, and dosage forms of the invention are suitable to treat bladder cancers by intravesical administration and to treat urothelial cancers. The formulations according to the invention include (a) a taxane (e.g., paclitaxel, docetaxel) or cisplatin, (b) a first phospholipid, dipalmitoyl phosphatidylcholine (DMPC), and (c) a second phospholipid, dimyrsityl phosphatidyl glycerol sodium (DMPG). The proliposomal formulations form liposomes upon contact with an aqueous vehicle.

Abstract: The invention described herein is directed to treating neoplasms by intraperitoneal administration of liposomal formulations of chemotherapeutic drugs. Methods of instilling liposomal formulations of taxane and platin chemotherapeutic agents into the peritoneal cavity of a subject to treat ovarian cancer or a primary peritoneal cancer are disclosed.

Abstract: Compositions and methods for making and using proliposomal and liposomal formulations of chemotherapeutic agents are disclosed. The proliposomal and liposomal formulations of chemotherapeutics, as well as medicaments and dosage forms that include such formulations, can be used with treatment regimens for bladder cancer and urothelial cancer. Hence, the formulations, medicaments, and dosage forms of the invention are suitable to treat bladder cancers by intravesical administration and to treat urothelial cancers. The formulations according to the invention include (a) a taxane (e.g., paclitaxel, docetaxel) or cisplatin, (b) a first phospholipid, dipalmitoyl phosphatidylcholine (DMPC), and (c) a second phospholipid, dimyrsityl phosphatidyl glycerol sodium (DMPG). The proliposomal formulations form liposomes upon contact with an aqueous vehicle.

Abstract: Compositions and methods for making and using liposomal formulations of paclitaxel are disclosed. The liposomal paclitaxel formulations are used with treatment regimens for bladder cancer and both lower and upper tract urothelial cancer. Hence, the formulations are suitable to treat bladder cancers by intravesical administration and to treat urothelial cancers. The formulations according to the invention include paclitaxel, lecithin, cholesterol, threonine, and glucose.

Abstract: The invention relates to methods for locally delivering a chemotherapeutic agent to an upper tract urothelial carcinoma (UTUC). The methods involve placing a balloon catheter that has a working channel and a balloon into the ureter/renal pelvis via retrograde or antegrade ureteral access; inflating the catheter balloon to temporarily obstruct the ureter; infusing (instilling) a liposomal formulation that includes a chemotherapeutic agent into the working channel of the catheter; and allowing the infused liposomal formulation to dwell in the ureter and/or renal pelvis for a time sufficient to allow at least a portion of the liposomal formulation to adhere to the urothelial wall. In the methods of the invention, at least a portion of the infused chemotherapeutic-agent formulation adheres to the urothelial wall while it is instilled and dwells in the ureter and/or renal pelvis.

Abstract: Novel testosterone undecanoate (TU) formulations are disclosed in which TU is incorporated into proliposomal powder dispersions of TU and distearoyl phosphatidylcholine (DSPC). The proliposomal powder dispersions of the invention can also be combined with pharmaceutically acceptable excipients, and incorporated into enterically coated oral dosage forms that are useful for testosterone replacement therapy.

Abstract: This invention is directed to a novel method of treating an individual suffering from a bacterial infection, such as bacterial infections of various tissues or organs of an individual. In general, the method of treatment involves administering to an individual a pharmaceutical formulation that comprises a liposome-encapsulated antimicrobial agent, wherein polyethylene glycol (PEG) molecules are covalently attached to the surface of the liposomes.

Abstract: Compositions and methods for making and using proliposomal and liposomal formulations of chemotherapeutic agents are disclosed. The proliposomal and liposomal formulations of chemotherapeutics, as well as medicaments and dosage forms that include such formulations, can be used with treatment regimens for bladder cancer and urothelial cancer. Hence, the formulations, medicaments, and dosage forms of the invention are suitable to treat bladder cancers by intravesical administration and to treat urothelial cancers. The formulations according to the invention include (a) a taxane (e.g., paclitaxel, docetaxel) or cisplatin, (b) a first phospholipid, dipalmitoyl phosphatidylcholine (DMPC), and (c) a second phospholipid, dimyrsityl phosphatidyl glycerol sodium (DMPG). The proliposomal formulations form liposomes upon contact with an aqueous vehicle.

Abstract: The invention relates to a novel free-flowing powder pharmaceutical formulation for the delivery of a poorly-water-soluble drug substance that increases the solubility and bioavailability of the poorly-water soluble drug substance, as well as to a method of making the free-flowing powder pharmaceutical formulation. The invention also relates to dispersed particles that disperse instantaneously from the free-flowing powder formulation when the formulation is added to water, aqueous solvent, or organic solvent, wherein the bulk distribution of the poorly-water soluble drug substance of the free-flowing powder formulation in the dispersed particles is uniform. Such dispersed particles increase the bioavailable surface area of the poorly water-soluble drug substance and facilitate the drug substance's dissolution.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: The invention relates to a novel free-flowing powder pharmaceutical formulation for the delivery of a poorly-water-soluble drug substance that increases the solubility and bioavailability of the poorly-water soluble drug substance, as well as to a method of making the free-flowing powder pharmaceutical formulation. The invention also relates to dispersed particles that disperse instantaneously from the free-flowing powder formulation when the formulation is added to water, aqueous solvent, or organic solvent, wherein the bulk distribution of the poorly-water soluble drug substance of the free-flowing powder formulation in the dispersed particles is uniform. Such dispersed particles increase the bioavailable surface area of the poorly water-soluble drug substance and facilitate the drug substance's dissolution.

Abstract: This invention is directed to a novel method of treating an individual suffering from a bacterial infection, such as bacterial infections of various tissues or organs of an individual. In general, the method of treatment involves administering to an individual a pharmaceutical formulation that comprises a liposome-encapsulated antimicrobial agent, wherein polyethylene glycol (PEG) molecules are covalently attached to the surface of the liposomes.

Abstract: The invention relates to a novel free-flowing powder pharmaceutical formulation for the delivery of a poorly-water-soluble drug substance that increases the solubility and bioavailability of the poorly-water soluble drug substance, as well as to a method of making the free-flowing powder pharmaceutical formulation. The invention also relates to dispersed particles that disperse instantaneously from the free-flowing powder formulation when the formulation is added to water, aqueous solvent, or organic solvent, wherein the bulk distribution of the poorly-water soluble drug substance of the free-flowing powder formulation in the dispersed particles is uniform. Such dispersed particles increase the bioavailable surface area of the poorly water-soluble drug substance and facilitate the drug substance's dissolution.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with phamarceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: The invention relates to a novel free-flowing powder pharmaceutical formulation for the delivery of a poorly-water-soluble drug substance that increases the solubility and bioavailability of the poorly-water soluble drug substance, as well as to a method of making the free-flowing powder pharmaceutical formulation. The invention also relates to dispersed particles that disperse instantaneously from the free-flowing powder formulation when the formulation is added to water, aqueous solvent, or organic solvent, wherein the bulk distribution of the poorly-water soluble drug substance of the free-flowing powder formulation in the dispersed particles is uniform. Such dispersed particles increase the bioavailable surface area of the poorly water-soluble drug substance and facilitate the drug substance's dissolution.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with phamarceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.