Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Aciclovir

被引:64
作者
Arnal, J. [2 ]
Gonzalez-Alvarez, I. [2 ]
Bermejo, M. [2 ]
Amidon, G. L. [3 ]
Junginger, H. E. [4 ]
Kopp, S. [5 ]
Midha, K. K. [6 ]
Shah, V. P. [7 ]
Stavchansky, S. [8 ]
Dressman, J. B. [9 ]
Barends, D. M. [1 ]
机构
[1] Natl Inst Publ Hlth & Environm, RIVM, NL-3720 BA Bilthoven, Netherlands
[2] Univ Valencia, Fac Farm, Valencia 46100, Spain
[3] Univ Michigan, Coll Pharm, Ann Arbor, MI 48109 USA
[4] Naresuan Univ, Fac Pharmaceut Sci, Phitsanulok, Thailand
[5] WHO, CH-1211 Geneva, Switzerland
[6] Univ Saskatchewan, Saskatoon, SK, Canada
[7] Int Pharmaceut Federat FIP, The Hague, Netherlands
[8] Univ Texas Austin, Coll Pharm, Div Pharmaceut, Austin, TX 78712 USA
[9] Univ Frankfurt, Inst Pharmaceut Technol, Frankfurt, Germany
关键词
absorption; aciclovir; bioequivalence; biopharmaceutics classification system (BCS); permeability; solubility; regulatory science;
D O I
10.1002/jps.21392
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were also taken into consideration in order to ascertain whether a biowaiver can be recommended. According to the Biopharmaceutics Classification System (BCS) and considering tablet strengths up to 400 mg, aciclovir would be BCS Class III. However, in some countries also 800 mg tablets are available which fall just within BCS Class IV. Aciclovir seems not to be critical with respect to a risk for bioinequivalence, as no examples of bioinequivalence have been identified. It has a wide therapeutic index and is not used for critical indications. Hence, if. (a) the test product contains only excipients present in aciclovir solid oral IR drug products approved in ICH or associated countries, for instance as presented in this article; and (b) the comparator and the test product both are very rapidly dissolving, a biowaiver for IR aciclovir solid oral drug products is considered justified for all tablet strengths. (c) 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:5061-5073, 2008
引用
收藏
页码:5061 / 5073
页数:13
相关论文
共 76 条
[1]  
Al-Yamani MJMS, 1998, INT J CLIN PHARM TH, V36, P222
[2]  
*ALPH PHARM, 1999, ALPH AC DAT SHEET
[3]   Pharmacokinetics of novel dipeptide ester prodrugs of acyclovir after oral administration: Intestinal absorption and liver metabolism [J].
Anand, BS ;
Katragadda, S ;
Mitra, AK .
JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS, 2004, 311 (02) :659-667
[4]  
[Anonymous], 2006, WHO TECHN REP SER
[5]  
[Anonymous], MICR HEALTHC SER
[6]  
[Anonymous], 2001, NOT GUID INV BIOAV B
[7]  
[Anonymous], 2004, AHFS DRUG INF, P765
[8]   Determination of acyclovir in human serum by high-performance liquid chromatography using liquid-liquid extraction and its application in pharmacokinetic studies [J].
Bahrami, G ;
Mirzaei, S ;
Kiani, A .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2005, 816 (1-2) :327-331
[9]   Drug liposome partitioning as a tool for the prediction of human passive intestinal absorption [J].
Balon, K ;
Riebesehl, BU ;
Müller, BW .
PHARMACEUTICAL RESEARCH, 1999, 16 (06) :882-888
[10]   Biowaiver monographs for immediate release solid oral dosage forms: Ethambutol dihydrochloride [J].
Becker, C. ;
Dressman, J. B. ;
Amidon, G. L. ;
Junginger, H. E. ;
Kopp, S. ;
Midha, K. K. ;
Shah, V. P. ;
Stavchansky, S. ;
Barends, D. M. .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2008, 97 (04) :1350-1360