Abstract: A composition comprising a therapeutically effective amount of cyclosporin A, a blend of oils having a specific gravity of from 0.90 to 1.07, and a surfactant is disclosed herein.

Abstract: A composition comprising from about 0.001% to about 0.4% cyclosporin A, a surfactant, and an oil having a specific gravity from 0.8 to 0.95 is disclosed herein.

Abstract: Described herein is an aqueous ophthalmic solution containing an immunosuppressive agent, such as cyclosporin A, and at least three polymers. The three polymers are preferably a combination of a cellulose derivative, a polyvinyl derivative, and a macrogolglycerol hydroxystearate.

Abstract: The present invention relates to novel cyclosporine analogues having antiviral activity against HCV and useful in the treatment of HCV infections. More particularly, the invention relates to novel cyclosporine analogue compounds, compositions containing such compounds and methods for using the same, as well as processes for making such compounds.

Abstract: The present invention relates to a calcineurin inhibitor for use in the treatment of a lesional vestibular disorder.

Abstract: Disclosed herein is a composition comprising cyclosporin A at a concentration between about 0.001% (w/v) and about 1.0% (w/v), a plant oil at a concentration between about 0.01% (w/v) and about 10% (w/v), and macrogol 15 hydroxystearate at a concentration between about 0.01% (w/v) and about 10% (w/v).

Abstract: This invention relates to novel macrocyclic compounds (e.g., those delineated in the formulae herein), pharmaceutically acceptable salts, solvates, and hydrates thereof. This invention also provides compositions comprising a compound of this invention and the use of such compounds and compositions in methods of treating diseases and conditions that are beneficially treated by administering inhibitors of the protease elastase.

Abstract: Provided herein are methods of evaluating efficacy of a treatment in a subject having eye inflammation (e.g., a subject having dry eye syndrome) and selecting a subject for participation in a clinical study. Also provided are methods of treating a subject having eye inflammation (e.g., a subject having dry eye syndrome).

Abstract: Oral dosage compositions for drugs normally given intravenously such as Paclitaxel, containing a plant sterol to enhance solubility and a small intestine efflux inhibitor to prevent P-glycoprotein from being a barrier to absorption.

Abstract: The present invention relates to a self-preserved oil dispersion. Especially, the present invention relates to a self-preserved oil dispersion including a dispersed oil phase, an aqueous phase and at least one surfactant, wherein said oil dispersion comprises boric acid in an amount ranging from 0.005% to 0.075% in weight of the total weight of the oil dispersion, said amount of boric acid being a preservative effective amount so that the oil dispersion has a preservative activity.

Abstract: Disclosed herein is a method of treating blurred vision, of increasing keratocyte density, of increasing goblet cell density, and of treating psychological distress following surgery on the eye, the method comprising administering a cyclosporin composition to the affected eye of an individual.

Abstract: Described herein are liquid formulations which deliver a variety of therapeutic agents, including but not limited to rapamycin, to a subject for an extended period of time; liquid formulations which form a non-dispersed mass when placed in an aqueous medium of a subject; liquid formulations, comprising a therapeutic agent and a plurality of polymers; and methods for delivering therapeutic agents to a subject for an extended period of time using the liquid formulations. The liquid formulation may be placed in an aqueous medium of a subject, including but not limited to via intraocular or periocular administration. A method may be used to administer rapamycin to treat or prevent angiogenesis, choroidal neovascularization, or age-related macular degeneration in a subject.

Abstract: The ophthalmic drug delivery vehicles provide comfort and compliance; drug solubility, residence time and permeability; and reduce side effects. In addition, the delivery vehicle can be slightly modified to provide an artificial tear formulation.

Abstract: The ophthalmic drug delivery vehicles provide comfort and compliance; drug solubility, residence time and permeability; and reduce side effects. In addition, the delivery vehicle can be slightly modified to provide an artificial tear formulation.

Abstract: A composition is described herein comprising cyclosporin A, polysorbate 80, a polyoxyethylene stearate, and an oil; wherein the composition is an emulsion which is ophthalmically acceptable. Methods of treating diseases or conditions using said compositions, and medicaments related thereto, are also disclosed herein.

Abstract: The invention relates to the use of a cyclic undecapeptide, with the structure in formula (I), for the preparation of a medicament for administration during a myocardial ischaemic event.

Abstract: Disclosed herein are methods of formulating cyclosporin A Form 2.

Abstract: Provided herein are methods of treating or ameliorating hypercholemia or a cholestatic liver disease by administering to an individual in need thereof a therapeutically effective amount of an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising administering to an individual in need thereof a therapeutically effective amount of ASBTI or a pharmaceutically acceptable salt thereof.

Abstract: The present invention relates generally to crystalline forms of cyclosporine A and particularly to a newly identified form of cyclosporine A. The invention further relates to methods for its preparation and to methods for treating certain ocular disorders.

Abstract: Methods are described and related devices, compositions, and systems, in which a caged compound is administered to a biological environment, the caged compound being caged with a long wavelength absorber, the long wavelength being a wavelength greater than or equal to 750 nm; and irradiating the biological environment to excite the long wavelength absorber with light at a wavelength in a range from 900-1100 nm, thus decaging the compound.

Abstract: Ophthalmic compositions containing norketotifen and methods of making the same and the use thereof are disclosed. The methods also comprise administering to the eyes of a mammal in need thereof topical ophthalmic compositions containing norketotifen.

Abstract: The present application provides methods and compositions for treatment or prevention of dsDNA virus infection in post-hematopoietic cell transplant (HCT or HSCT) patients.

Abstract: Disclosed herein are methods of treating diseases of the eye by administering to the subconjunctival space a formulation comprising cyclosporin A form 2 and a hydrogel.

Abstract: A class of compounds that inhibit Hepatitis C Virus (HCV) is disclosed, along with compositions containing the compound, and methods of using the composition for treating individuals infected with HCV.

Abstract: A process for making particles for delivery of drug nanoparticles is disclosed herein. The process comprises the steps of (a) forming a suspension of drug nanoparticles by mixing a precipitant solution with an anti-solvent solution under micro-mixing environment, where the formed nanoparticles have a narrow particle size distribution; (b) providing an excipient to at least one of the precipitant solution, the anti-solvent solution and the suspension of drug nanoparticles, the excipient being selected to maintain said drug nanoparticles in a dispersed state when in liquid form; and (c) drying the suspension of drug nanoparticles containing the excipient therein to remove solvent therefrom, wherein removal of the solvent causes the excipient to solidify and thereby form micro-sized matrix particles, each micro-sized particle being comprised of drug nanoparticles dispersed in a solid matrix of the excipient.

Abstract: The present invention describes Cyclosporine A/steroid hybrid analogs. These single drug entities are formed by connecting a steroid with Cyclosporine A. Upon topical application to the eye, the conjugate hybrid would undergo enzymatic and/or hydrolytic cleavage to release the individual drugs.

Abstract: The present disclosure relates to formulations containing cyclosporin analogs that are structurally similar to cyclosporin A, in particular isomeric mixtures of cyclosporin analogs that are structurally similar to cyclosporin A. The formulations form stable microemulsion preconcentrates and may provide superior drug bioavailability and/or may reduce one or more adverse effects associated with the administration of cyclosporin. Also disclosed are methods for using and preparing the formulations.

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: Provided is a novel anti-HCV agent including as an active ingredient a peroxide derivative represented by the general formula (I). In the general formula (I), C represents an alicyclic hydrocarbon ring group which may be substituted, n represents an integer of from 1 to 6, and R represents a hydrogen atom or a hydroxyalkyl group. The peroxide derivative exhibits potent anti-HCV activity by remarkably suppressing HCV-RNA replication.

Abstract: To date, no immune tolerance agent or combination of immune tolerance agents has been able to sustain insulin-independence among type 1 diabetes patients. This patent provides methods and pharmaceutical compositions for providing insulin independence among newly diagnosed and existing type 1 diabetes. Methods include utilization of PPIs, which increase gastrin resulting in the transformation of human ductal tissue into insulin-secreting new beta cells, used in combination with an immune tolerance agent to protect the new insulin-producing beta cells generated by the PPI from immune destruction. Compositions and methods are provided for beta cell generation therapy comprising at least one member from a group of PPIs with formulations selected from immune tolerance agents, when used in combination result in insulin-independence among new and existing type 1 patients whom currently require insulin to sustain life.

Abstract: A method for treating intestinal fibrosis in a subject, comprising enterally administering a steroid to the subject. The steroid may be in a multiple minibead formulation.

Abstract: A pharmaceutical formulation comprises a plurality of seamless minicapsules having a diameter from 0.5 mm to 5 mm, at least some of the minicapsules containing a methyxanthine as one active ingredient, and at least some of the minicapsules containing a corticosteroid as another active ingredient.

Abstract: Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), or a salt or an ester thereof, are provided for use in the treatment and/or prophylaxis of a condition selected from macular oedema, conditions causing damage to retinal photoreceptors and/or retinal pigment epithelial cells, and dry eyes in a mammal, wherein the combined dosage of eicosapentaenoic acid and docosahexaenoic acid is from 5 mmol to 25 mmol per day, and wherein the molar ratio of eicosapentaenoic acid to docosahexaenoic acid is in the range of from 1:1 to 5:1. Compositions comprising EPA and DHA and at least one pharmaceutically acceptable excipient, and kits containing EPA, DHA and further therapeutic agents are also provided. The EPA and DHA, or composition comprising the EPA and DHA may be administered orally.

Abstract: The invention relates to stable oleaginous cosmetic or therapeutic foam compositions containing certain active agents, having unique therapeutic properties and methods of treatment using such compositions. The foamable composition includes at least one solvent selected from a hydrophobic solvent, a silicone oil, an emollient, a co-solvent, and mixtures thereof, wherein the solvent is present at a concentration of about 70% to about 96.5% by weight of the total composition, at least a non-ionic surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; at least one gelling agent at a concentration of about 0.1% to about 5% by weight of the total composition; a therapeutically effective amount of at least one active agent; and at least one liquefied or compressed gas propellant, at a concentration of about 3% to about 25% by weight of the total composition.

Abstract: A special class of drug-depot forming triblock copolymers which are very suitable for the loading, containment and releasing of sensitive drugs such as proteins from biodegradable, injectable drug depots. How to visualize these depots for various imaging related purposes is described. A composition comprising a tri-block copolymer according to formula 1 B-A-B (1), wherein A stands for a linear poly-(ethylene glycol) block and wherein B stands for wherein B stands for a poly(lactide-co-?-caprolactone) block, wherein the hydroxyl end-groups of the tri-block copolymer are at least partially acylated with an optionally substituted acyl having 2 to 12 C-atoms, C-atoms of the substituents included; an active ingredient, preferably a pharmaceutically active ingredient and a solvent, wherein the block ratio of the tri-block copolymer, which ratio is defined as the ratio between the sum of the average molecular weight of the B-blocks and the sum of the average molecular weight of the A-block ranges from 1.4 to 3.5.

Abstract: A process for producing a small-sized, lipid-based cochleates. Cochleates are derived from liposomes which are suspended in an aqueous two-phase polymer solution, enabling the differential partitioning of polar molecule based-structures by phase separation. The liposome-containing two-phase polymer solution, treated with positively charged molecules such as Ca2+ or Zn2+, forms a cochleate precipitate of a particle size less than one micron. The process may be used to produce cochleates containing biologically relevant molecules.

Abstract: The present invention relates to methods of diagnosing lupus in a patient, as well as methods of monitoring the progression of lupus and/or methods of monitoring a treatment protocol of a therapeutic agent or a therapeutic regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.

Abstract: Disclosed herein are methods of formulating cyclosporin A Form 2.

Abstract: Disclosed herein are methods of making cyclosporin A Form 2.

Abstract: Cyclosporin derivatives, methods of manufacturing the cyclosporin derivatives and methods for treating subjects infected with certain viruses, including hepatitis virus or HIV by administering the cyclosporin derivatives are described.

Abstract: Methods for prevention and treatment of kidney transplant rejection are described that involve determination, analysis and computation of a 3-gene molecular signature of levels of specific RNAs (IP-10 mRNA, CD3? mRNA, and 18S rRNA) in urinary sample cells. The methods and devices described herein are diagnostic and prognostic of acute cellular rejection in kidney allografts.

Abstract: This invention provides compositions and methods for enhancing delivery of drugs and other agents across epithelial tissues, including the skin, gastrointestinal tract, pulmonary epithelium, ocular tissues and the like. The compositions and methods are also useful for delivery across endothelial tissues, including the blood brain barrier. The compositions and methods employ a delivery enhancing transporter that has sufficient guanidine or amidino sidechain moieties to enhance delivery of a compound conjugated to the reagent across one or more layers of the tissue, compared to the non-conjugated compound. The delivery-enhancing polymers include, for example, poly-arginine molecules that are preferably between about 6 and 25 residues in length.

Abstract: Cyclosporin derivatives, methods of manufacturing the cyclosporin derivatives and methods for treating subjects infected with certain viruses, including hepatitis virus or HIV by administering the cyclosporin derivatives are described.

Abstract: Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin exponent to the hydrophobic component is less than 0.8.

Abstract: Dopamine reuptake inhibitors, and their analogs, are disclosed for treating and delaying the progression of autoimmune diseases.

Abstract: Disclosed herein are methods of treating diseases of the eye by administering to the subconjunctival space a formulation comprising cyclosporin A form 2 and a hydrogel.

Abstract: Described herein are ophthalmic pharmaceutical compositions, wherein the ophthalmic pharmaceutical compositions are in a form suitable for administration to an eye of a mammal. Ophthalmic pharmaceutical compositions disclosed herein include at least one DP2 receptor antagonist compound and are used to treat or prevent ophthalmic diseases or conditions.

Abstract: The present invention provides a method for the treatment of ocular or dermal diseases and/or conditions, e.g. an aqueous deficient dry eye state, uveitis or phacoanaphylactic endophthalmitis in an eye, or balanitis, psoriasis, or atopic dermatitis of the skin, said method comprising administering, topically to the eye or the skin, a therapeutically effective amount of a novel cyclosporin A derivative selected from the group consisting of compounds represented by the formula: wherein R1 is S-Alk-R wherein Alk is an alkylene linkage, preferably a methylene or poly methylene linkage, e.g. a C2 to C6 polymethylene linkage, or a polyalkenylene linkage, e.g. a C3 to C6 alkenylenyl linkage, R is R is —N?C(NR3R4)(NR5R6) or —NR2[(NR3R4)C?NR5], i.e. guanidines or —N?C(R8)(NR9R10), i.e.

Abstract: Buccal aerosol sprays or capsules using polar and non-polar solvent have now been developed which provide biologically active compounds for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, active compound, and optional flavoring agent; formulation II; aqueous polar solvent, active compound, optionally flavoring agent, and propellant; formulation III: non-polar solvent, active compound, and optional flavoring agent; and formulation IV: non-polar solvent, active compound, optional flavoring agent, and propellant.

Abstract: A nanodispersion containing nanoparticles having a mean size less than 300 nm dispersed in a vehicle that includes a water miscible solvent and water. The nanoparticles contain one or more drugs, a polymer and a surfactant, and the surfactant includes a mixture of fatty acids or its salts and sterol or its derivatives or its salts.