Efficient Evaluation of In Vivo Performance in Human for Generic Formulation by Novel Dissolution-Absorption Prediction (DAP) Workflow.

PURPOSE: The pharmaceutical bioequivalence of generic medicines must be confirmed with corresponding original drugs. Although the in vitro dissolution tests are required, results of the mandatory in vitro study do not necessarily reflect the in vivo performance after oral administration. Then, we have tried to develop the novel "Dissolution-Absorption Prediction (DAP) workflow" to evaluate the in vivo performance of generic medicines. METHODS: The DAP workflow consists of an "In vitro two-cell connected dissolution (TCCD) system" mimicking the changes in the luminal pH associated with gastrointestinal transit of medicines, "Evaluation of pharmacokinetics of active pharmaceutical ingredient (API)" and "Prediction of plasma concentration-time profile". TCCD system-evaluated dissolution kinetics of APIs from generic formulations and pharmacokinetic parameters based on human data regarding the original drugs were used to calculate the plasma concentration-time profiles of APIs after the oral administration of generic medicines. RESULTS: The mandatory in vitro dissolution tests indicated that the dissolution properties of valsartan (BCS class II) and fexofenadine (BCS class III/IV) in generic formulations did not coincide with those in the corresponding original formulations. The TCCD system provided the very similar dissolution kinetics for the generic and original formulations for the two APIs. Plasma concentration-time profiles evaluated utilizing the dissolution profiles obtained by the TCCD system were in good agreement with the observed profiles for both the generic and original formulations for each API. CONCLUSIONS: The DAP workflow would be valuable for estimating the in vivo performance of generic formulation and deducing their bioequivalence with the original formulation.

Bio-mimic energy storage system with solar light conversion to hydrogen by combination of photovoltaic devices and electrochemical cells inspired by the antenna-associated photosystem II.

Global warming caused by anthropogenic activity is one of the serious problems today. In order to suppress the global warming, the shift from fossil fuel-based energy source to the nature-oriented sustainable energy is encouraged. In this concept paper, possible biomimetic engineering approach inspired by the efficient and sustainable natural energy utilization in living plants is demonstrated. The focal features in plants include (1) the light-harvesting and energy condensing apparatus, (2) water splitting O2 evolving apparatus, (3) storage of energy-related chemicals, and (4) reversal conversion of storage into the "energy in use" by meeting the demands. Demonstration of solar-driven chemical energy conversion was performed using a system consisted of (i) photovoltaic power-generating device, (ii) an electrochemical unit converting electric power into chemical energy, (iii) storage of H2, and (iv) polymer electrolyte cells converting H2 back to electricity by meeting the demands on site. The present concept paper presenting a technical perspective based on the plant-inspired knowledge (conceptual similarity between natural photosynthesis and solar-to-H2 conversion) is a fruit of interdisciplinary collaboration between the team of chemical energy conversion renown for the world highest record of solar-to-hydrogen conversion efficiency (24.4%, as of 2015) and a group of plant biologists.

First principles calculations of surface dependent electronic structures: a study on ß-FeOOH and γ-FeOOH.

We report a theoretical study on iron oxyhydroxide (FeOOH). The FeOOH surface is expected to act as an efficient electrochemical catalyst for the oxygen evolution reaction (OER), because it is based on iron, an element of the fourth highest Clarke number. Experimentally, the OER activity of ß-FeOOH is known to be higher than that of γ-FeOOH. However, the details of the OER mechanism and the surface reactivities of the FeOOH polymorphs have not yet been fully understood. We performed first-principles calculations of bulk and surfaces of ß-FeOOH and γ-FeOOH using density functional theory, to investigate their electronic structures and catalytic activities. The calculations suggest that depending on the surface indices, several surfaces may be favored for catalytic activities.