[KSCI] Korea Science Citation Index Service

http://dx.doi.org/10.4333/KPS.2003.33.1.067

The Quality Regulation of Drug Excipients 의약품첨가물과 규격관리

Choi, Myoeng-Sin (Division of Drug Standardization, Department of Drug Evaluation, Korea Food and Drug Administration)
Hong, Chong-Hui (Division of Drug Standardization, Department of Drug Evaluation, Korea Food and Drug Sdiministration)
Jang, Seung-Jae (Division of Drug Standardization, Department of Drug Evaluation, Korea Food and Drug Sdiministration)
Kang, Chan-Soon (Division of Drug Standardization, Department of Drug Evaluation, Korea Food and Drug Sdiministration)

Publication Information

Journal of Pharmaceutical Investigation / v.33, no.1, 2003 , pp. 67-71 More about this Journal

Abstract

Drug excipients are material used in the formulation of pharmacologically active drugs. They have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives, propellant, disintegrants, lubricants/dlidants, colors, flavors, coating agents, polising agents, fragrance, sweeteening agent, polymers and waxes. Excipient should be inert or inactive and does not interfere with the test. Nowadays within industry there has been a recent surge of interest in novel excipient for novel dosage forms. The purpose of the review is to introduce the administration systems of drug excipient about kinds, matters to be attended to change of excipients.

Keywords

Drug Excipients; Quality Control;

Citations & Related Records

Reference

1	김형국, 약전해설서, Pharma Koreana (2000)
2	이범진. 한건, 제형의 원리와 기술, 신일상사 (1998)
3	대한약전 제 7개정, 보건복지부 (1997)
4	The United States Pharmacopeia 25, United States Pharmacopeial Convention, Inc. (2002)
5	일본약국방 제 13개정 해설서, 광천서점 (1996)
6	British Pharmacopoeia, Medicines Commission, London (2000)
7	의약품. 의약외품의 재조. 수입품목허가 신청(신고)서 검토에 관한 규정. 식품의약품안전청고시 제 2000-49호 (2000.10.11)