Abstract: Disclosed herein are compositions and methods for the treatment of otic disorders with steroid, NSAID, and/or adenosine triphosphatase (“ATPase”) modulator agents. In these methods, the steroidal, NSAID, and/or ATPase compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: Disclosed herein are compositions and methods for the treatment of otic disorders with steroid, NSAID, and/or adenosine triphosphatase (“ATPase”) modulator agents. In these methods, the steroidal, NSAID, and/or ATPase compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: Methods for sealing an orifice in tissue in the body of a living animal using an adhesive formed by reacting an oxidized polysaccharide with a poly(hydroxylic) compound derivatized with acetoacetate groups in the presence of a base catalyst are disclosed. Methods for using the adhesive for medical and veterinary applications such as topical wound closure; and surgical procedures, such as intestinal anastomosis, vascular anastomosis, tissue repair, and ophthalmic procedures; and drug delivery are described.

Abstract: Adhesives formed by reacting an oxidized polysaccharide with a poly(hydroxylic) compound derivatized with acetoacetate groups in the presence of a base catalyst are disclosed. The use of the adhesives for medical and veterinary applications such as topical wound closure; and surgical procedures, such as intestinal anastomosis, vascular anastomosis, tissue repair, and ophthalmic procedures; and drug delivery are described. The adhesive may also be used for industrial and consumer applications.

Abstract: An immunoisolation patch system, and particularly a patch system comprising multiple immunoisolation microcapsules, each encapsulating biological material such as cells for transplantation, which can be used in the prophylactic and therapeutic treatment of disease in large animals and humans without the need for immunosuppression.

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: Described herein are methods and compositions related to biologic matrices comprising at least one anti-infective. In certain embodiments, the invention relates to a biologic matrix comprising a slowed release anti-infective agent. In a particular embodiment, the invention relates to an acellular dermal matrix comprising a slowed release anti-infective agent, wherein the anti-infective agent is triclosan. In further embodiments, the invention relates to a biologic matrix comprising at least one anti-infective agent, wherein the biologic matrix is suitable for use in surgical procedures, such as, for example, for the replacement of damaged or inadequate integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects.

Abstract: Provided are a delivery system that is useful in delivering a double-stranded ribonucleic acid that functions in gene silencing in glomeruli, particularly in mesangial cells and the like, to the tissue or cells, and the like. A polyion complex in the form of a non-polymeric micelle consisting of a double-stranded ribonucleic acid and a block copolymer represented by the formula (I) or (II) below, which are electrostatically bound together, wherein the polyion complex has an average particle diameter of less than 100 nm as measured by a dynamic light scattering measuring method: wherein each symbol is as defined in the specification.

Abstract: Semisolid mucoadhesive formulations for vaginal application, with improved technical and organoleptic characteristics, which contain at least two bioadhesive gelling polymers and an active ingredient, useful in the prevention and/or treatment of various pathologies and disorders in human beings or animals.

Abstract: The present invention provides compositions comprising an interpolymer of chitosan and polyethylene glycol, wherein the interpolymer is a liquid below 25° C. and a gel above 35° C. The present invention also provides methods for using the compositions to deliver drugs to a living body over time.

Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films contain at least one active agent, which may be administered to a user topically, transmucosally, vaginally, ocularly, aurally, nasally, transdermally or orally.

Abstract: There is presently provided a stimulus-responsive polymer comprising a biodegradable polymer backbone and a stimulus-responsive pendant group attached to the biodegradable polymer backbone, wherein the biodegradable polymer backbone comprises a poly(amino ester) or a poly(amido amine), the poly(amido amine) optionally comprising a disulfide linkage in the backbone.

Abstract: The present invention is directed to compounds, compositions, and methods useful for delivering polynucleotides or other cell-impermeable molecules to mammalian cells. Described are polyconjugates systems that incorporate targeting, anti-opsonization, anti-aggregation, and transfection activities into small biocompatible in vivo delivery vehicles. The use of multiple reversible or labile linkages connecting component parts provides for physiologically responsive activity modulation.

Abstract: The present invention provides pharmaceutical release systems comprising an therapeutically effective amount of flibanserin and at least one pharmaceutically acceptable excipient, characterized in that said pharmaceutical release systems exhibit a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax lower than 300 ng/mL, preferably lower than 200 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.

Abstract: A therapeutic agent delivery system formed of a specific type of poly(ester amide) (PEA), a therapeutic agent, and a water miscible solvent is described herein. A method of delivering the therapeutic agent delivery system by delivering the therapeutic agent delivery system formed of a PEA polymer, a therapeutic agent, and a water miscible solvent to a physiological environment and separating the phase of the therapeutic agent delivery system to form a membrane from the polymer to contain the therapeutic agent within the physiological environment is also described. Additionally disclosed is a kit including a syringe and a therapeutic agent delivery system within the syringe.

Abstract: The present invention provides immediate release pharmaceutical compositions for oral administration that are resistant to abuse.

Abstract: A topical formulation for application to exposed body tissue, the formulation comprising a silver(II) oxide and zinc oxide, intimately dispersed within a carrier medium.

Abstract: Pharmaceutical compositions suitable for the oral administration of heparin or derivatives thereof, particularly controlled-release oral pharmaceutical compositions containing heparin with different molecular weight, for the treatment of inflammatory bowel diseases and related conditions, are disclosed.

Abstract: A composition of matter comprises a cationic polymer comprising a polycarbonate chain fragment, the polycarbonate chain fragment comprising a repeat unit comprising a side chain moiety containing a quaternary amine group; and a non-charged polymer comprising a polyester chain segment and a poly(alkylene oxide) chain segment; wherein i) the cationic polymer and the non-charged polymer are amphiphilic and biocompatible, ii) the cationic polymer and the non-charged polymer form a mixed complex by non-covalent interactions in water, and iii) the mixed complex is a more effective antimicrobial agent against at least a Gram-negative microbe compared to the cationic polymer and the non-charged polymer alone when tested using otherwise identical conditions.

Abstract: A blended electrophilic material with a first component having a functionality of at least three and a second component having a functionality of two is mixed with a nucleophilic material. The blended electrophilic material cross-links with the nucleophilic material to form a non-liquid, three dimensional structure which can applied, e.g., as an adhesion barrier.

Abstract: An improved drug delivery composition and method of use is disclosed. The composition comprises one or more biodegradable block copolymer drug carriers; and a reconstitution enhancing and enabling agent comprising polyethylene glycol (PEG), a PEG derivative or a mixture of PEG and a PEG derivative. The composition can be administered as is or after being be dissolved or rapidly reconstituted in an aqueous vehicle to afford a homogeneous solution or uniform colloidal systems.

Abstract: An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making the coated complex and the liquid suspension are described.

Abstract: The invention relates to a bioactive surface comprising a polymer matrix, a connecting complex comprising at least one compound covalently bound to the surface of the polymer matrix, and a gene transfer vector bound to the connecting complex, wherein the compound of the complex is covalently bound to the transfer vector using a group selected from among carboxyl, amino, isocyanate and hydroxyl. The invention also relates to the use of the bioactive surface for transferring a nucleic acid to a cell. The invention further relates to: an implantable device characterized in that at least part of the surface thereof is coated with said bioactive surface, and to the use of the implantable device for transferring a nucleic acid to a cell. In addition, the invention relates to a method for transferring a nucleic acid to a cell and to a kit for performing said method.

Abstract: A composite hydrogel comprises an amphiphilic triblock copolymer (ABA) and a loaded micelle bound by noncovalent interactions. The loaded micelle comprises a biologically active substance and an amphiphilic diblock copolymer (CD). The A blocks comprise a steroidal repeat unit (repeat unit 1) having both a backbone carbonate and a side chain bearing a steroid functional group. Each of the A blocks has a degree of polymerization of about 0.5 to about 4.0. The B block comprises a first poly(alkylene oxide) backbone. The C block comprises a second poly(alkylene oxide) backbone. The D block comprises a steroidal repeat unit (repeat unit 2) having both a backbone carbonate group and a side chain comprising a steroid functional group. The composite hydrogel is capable of controlled release of the biologically active substance.

Abstract: The use of copolymers obtained by free-radical polymerization of a mixture of i) 30 to 80% by weight of N-vinyllactam, ii) 10 to 50% by weight of vinyl acetate, and iii) 10 to 50% by weight of a polyether, with the proviso that the total of components i), ii) and iii) equals 100% by weight, as solubilizers for slightly water-soluble substances.

Abstract: Isolated mixed populations of fetal pulmonary cells, engineered three-dimensional tissue constructs of these cells, and uses thereof in identifying therapeutic agents which augment, repair, and/or replace dysfunctional native lung and to perform in vitro studies such as pharmaceutical screening, models for lung development and disease and characterization of chemical or mechanical injury are provided.

Abstract: A chemically patterned modified hydrogel formed from a modified hydrogel is provided. The hydrogel is conjugated with a multiphoton photocleavable molecule. The molecule has a multiphoton-labile protective group and a protected group. The protective group is cleavable upon multiphoton excitation to deprotect the protected group, without substantial polymerization of the hydrogel. The chemically patterned modified hydrogel is formed by exposing the modified hydrogel to multiphoton excitation to deprotect a portion of the protected groups.

Abstract: The present invention is directed to medical devices and pharmaceutical compositions containing a synthetic, bioabsorbable, biocompatible liquid polymer that is the reaction product of a polybasic acid or derivative thereof, a polyol and a fatty acid, the liquid polymer having a melting point less than about 40° C., as determined by differential scanning calorimetry.

Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Abstract: The present invention relates to a hydrogel suspension which comprises a fine particle and high molecular weight hydroxypropylmethyl cellulose or methylcellulose, which exhibits high transparency and stability; and a manufacturing process thereof.

Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Abstract: Hemostatic devices for promoting blood clotting can include a substrate (e.g., gauze, textile, sponge, sponge matrix, one or more fibers, etc.), a hemostatic material disposed thereon such as kaolin clay, and a binder material such as crosslinked calcium alginate with a high guluronate monomer molar percentage disposed on the substrate to substantially retain the hemostatic material material. When the device is used to treat a bleeding wound, at least a portion of the clay material comes into contact with blood to accelerate clotting. Moreover, when exposed to blood, the binder has low solubility and retains a majority of the clay material on the gauze. A bandage that can be applied to a bleeding wound to promote blood clotting includes a flexible substrate and a gauze substrate mounted thereon.

Abstract: The invention relates to a pharmaceutical composition for the modulation of effector T cell responses made of one or more preparations and comprising a therapeutically effective dose of at least one recombinant human C3-derivative and of at least one antigen or allergen.

Abstract: The invention relates to a pharmaceutical composition made of one or more preparation and comprising a therapeutically effective dose of at least one recombinant human C3-derivative and at least one antigen für vaccination.

Abstract: Biocompatible intraocular microspheres and implants include an alpha-2 adrenergic receptor agonist and a polymer associated with the alpha-2 adrenergic receptor agonist to facilitate release of the alpha-2 adrenergic receptor agonist into an eye for an extended period of time. The alpha-2 adrenergic receptor agonist may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. The implants may be placed in an eye to treat or to prevent the occurrence of one or more ocular conditions, to reduce one or more symptoms of an ocular condition, such as an ocular neurosensory disorder and the like, to enhance normal retinal function and/or to lower intraocular pressure.

Abstract: A pharmaceutical composition for controlled release of an active substance is provided. The active substance is released into an aqueous medium by erosion of at least one surface of the composition. The composition comprises i) a matrix comprising a) polymer or a mixture of polymers, b) an active substance and, optionally, c) one or more pharmaceutically acceptable excipients, and ii) a coating.

Abstract: In one aspect, the disclosure provides cross-linked materials that include multivalent polynucleotide aptamers that bind a target molecule; and conjugates that include two or more separate affinity ligands bound to a conjugate framework, wherein the two or more affinity ligands compete with the target molecule for binding with the aptamers and wherein conjugates are cross-linked within the material as a result of non-covalent interactions between aptamers and affinity ligands on different conjugates. These materials are designed to release amounts of conjugate in response to desired concentrations of the target molecule. Depending on the end application, in various embodiments, the conjugates may also include a drug and/or a detectable label. The drug, detectable label and affinity ligands may be covalently or non-covalently bound to the conjugate framework.

Abstract: This invention relates to poly(ester amide)s (PEAs) comprising inactivated terminal amino and carboxyl groups, methods of synthesizing the inactivated PEAs and uses for them in the treatment of vascular diseases.

Abstract: The present invention is directed to emulsion composition, in solid form, capable of imparting shine, hydration and/or moisturization onto lips containing: a) at least one polyamine; (b) at least one oil-soluble high carbon polar modified polymer; (c) water; (d) at least one non-volatile solvent; (e) at least one wax having a high melting point; and (e) optionally, at least one colorant.

Abstract: An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making the coated complex and the liquid suspension are described.

Abstract: The present invention is directed to a bio-functionalized stimulus-responsive dissolvable PEG-hydrogel. This inventive stimulus-responsive dissolvable PEG-hydrogel comprises a matrix of PEG-polymers, which are modified to contain at least one multifunctional fusion protein, the multifunctional fusion protein preferably comprising as components a substrate binding peptide (SBP), preferably a repetitive RGD-binding peptide and/or a ZZ-binding domain, preferably a tag for purification, and at least one N- and/or C-terminal linker. The present invention is furthermore directed to the use of such inventive stimulus-responsive dissolvable PEG-hydrogels in the treatment of lesions, in surgical dressings, for wound treating, for soft and hard tissue regeneration, for the treatment of wounds in the oral cavity, in the field of ophthalmology, in the field of periodontal defects, etc. The invention also describes a method of treatment for such diseases.

Abstract: The present disclosure relates to a hydrogel composition and methods of using the same. The hydrogel composition may include precursors that react with each other upon contact as well as precursors that react upon contact with an initiator. In embodiments, the resulting hydrogels may have varying levels of crosslinking with both denser and less dense regions.

Abstract: Biocompatible non-toxic triblock copolymers having an A-B-A structure wherein each A is a hydrophilic, biocompatible end block and the B middle block is a hydrophobic desaminotyrosyl tyrosine polycarbonate or polyarylate. The copolymers spontaneously self-assemble to form low critical aggregation concentration nanospheres having utility as delivery vehicles for hydrophobic biologically or pharmaceutically active compounds.

Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Abstract: Improved compositions for tissue augmentation are provided. These compositions comprise an amount of crosslinked material sufficient to provide a melt temperature (Tm) greater than 37C, wherein microparticles can be substantially uniformly dispersed and maintained at ambient room temperature as well as body temperature. Said compositions also provide high shear moduli, sufficient to effectively deliver microparticles into dense tissue and narrow intersticial spaces without significant disruption to the homogeneous distribution of microparticles within the solution. The provided compositions can be stored and shipped at room temperature without significant detriment to the material composition. Additional embodiments include a system for delivery of tissue augmentation materials and methods of manufacture thereof.

Abstract: An amphiphilic pentablock copolymer that is temperature- and pH-sensitive and has superior and sustained gel strength, includes (a) a hydrophilic triblock copolymer that is temperature-sensitive and that is a copolymer of a poly(ethylene glycol)-based compound and a biodegradable polymer that is one or more polymer selected from the group consisting of polylactide, polyglycolide, polycaprolactone, poly(caprolactone-lactide) random copolymer, poly(caprolactone-glycolide) random copolymer, poly(lactide-glycolide) random copolymer, and mixtures thereof; coupled with (b) a polyurethane-based oligomer (PU) that is pH sensitive and that includes a diisocyanate compound represented by a Formula as follows: OCN—(CH2)n—NCO, where n is an integer of 4 to 10, polymerized with a diol compound having a tertiary amine on a main chain thereof that is one or more of 1,3-bis{1-(2-hydroxyethyl) -4-pyridyl}propane and 1,4-bis(2-hydroxyethyl)piperazine, and is represented by Formulae as follows: where R and R? are alkyl grou

Abstract: A method of manufacturing a biopolymer optical device includes providing a polymer, providing a substrate, casting the polymer on the substrate, and enzymatically polymerizing an organic compound to generate a conducting polymer between the provided polymer and the substrate. The polymer may be a biopolymer such as silk and may be modified using organic compounds such as tyrosines to provide a molecular-level interface between the provided bulk biopolymer of the biopolymer optical device and a substrate or other conducting layer via a tyrosine-enzyme polymerization. The enzymatically polymerizing may include catalyzing the organic compound with peroxidase enzyme reactions. The result is a carbon-carbon conjugated backbone that provides polymeric “wires” for use in polymer and biopolymer optical devices. An all organic biopolymer electroactive material is thereby provided that provides optical functions and features.

Abstract: An injectable hydrogel includes a hydrogel matrix based on (a) single-phase-type cross-linked biopolymer(s), characterized in that previously cross-linked biopolymer hydrogel particles are co-cross-linked with the matrix. A method of and a process for production of the above-mentioned hydrogel are also disclosed.

Abstract: Water-soluble polymeric adhesive compositions and their use as delivery vehicles for carrying therapeutic agents on implantable devices, such as vascular grafts, are disclosed. Use of drug-coated vascular grafts is demonstrated for delivery of the therapeutic agents in vivo, thereby inhibiting restenosis or neointimal hyperplasia of the vascular graft and inhibiting infection at the vascular graft site. Methods of forming the adhesive and making the coated vascular grafts are also disclosed.