抄録
Pharmaceuticals contain many excipients other than the active ingredient. Considering the weight ratio of excipients and active ingredient, excipients can determine the safety of pharmaceuticals . Pharmaceutical excipients are generally required to be inactive and non-toxic as defined in the general rules for preparations of The Japanese Pharmacopoeia Sixteenth Edition as follows: “Pharmaceutical excipients are substances other than active substances contained in preparations, and they are used to increase the utility of the active substance(s) and preparation, to make formulation process easier, to keep the product quality, to improve the usability, and so forth. Suitable excipients may be added for these purposes. The excipients to be used, however, must be pharmacologically inactive and harmless in the administered amount and must not interfere with the therapeutic efficacy of the preparations.” Recently, the use of functional excipients as carriers in drug delivery systems (DDS) is increasing. Functional excipients are characteristically active and do have some effects on the human body. Also, conventional pharmaceutical excipients may cause toxic reactions resulting from the user's health condition, overdose or poor quality etc. Considering these situations, sufficient safety information for excipients should be collected and appropriate risk assessment / management should be done. Pharmaceutical excipients are reviewed for approval by the Pharmaceuticals and Medical Devices Agency. Because of the nature of pharmaceutical excipients, approval review for excipient is flexible and on a case-by-case basis. A need for pharmaceutical excipient guidelines in Japan has been recognized. On development of guidelines, FDA / EU guidelines may be used as a reference.
