Japanese Pharmaceutical Excipients

Japanese Pharmaceutical Excipient Directory. Japanese Pharmaceutical Excipient Council (JPEC), ed. Tokyo Yakuji Nippon Ltd, 1996. 

The International Pharmaceutical Excipient Council in the United States (Arlington, Virginia 703-521-3338) has issued a GMP guideline for excipient bulk pharmaceutical chemicals. In conjunction with both the European and Japanese Pharmaceutical Excipient Councils, the council is currently engaged in establishing international harmonization excipient monographs for the more popular pharmaceutical excipients. A list of important and popular pharmaceutical excipients is given in Table 1. 

Similar results are reported in the literature when Kollidon VA 64 is compared to povidone (Kollidon K 25, K 30, and 90 F). Copovidone absorbs about three times less water than the other soluble Kollidon K 25, 30, and 90F after seven days at 25 °C up to 80% relative humidity [62], Kollidon VA 64 is manufactured by free-radical polymetization of 6 parts of vinylpyrrolidone and 4 parts of vinyl acetate in 2-propanol. A water-soluble copolymer with a chain structure is obtained. In contrast to the soluble grades of Kollidon, the number 64 is not a K value but the mass ratio of the two monomers, vinylpyrrolidone and vinyl acetate. The K value of Kollidon VA 64 is of the same order of magnitude as that of Kollidon 30. Synonyms for Kollidon VA 64 are copovidone, copovidonum, copolyvidone, copovidon, and PVP-VAc-copolymer [Eur. Ph., Japanese Pharmaceutical Excipients, and USP National Formulary (NF)] [63],... 

Additional non-synthetic colors may be acceptable for pharmaceutical applications based on previous precedence of use. These colors are typically listed in the Japanese Pharmaceutical Excipients (JPE) Directory along with their Japanese Pharmacopoeia (JP) or JPE specification. ... 

Japanese Pharmaceutical Excipients Directory,, The Japan Pharmaceutical Excipients Council, Yakuji Nippo Ltd Tokyo, 2000. 

The parent CDs in Japan are classified as natural starches that have received approval by the Ministries of Health for use in foods. Relative to pharmaceutical applications, monographs for a- and p-CD have been included in the Japanese Pharmaceutical Excipients compendium (JPE). Even though nine pharmaceutical products with CD formulations have been marketed in Japan, the use of CDs has not been extensive enough in approved formulations to receive precedent status. ... 

The Japanese Pharmaceutical Excipients Council. Japanese Pharmaceutical Excipients 1993, Yakuji Nippo, Ltd. Tokyo, 1994 415. 

Japanese Pharmaceutical Excipients Directory 1996 Japanese Pharmaceutical Excipients Council, Eds. Yakuji Nipo Ltd. Tokyo, 1996. 

Similarly, in Japan the Japanese Pharmaceutical Excipients Directory is published by the Japanese Pharmaceutical Excipients Council, with the cooperation and guidance of the Ministry of Health and Welfare. This directory divides the excipients into ... 

Official. Those 590 excipients that have been recognized in the JP, Japanese Pharmaceutical Codex, and Japanese Pharmaceutical Excipients, and for which testing methods and standards have been determined. Table 11 summarizes official excipients used in parenteral products. 

Table 11 Official Japanese pharmaceutical excipients Continued)...

Excipients Parenteral Dosage Forms and Their Role Table 11 Official Japanese pharmaceutical excipients (Continued) 1637... 

Japanese Pharmaceutical Excipients, which has 206 monographs for pharmaceutical excipient. 

A specification for acetone is included in the Japanese Pharmaceutical Excipients (JPE). The EINECS number for acetone is 200-662-2. 

A specification for aluminum oxide is included in Japanese Pharmaceutical Excipients 2004 (JPE), see Table I. A specification for light aluminum oxide is also included. The PhEur 2005 includes a specification for hydrated aluminum oxide that contains the equivalent of 47.0-60.0% of AI2O3. The EINECS number for aluminum oxide is 215-691-6. 

Although it is not currently included in the pharmacopeias, a specification for hydroxypropyl starch is included in the Japanese Pharmaceutical Excipients (JPE) 2004 see Table I. Hydroxypropyl starch is compatible with cationic ingredients (monovalent, divalent), oils, emollients, and silicone. 

Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical Excipients 2004. Tokyo Yakuji Nippo, 2004 102—103. Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical Excipients 2004. Tokyo Yakuji Nippo, 2004 746—747. Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical Excipients 2004. Tokyo Yakuji Nippo, 2004 939. 

Table I Food Chemicals Codex and Japanese Pharmaceutical Excipients specifications for myristic acid.

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