Abstract: An improved method for treating acne is described. The method involves 16-week, once daily, oral administration of about 40 mg doxycycline in a pharmaceutical composition containing about 30 mg doxycycline in an immediate release portion and about 10 mg doxycycline in a delayed release portion. It was surprisingly discovered that the 16-week, once daily, oral administration of about 40 mg doxycycline has achieved same or superior efficacy than that of 100 mg doxycycline, but with a significant reduction in adverse events.

Abstract: This invention pertains to dental care compositions with antimicrobial benefits. In particular, the invention provides for compositions of oral tissue-adherent salts that release biocidal ions on a controlled release basis and thereby provide and maintain an essentially uniform concentration of biocidal ions above the MBC or MIC of the target bacteria at the site of application in the mouth for an extended period of time. The compositions are useful for treating or preventing oral diseases resulting from bacteria, fungal or yeast infections, such as caries, gingivitis, periodontal disease and candidiasis.

Abstract: This invention pertains to dental care compositions with antimicrobial benefits. In particular, the invention provides for compositions of oral tissue-adherent salts that release biocidal ions on a controlled release basis and thereby provide and maintain an essentially uniform concentration of biocidal ions above the MBC or MIC of the target bacteria at the site of application in the mouth for an extended period of time. The compositions are useful for treating or preventing oral diseases resulting from bacteria, fungal or yeast infections, such as caries, gingivitis, periodontal disease and candidiasis.

Abstract: Provided are methods of determining a response to a chemotherapeutic agent in a subject with ovarian cancer, comprising: determining a RNA integrity value of a sample comprising ovarian cancer cell RNA from the subject after the subject has received one or more doses of the chemotherapeutic agent; wherein a low RNA integrity value and/or RNA degradation of the cancer cell RNA is indicative that the cancer is responding to the chemotherapeutic agent and/or a high RNA integrity value and/or stable RNA integrity of the ovarian cancer cell RNA is indicative that the cancer is resistant to the chemotherapeutic agent.

Abstract: The present invention is directed to a pharmaceutical composition in unit dose form for orally delivering doxycycline to a human, the pharmaceutical composition comprising: a capsule, wherein the capsule is coated with a delayed release layer; wherein the delayed release layer comprises about 4 to 6 mg of doxycycline monohydrate and a binding agent, and wherein the delayed release layer is coated with an enteric coating; wherein the enteric coating dissolves at pH of about 5 to 6, and wherein the enteric coating is coated with an immediate release layer; wherein the immediate release layer comprises about 32 mg of doxycycline monohydrate and a binding agent, wherein the relative mean Cmax of the pharmaceutical composition is within 80.00% to 125.00% of a Cmax value of 510±220.7 ng/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state; and wherein the relative mean AUC(0-?) of the pharmaceutical composition is within 80.00% to 125.

Abstract: Pharmaceutical compositions in unit dose form comprising a hollow substrate and one or more coatings on the hollow substrate, wherein at least one coating comprises at least one active pharmaceutical ingredient, and methods of making the same are provided.

Abstract: Methods, devices and systems are disclosed for chemically bonding antibiotics to selected substrate materials which are not dissolved in normal physiological processes so that high local concentrations can be achieved during the inflammatory response. The antibiotics will remain permanently bonded to the substrate material until an infection occurs which releases the antibiotic in high concentrations to help control the infection. The high local concentrations may be much higher than systemic toxic levels, and can never reach toxic levels because the local dose is much less than needed to reach systemic toxicity if completely dissolved.

Abstract: The present invention generally relates to methods of modulating Cav1.2 channels and Cav1.2 channel activators.

Abstract: A dosing regime for providing therapy for a neurological trauma such as spinal cord injury in a human subject. The dosing regime comprises intravenous administration of a plurality of minocycline doses for a 7-day period at 12-h intervals such that a steady state level of minocycline is reached and maintained in a subject's serum and/or cerebrospinal fluid after administration of three minocycline doses. An initial minocycline dose of at least 800 mg is preferably administered within 12 h after an occurrence of the neurological trauma. The minocycline dosage is sequentially tapered to 400 mg and then maintained at 400 mg for the remainder of the 7-day treatment period.

Abstract: The present disclosure provides novel controlled release pharmaceutical dosage form, methods of making the same, and methods of using the same to treat dermatological conditions.

Abstract: Disclosed herein are compositions and methods for diagnosing, treating, and monitoring Lyme disease.

Abstract: The present invention relates to a pharmaceutical composition, in particular a composition formulated for enema administration, wherein the composition comprises metronidazole or a pharmacologically acceptable derivative thereof in an amount to effectively treat both acute and chronic pouchitis and/or proctitis.

Abstract: The present invention provides a method for treating a vertebrate subject suffering from a degenerative disc disease by administering an inhibitor of a matrix metalloprotease (MMP) to the subject in an amount effective to treat the subject.

Abstract: The present invention relates in essence to a compound which decreases or inhibits the binding of mammalian T-cells to mammalian endothelial cells for use in a method of prophylaxis and/or amelioration and/or treatment of clinical adverse events caused by therapy which comprises re-directing of T-cells against target cells in a patient. Methods of treatment of patients having or being at risk of clinical adverse events caused by therapy which comprises re-directing of T-cells against target cells are also contemplated.

Abstract: This invention is a method of killing the stealthy intra-cellular bacteria which are key to the pathogenesis Cancers. These very tiny L-form Cell-Wall-Deficient (CWD) antibiotic-resistant bacteria live within the cytoplasm of cells, including the phagocytic cells (e.g. monocytes, macrophages, lymphocytes, neutrophils and polymorphonuclear cells) of the immune system itself. The cellular proliferation in Cancer is catalysed the action of the same tiny L-form bacteria. They cause the cell nucleus to release mRNA signaling the Th1 cytokine cascade without the need for conventional signaling via, for example, CD4+T -Lymphocytes. Some of these Cytokines and Chemokines, including, without limitation, Cellular Adhesion Molecule (CAM), create the environment which allows the cellular proliferation to start, and then allows the cancerous growth to gain a foothold in the body. Killing these stealthy pathogens removes the environment needed to initiate and feed the cellular proliferation commonly called ‘Cancer’.

Abstract: In some embodiments, a device (102) may include a mesh having at least one bioresorbable polymer coating. The coating may comprise at least one active agent which is eluted over time. The device (102) may at least partially cover at least a portion of an implanted transdermal medical device (100).

Abstract: Bioactive hydroforming luminal liner compositions are formed of an absorbable crystalline amphiphilic polyether-ester-urethane dissolved in a liquid derivative of a polyether glycol that undergoes transformation into a tissue-adhering, resilient interior cover or liner for the controlled release of its bioactive payload at clinically compromised conduits in humans as in the case of bacteria- and yeast-infected vaginal canals, esophagi, and arteries following angioplasty.

Abstract: The method of the present application is directed towards a method for suppressing an allergic response in response to an allergic trigger. This method comprises the following steps; applying, topically, to an affected area an effective amount of a minocycline composition so that the minocycline composition contacts the affected area for an effective amount of time and removing the minocycline composition from the affected area.

Abstract: The present invention is directed to a compound represented by Structural Formula (A): or a pharmaceutically acceptable salt thereof. The variables for Structural Formula (A) are defined herein. Also described is a pharmaceutical composition comprising the compound of Structural Formula (A) and its therapeutic use.

Abstract: Disclosed is a method of treating small intestinal bacterial overgrowth (SIBO) or a SIBO-caused condition in a human subject. SIBO-caused conditions include irritable bowel syndrome, fibromyalgia, chronic pelvic pain syndrome, chronic fatigue syndrome, depression, impaired mentation, impaired memory, halitosis, tinnitus, sugar craving, autism, attention deficit/hyperactivity disorder, drug sensitivity, an autoimmune disease, and Crohn's disease. Also disclosed are a method of screening for the abnormally likely presence of SIBO in a human subject and a method of detecting SIBO in a human subject. A method of determining the relative severity of SIBO or a SIBO-caused condition in a human subject, in whom small intestinal bacterial overgrowth (SIBO) has been detected, is also disclosed.

Abstract: Disclosed are methods of treating subjects having conditions related to angiogenesis including administering an effective amount of a polymeric Nanoparticle form of thyroid hormone agonist, partial agonist or an antagonist thereof, to promote or inhibit angiogenesis in the subject. Compositions of the polymeric forms of thyroid hormone, or thyroid hormone analogs, are also disclosed.

Abstract: The present invention provides a method for treating a subject suffering from tuberculosis which comprises administering to the subject a composition comprising an amount of an inhibitor of a matrix metalloproteinase (MMP) in an amount effective to treat the subject, such that the therapeutic effect of said composition is different than the therapeutic effect attributable to the antibiotic properties of said composition. The present invention also provides a method for reducing or inhibiting destruction of lung extracellular matrix in a subject comprising administering to the subject at risk for such destruction a composition comprising an amount of an inhibitor of a matrix metalloproteinase (MMP) in an amount effective to reduce or inhibit destruction of lung extracellular matrix in the subject.

Abstract: The present invention relates to methods of increasing lifespan, delaying aging, and/or preventing or treating an age-related disease or a mitochondrial disease in a subject, comprising inducing a nuclear-mitochondrial OXPHOS protein dyssynchrony, including inhibiting the mitochondrial translation machinery function, as well as methods for screening agents that are able to increase lifespan, inhibit or delay aging, and/or prevent or treat an age-related disease or disorder, or a mitochondrial disease or disorder, in a subject.

Abstract: An anhydrous multiphase gel system consisting of an outer lipid matrix and an inner phase gelled by means of a polymer is described, which can be obtained by a) Melting the lipid phase with the formation of a liquid lipid phase, b) Mixing and homogenizing polymers or polymer blends capable of swelling with the formation of a polymer phase to be dispersed, c) Combining the polymer phase with the liquid lipid phase and homogenizing the phases, and d) Cold stirring the phase mixture until a solid gel-like mixed structure of the entire system is formed. The anhydrous multiphase gel system is particularly suitable for taking up difficulty soluble active substances in high concentration and for providing topical and transdermal applications. The described system is called an EDRS, “Entrapped Drug Reservoir System”.

Abstract: The present invention relates to 9-aminomethyl substituted tetracycline compounds represented by formula (I), or pharmaceutically acceptable salt, prodrug, solvate or isomer thereof, as well as a method for preparing these compounds and a pharmaceutical composition comprising the same. The present invention relates also to a use of these compounds in the preparation of a medicament for the treatment and/or prophylaxis of tetracycline drug-sensitive disease. wherein, R2a, R2b, R3, R4a, R4b, R5, R6a, R6b, R7, R8, R9a, R9b, R10, R11, R12, R13a and R13b are each independently as defined in the description.

Abstract: A compound having an antiviral activity for inhibiting release of an enveloped virus from a cell is disclosed, including methods of inhibiting release of an enveloped virus from a cell. The antiviral activity of the compound includes inhibiting formation of an associative complex or disrupting formation of an associative complex. The associative complex comprises an L-domain motif of the enveloped virus and at least one cellular polypeptide, or fragment thereof, capable of binding the L-domain motif of the enveloped virus.

Abstract: A liquid embolic material may include a mixture of a first solution comprising between about 1.2% and about 2.5% weight per volume (w/v) carboxymethyl chitosan (CCN) in a first solvent and a second solution comprising between about 1.2% and about 2.5% w/v oxidized carboxymethyl cellulose (OCMC) in a second solvent. The liquid embolic material may be used to embolize a targeted embolization location by mixing the first solution and the second solution to form a liquid embolic material (or hydrogel precursor material), introducing the hydrogel precursor material to a targeted embolization location within a body of a patient, and allowing the CCN and the OCMC to react to form the hydrogel material and embolize the targeted embolization location.

Abstract: The present invention pertains, at least in part, to novel substituted tetracycline compounds. These tetracycline compounds can be used to treat numerous tetracycline compound-responsive states, such as bacterial infections and neoplasms, as well as other known applications for tetracycline compounds such as blocking tetracycline efflux and modulation of gene expression.

Abstract: A novel composition, kit, and method of using the composition as a bone substitute for dental, orthopedic and drug delivery purposes. Specifically, the bone substitute comprises a plurality of polymeric beads having a crosslinkable shell where the shell is cured by light and/or chemical curing.

Abstract: The present invention provides compositions and methods relating to polylactides which may be used for drug delivery (e.g., parenteral delivery), wherein an organic solvent is not required.

Abstract: A method for treating a patient having ulcerative colitis, by administering a drug which containing an effective amount of tetracyclines is provided. The drug may also contain penicillins and/or metronidazoles.

Abstract: A combination product is described. The combination product can include composition “A”, which can have at least one filler product and a composition “B”, which can have at least one compound of the tetracycline family used at a subantimicrobial dose for the treatment of skin aging and scars. Compositions “A” and “B” can be used simultaneously, separately or sequentially over time. Also described, is a single pharmaceutical composition having, in the same physiologically acceptable medium, at least one filler product and at least one compound of the tetracycline family used at a subantimicrobial dose.

Abstract: The invention relates to a topical suspension formulation that includes a tetracycline, a liquid medium and a polymeric gelling agent. The tetracycline may be in the form of its pharmaceutically acceptable salts, hydrates, or polymorphs and is in a suspended form within the formulation. The liquid medium is selected such that it does not dissolve or substantially minimally dissolves the tetracycline. The gelling agent is a polymeric hydrocarbon gelling agent. Preferably, the tetracycline has a particle size of less than or equal to about 20 microns.

Abstract: A method of treating shingles in a human in need thereof. The method comprises administering a tetracycline compound in an amount that is effective to treat shingles, but has substantially no antibacterial activity.

Abstract: A method for manufacturing a porous ceramic scaffold having an organic/inorganic hybrid coating layer containing a bioactive factor includes (a) forming a porous ceramic scaffold; (b) mixing a silica xerogel and a physiologically active organic substance in a volumetric ratio ranging from 30:70 to 90:10 and treating by a sol gel method to prepare an organic/inorganic hybrid composite solution; (c) adding a bioactive factor to the organic/inorganic hybrid composite solution and agitating until gelation occurs; and (d) coating the porous ceramic scaffold with the organic/inorganic composite containing the bioactive factor added thereto. In accordance with the method, the porous ceramic scaffold may be uniformly coated with the organic/inorganic hybrid composite while maintaining an open pore structure, and stably discharge the bioactive factor over a long period of time.

Abstract: An oral dosage form has the following: an amount of minocycline selected from the group consisting of 55 mg, 80 mg, and 105 mg; an amount of lactose monohydrate; an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is at least 8.3 to about 9.8% hydroxypropoxylated. The minocycline in the oral dosage form has a dissolution profile or release rates about 35% to about 50% in 1 hour, about 60% to about 75% in 2 hours, and at least about 90% in 4 hours. There is also provided a method of treating acne in a human and a method of assisting a physician in prescribing a dose of minocycline for the treatment of acne.

Abstract: A process for producing a compressed solid dosage form containing an active ingredient. The process includes a step of preparing core elements containing the active ingredient. Optionally the core elements are coated with a pharmaceutically acceptable coating layer to form coated pellets. The core elements or pellets are treated with an anti-static agent and compressed with suitable excipients to form the compressed solid dosage form. Preferred anti static agents are starch, microcrystalline cellulose, kaolin, bentonite, silicates, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate and glyceryl behenate.

Abstract: Methods of treatment and dosage regimes using hydrophobic gel or foam composition comprising a tetracycline antibiotic in treating or alleviating a disorder including, acne, acne related symptoms, a tetracycline antibiotic responsive acne related disorder, skin disorder caused by a bacteria, and a tetracycline antibiotic responsive sebaceous gland disease, P. acne bacteria associated disorders and other superficial infections, including skin infections wherein the foam composition or gel is administered topically to a target area on a subject having the disorder and wherein the target area comprises an area of skin.

Abstract: A method of treating acne in a human in need thereof comprising administering systemically to said human a tetracycline compound in an amount that is effective to treat acne but has substantially no antibiotic activity, without administering a bisphosphonate compound.

Abstract: Formulations of cross-linkable polymers, capable of forming non-toxic and biocompatible hydrogels in situ, containing at least one of doxycycline or minocycline. Methods of using the hydrogels for treating the skin or ocular tissues of mammals exposed to vesicant compounds such as sulfur mustard (SM), nitrogen mustard (NM) or half mustard (2-chloroethyl ethyl sulfide (CEES)) are also disclosed.

Abstract: The present invention relates to polymers modified to increase their resorbability. In particular, the polymers of the invention have phenyl ester side chains which are good leaving groups and which thereby increase the resorption rate of the polymer relative to the same polymer, for example, bearing a comparable amount of an alkyl ester side chain. Such polymers are generally water insoluble, but when modified are able to solubilize drugs and upon degradation and resorption, release those in a physiological environment in a controlled and/or sustained manner.

Abstract: Provided herein is technology relating to liposomes and particularly, but not exclusively, to compositions of liposomes encapsulating a biologically active agent, methods of preparing liposomes encapsulating a biologically active agent, and uses of liposomes encapsulating a biologically active agent to treat a subject.

Abstract: The invention refers to agents for the preventive therapy after acute stroke, in particular having the aim to prevent infections after stroke. The agents inventively employed in pharmaceutical preparations are anti-infective agents and/or immunomodulating agents, e.g. cytokines and/or inhibitors of the SNS.

Abstract: Disclosed are once-daily formulations containing tetracyclines, especially doxycycline. Such formulations are useful, for instance, for the treatment of collagenase destructive enzyme-dependent diseases, such as periodontal disease and acne, and acute and chronic inflammatory disease states, such as rosacea and arthritis.

Abstract: The disclosure relates to a platform of using zebrafish in screening candidates for treating and/or preventing myopia and keratoconus disease. The disclosure is mainly based on that Lumican, one of several SLRPs, plays an important role in the regulation of fibrillogenesis or the genes affecting the size of eyeballs in zebrafish, in addition to playing an important role in clinical myopia. Therefore, the disclosure uses the established zebrafish model to further identify the drugs affecting the expression of lumican and collagen fibrillogenesis, and/or the regulation of eyeball size. These drugs are potential candidates for treating myopia and/or keratoconus disease.

Abstract: Methods of treating a subject having, or at risk of having, a myeloproliferative disorder are provided according to embodiments of the present invention which include administering a therapeutically effective amount of an arachidonate 5-lipoxygenase (5-LO) inhibitor to the subject. Combinations of therapeutic agents are administered according to embodiments of the present invention. In some embodiments, two or more 5-LO inhibitors are administered to a subject to treat a myeloproliferative disorder. In further embodiments, at least one 5-LO inhibitor and at least one additional therapeutic agent are administered to a subject to treat a myeloproliferative disorder. Methods of inhibiting leukemia stem cells are provided according to embodiments of the present invention which include contacting leukemia stem cells with an effective amount of an arachidonate 5-lipoxygenase inhibitor.

Abstract: The disclosure provides a method of reducing infarct size in the heart following permanent ischemia or ischemia/reperfusion (IR) event or method for delaying, attenuating or preventing adverse cardiac remodeling comprising administering a drug selected from the group consisting of epicatechin, derivatives thereof and pharmaceutically acceptable salts thereof, wherein the subject is a human or a veterinary animal. Additionally the disclosure provides a method of treating subarachnoid hemorrhage or atrial fibrillation or of enhancing or preserving migration, seeding, proliferation, differentiation and/or survival of stem cells in injured heart tissue comprising administering a drug selected from the group consisting of epicatechin, derivatives thereof and pharmaceutically acceptable salts thereof. The effects of epicatechin administration are sustained over time.

Abstract: Methods for the synthesis and purification of 9-amino alkyl tetracycline compounds are described.

Abstract: A composition which comprises a biologically active agent and a polymer that exhibits a reverse thermal gelation at a physiological temperature, in a carrier, and in which the active agent is in an undissolved form is disclosed herein. Further disclosed herein are methods utilizing the compositions for treating subjects, including non-human subjects, as well as kits for preparing and using a composition. The composition is preferably a sustained release formulation, and is particularly useful for treating animals, where single-dose treatment is desired.

Abstract: The present invention is a process and the product produced by that process for solid, particulate animal feed premixes, characterized by having a certain particle size range, physical stability, hardness range, and rapid dissolution, wherein the premixes contain various drugs and other, pharmaceutically and nutritionally acceptable diluents, binders and formulation aids as needed, or desired.