Abstract: Provided is a means that is capable of preventing initial excessive release of an active ingredient, and that allows for sustained release of a pharmaceutically active amount of the active ingredient over a long period of time.

Abstract: Provided is a heat shock protein expression-inducing agent, more specifically, a heat shock protein expression-inducing agent comprising a compound represented by formula (I): wherein R is a lower alkyl, phenyl, or hydroxyphenyl, or a salt thereof.

Abstract: An object of the present invention is to provide a freeze-dried aripiprazole powder formulation that exhibits good dispersibility and is easily dispersed into a homogenous suspension when reconstituted with water.

Abstract: Provided is a means that is capable of preventing initial excessive release of an active ingredient and that allows for sustained release of the active ingredient in a pharmaceutically active amount over a long period of time.

Abstract: The invention relates to methods of synthesizing 2?-deoxy-2?,2?-difluorotetrahydrouridine with increased purity and uniform particle size distribution. In particular, methods of the invention include crystallization and isolation procedures rendering synthetic reaction intermediates. The invention further includes compositions comprising the final compound in highly pure form, including lower number of impurities and lower levels of individual and total impurities.

Abstract: The invention relates to methods of synthesizing 2?-deoxy-2?,2?-difluorotetrahydrouridine with increased purity and uniform particle size distribution. In particular, methods of the invention include crystallization and isolation procedures rendering synthetic reaction intermediates. The invention further includes compositions comprising the final compound in highly pure form, including lower number of impurities and lower levels of individual and total impurities.

Abstract: Systems and methods for monitoring a receiver assembly configured to detect an ingestible event marker signal, the receiver including a disposable component and a reusable component. The methods can include monitoring the skin impedance experienced by the electrodes of the receiver assembly to determine whether the receiver assembly has poor contact quality or is off-body to notify the user accordingly. The methods can also include monitoring a power source level of the receiver assembly, which can be normalized according to the temperature of the receiver assembly, to determine when the power source is at a critical level to notify the user accordingly.

Abstract: Provided is packaged medicine capable of inhibiting deterioration of electrodes over a long period of time and reliably transmitting a signal after ingestion even when a long period of time has elapsed since production to ingestion. The packaged medicine includes a solid medicine including drug powder and a micro-device, a container provided with a solid medicine accommodating space accommodating the solid medicine therein, and inert gas encapsulated in the solid medicine accommodating space. The micro-device includes two electrodes with mutually different ionization tendencies and a transmitter operable to transmit a signal using electromotive force generated when the electrodes come in contact with electrolyte.

Abstract: The present invention provides a oxazole compound represented by Formula (1), or a salt thereof: wherein R1 is an aryl group which may have one or more substituents; R2 is an aryl group or a nitrogen atom-containing heterocyclic group each of which may have one or more substituents; and W is a divalent group represented by —Y1-A1- or —Y2—C(?O)— wherein Y1 is a group such as —C(?O)—, A1 is a group such as a lower alkylene group, and Y2 is a group such as a piperazinediyl group. The oxazole compound has a specific inhibitory action against phosphodiesterase 4.

Abstract: Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.

Abstract: Provided is a crystal of a specific oxazole compound that has specific inhibitory activity against PDE4, and that shows excellent stability. Specifically, provided is a crystal of an oxazole compound represented by formula (5) wherein the crystal has peaks at diffraction angles)2?(°) of 9.6±0.2, 19.1±0.2, and 21.2±0.2 in an X-ray powder diffraction pattern measured using CuK? characteristic X-rays.

Abstract: An object of the present invention is to provide a freeze-dried aripiprazole powder formulation that exhibits good dispersibility and is easily dispersed into a homogenous suspension when reconstituted with water.

Abstract: A risk management system (RMS) device includes a RMS database and a RMS processor. The RMS processor includes a prescriber module to receive a request to enroll a patient in a RMS program of a therapeutic agent associated with multiple indications. The request includes a specification of at least one indication, and a confirmation of a diagnostic test conducted on the patient. The RMS processor also includes a patient module configured to generate a patient profile. The RMS processor also includes a database module configured to store the patient profile in the RMS database. The RMS processor also includes an authorization module configured to generate an authorization code indicating whether the patient is authorized to receive the therapeutic agent. The RMS processor also includes a communication module configured to transmit the authorization code to a pharmacy or a prescriber.

Abstract: The subject invention provides a novel pharmaceutical solid preparation that has superior disintegration properties and excellent solubility, leading to sufficient absorbability of active ingredients through the gastrointestinal tract. The pharmaceutical solid preparation of the present invention comprises: (a) 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoylamino)benzoyl]-2,3,4,5-tetrahydro-1H-benzoazepine and/or salt thereof; (b) hydroxypropylcellulose containing a hydroxypropoxyl group in an amount of 50% or greater; and (c) at least one member selected from the group consisting of carmellose, sodium carboxy methyl starch, crospovidone, and low substituted hydroxypropylcellulose with an average particle diameter of 30 to 70 ?m, and a 90% cumulative particle diameter of 100 to 200 ?m.

Abstract: This invention relates to methods and compositions for administering an effective amount of a CDA substrate drug and an effective amount of cedazuridine. In particular, the invention relates to methods for treating cancer, inhibiting degradation of a CDA substrate drug, and reducing DNA methylation in a subject in need thereof comprising administering an effective amount of a CDA substrate drug and an effective amount of cedazuridine.

Abstract: The present invention provides a medical device containing a cake composition comprising aripiprazole as an active ingredient and capable of suppressing agglomeration of aripiprazole in a suspension obtained by resuspending a freeze-dried substance; and a cake composition comprising aripiprazole as an active ingredient. The present invention relates to a medical device containing, in a storage container whose inner wall is treated with silicone, a freeze-dried cake composition comprising separately prepared aripiprazole as an active ingredient, wherein there is a space between the inner wall and the cake composition; and a cake composition comprising aripiprazole as an active ingredient and having a strength of 5 to 100 N.

Abstract: A medicament comprising (I) brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) nalmefene or a pharmaceutically acceptable salt thereof in combination, wherein brexpiprazole or a pharmaceutically acceptable salt thereof, and nalmefene or a pharmaceutically acceptable salt thereof are contained in a single preparation, or a pharmaceutical composition containing brexpiprazole or a pharmaceutically acceptable salt thereof and a pharmaceutical composition containing nalmefene or a pharmaceutically acceptable salt thereof are formulated for use in combination. The medicament is used for the prophylaxis or treatment of a substance-related disorder, preferably an alcohol-related disorder.

Abstract: An object of the present invention is to provide a storage-stable injectable preparation comprising a composition comprising a poorly soluble drug as an active ingredient and a dispersion medium. Another object of the present invention is to provide a compact, lightweight prefilled syringe by filling a syringe with the injectable preparation. The present invention provides an injectable preparation comprising a composition comprising a poorly soluble drug, a dispersion medium, and a specific suspending agent, the composition having a viscosity of 40 pascal-seconds or more in at least one point in the shear rate range of 0.01 to 0.02 s?1 and having a viscosity of 0.2 pascal-seconds or less in at least one point in the shear rate range of 900 to 1,000 s?1, as measured.

Abstract: Provided is a heat shock protein expression-inducing agent, more specifically, a heat shock protein expression-inducing agent comprising a compound represented by formula (I): wherein R is a lower alkyl, phenyl, or hydroxyphenyl, or a salt thereof.

Abstract: The present invention provides a heat shock protein expression-inducing agent, more specifically, a heat shock protein expression-inducing agent comprising a compound represented by formula (I): wherein R is a lower alkyl, phenyl, or hydroxyphenyl, or a salt thereof.