International harmonization of generic drugs: In vitro dissolution tests for Japanese and American generic tablets

Bio-Medical Materials and Engineering

Volumn 16, Issue 2, 2006, Pages 129-135

  Otsuka, Makoto ^a   Tomita, Hisako ^b   Otsuka, Kuniko ^c,d   Kamae, Isao ^d   Jorgenson, James A ^e  

^a MUSASHINO UNIVERSITY   (Japan)

^b KOBE PHARMACEUTICAL UNIVERSITY   (Japan)

^c SHOWA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d KOBE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^e UNIVERSITY OF UTAH HOSPITAL   (United States)

Author keywords

Automatic dissolution test; Generic drug; Ibuprofen tablets; International harmonization

Indexed keywords

DISSOLUTION; DRUG DOSAGE; ERROR ANALYSIS; PH EFFECTS; PHOSPHATES; THIN FILMS;

AUTOMATIC-DISSOLUTION TEST; GENERIC DRUG; IBUPROFEN TABLETS; INTERNATIONAL HARMONIZATION;

DRUG PRODUCTS;

GENERIC DRUG; IBUPROFEN; NON PRESCRIPTION DRUG; PHOSPHATE BUFFERED SALINE; SUGAR;

ARTICLE; AUTOANALYSIS; COMPARATIVE STUDY; DRUG COATING; DRUG DOSAGE FORM; DRUG SOLUBILITY; FILM COATING; IN VITRO STUDY; INTERMETHOD COMPARISON; JAPAN; PH; PRESCRIPTION; PRIORITY JOURNAL; REPRODUCIBILITY; SAMPLING; SYSTEMATIC ERROR; TABLET PROPERTY; UNITED STATES;

ABSORPTION; DRUG EVALUATION, PRECLINICAL; DRUGS, GENERIC; GUIDELINES; IBUPROFEN; INTERNATIONAL COOPERATION; JAPAN; SOLUBILITY; TABLETS; UNITED STATES;

EID: 32344442203     PISSN: 09592989     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (8)

1. N. Aoyagi, N. Kaniwa, Y. Takeda and M. Uchiyama, JP Forum 3 (1994), 46-60.
2. Orange Book, No.1, Society of Japanese Pharmacopoeia, 1999.
3. K.U. Petersen, In vitro release of felodipine from original brand and generic products. Arzneimittelforschung 53 (2003), 40-43.
4. Ministry of Health, Labour and Welfare, Pharmaceutical and Medical Safety Bureau, http://www.mhlw.go.jp/english/ org/policy/p13-14.html.
5. F.J. Ciffi, H.M. Abdou and A.T. Warren, Computerized automated system for determining dissolution rate profiles for solid dosage form, J. Pharm. Sci. 65 (1976), 1234-1240.
6. F.J. Ciffi, S. Martynovych and H. Bendrot, ADS-12: An automated programmable 12-tablet dissolution testing system, J. Pharm. Sci. 68 (1979), 1280-1286.
7. United States Pharmacopeial Convention, Inc., USP 24, 2000, pp. 856-857.
8. H. Sato, Turbulent flow, in: One Point for Physics 17, Kyoritu Pub. Co., Tokyo, Japan, 1982.