Abstract: The present invention provides stable pharmaceutical compositions of poorly water soluble pharmaceutical agents and stabilizing agents which function to increase stability of the compositions. The use of stabilizing agents provide extended stability of nanoparticle suspensions and other formulations of poorly water soluble pharmaceutical agents such as docetaxel under certain conditions, for example upon dilution for administration.

Abstract: A design strategy for constructing hierarchically structured materials using nanoparticles and synthetic biopolymers has been developed. Block copolypeptides or homopolymer polyelectrolytes are used as structure-directing agents to arrange nanoparticles (composed of metals, metal non-oxides, metal oxides, or organics) into unusual microstructures, such as spheres, “apples” and “cups.” Hollow spheres can be made wherein nanoparticles of one composition are spatially oriented completely interior or exterior to nanoparticles of a second composition. These aggregates contain nanoparticles only in the shell walls, and maintain their hollowness upon calcination. These shapes can also be fabricated into films. These robust materials are anticipated to have great promise in applications that require surface catalysis, magnetic/electronic/optic properties, transport capabilities, and combinations thereof, such as drug delivery, packaging, catalysis, and sensors.

Abstract: Methods for stabilizing chemical compounds, particularly pharmaceutical agents, using nanoparticulate compositions are described. The nanoparticulate compositions comprise a chemical compound, such as a pharmaceutical agent, and at least one surface stabilizer. The component chemical compound exhibits chemical stability, even following prolonged storage, repeated freezing-thawing cycles, exposure to elevated temperatures, or exposure to non-physiological pH conditions.

Abstract: Dry cross-linked gelatin compositions are prepared that rapidly re-hydrate to produce gelatin hydrogels suitable as hemostatic sealants. Gelatin is cross-linked in the presence of certain re-hydration aids, such as polyethylene glycol, polyvinylprovidone, and dextran, in order to produce a dry cross-linked gelatin powder. The use of the re-hydration aids has been found to substantially increase the re-hydration rate in the presence of an aqueous re-hydration medium, typically thrombin-containing saline.

Abstract: An apparatus for treating polymeric materials comprises a treatment chamber adapted to maintain a selected atmosphere; a means for supporting the polymeric material within the chamber; and, a source of plasma-derived gas containing at least one reactive oxidative species whereby the polymer is stabilized and cross linked through exposure to the oxidative species in the chamber at a selected temperature. The polymer may be directly exposed to the plasma, or alternatively, the plasma may be established in a separate volume from which the reactive species may be extracted and introduced into the vicinity of the polymer. The apparatus may be configured for either batch-type or continuous-type processing. The apparatus and method are especially useful for preparing polymer fibers, particularly PAN fibers, for later carbonization treatments.

Abstract: A tubular or spherical nanostructure composed of a plurality of peptides, wherein each of the plurality of peptides includes no more than 4 amino acids and whereas at least one of the 4 amino acids is an aromatic amino acid.

Abstract: Polymeric microcarriers suitable for use in cell culture processes and the methods of making such polymeric microcarriers by emulsion/aggregation polymerization processes.

Abstract: Compositions and methods for delivery of a pharmaceutical to an individual. Delivery vehicles are provided in a formulation of a pharmaceutical that is encapsulated in a synthetic self assembled nanoparticle that includes a lipid binding protein and a lipid monolayer. The interior of the particle represents a hydrophobic core region where lipophilic highly-water insoluble drug molecules may be incorporated. In contrast to liposomes, that include an aqueous interior core surrounded by phospholipid bilayer, the drug carrier nanoparticle described here is composed of a monolayer and a hydrophobic interior.

Abstract: There invention discloses aqueous dispersions of nanoparticulate aerosol formulations, dry powder nanoparticulate aerosol formulation, propellant-based aerosol formulations, methods of using the formulations in aerosol delivery devices, and methods of making such formulations. The nanoparticles of the aqueous dispersions or dry powder formulations comprise insoluble drug particles having a surface modifier on the surface thereof.

Abstract: The invention relates to the combination of polyvinyl acetate and water-insoluble, acid-insoluble, or alkali-insoluble polymers used for producing film coatings for forms of administration in which agents are released in a controlled manner, and methods for the production thereof. The controlled-release properties can be specifically adjusted by means of said combinations, resulting in films having excellent mechanical stability and storage stability. In particular, agents are released independent of the pH by means of the inventive forms of administration.

Abstract: A method of forming microspheres of a bioactive material, such as a protein polymer or drug by nebulizing a solubilized form of a material to be encapsulated and an encapsulating material, such as albumin, in a stirred chilled solvent system comprising a vegetable oil, mineral oil and/or a lower alcohol such that the formed microspheres demonstrate intracellular bioactivity when taken up by macrophages.

Abstract: Microparticles with absorbed polypeptide-containing molecules formed without the use of surfactant, methods of making such microparticle compositions, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(?-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like. Preferred polymers are poly(D,L-lactide-co-glycolides), more preferable those having a lactide/glycolide molar ratio ranging from 40:60 to 60:40 and having a molecular weight ranging from 20,000 Daltons to 70,000 Daltons. Preferred polypeptide containing molecules are bacterial and viral antigens (including HIV antigens, meningitis B antigens, streptococcus B antigens, and Influenza A hemagglutinin antigens).

Abstract: Nanoparticle compositions and methods are disclosed for the sustained release of small molecules, such as pharmaceutical compounds in vivo, for example ligand-lytic peptide conjugates. The construction of the nanoparticles helps to prevent self-aggregation of the molecules, and the consequent loss of effectiveness. The system employs layer-by-layer self-assembly of biocompatible polyelectrolyte layers, and layers of charged small molecules such as drug molecules, to form a multilayer nanoparticle in which the drug or other small molecule itself acts as one of the alternating charged layers in the multilayer assembly. The small molecules can then be released over time in a sustained manner. The LbL nano-assemblies can specifically target cancers, metastases, or other diseased tissues, while minimizing side effects.

Abstract: The present invention relates to a biodegradable polymeric nanocapsule composition, adaptable for encapsulation of an agent of therapeutic interest for enhancing the in vivo circulation time of thereof and uses thereof.

Abstract: An engineered lipoprotein including (a) a core particle or a plurality of core particles, each core particle has (i) an inner part comprising a hydrophilic active agent and a hydrophilic portion of an amphiphilic cholesterol and (ii) an outer part including a hydrophobic portion of the amphiphilic cholesterol, (b) a layer surrounding the core particle or a plurality of core particles, the layer includes a phospholipid, (c) an apoprotein associated with the layer, and optionally, (d) a homing molecule associated with at least one of the apoprotein or the phospholipid.

Abstract: The present invention generally relates to particles comprising hyaluronic acid, wherein the particles are coated or encapsulated with a coating. The coating preferably comprises a polymer, protein, polysaccharide, or combination thereof that decreases the rate of degradation of the hyaluronic acid once the particles are placed in an aqueous environment, such as inside mammalian skin. The compositions of the present invention comprising such coated hyaluronic acid are useful for soft tissue augmentation, and are particularly useful as dermal fillers.

Abstract: Lipidated micro- or macroparticles are prepared by covalently linking a glycoprotein, typically collagen, with at least one lipid. An amino group in the glycoprotein is joined with a primary amine in the lipid. These particles can be used to encapsulate active ingredients, such as drugs.

Abstract: There is provided pharmaceutical compositions in the form of homogeneous interactive mixtures, which compositions comprise a pharmacologically-effective amount of an active ingredient in the form of microparticles of a size between about 0.5 ?m and about 10 ?m, which particles are attached to the surfaces of larger carrier particles with a size range of between about 10 and about 100 ?m. The carrier particle material is preferably bio- and/or mucoadhesive in its nature.

Abstract: Targeted therapeutic delivery systems comprising specially designed nanocarriers for intracellular therapeutic delivery, mediated by acoustic energy, for use either in vivo or in vitro, are described. Nanocarriers comprised of substantially peptosomes, and mixtures thereof, are used to treat a variety of diseases in humans and other species, such as cancer, opthalmological, pulmonary, urinary or other pathologies. Methods for preparing the targeted therapeutic delivery systems are also embodied, which comprise processing a solution comprised of biopolymers or other species and components, with or without targeting moieties, adding said biopolymers and other compounds to a solution containing one or more therapeutic agents, stabilizing or not stabilizing said nanocarriers, adding one or more contrast agents, and resulting in a targeted therapeutic delivery system. Preferred therapeutics for use with the present invention include nucleic acids, proteins, peptides, and other therapeutic macromolecules.

Abstract: Topical formulation containing an active substance which is chemically or physically bound to, or encapsulated within, an exine shell of a naturally occurring spore. The active substance can be released from the exine shell on application to a living or non-living surface. The invention may be used to provide gradual release of the active substance over a period of time subsequent to application of the formulation to the surface.

Abstract: The present invention relates to compositions of microspheres suitable for application to ocular injuries and inflammation, and to methods of use of the compositions alone or in combination with other agents in the prevention and treatment of ocular injuries and inflammation. The compositions, which increase the rate of healing, can be used to treat injuries and inflammation, including but not limited to those caused by foreign bodies, infections, burns, lesions, lacerations, ischemia, injuries from blunt trauma, traumatic hyphema, sympathetic ophthalmia, injuries from radiant energy, cataracts, corneal erosions or optic nerve injuries, and in procedures such as post-trabeculectomy (filtering surgery), post pterygium surgery; post ocular adnexa trauma and surgery, post intraocular surgery, post vitrectomy, post retinal detachment or post retinotomylectomy.

Abstract: The present inventive subject matter relates to amorphous drug beads comprising an amorphous active drug and an organic surfactant having improved solubility, absorption and wettability characteristics. The present inventive subject matter further relates to methods of preparing the amorphous drug beads, wherein molten drug beads are subject to a cooling step with or without shear.

Abstract: The invention relates to a medicotechnical product having an antimicrobial finish consisting of a complex material of metal nanoparticles and macromolecules, the macromolecules being at least partially formed from amphiphilically modified polyamino acids which contain amino acid units, which aside from the functional groups bonded in the peptide bond contain at least one further functional group and at least some of these groups are modified with substances bearing hydrophobic radicals via covalent bonds. The hydrophobic radicals are bonded by addition of substances bearing epoxy groups to the at least one further functional group and/or via at least one amino group of an amino acid unit bearing at least one amino group as a further functional group with maintenance of an amino function on the polyamino acids. The invention furthermore relates to the production of the complex material and of the medicotechnical product.

Abstract: The present invention relates to a product named “immunogenical complex”, which comprises an adjuvant characterized by solid particles of highly ordinated nanostructured mesoporous silica, preferably, SBA-15 Silica, and vaccinal antigens of several natures, encapsulated in the referred to adjuvants. The immunogenical complex of the present invention allows the presentation of the antigens that compose it to lymphocytes, in a safe, gradual and extended way, which leads to a more efficient immunological memory, increases the immunogenicity of the antigen and improves the production of antibodies. This ensures an efficient immunological protection with fewer amounts of antigens and/or less repetitions of vaccinal doses. In addition, the characteristics of the immunogenical complex of the present invention promotes effective immunity induction, homogeneous in “god and bad respondent” individuals.

Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

Abstract: Disclosed are methods and compositions for delivering a therapeutic agent to target organs or tissues, such as brain. The methods and compositions use bone marrow stem cells, monocytes, macrophages or microglial cells to deliver the therapeutic agent associated with nanoparticles to the target organ or tissue.

Abstract: A composition for delivering an active agent to a patient. The composition includes a polymer core encapsulating the active agent and a mucoadhesive coating disposed about the core. The polymer may include covalently linked poly(ethylene glycol) chains, and the mucoadhesive coating may be selected to facilitate transfer of the particle through the intestinal mucosa. A molecular weight and cross-link density of the polymer may be selected such that the polymer core will decompose in a predetermined time interval. The fraction of the dose of the drug entering the system at circulation during the predetermined time interval may be between about 0.25% and about 25%. The composition may be formulated as a plurality of nanoparticles or microparticles that are combined with a pharmaceutically acceptable carrier to produce an edible or inhalable drug product.

Abstract: It is an object of the present invention to provide a transpulmonary preparation wherein physiologically active ingredient can be stably retained and which has high absorption efficacy and gives low damage to tissue. The present invention provides a transpulmonary preparation which comprises protein nanoparticles containing an active ingredient and having an average particle size of 200 nm to 500 nm.

Abstract: The present invention includes compositions and methods of making an activated polymeric nanoparticle for targeted drug delivery that includes a biocompatible polymer and an amphiphilic stabilizing agent non-covalently associated with a spacer compound that includes at least one electrophile that selectively reacts with any nucleophilic on a targeting agent and places the targeting agent on the exterior surface of a biodegradable nanoshell, wherein an active agent is loaded with the nanoshell.

Abstract: Described are controlled release nanoparticulate formulations comprising a nanoparticulate agent to be administered and a rate-controlling polymer which functions to prolong the release of the agent following administration. The novel compositions release the agent following administration for a time period ranging from about 2 to about 24 hours or longer.

Abstract: The present invention is directed to systems, apparatus and methods for creating derivatives of at least one form of HDL without substantially affecting LDL. These derivatives of HDL are particles with reduced lipid content, particularly reduced cholesterol content. These particles have the capacity to bind cholesterol and are administered to a patient to enhance cellular cholesterol efflux and reduce cholesterol levels in cells, tissues, organs, and blood vessels. The present method is useful for treating atherogenic vascular disease and may be combined with other therapies such as statins, inhibitors of cholesterol absorption, niacin, anti-inflammatories, exercise and dietary restriction.

Abstract: A method of forming microspheres of a bioactive material, such as a protein polymer or drug by nebulizing a solubilized form of a material to be encapsulated and an encapsulating material, such as albumin, in a stirred chilled solvent system comprising a vegetable oil, mineral oil and/or a lower alcohol such that the formed microspheres demonstrate intracellular bioactivity when taken up by macrophages.

Abstract: In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of substantially water insoluble pharmacologically active agents (such as the anticancer drug paclitaxel) in which the pharmacologically active agent is delivered in the form of suspended particles coated with protein (which acts as a stabilizing agent). In particular, protein and pharmacologically active agent in a biocompatible dispersing medium are subjected to high shear, in the absence of any conventional surfactants, and also in the absence of any polymeric core material for the particles. The procedure yields particles with a diameter of less than about 1 micron. The use of specific composition and preparation conditions (e.g., addition of a polar solvent to the organic phase), and careful selection of the proper organic phase and phase fraction, enables the reproducible production of unusually small nanoparticles of less than 200 nm diameter, which can be sterile-filtered.

Abstract: This invention provides novel methods for the formation of biocompatible membranes around biological materials using photopolymerization of water soluble molecules. The membranes can be used as a covering to encapsulate biological materials or biomedical devices, as a “glue” to cause more than one biological substance to adhere together, or as carriers for biologically active species. Several methods for forming these membranes are provided. Each of these methods utilizes a polymerization system containing water-soluble macromers, species, which are at once polymers and macromolecules capable of further polymerization. The macromers are polymerized using a photoinitiator (such as a dye), optionally a cocatalyst, optionally an accelerator, and radiation in the form of visible or long wavelength UV light. The reaction occurs either by suspension polymerization or by interfacial polymerization.

Abstract: In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of substantially water insoluble pharmacologically active agents (such as the anticancer drug paclitaxel) in which the pharmacologically active agent is delivered in the form of suspended particles coated with protein (which acts as a stabilizing agent). In particular, protein and pharmacologically active agent in a biocompatible dispersing medium are subjected to high shear, in the absence of any conventional surfactants, and also in the absence of any polymeric core material for the particles. The procedure yields particles with a diameter of less than about 1 micron. The use of specific composition and preparation conditions (e.g., addition of a polar solvent to the organic phase), and careful selection of the proper organic phase and phase fraction, enables the reproducible production of unusually small nanoparticles of less than 200 nm diameter, which can be sterile-filtered.

Abstract: This invention relates to a highly efficient artificial low-density lipoprotein (LDL) carrier system for the targeted delivery therapeutic agents across the blood-brain barrier (BBB). In particular, this invention relates to artificial LDL particles comprised of three lipid elements: phosphatidyl choline, fatty-acyl-cholesterol esters, and at least one apolipoprotein. The present invention further relates to compositions, methods and kits comprising artificial LDL particles for targeting drugs to and across the BBB for the prevention and treatment of brain diseases.

Abstract: The present invention is directed to pharmaceutical nanoparticulate compositions of an immunosuppressive agent. The pharmaceutical compositions comprise solid particles of an immunosuppressive agent having an effective average particle size of less than about 2000 nm and one or more surface stabilizers associated with the surface of the immunosuppressive agent particles.

Abstract: The invention relates to a multiparticulate pharmaceutical form, comprising pellets with a multilayer structure for controlled active ingredient release, comprising a) optionally a neutral core (nonpareilles), b) an inner controlling layer comprising a substance having a modulating effect, which is embedded in a matrix which influences the delivery of the modulatory substance and which comprises pharmaceutically usable polymers, waxes, resins and/or proteins, and where appropriate an active ingredient, c) an active ingredient layer comprising an active pharmaceutical ingredient and, where appropriate, a substance having a modulating effect, d) an outer controlling layer comprising at least 60% by weight of one or a mixture of a plurality of (meth) acrylate copolymers where the outer controlling layer has a thickness from 20 to less than 55 ?m and contains 0,1 to 10% by weight of glycerol monostearate, where the multiparticulate pharmaceutical form contains 20 to 60% by weight of the pellets, which are compres

Abstract: This invention provides compositions and methods providing, e.g., stable powder particles containing bioactive materials. The methods include, e.g., high pressure spraying of the bioactive materials in solution or suspension, with viscosity enhancing agents and/or surfactants. Compositions of the invention provide, e.g., high initial purity, high stability in storage, and reconstitution at high concentrations.

Abstract: The in vivo synthesis of connective tissue by fibroblast or fibroblast precursor cells ensconced within a biocompatible scaffold is disclosed. The cells are preferably present in a biocompatible scaffold such as gelatin and placed between two other biocompatible scaffolds such as collagen sponges soaked with a collagenic amount of a member of the TGF-? family of proteins. This composition is then implanted in a host to produce cranial sutures, periodontal ligament or other fibrous tissue structures in vivo.

Abstract: This invention provides a method for delivery of agents such as genes, plasmids, and other active DNA-related molecules useful for treatment peritoneal disease, including peritoneal fibrosis or postoperative adhesion specifically using an ultrasound-triggered disruption of inducible Smad7 gene-bearing microbubble system.

Abstract: A microcapsule comprising a chemical skeleton with at least one ligand attached to the chemical skeleton. The chemical skeleton is placed within a capsule. The capsule can then separate a substance from a mixture. The capsule is placed within the mixture and the substance is allowed to enter the capsule. The substance binds to the ligand and cannot escape the capsule. The capsule is then removed from the mixture, thus removing the substance. The preferred embodiment envisions the use of the capsule to remove substances from animal digestive systems.

Abstract: The nanoparticles composed of ?-PGA-PLA block copolymers that are conjugated with galactosamine as a potential drug delivery system and loaded with anticancer drugs for treating liver cancers.

Abstract: The invention discloses the nanoparticles composed of ?-PGA-PLA block copolymers conjugated with galactosamine as a potential drug delivery system for treating liver cancers.

Abstract: A nanoparticle delivery vehicle, comprising a nanoparticle, an active agent and a nuclear localization signal and methods of modulating gene expression and protein expression employing the nanoparticle delivery vehicle. A representative method includes providing a nanoparticle delivery vehicle comprising a nanoparticle having a diameter of about 30 nm or less, an active agent and a nuclear localization signal; and contacting a target cell with the nanoparticle delivery vehicle, whereby an active agent is delivered to the nucleus of a target cell. Another representative method includes providing a nanoparticle delivery vehicle comprising a nanoparticle having a diameter greater than or equal to about 30 nm, an active agent and a nuclear localization signal; and contacting a target cell with the nanoparticle delivery vehicle, whereby an active agent is delivered to the cytoplasm of a cell.

Abstract: This invention is accomplished by producing an effective composition for enteric coated medicine of mistletoe extract C) containing lectin and producing an effective composition for enteric coated microcapsule which has lectin as a major ingredient. The problem with oral administration due to unstability in the digestive system was solved and it enhanced drug efficiency, medical cure effectiveness contributing to medical industry.

Abstract: A pharmaceutical composition for oral delivery of a peptide is in the form of a lamination having at least two layers. The first layer of the lamination includes at least one pharmaceutically acceptable pH-lowering agent. The second layer includes a therapeutically effective amount of the peptide. The composition also includes at least one absorption enhancer effective to promote bioavailability of the peptide, which is preferably in the second layer, and an enteric coating surrounding the lamination. In a preferred dosage form of a tablet, a water-soluble coating is applied between the lamination and enteric coating which substantially prevents contact between the pH-lowering agent and the enteric coating. In a preferred embodiment, the peptide is salmon calcitonin, the pH-lowering agent is citric acid, and the absorption enhancer is lauroyl l-carnitine.

Abstract: The present invention relates to a controlled release pellet of metoprolol and its pharmaceutically acceptable salts that uses a water soluble or a water swellable inert starting seed or core.

Abstract: A particle (and a composition that includes a plurality of the particles) that includes at least one polypeptide molecule and at least one polymer covalently bound to the polypeptide molecule so as to form a polymer shell substantially encompassing the polypeptide molecule, wherein the particle does not define a dimension greater than about 1 ?m. One example for making the particle includes modifying the polypeptide molecule to provide ?, ?-ethylenically unsaturated terminal functional groups, mixing the modified polypeptide molecule with a silicon-containing polymerizable compound, and subjecting the resulting mixture to conditions sufficient for polymerizing the polymerizable compound to form the particle.

Abstract: A process for stabilizing a sensitive substance; (a) plating a sensitive substance onto a solid carrier under a controlled atmosphere to reduce loss of the sensitive substance; (b) encapsulating the plated material under controlled atmosphere and airflow to reduce volatilization during the process and stabilize the sensitive substance.