Abstract: The present invention provides a lyophilized preparation that has excellent stability over time and excellent solubility when reconstituted, and that contains (8E,12E,14E)-7-((4-cycloheptylpiperazin-1-yl)carbonyl)oxy-3,6,16,21-tetrahydroxy-6,10,12,16,20-pentamethyl-18,19-epoxytricosa-8,12,14-trien-11-olide. The present invention discloses a lyophilized preparation containing 1) (8E,12E,14E)-7-((4-cycloheptylpiperazin-1-yl)carbonyl)oxy-3,6,16,21-tetrahydroxy-6,10,12,16,20-pentamethyl-18,19-epoxytricosa-8,12,14-trien-11-olide or a pharmaceutically acceptable salt thereof, 2) a pH regulator for adjusting a pH of the preparation to between 5 and 8, and 3) at least one of excipients selected from the groups consisting of sugars and sugar alcohols.

Abstract: A production process which comprises (1) a step in which a raw liquid containing a drug is prepared so that the drug is contained in an amount which exceeds the saturation amount thereof as determined at the temperature to be used in a treatment with a high-pressure homogenizer and is less than the amount which is larger than that drug saturation amount by 1 g per 100 mL of a solvent and that the raw liquid contains substantially no surface modifiers; and (2) a step in which the raw liquid is treated with a high-pressure homogenizer at a pressure of 15-300 MPa while regulating the temperature of the raw liquid so as to exceed the solidifying point of the liquid and be lower than the boiling point thereof. By the process, fine solid particles of a drug and a medicinal composition containing the fine solid drug particles can be obtained.

Abstract: The present invention provides pharmaceutical formulations suitable for intravenous injection comprising a lyophilized anti-ulcerative agent reconstituted in isotonic solutions suitable for intravenous administration, such as 5% dextrose or 0.9% sodium chloride. The solutions are brought to a pH of between about 9 and about 12, preferably between about pH 10 and 11, by a glycine-sodium hydroxide buffer. Such formulations are chemically and physically stable, and do not significantly change color, for at least between about 6 and about 12 hours at room temperature, and are stable to color change for from between about 24 and 48 hours if kept at 5° C.

Abstract: The present invention provides pharmaceutical formulations suitable for intravenous injection comprising a lyophilized anti-ulcerative agent reconstituted in isotonic solutions suitable for intravenous administration, such as 5% dextrose or 0.9% sodium chloride. The solutions are brought to a pH of between about 9 and about 12, preferably between about pH 10 and 11, by a glycine-sodium hydroxide buffer. Such formulations are chemically and physically stable, and do not significantly change color, for at least between about 6 and about 12 hours at room temperature, and are stable to color change for from between about 24 and 48 hours if kept at 5° C.

Abstract: The present invention provides fine drug particles with submicron sizes excellent in long-term dispersibility. Specifically, it provides a method for producing ultrafine drug particles having an average particle size of 10 nm to 1000 nm, by 1) dissolving a drug in a good solvent or a mixture of good solvents to prepare a drug-containing solution; 2) mixing the drug-containing solution with a solvent being a poor solvent or a mixture of poor solvents for the drug and being miscible with the drug-containing solution in the good solvent or a mixture of good solvents; and 3) subjecting the prepared mixture directly to emulsification under a set processing pressure using a high-pressure homogenizer without carrying out a pretreatment step for adjusting the drug to have an average particle size of 100 ?m or less, and an apparatus for producing the particles.

Abstract: In recognition of the need to facilitate the use of riboflavin as a pharmaceutical and additionally to increase the efficacy and stability of water soluble forms of riboflavin (that may contain precipitated riboflavin or that are subject to photodegradation), the present invention provides solubilized riboflavin, methods for solubilizing riboflavin, kits comprising solubilized riboflavin and provides photostable compositions comprising riboflavin and derivatives thereof.

Abstract: It has unexpectedly been found that the administration of high doses of riboflavin or derivatives thereof (including, but not limited to salts and prodrugs), results in an effective treatment for sepsis. Thus, the present invention provides methods for treating sepsis by administering to a subject in need thereof a high dose of a composition comprising riboflavin or derivatives thereof.

Abstract: The present invention provides pharmaceutical formulations suitable for intravenous injection comprising a lyophilized anti-ulcerative agent reconstituted in isotonic solutions suitable for intravenous administration, such as 5% dextrose or 0.9% sodium chloride. The solutions are brought to a pH of between about 9 and about 12, preferably between about pH 10 and 11, by a glycine-sodium hydroxide buffer. Such formulations are chemically and physically stable, and do not significantly change color, for at least between about 6 and about 12 hours at room temperature, and are stable to color change for from between about 24 and 48 hours if kept at 5° C.

Abstract: The present invention provides a preparation for injection containing a lipid A analog and a process for preparing the same. A preparation for injection prepared by dissolving a lipid A analog or a pharmacologically acceptable salt thereof in an alkaline aqueous solution, at an elevated temperature if necessary, and then adding a buffer thereto, and a process for preparing the same.