Abstract: The present invention provides for the first time the identification of salivary protein and RNA factors that can be used in the detection of diabetes. The present invention therefore provides methods of diagnosing and providing a prognosis for diabetes, by examining relevant proteins and RNA in a patient's saliva.

Abstract: Described herein are methods of treating fibrosis and fibrotic diseases with certain aminoglycosides, e.g., kasugamycin derivatives thereof.

Abstract: The present invention relates to treatment of neurological diseases such as multiple sclerosis (MS) and Alzheimer's disease, using an estrogen receptor beta (ER?) ligand.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to an actuator having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A powder preparation for nasal administration containing a particulate of steroid hormones having an average particle size of 50 to 300 ?m as an active ingredient is prepared.

Abstract: The present disclosure provides high concentration formulations of cortexolone-17?-propionate suitable for treating alopecia.

Abstract: Neuro-enhancing agents, compositions and methods are disclosed herein. Preferred neuro-enhancing agents of the present invention include progesterone and metabolites of progesterone, such as 3?-hydroxy-5?-pregnan-20-one (THP). These agents yield neuro-enhancing effects on neural cells that include neural progenitor and/or stem cells, whereby the agents stimulate mitosis of neural progenitor cells, stimulate neurite growth and organization, protect against neural loss, or one or more of these neural processes. Thus, the neuro-enhancing agents, compositions and methods disclosed herein are useful to reverse or prevent neurological disease or defects associated with neural loss or degeneration, such as Alzheimer's disease, neurological injuries, including injuries resulting from radiation therapy, and age-related neurological decline, including impairments in memory and learning.

Abstract: This invention provides for a method of treating secondary adrenal insufficiency by co-administrating therapeutically effective amounts of a glucocorticoid and a glucocorticoid receptor antagonist to the patient in need thereof. In some embodiments, the method includes the proviso that the patient not be otherwise in need of treatment with a glucocorticoid and a glucocorticoid receptor antagonist. The treatment method can increase the patient's morning or basal cortisol level to at least about 12 ?g/dL or a standard control level, and in turn, expedite significantly the recovery of the HPA axis. The method provided herein can improve health outcomes and life-threatening complications associated with secondary adrenal insufficiency.

Abstract: The present invention relates to compounds which are intermediates in the synthesis of bile acid derivatives with pharmacological activity. The invention relates to compounds of general formula (I): wherein: , R1, R2, R3, R4, R5, R6 and Y are as defined herein. The compounds are intermediates in the synthesis of synthetic bile acids which are useful in the treatment of conditions such as liver disease. In addition, the invention relates to a method of synthesizing these intermediates and a method of preparing obeticholic acid and obeticholic acid analogues from the compounds of the invention.

Abstract: Provided are systems and methods to identify subjects at risk for preterm labor and/or preterm birth. The systems and methods utilize biomarkers. Also provided are systems and methods for decreasing the risk of preterm labor by administering a treatment following a positive risk identification.

Abstract: The present invention relates to methods and pharmaceutical compositions for treating peripheral demyelinating diseases. In particular the present invention relates to a method of treating a peripheral demyelinating disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an inhibitor of VDAC1 activity or expression.

Abstract: A method of stabilizing tibolone in a solid dosage form using a sugar-alcohol, and a pharmaceutical composition, in particular a solid dosage form such as a tablet, including tibolone, a sugar-alcohol and a non-sugar-alcohol diluent. The weight ratio of the sugar-alcohol to the non-sugar-alcohol diluent is between 4:1 and 1:4.

Abstract: Provided are steroid analogues functionalized with polar substituents at the C3 and/or C20 positions of the steroid ring system that exhibit improved water solubility. Also provided are pharmaceutical compositions comprising the steroid analogues and methods using the novel steroid analogues for the treatment and prevention of neurodegeneration in a patient following injury to the central nervous system.

Abstract: Described herein are compositions and methods for the increasing the quantity of lipids secreted from meibomian glands. Such compositions and methods are useful for the treatment of meibomian gland dysfunction and disorders resulting therefrom.

Abstract: An image scanner includes a document detector configured to, each time line scanning is repeated a predetermined number of times, perform an edge detecting process to detect a position of a lateral side extending in a sub scanning direction from a non-reference corner of a sheet, in the edge detecting process performed for a first time, set a position of the non-reference corner in a main scanning direction as a detection reference position, in the edge detecting process performed for a second or later time, set a previously-detected position of the lateral side in the main scanning direction as the detection reference position, and in each edge detecting process, set a detection range in the main scanning direction on the basis of the detection reference position, and detect a specific pixel corresponding to the lateral side in the main scanning direction within the detection range in the main scanning direction.

Abstract: The present invention relates to a method of enhancing retention of recognition memory and/or recovering recognition memory deficits using 3?-methoxy-pregna-5-ene-20-one.

Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage forms containing testosterone undecanoate, as well as related methods of treatment. In one embodiment, the oral dosage form can include a therapeutically effective amount of testosterone undecanoate and a pharmaceutically acceptable carrier. The dosage form can be formulated such that, when measured using a USP Type II apparatus in 1000 mL of 8 wt % Triton X-100 in water at 37° C. and 100 rpm, the oral dosage form releases at least 20% more testosterone undecanoate after the first 120 minutes than an equivalent dose testosterone undecanoate containing oral dosage form without the pharmaceutically acceptable carrier.

Abstract: The invention relates to compounds of formula (I) wherein R1, R2, Y1, R4 and R5 are as defined herein. The compounds are intermediates in the synthesis of synthetic bile acid derivatives with pharmacological activity. The invention further provides methods related to the synthesizing of these intermediates, and methods of preparing obeticholic acid and obeticholic acid analogues from the compounds of the invention.

Abstract: This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.

Abstract: This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.

Abstract: An improved process for producing an oil-in-water emulsion to deliver a substantially water insoluble active pharmaceutical ingredient includes creating a microemulsion containing such ingredient in the oil phase of the emulsion by mixing an aqueous phase including non-ionic surfactant, polyol, and water, wherein the weight ratio of the surfactant to polyol to water is between 10:20:70 and 1:1:1, to generate a mixture, with an oil phase comprising a substantially water insoluble active pharmaceutical ingredient and a long-chain triglyceride; circulating the said mixture through a homogenizer at a temperature from 20° C. to 60° C. to generate a coarse emulsion; passing the coarse emulsion through a microfluidizer at a pressure of from 70 MPa to 150 MPa at least once to produce an oil-in-water microemulsion; and, optionally, filtering the microemulsion through a 0.2 ?m filter and/or mixing the microemulsion with a polymeric stabilizer.

Abstract: Pregn-4-en-20-yn-3?-one is useful in the treatment of depressive disorders by nasal administration.

Abstract: A process and system directed to a more effective, individual based treatment regimen which is built on clinical identified target biomarkers associated with gender differential responses to mesalamine, and includes one or more panels of target biomarkers that distinguishes mesalamine response differences between genders and determines the efficacy of mesalamine for patients being treated for various UC conditions and effectively identifies and validates novel drug targets for new UC therapeutics, new diagnostics and diagnostics standards for UC therapeutic strategies.

Abstract: Provided are methods of determining whether a subject having ER+ breast cancer is expected to benefit from treatment with combination endocrine therapy and mTOR inhibitor therapy. Also provided are methods of treating a subject having ER+ breast cancer.

Abstract: Formulations for oral transmucosal compositions including a synergistic combination of low doses of testosterone with an aromatase inhibitor (AI) that are combined with transmucosal absorption enhancers are disclosed. Oral transmucosal compositions can be for fast release or slow release, and can be administered to increase bloodstream testosterone levels and thereby reduce symptoms of testosterone deficiency. Oral transmucosal compositions include liquid dosage forms, solid dosage forms, and chewing gums. Further dosage forms include mucoadhesive thin strips, thin films, tablets, patches, and tapes, among others. Other dosage forms are: mucoadhesive liquids such as gel-forming liquids; gel-forming semisolids; and gel-forming powders, among other dosage forms that exhibit mucoadhesive properties, and provide oral transmucosal delivery of testosterone and AI.

Abstract: The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

Abstract: Drag derivatives are provided herein which are suitable for loading into liposomal nanoparticle carriers. In some preferred aspects, the derivatives comprise a poorly water-soluble drag derivatized with a weak-base moiety that facilitates active loading of the drag through a LN transmembrane pH or ion gradient into the aqueous interior of the LN. The weak-base moiety can optionally comprise a lipophilic domain that facilitates active loading of the drag to the inner monolayer of the liposomal membrane. Advantageously, LN formulations of the drag derivatives exhibit improved solubility, reduced toxicity, enhanced efficacy, and/or other benefits relative to the corresponding free drags.

Abstract: The present invention aims to provide an eye drop for treating macular edema. The present invention provides an eye drop for treating macular edema, which contains difluprednate as an active ingredient. The eye drop can afford effects such as improvement of visual acuity and decreased foveal retinal thickness in macular edema.

Abstract: This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.

Abstract: The present invention provides a disinfecting formulation useful, for example, for cleaning and disinfecting human or animal body parts, and in particular for disinfecting human hands. The disinfecting formulation comprises alcohol including ethanol; an essential oil comprising cineole, in particular eucalyptus oil; an emollient including glycerin; and other ingredients comprising piroctone olamine, acrylic acid based polymer and 2-amino-2-methyl-1-propanol. The invention also provides methods of disinfection of human and animal body parts and methods for preparing the formulation.

Abstract: A composition comprising an INTEROMONE® is described for the modification of undesirable or harmful stress-related behaviors or other behaviors or physiology in a variety of vertebrate species, as well as methods of using the compositions in vertebrates from a species different than the species in which the INTEROMONE® is a naturally occurring pheromone.

Abstract: The present disclosure refers to a synergistic blend of Konjac powder and Xanthan gum that is included, as a natural suspending agent, in oral pharmaceutical suspensions. Oral pharmaceutical suspensions comprising the synergistic blend are aqueous solutions. The synergistic blend, used as a suspension agent to suspend suitable active pharmaceutical ingredients (APIs), improves the stability of oral pharmaceutical suspensions, and helps in the formation of a thermo-reversible gel and shear thinning necessary to keep APIs suspended within oral pharmaceutical suspensions. The synergistic blend of Konjac powder and Xanthan gum has unique anti-flocculation properties, which improve the homogeneity of the oral pharmaceutical suspensions. Additionally, the blend provides a better texture and mouth feel.

Abstract: A composition for use in inhibiting the binding of a Norovirus to the histo-blood group antigen on the surface of epithelia is disclosed. The composition may contain a therapeutically effective amount of a binding-inhibiting compound and a carrier and/or excipient. The compounds may competitively bind a Norovirus that has the capability of binding with the histo-blood group antigens of secretor blood type, including A, B, AB, and O blood types. The compositions may be administered to a human prior to or after infection by a Norovirus, to prevent, ameliorate, or reduce the effects of an infection.

Abstract: Described herein are therapeutic methods using progesterone and progesterone analogs to improve sleep quality. The methods may be particularly useful to treat subject with perturbed sleep patterns, such as subjects who suffer from mid-sleep period awakenings.

Abstract: Solutions of testosterone for oromucosal administration providing an increase in serum testosterone levels in subjects deficient in endogenous testosterone levels, and therapeutic methods for providing an increase in serum testosterone levels and methods for treating a disease or a symptom associated with deficient endogenous levels of testosterone.

Abstract: The present disclosure provides for compositions and methods of stimulating reproductive behavior and reproductive success and productivity in a suid, such as pigs. The composition may comprise at least one steroid hormone and a heterocyclic aromatic compound. The method comprises administering the pheromone composition to the suid for a period of time.

Abstract: Endometriosis, including endometriosis externa, endometrioma, adenomyosis, adenomyomas, adenomyotic nodules of the uterosacral ligaments, and endometriotic nodules, such as scar endometriosis are effectively treated by the intralesional administration, including transvaginal, endoscopic or open surgical administration including via laparotomy, of a progestogen. Compositions therefor also are provided.

Abstract: The present invention relates to formulations of poorly water soluble pharmaceutical agents of Formula I and II. The present invention also relates to compositions containing compounds of Formula I or II, and glucocorticoids, and methods for reducing side effects from glucocorticoid treatment by co-administration of compounds of Formula I and II. The compositions herein are useful for the treatment of diabetes and obesity related diseases including metabolic syndrome.

Abstract: The present invention relates to formulations of poorly water soluble pharmaceutical agents of Formula I and II. The present invention also relates to compositions containing compounds of Formula I or II, and glucocorticoids, and methods for reducing side effects from glucocorticoid treatment by co-administration of compounds of Formula I and II. The compositions herein are useful for the treatment of diabetes and obesity related diseases including metabolic syndrome.

Abstract: A pharmaceutical composition of botulinum toxin and an adjuvant is disclosed. The composition is formulated for topical administration to deliver a therapeutically effective dose of botulinum toxin to an area of a subject suffering from inflammation. The botulinum toxin composition reduces a symptom of inflammation without producing substantial muscle weakness. The composition may optionally contain additional anti-inflammatory agents, such as steroidal or non-steroidal agents.

Abstract: The present invention provides a process for preparing a crystalline form of halobetasol propionate, comprising the step of crystallizing halobetasol propionate from absolute ethanol or a mixture of ethanol and water, wherein the crystalline form of halobetasol propionate is characterized by an x-ray powder diffraction pattern having peaks at 10.0, 11.6, 12.9, 13.4, 14.5, 16.4, 17.6, and 23.5±0.2 degrees 2?.

Abstract: A method for the treatment of a traumatic brain lesion comprises administering to the patient an effective quantity of 3?-methoxy-pregna-5-ene-20-one (3?-methoxy-PREG).

Abstract: The present invention relates to the use of cholest-4-en-3-one derivatives for obtaining a cytoprotective drug, with the exception of a neuroprotective drug.

Abstract: Provided herein are methods and systems of molecular profiling of diseases, such as cancer. In some embodiments, the molecular profiling can be used to identify treatments for a disease, such as treatments that were not initially identified as a treatment for the disease or not expected to be a treatment for a particular disease.

Abstract: In one embodiment, the invention provides methods of identifying genes and genetic variants that, either alone or in combination, are important to the pathogenesis of a disease. In another embodiment, the disease is stratified by use of an immune response to disease-associated antigens. In another embodiment, the invention provides methods of identifying pathways that, either alone or in combination, are important to the pathogenesis of a disease. In another embodiment, the invention provides a method of diagnosing or predicting susceptibility to a disease in an individual by determining the presence or absence of genes and genetic variants that, either alone or in combination, are important to the pathogenesis of the disease.

Abstract: A stable ophthalmic pharmaceutical composition for relief, treatment, control, alleviation, or prevention of a pathological ocular condition of the eye comprises: (a) a first polymer, a viscosity of which changes with a change in a concentration of an electrolyte, such as a salt, when added to said first polymer; (b) a second polymer that is different from the first polymer and can modify the viscosity of the first polymer; and (c) an oil. In some embodiments, the composition further comprises a non-ionic surfactant. The composition can form a stable oil-in-water emulsion on storage, but separate into an oil phase and a water phase when applied in the eye. The emulsion can comprises an ophthalmic active pharmaceutical ingredient dissolved in the oil or water phase. The emulsion can provide enhanced stability to said active pharmaceutical ingredient.

Abstract: This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.

Abstract: The present document describes a composition for sustained, targeted or sustained and targeted delivery of an active ingredient which includes a complex formed between a carboxyl substituted polymer and a lipid. The present document also describes dosage forms containing the composition, and an active ingredient, and methods of using the same for the treatment of diseases.

Abstract: Described herein are therapeutic methods using progesterone and progesterone analogs to improve sleep quality. The methods may be particularly useful to treat subject with perturbed sleep patterns, such as subjects who suffer from mid-sleep period awakenings.

Abstract: Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.