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(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.
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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.
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Pharmacoat Coating in an Aqueous System : The Dissolution Behavior and Reduction in Coating Time
Sekigawa Fujio,Muto Hiroaki,Araume Kiyoshi The Korean Society of Pharmaceutical Sciences and 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 dgree of polymerization, and thus it is uneconomical for coating. Now, there is a strong demand to reduce the coating time even when HPMC 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.
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의약품 첨가제의 공정서 각조의 국제 규격화 : 그 진행과 문제점 Its Progress and the Matters at Issue
후지오세키가와 한국약제학회 1993 Journal of Pharmaceutical Investigation Vol.23 No.4
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.
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