Publications by authors named "Yasuhiro Miyako"

Drug solubilization is an important aspect of drug development. We investigate the relationship between solute hydrophobicity on the solubilization properties of water-cosolvent mixtures. The solubilization in water-cosolvent mixtures of seven chemically unrelated drugs was determined.

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The solubility of organic compounds in mixtures of water and an organic cosolvent can be reasonably estimated from the solubility values in the neat solvents and the composition of the solvent mixture, by means of the log-linear solubilization model. However, deviations from the model are frequently observed in different degree. Such deviations, which tend to become more pronounced with decreasing polarity of the cosolvent, are to a good extent the result the nonideal mixing of water and cosolvent, due to the interactions between the two solvent components.

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A homologous series of solutes was chosen as a model for a group of structurally related compounds with different physicochemical properties, as is commonly the case during the screening of potential drug candidates. Thermal properties of the crystalline solutes and solubility determinations were used to quantify the two independent factors that determine the solubility of organic compounds: crystallinity and hydrophobicity. A solubility screening study was conducted on the series.

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To establish a simpler and more reliable method for retaining the aseptic condition of freeze-dried bulk product of a drug substance, a helium leak test method was developed. The bulk product is for the new kit system for infusion of our antibiotic product. In manufacturing the kit system, the bulk product needs to be transported outside of the aseptic area.

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Article Synopsis
  • The text outlines a method to keep drug substances sterile during the manufacturing of a dual-compartment infusion kit, which separates the infusion liquid from the drug product.
  • The method involves using an aluminum laminate bag inside a polyethylene bag to ensure aseptic conditions, with a test for detecting leaks using helium.
  • Results indicated that pinhole size significantly affects helium leakage, with effective detection of small holes, confirming experimental data matched theoretical calculations.
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