Abstract: An aqueous pharmaceutical solution composition comprising between about 20 mg/ml to about 100 mg/ml of a radioprotective ?,?-unsaturated aryl sulfone, a cosolvent comprising polyethylene glycol (PEG), polypropylene glycol, polyglycerol, DMA, propylene glycol, glycerol, ethanol, sorbitol, isopropyl alcohol, or a combination thereof in an amount between about 25% and about 90% w/v, and a water soluble Vitamin E derivative, wherein the composition has a pH within the range of about 7.0 to about 9.5.

Abstract: Formulations and methods are provided for the treatment of pain, and neuropathic pain in particular. The formulations are eutectic mixtures of a capsaicinoid and a local anesthetic agent and/or an anti-pruritic agent.

Abstract: Formulations are provided for parenteral administration of (amino substituted (e)-2,6-dialkoxystyryl 4-substituted benzylsulfones and the sodium and potassium salts thereof for the prevention and/or treatment of conditions mediated by abnormal cell proliferation. Composition for parenteral administration are provided which comprise an effective amount of compound of formula I or a compound of formula IIa and at least about 50% by weight of at least one water soluble polymer selected from the group consisting essentially of polyethylene glycol (PEG), poly-oxyethylene, poly-oxyethylene-poly-oxypropylene copolymers, polyglycerol, polyvinylalcohol, polyvinylpyrrolidone (PVP), polyvinylpyridine N-oxide, copolymer of vinylpyridine N-oxide and vinylpyridine.

Abstract: A pharmaceutical composition is provided for administration prior to or after exposure to ionizing radiation for reducing toxic effects of the radiation in a subject. An effective amount of the pharmaceutical composition provided comprising an effective amount of at least one radioprotective ?, ? unsaturated aryl sulfone, and at least one component selected from the group consisting of a) at least one water soluble polymer in an amount between about 0.5% and about 90% w/v, b) at least one chemically modified cyclodextrin in an amount between about 20% and about 60% w/v, and c) DMA in an amount between about 10% and about 50% w/v.

Abstract: Formulations are provided for parenteral administration of (amino substituted (e)-2,6-dialkoxystyryl 4-substituted benzylsulfones and the sodium and potassium salts thereof for the prevention and/or treatment of conditions mediated by abnormal cell proliferation. Composition for parenteral administration are provided which comprise an effective amount of a compound of formula I or a compound of formula IIa and at least about 50% by weight of at least one water soluble polymer selected from the group consisting essentially of polyethylene glycol (PEG), poly-oxyethylene, poly-oxyethylene-poly-oxypropylene copolymers, polyglycerol, polyvinylalcohol, polyvinylpyrrolidone (PVP), polyvinylpyridine N-oxide, copolymer of vinylpyridine N-oxide and vinylpyridine.

Abstract: Solution and suspension formulations are provided for administration prior to or after exposure to ionizing radiation for reducing toxic effects of the radiation in a subject which comprises an effective amount of at least one radioprotective ?,? unsaturated aryl sulfone wherein the composition has a pH within the range of about 8 to about 9.

Abstract: Formulations are provided for parenteral administration of (amino substituted (e)-2,6-dialkoxystyryl 4-substituted benzylsulfones and the sodium and potassium salts thereof for the prevention and/or treatment of conditions mediated by abnormal cell proliferation. Composition for parenteral administration are provided which comprise an effective amount of compound of formula I or a compound of formula IIa and at least about 50% by weight of at least one water soluble polymer selected from the group consisting essentially of polyethylene glycol (PEG), poly-oxyethylene, poly-oxyethylene-poly-oxypropylene copolymers, polyglycerol, polyvinylalcohol, polyvinylpyrrolidone (PVP), polyvinylpyridine N-oxide, copolymer of vinylpyridine N-oxide and vinylpyridine.

Abstract: Formulations and methods are provided for the treatment of pain, and neuropathic pain in particular. The formulations are eutectic mixtures of a capsaicinoid and a local anesthetic agent and/or an anti-pruritic agent.

Abstract: The present invention provides a delivery system for the intravaginal administration of prophylactic and therapeutic agents. In one embodiment, the invention provides a pH-responsive, biocompatible film for intravaginal administration of a beneficial agent, comprising a biocompatible, hydrophilic polymer that is positively charged at a first pH and in electronically neutral form at a higher pH; an effective amount of a beneficial agent; and, optionally, at least one film-forming binder. The pH responsive film may also include other additives such as plasticizers, sustained release polymers, antioxidants, and antimicrobial agents. In another embodiment, the pH-responsive film of the present invention comprises a laminated composite of (a) a bioadhesive layer that serves to affix the film to a mucosal surface within the vagina and, laminated thereto, (b) at least one reservoir layer comprising at least one beneficial agent and a biocompatible hydrophilic polymer.

Abstract: Blends of polymers having properties distinct from the individual polymer components and that are suitable for use as carriers of pharmaceutically active agents, are prepared from two or more polyanhydrides, polyesters or mixtures of polyanhydrides and polyesters. The blends have different properties than the polymers used to prepare the blends, providing a means for altering the characteristics of a polymeric matrix without altering the chemical structure of the component polymers. Blends of various polyanhydrides, polyesters, and polyanhydrides and polyesters, containing pharmaceutically active agents, are prepared using solvent mixing or melt mixing procedures.

Abstract: The present invention provides a composition comprising an ion exchange resin and a therapeutically active biopolymer in a form for oral administration. The present invention also provides a composition comprising Amberlite.RTM. IRP-64 and a cytokine regulatory agent having the amino acid sequence:Ac-Nle-Gln-His-(D)Phe-Arg-(D)Trp-Gly-NH.sub.2,in a form for oral administration. The present invention further provides a method of protecting a therapeutically active biopolymer from degradation by forming a complex of the biopolymer and an ion exchange resin. In addition, the present invention provides a method of reducing or inhibiting the severity of a pathological condition by orally administering a therapeutically effective dose of the composition.

Abstract: Devices are provided having a polymer coating incorporating compounds inhibiting inflammation and infection, along with subsequent tissue growth onto and around the device. Preferred embodiments include catheters, tubes, and implants that abut tissue following implantation into the body, especially for use in the naso-oto-pharyngeal areas of the body, where localized chronic infection/inflammation of the tissues surrounding the implant may be decreased by sustained release of antibiotics, antifungals, antivirals, anti-inflammatories, and other compounds, such as anticoagulants and anesthetics. Preferred polymeric coatings are thin, well adhered to the underlying device, and formed of a biocompatible, non-bioerodible polymer such as polyurethane or ethylene vinyl acetate. The drug is incorporated either by solvent casting or by absorption into the solidified polymer. The drug incorporated polymer can also be used to form devices, or portions of devices, for implantation.

Abstract: An improved surface erodible controlled release composition and the manufacturing thereof, for the continuous administration of biologically active proteins or peptide fragments, is described. The biologically active protein is dissolved in water or a suitable solvent, alone or in combination with stabilizing agents. The solution is either lyophilized or spray dried to obtain a free flowing powder. The powder is then sieved to obtain the desired average particle size. The free flowing powder of the protein or the stabilized protein is then incorporated into a biodegradable matrix formed of fatty acid anhydride, fatty acid and/or a salt thereof. Examples using growth hormone and bovine serum albumin demonstrate enhanced release, stability and controlled release properties for the fatty acid anhydride microparticular system.

Abstract: Fatty acid terminated polyanhydrides suitable for use as controlled release matrices in biodegradable sustained release drug delivery systems and methods for making thereof are described. The polymers are more soluble in organic solvents, and have a lower melting point than the corresponding non-fatty acid terminated polyanhydrides. The fatty acid terminated polyanhydrides are also more hydrophobic than the corresponding polyanhydrides that are not terminated with a fatty acid, and combine the properties of thermodynamic and hydrolytic stability, and easy storage. The polymers can be produced with a controlled and low molecular weight. The polyanhydrides are useful in a number of applications, including as a matrix in biodegradable drug delivery systems.

Abstract: Branched polyanhydrides that have superior properties for use in the controlled delivery of substances, prepared by the polymerization of a dicarboxylic acid monomer and a branching agent. The branching agent is a polycarboxylic acid monomer such as 1,3,5-benzenetricarboxylic acid ("BTC"), or an oligomerized fatty acid trimer. Alternatively, the branching agent is a polycarboxylic acid polymer such as poly(acrylic acid) ("PAA"). These branched polymers have significantly higher molecular weights and lower specific viscosity than linear polymers prepared under similar conditions. A major advantage of branched polyanhydrides is that the degradation and release kinetics can be substantially altered without significantly changing the physical properties of the polymer relative to the corresponding linear polymer. By manipulating both the diacid and the branching agent, a wide variety of biodegradable controlled delivery devices for diverse applications can be prepared.

Abstract: A local anesthetic microsuspension system is disclosed that includes lipospheres, that are solid, water-insoluble microparticles that have a layer of a phospholipid embedded on their surface. The core of the liposphere is a solid anesthetic such as lidocaine or marcaine, or an anesthetic dispersed in an inert solid vehicle, such as a wax. Anesthetic lipospheres provide a controlled delivery of local anesthetics to achieve extended, effective relief from pain by slowly releasing the anesthetic from the solid hydrophobic core. This is highly preferred over the situation in which an aqueous solution of local anesthetic must be frequently administered because it is quickly systemically absorbed.

Abstract: Fatty acid terminated polyanhydrides suitable for use as controlled release matrices in biodegradable sustained release drug delivery systems and methods for making thereof are described. The polymers are more soluble in organic solvents, and have a lower melting point than the corresponding non-fatty acid terminated polyanhydrides. The fatty acid terminated polyanhydrides are also more hydrophobic than the corresponding polyanhydrides that are not terminated with a fatty acid, and combine the properties of thermodynamic and hydrolytic stability, and easy storage. The polymers can be produced with a controlled and low molecular weight. The polyanhydrides are useful in a number of applications, including as a matrix in biodegradable drug delivery systems.

Abstract: Branched polyanhydrides that have superior properties for use in the controlled delivery of substances, prepared by the polymerization of a dicarboxylic acid monomer and a branching agent. The branching agent is a polycarboxylic acid monomer such as 1,3,5-benzenetricarboxylic acid ("BTC"), or an oligomerized fatty acid trimer. Alternatively, the branching agent is a polycarboxylic acid polymer such as poly(acrylic acid) ("PAA"). These branched polymers have significantly higher molecular weights and lower specific viscosity than linear polymers prepared under similar conditions. A major advantage of branched polyanhydrides is that the degradation and release kinetics can be substantially altered without significantly changing the physical properties of the polymer relative to the corresponding linear polymer. By manipulating both the diacid and the branching agent, a wide variety of biodegradable controlled delivery devices for diverse applications can be prepared.