International Harmonization of Compendium Monographs of Pharmaceutical Excipients : Its Progress and the Matters at Issue

(Fujio Sekigawa) 한국약제학회 1993 PROCEEDINGS OF THE FIP POST-SATELLITE SYMPOSIUM `9 Vol.- No.-

These days, it is not uncommon that a same kind of drug is circulated globally. However, the qualities of excipients used in the same drug have to be sometimes different depending on the different requirements in the qualities stipulated by each country. For a supplier of pharmaceutical excipients, it is generally necessary to carry out different tests on the same kind of testing criteria depending on the country of destination. Thus, the discrepancies between compendium requirements of pharmaceutical excipients create severe problems in various area of industrial activities. The decision of the United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia Commissions to harmonize the requirements is a unique chance for the industries to overcome these problems. On the other hand, discrepancies of general test methods and requirements in each monograph of pharmaceutical excipient between the compendia valid at present are in most cases extensive. Consequently their harmonization needs a lot of detailed work requiring strong support from the industry. Based on these circumstances, pharmaceutical excipients councils have been established first in U.S.A. and successively in Europe and in Japan to contribute to the harmorization process. We should like to review here the progress since the Orlando Conference in 1991 and comment about the matters at issue with regard to the international harmonization of pharmaceutical excipients.

Step-by-Step Sublaminar Approach With a Newly-Designed Spinal Endoscope for Unilateral-Approach Bilateral Decompression in Spinal Stenosis

Fujio Ito,Zenya Ito,Motohide Shibayama,Shu Nakamura,Minoru Yamada,Hideki Yoshimatu,Mikinobu Takeuchi,Kenzo Shimizu,Yasushi Miura 대한척추신경외과학회 2019 Neurospine Vol.16 No.1

Objective: Spinal stenosis is increasingly common due to population aging. In elderly patients with lumbar central canal stenosis (LCCS), minimizing muscle damage and bone resection is particularly important. We performed a step-by-step operation with a newly designed spinal endoscope to obtain adequate decompression in patients with spinal stenosis. Methods: From April 2015 to August 2016, 78 patients (48 males, 30 females) with LCCS (91 segments) underwent endoscopic decompression using a newly designed endoscope system. The inclusion criteria were: (1) neurogenic intermittent claudication with or without radiculopathy, (2) LCCS, and (3) having exhausted conservative treatment (>3 months). The exclusion criteria were: (1) >10° of instability, (2) spondylolisthesis grade II or greater according to the Meyerding criteria, (3) foraminal stenosis, (4) vascular intermittent claudication, (5) infection, and (6) stenosis combined with malignancy. We performed a step-by-step procedure using a newly designed endoscope system for unilateral-approach bilateral decompression. We used the same incision for 2–3 segments, only moving the skin. Results: The mean follow-up was 2.3±1.3 years. Excellent or good results were found according to the MacNab criteria in 85.9% of cases (67 of 78). The visual analogue scale, Japanese Orthopedic Association score, and Oswestry Disability Index showed significant decreases at 1 month, persisting until the 2-year follow-up. Dural tear occurred in 4 cases (5.1%), and patch repair was performed under endoscopy. No patients experienced aggravated instability requiring surgery. Conclusion: We obtained good results with endoscopic decompression surgery using a newly designed instrument that minimized muscle and bone damage in elderly patients with spinal stenosis.

A New High Performance Auto-Tuning Digital Control Circuit for Buck-Boost Converter

Fujio Kurokawa,Taku Ishibashi,Yoshihiko Komichi,Tadatoshi Babasaki 전력전자학회 2011 ICPE(ISPE)논문집 Vol.2011 No.5

The purpose of this paper is to present the dynamic characteristics of the new high performance autotuning digital control circuit for buck-boost converter when the step change of the load resistance R from 20 Ω to 10Ω. The buck-boost dc-dc converter is used with wide input voltage changing. At the same time, the suitable proportional gain and bias value are changing against the input voltage and the load resistance of the converter. So, we took two methods that changing proportional gain automatically and changing bias value against the input voltage, the load resistance and the loss of the converter. As a result, using this proposed method it is revealed that not only the dynamic characteristic but also regulation characteristic can be improved and it is effective for wide range input voltage. Especially, the steady-state error is improved from 470㎷ to 50㎷ when the input voltage is 5V, 700㎷ to 40㎷ when the input voltage is 15V, respectively.

Pharmacoat Coating in an Aqueous System : The Dissolution Behavior and Reduction in Coating Time

Fujio Sekigawa,Hiroaki Muto,Kiyoshi Araume 한국약제학회 1990 Journal of Pharmaceutical Investigation Vol.20 No.3

It is sometimes said lately that the pH of the human gastric juice is significantly different among individuals. Thus, the dissolution behavior of coated solid dosage forms should preferably be independent of the pH of the test solution. With these points as a background, the effect of pH on the dissolution velocity of coated tablets was studied to compare that of Pharmacoat with other gastric soluble film coating materials. Three viscosity types of Pharmacoat have been available(3, 6 and 15cP) until now. The 6cP type has been considered to be the most suitable for a tablet coating amongst the three types. The 3 cP type with a low degree of polymerization, is capable of providing high concentration, but the film strength is so inferior that sometimes cracking of the film may occur. On the other hand, in the case of the 15cP type, high polymer concentration cannot be achieved because of the high degree of polymerization, and thus it is uneconomical for coating. Now, there is a strong demand to reduce the coating time even when IIPMC is used in the 6cP type in order to reduce the coating cost. In order to improve this problem, we have concentrated our attention on reducing the viscosity value of HPMC to an allowable lower limit from 6cP. As a result of this study, it was found that the reduction of the viscosity value to around 4.5cP enabled the use of a higher solution concentration and an incidental shorter coating time without giving any substantial adverse effects on the properties of coated preparations. These experiment results are presented in the later part of this presentation. Based on this study, we have added the viscosity type of 4.5cP as one of the Pharmacoat products as Pharmacoat-645.

Static and Dynamic Characteristics of DC-DC Converter Using a Digital Filter

Fujio Kurokawa,Masashi Okamatsu 전력전자학회 2007 ICPE(ISPE)논문집 Vol.- No.-

This paper presents the regulation and dynamic characteristics of the dc-dc converter with the digital PID control, the minimum phase FIR filter or the IIR filter. Further, we discuss the comparison of these performance characteristics. As a result, it is clarified that the variable rate of the regulation is within 1.3%, the undershoot is less than 200㎷ and the transient time is less than 0.4㎳ in the IIR filter method.

日本における環境保全政策と港灣の整備 - 瀨戶內海沿岸域の事例 -

Fujio Chisuwa 한국항만경제학회 1994 韓國港灣經濟學會誌 Vol.10 No.-

Out line of the theme<br/> l. Japan has a tendency of partial accumulation on metropolis and Osaka Bay Areas consisting of economic, political, cultural and social activities. The plans and policies intend ing to correct this tendency and accerate economic growth brought out environmental destroys for nature and human life over Japan.<br/> 2. Japanese government enacted a number of laws and regulations on conservating human life environment, restricting outbreak of many kinds of harms for health, making remedies for sufferers and preservation systems for natural environment from the end of 1960's.<br/> 3. Laws and regulations have been enacted by power balance between circles of industries and peoples. Peoples have brought suits against firms which had caused public disasters, also against local and central governments upon their directing responsibilities to these firms, and resisted against local and/or central governments and their agencies for development plans like as port development ,etc.<br/> 1. There are three main measures in environment conservation projects among port , development. One of them is to receive waste matters and neccessary fad Ii ties from back and inland cities or districts. The second is to recover and maintain natural and labour environment in port areas themselves. And the third is to create amenities spaces fer all classes' peoples. These projects have been planning and performing in Seta Inner Sea Area.

Control of Single-Electron Device Using Environmental Impedance Modulation

Fujio Wakaya,Fumiyoshi Yoshioka,Shuichi Iwabuchi,Yosuke Nagaoka,Kenji Gamo 대한전자공학회 1998 International Conference on Electronics, Informati Vol.- No.-

An Experimental Study for Simulation of Pneumatic Conveying ( 2nd Report : Fluid Forces Applied on a Sphere in Linear Turbulent Shear Flow )

Fujio Yamamoto,Atsushi Teranishi,Hideki Monya 대한기계학회 1988 KSME/JSME THERMAL and FLUID Engineering Conference Vol.2 No.1

Dynamic Characteristics of DC-DC Converters Using Digital Filters

Fujio Kurokawa,Masashi Okamatsu,Taku Ishibashi,Yasuyuki Nishida 전력전자학회 2009 JOURNAL OF POWER ELECTRONICS Vol.9 No.3

This paper presents the dynamic characteristics of buck and buck-boost dc-dc converters with digital filters. At first, the PID, the minimum phase FIR filter and the IIR filter controls are discussed in the buck dc-dc converter. Comparisons of the dynamic characteristics between the buck and buck-boost converters are then discussed. As a result, it is clarified that the superior dynamic characteristics are realized in the IIR filter method. In the buck converter, the undershoot is less than 2% and the transient time is less than 0.4ms. On the other hand, in the buck-boost converter, the undershoot is about 3%. However, the transient time is approximately over 4ms because the output capacitance is too large to suppress the output voltage ripple in this type of converter.

Studies on a Wind Turbine Generator System using a Shaft Generator System

Fujio Tatsuta,Toshiyuki Tsuji,Nobuharu Emi,Shoji Nishikata 대한전기학회 2006 Journal of Electrical Engineering & Technology Vol.1 No.2

In this paper a new de-link type wind turbine generator system using a shaft generator system, which is widely used for power sources in a ship, is proposed. The basic configuration of the proposed wind turbine generating system is first explained. And the equations expressing the system are derived. Then the steady-state characteristics of the generating system are discussed. We use an experimental system that can simulate the characteristics of a wind turbine in this study, because it is hard to operate an actual wind turbine in a laboratory. In addition, the transient responses of this system are investigated when the velocity of the wind is changed. It is shown that experimental results were very close to the simulated ones, supporting the usefulness of the theory.