Abstract: This invention provides long-acting, superactive analogs of glycoprotein hormones demonstrating enhanced bioactivity both in vitro and in vivo as compared to wild type counterparts. The analogs are particularly useful for treating subjects showing low receptor expression or poor receptor responsiveness, and for the treatment of any condition associated with glycoprotein hormone activity.

Abstract: There is provided insect screening models to determine gastrointestinal absorption of different chemical compounds in vertebrates, and in particular humans, in order to improve the compound screening procedures/processes in the early drug discovery process. This offers many advantages relative to prior technologies since insect models are more reliable tools for the decision-making process than the existing in vitro models, and will speed up the drug screening process and reduce the late phase attrition rate. Moreover, it will reduce the number of mammals sacrificed during the drug discovery phase.

Abstract: An effective method for prolonging localization of therapeutics within the rat gastrointestinal tract of at least about 12 hours is provided. The method includes localization of therapeutic agents that are nanoparticulated or nanoencapsulated. Attractive forces between an orally administered magnetic dose and an external magnet were monitored and internal dose motion in real time using biplanar videofluoroscopy was visualized. Tissue elasticity was quantified as a measure of tissue health by combining data streams. The methods address safety, efficacy, and monitoring capacity of magnetically localized doses and show a platform for testing the benefits of localized drug delivery.

Abstract: Provided is a method for producing a functional material, including the steps of: bringing a polyvalent metal cation aqueous solution into contact with a base material; bringing a polyanion aqueous solution containing a functional component into contact with the base material previously in contact with the polyvalent metal cation aqueous solution to bond the polyvalent metal cations and the polyanions to each other, and thereby forming an insoluble compound containing the functional component; and drying the base material including the insoluble compound.

Abstract: The present invention provides a novel base material for a dry solid dispersion, a solid dispersion containing the base material, and a composition containing the dispersion; the solid dispersion of the present invention, which contains a poorly soluble component with improved dissolvability, can be obtained by mixing a polyvinyl alcohol-based copolymer, as a base material for the dry solid dispersion, with a poorly soluble component, and then heating it.

Abstract: The present invention pertains to a process for the preparation of an orally disintegrating tablet for administration to a human subject, the tablet containing a medicinal substance to treat a disorder of the human subject, comprising the steps of providing a fluid formulation comprising the medicinal substance, providing a solid element having formed therein at least one cavity, cooling the solid element to a temperature below a freezing temperature of the formulation, filling the cavity with the fluid formulation, solidifying the formulation while present in the cavity by extracting heat from the formulation through a cavity wall by conduction, to form a solid pellet comprising the medicinal substance without actively shaping the entire surface of the pellet, taking the pellet out of the cavity, and drying the pellet in a vacuum to obtain the tablet. The invention also pertains to the tablet itself and a package comprising such a tablet.

Abstract: Dry powder compositions are useful in the treatment or prevention of tissue adhesions during or after surgery or during wound therapy. The dry powder compositions may contain trehalose. The dry powder compositions may be fibrin sealant compositions comprising fibrinogen and/or thrombin.

Abstract: Solid dry powder compositions comprising active agents and dextran polymer derivatives comprising an ester-linked amine-containing substituent and an alkyl ester substituent are disclosed, as are methods for making such compositions.

Abstract: LEDGF peptides with anti-protein aggregation activity and methods of use are provided. The LEDGF peptides disclosed herein demonstrate an ability to treat degenerative diseases and diseases with various cellular stresses including oxidative stress and protein-aggregation stress. In addition, extended release formulations, including formulations suitable for ophthalmic administration are provided.

Abstract: The present invention relates to the field of pharmacology and medicine, specifically to a new generation of anticancer drugs with the cytostatic action based on docetaxel. In the drug composition of the invention docetaxel is included in biodigestible stable nanoparticles. The nanoparticles comprise of docetaxel, PLGA, serum albumin and D-mannitol The developed drug is proposed to be manufactured as enterosoluble tablets, capsules granules, powder, or in any other peroral form.

Abstract: There are provided compositions comprising lipidated glycosaminoglycan particles, methods for their preparation and uses thereof for the efficient in-vivo and in-vitro delivery of nucleic acids, such as, siRNA molecules.

Abstract: The disclosure describes nanocarried and/or microcarried jasmonate compounds and their pharmaceutical compositions, as well as use thereof for treating or preventing angiogenesis-related or NF-?B-related disorders. Also disclosed are methods of making the nanocarried and/or microcarried compounds and their compositions.

Abstract: Materials and Methods are disclosed for producing nanoparticles linked to antibacterial ligands, including antibiotics and/or molecules which bind to bacterial markers, and for the use of the nanoparticles for the treatment of conditions treatable by the antibiotic ligands.

Abstract: The present invention provides solution to the problem involved in delivery of active molecules to nucleus. More particularly, the invention provides intrinsically fluorescent and inherently surface functionalized carbon nanospheres which are non-toxic. Also, these carbon nanospheres [CSP] were adsorbed with CTPB [CSP-CTPB] and the adsorbed CSP-CTPB are permeable to cells with nuclear targeting ability. In addition, the present invention provides a composition, a process to prepare the composition comprising CSP with adsorbed active/therapeutic molecules. Further, the instant invention provides a method for delivering active molecules inside a cell nucleus.

Abstract: A vaccine formulation as disclosed which is comprised of a pharmaceutically acceptable carrier in a plurality of particles with mannose on their surface. The particles are comprised of a biocompatible polymer which maybe a co-polymer such as PLGA combined with a peptide of a sequence which corresponds to a sequence on a surface of a pathogen. A plurality of different groups of particles are provided in the formulation wherein the particles within any single group include peptides of identical amino acid sequence. The particles are sized such that they are sufficiently large so as to prevent more than a single particle from being presented to a single immune system cell.

Abstract: This disclosure provides compositions and methods for promoting the formation, expansion and recruitment of TR1 cells and/or Breg cells in an antigen-specific manner and treating autoimmune diseases and disorders in a subject in need thereof.

Abstract: In a gel-like mass having natural or synthetic polymers, preferably polygalactomannans, at least one cross-linking agent and further ingredients, according to this invention that the at least one cross-linking agent is of amphiphilic core-shell nanoparticles. This invention further refers to a method for producing a gel-like mass, a composition for producing a gel-like mass comprising natural or synthetic polymers, preferably polygalactomannans and amphiphilic core-shell nanoparticles and the use of a gel-like mass as drug delivery system for topical medication.

Abstract: Modular nanoparticle vaccine compositions and methods of making and using the same have been developed. Modular nanoparticle vaccine compositions comprise an antigen encapsulated in a polymeric particle and adaptor elements which modularly couple functional elements to the particle. The modular design of these vaccine compositions, which involves flexible addition and subtraction of antigen, adjuvant, immune potentiators, molecular recognition and transport mediation elements, as well as intracellular uptake mediators, allows for exquisite control over variables that are important in optimizing an effective vaccine delivery system.

Abstract: Improved hemostatic agents take the form of granules or particles that can be used to stanch, seal, or stabilize a site of hemorrhage, including a noncompressible hemorrhage.

Abstract: This invention provides a peptide/nucleic acid composition for oral/mucosal, dual-modal activation of immune protection systems.

Abstract: The present invention describes novel and improved parenteral depot pharmaceutical compositions containing cosyntropin (tetracosactide), for the treatment of infantile spasm.

Abstract: Provided herein are methods comprising providing a tyrosine derivative and a solid particulate material (and, optionally, melanin) and applying force to said tyrosine derivative and said solid particulate material for a time and under conditions effective to impregnate at least one of said tyrosine derivative and said solid particulate material with the other of said tyrosine derivative and said solid particulate material. The invention also provides compositions comprising at least one of a tyrosine derivative impregnated with a solid particulate material and a solid particulate material impregnated with a tyrosine derivative.

Abstract: The present invention relates to a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, which carrier comprises a protein, for example, human serum albumin and/or deferoxamine. The human serum albumin is present in an amount effective to reduce one or more side effects associated with administration of the pharmaceutical composition. The invention also provides methods for reducing one or more side effects of administration of the pharmaceutical composition, methods for inhibiting microbial growth and oxidation in the pharmaceutical composition, and methods for enhancing transport and binding of a pharmaceutical agent to a cell.

Abstract: The present invention relates to a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, which carrier comprises a protein, for example, human serum albumin and/or deferoxamine. The human serum albumin is present in an amount effective to reduce one or more side effects associated with administration of the pharmaceutical composition. The invention also provides methods for reducing one or more side effects of administration of the pharmaceutical composition, methods for inhibiting microbial growth and oxidation in the pharmaceutical composition, and methods for enhancing transport and binding of a pharmaceutical agent to a cell.

Abstract: Systems, methods, compositions, and devices related to the delivery of one or more biologically active agents to a body include the admixture of one or more biologically active agents with one or more biocompatible polymeric mixtures in a solid-state shear extrusion system. The extrusion systems may include one or more extrusion screws. One or more portions of the one or more extrusion screws, one or more extrusion system active elements, one or more barrel sections, and/or one or more extruder work zones may be temperature controlled to maintain a temperature of the biocompatible polymeric mixture in contact therewith at or below the liquefication temperature of the biocompatible polymeric materials. The resulting compositions from the extrusion systems may be fabricated into devices to deliver the one or more biologically active agents to a body.

Abstract: A liquid pharmaceutical compositions comprising Aprepitant is preferably prepared as an oral suspension dosage form for the prevention and control of acute and delayed chemotherapy induced nausea and vomiting, and/or for prevention of postoperative nausea and vomiting.

Abstract: A high drug loading system is described comprising of at least one anticancer drug; at least one peptide; and at least one nucleic acid.

Abstract: The present invention relates to methods and kits for the treatment of breast cancer based on hormone receptor status of progesterone receptor and estrogen receptor comprising the administration of a taxane alone, in combination with at least one other and other therapeutic agents, as well as other treatment modalities useful in the treatment of breast cancer. In particular, the invention relates to the use of nanoparticles comprising paclitaxel and albumin (such as Abraxane®) either alone or in combination with other chemotherapeutic agents or radiation, which may be used for the treatment of breast cancer which does not express estrogen receptor and/or progesterone receptor.

Abstract: The invention relates to a liquid pharmaceutical composition, in the form of a suspension of micronized powder of active substance in an acceptable physiological liquid medium, stabilized over time, for administration via the oral route.

Abstract: A composition and method comprising an anti-adjuvant such as DOI (an anti-inflammatory) together with any gene therapy plasmid is disclosed. A method for GHRH production in-vivo using a set of compositions and methods for use of those compositions is provided.

Abstract: The present invention provides compositions of modified pectin and methods for preparing and using them.

Abstract: The present invention relates to the therapeutic treatment of Acute Myeloid Leukemia (AML). It concerns in particular a novel composition for the treatment of this cancer and an associated therapeutic treatment method. The invention concerns a suspension of erythrocytes encapsulating asparaginase as a medicament for treating Acute Myeloid Leukemia (AML). The invention also concerns a method for treating Acute Myeloid Leukemia (AML) comprising administering an efficient amount of a suspension of erythrocytes encapsulating asparaginase.

Abstract: In one embodiment, the present application discloses synthetic LDL nanoparticles comprising mixtures of components selected from the group consisting of phospholipids, triglycerides, cholesterol ester and free cholesterol; optionally further comprising an agent selected from the group consisting of natural antioxidants, ubiquinol and vitamin E, and methods for preparing the synthetic nanoparticles. The disclosed synthetic LDL nanoparticles are capable of selectively delivering lipophilic drugs and prodrugs to cellular targets expressing LDL receptors after intra venous injection.

Abstract: Osteogenic implants, carriers and concentrates are described, along with methods of making and using the same. The implants include a carrier and, optionally, an osteoinductive agent. The carrier includes a mineral component, a binder and, optionally, a collagen additive, while the osteoinductive agent may be a protein such as a bone morphogenetic protein.

Abstract: A particle includes a ferromagnetic material, a radiopaque material, and/or an MRI-visible material.

Abstract: Fibrinolytic nanoparticles including a polymeric core having a surface that is functionalized with a cationic amphiphilic compound, and a fibrinolytic agent dispersed within the core, are described herein. The fibrinolytic nanoparticles can be used in method of dissolving a blood clot in a subject by administering to the subject a therapeutically effective amount of fibrinolytic nanoparticles.

Abstract: Provided herein relates to methods and compositions for preparing a silk microsphere and the resulting silk microsphere. In some embodiments, the methods and compositions described herein are all aqueous, which can be used for encapsulating an active agent in a silk microsphere, while maintaining activity of the active agent during processing. In some embodiments, the resulting silk microsphere can be used for sustained delivery of an active agent encapsulated therein.

Abstract: The present invention provides for methods of preparing silk nanoparticles and microparticles, methods of encapsulating an active agent into the silk nano- and microparticles and compositions comprising these silk particles. In particular, the silk spheres are prepared from phase separation of silk and polyvinyl alcohol (PVA), without exposure to an organic solvent. The method employs a chemical, PVA, which is an FDA-approved ingredient in drug formulations. Different parameters can be adjusted to control the size and shape of the silk spheres during the fabrication process. The silk particle compositions of the present invention may also encapsulate active agents or chemicals. Such compositions allow the active agents to be controllably and sustainably released to the target organs or tissues. The silk composition entrapping active agents also provides for a long-term storage medium for the active agents so entrapped.

Abstract: Compositions, methods, and kits are provided for sealing applications. Compositions are prepared by combining a first cross-linkable component with a second cross-linkable component to form a porous matrix having interstices, and combining the porous matrix with a hydrogel-forming component to fill at least some of the interstices. The compositions exhibit minimal swelling properties.

Abstract: The present invention relates to a fibrin matrix, its preparation and use for effectively sealing a defect in a mucosa or other moist tissue.

Abstract: Milled nanoparticles comprising a biologically active agent, at least one biopolymer and a coating containing at least one coating which is a polymer or ligand are produced using milling and coating techniques which have not previously been used for these applications.

Abstract: The present invention features methods for treating, stabilizing, preventing, and/or delaying cancer by administering nanoparticles that comprise rapamycin or a derivative thereof. The invention also provides compositions (e.g., unit dosage forms) comprising nanoparticles that comprise a carrier protein and rapamycin or a derivative thereof. The invention further provides combination therapy methods of treating cancer comprising administering to an individual an effective amount of nanoparticles that comprise rapamycin or a derivative thereof and a second therapy.

Abstract: A particulate SAE-CD composition is provided. The SAE-CD composition has an advantageous combination of physical properties not found in known solid forms of SAECD. In particular, the SAE-CD composition possesses an advantageous physicochemical and morphological property profile such that it can be tailored to particular uses. The SAE-CD composition of the invention has improved flow and dissolution performance as compared to known compositions of SAE-CD.

Abstract: The present invention relates to a method for producing particles of a compound of interest. In a method according to the invention a solution is provided of the compound of interest in a solvent. This solution is thickened or gelled and particles are formed. The invention further relates to a particle that is obtainable by the invention.

Abstract: Improved hemostatic agents take the form of granules or particles that can be used to stanch, seal, or stabilize a site of hemorrhage, including a noncompressible hemorrhage.

Abstract: An extrusion process comprises extruding a material that is flowable when heated and passing the extrudate thus formed through a nozzle 10 to shape the extrudate into a plurality of substantially uniformly shaped elements such as minispheres or minicapsules.

Abstract: Provided are polymer vesicles comprising polymersomes, a radiofrequency absorbing moiety, a protein or a polysaccharide associated with the inner leaflet of the membrane and a therapeutic or diagnostic cargo. The invention also concerns the use of these polymer vesicles for selective electromagnetic energy-induced delivery of therapeutic or diagnostic agents.

Abstract: The present invention makes use of a unique methodology of double nano-encapsulation for protecting and controlling the release of active agents, either hydrophobic or hydrophilic, from stable nanoparticles of opposite characteristics. The protection of the active agent was achieved by loading the agent to be protected, into nanocarriers, which were subsequently encapsulated into sub-micron nanoparticles. The sub-micron nanoparticles formation has been successfully achieved by the use of novel nano spray techniques.

Abstract: This application provides a microsphere suitable for tissue engineering that comprises connective tissue growth factor (CTGF). Also provided is a matrix, material or scaffold suitable for tissue engineering that comprises connective tissue growth factor (CTGF) and basic fibroblast growth factor (bFGF). Additionally, methods of treating skin of a human are provided. The methods comprise administering to the skin microspheres comprising a growth factor that increases fibroblast proliferation or collagen, elastin, or glycosaminoglycan synthesis. Further provided are the use of the above microspheres for the treatment of the skin of a human. Additionally, this application proves the use of the above microsphere for the manufacture of a medicament for the treatment of the skin of a human.

Abstract: A modified starch material for biocompatible hemostasis, biocompatible adhesion prevention, tissue healing promotion, absorbable surgical wound sealing and tissue bonding, when applied as a biocompatible modified starch to the tissue of animals. The modified starch material produces hemostasis, reduces bleeding of the wound, extravasation of blood and tissue exudation, preserves the wound surface or the wound in relative wetness or dryness, inhibits the growth of bacteria and inflammatory response, minimizes tissue inflammation, and relieves patient pain. Any excess modified starch not involved in hemostatic activity is readily dissolved and rinsed away through saline irrigation during operation. After treatment of surgical wounds, combat wounds, trauma and emergency wounds, the modified starch hemostatic material is rapidly absorbed by the body without the complications associated with gauze and bandage removal.