Lack of bioequivalence between two aciclovir tablets in healthy subjects

Clinical Drug Investigation

Volumn 28, Issue 1, 2008, Pages 47-53

  Amini, Hossein ^a,b   Javan, Mohammad ^c   Gazerani, Parisa ^d   Ghaffari, Alireza ^e   Ahmadiani, Abolhassan ^b  

^a GOLESTAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^c TARBIAT MODARES UNIVERSITY   (Iran)

^d AALBORG UNIVERSITY   (Denmark)

^e Research and Development Center   (Iran)

Author keywords

Aciclovir, pharmacokinetics; Bioequivalence

Indexed keywords

ACICLOVIR; ROUZ ACICLOVIR; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG TOLERANCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; SINGLE DRUG DOSE; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 37249028624     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200828010-00006     Document Type: Article

References (18)

1. Elion GB, Furman PA, Fyfe JA, et al. The selectivity of action of an antiherpetic agent, 9-(2-hydroxyethoxymethyl) guanine. Proc Natl Acad Sci USA 1977; 74: 5716-20
2. De Clercq E. Antivirals for the treatment of herpesvirus infections. J Antimicrob Chemother 1993; 32 Suppl. A: 121-32
3. McEvoy G. AHFS Drugs information, American Society of Health System Pharmacists. Bethesda (MD): Atlantic Books, 1998: 471-80
4. Fletcher C, Bean B. Evaluation of oral acyclovir therapy. Drug Intell Clin Pharm 1985; 19: 518-24
5. Wagstaff AJ, Faulds D, Goa KL. Acyclovir: a reappraisal of its antiviral activity, pharmacokinetic properties and therapeutic efficacy. Drugs 1994; 47: 153-205
6. Bahrami G, Mirzaeei S, Kiani A. Determination of acyclovir in human serum by high-performance liquid chromatography using liquid-liquid extraction and its application in pharmacokinetic studies. J Chromatogr B 2005; 816: 327-31
7. Bangaru RA, Bansal YK, Rao ARM, et al. Rapid, simple and sensitive high-performance liquid chromatographic method for detection and determination of acyclovir in human plasma and its use in bioavailability studies. J Chromatogr B 2000; 739: 231-7
8. Vergin H, Kikuta C, Mascher H, et al. Pharmacokinetics and bioavailability of different formulations of acyclovir. Arzneimittelforschung 1995; 45: 508-15
9. Najib NM, Idkaidek N, Beshtawi M, et al. Bioequivalence assessment of Lovrak (Julphar, UAE) compared with Zovirax (GlaxoWellcome, UK), two brands of acyclovir, in healthy human volunteers. Biopharma Drug Dispos 2005; 26: 7-12
10. Meadows KC, Dressman JB. Mechanism of acyclovir uptake in rat jejunum. Pharm Res 1990; 7: 299-303
11. Miserocchi E, Modorati G, Galli L, et al. Efficacy of valacyclovir vs acyclovir for the prevention of recurrent herpes simplex virus eye disease: a pilot study. Am J Ophthalmol 2007; 144: 547-51
12. Ghosh PK, Majithiya RJ, Umrethia ML, et al. Design and development of microemulsion drug delivery system of acyclovir for improvement of oral bioavailability. AAPS PharmSciTech 2006; 7 (article 77): E1-6
13. Corti G, Maestrelli F, Cirri M, et al. Development and evaluation of an in vitro method for prediction of human drug absorption: II. Demonstration of the method suitability. Eur J Pharm Sci 2006; 27: 354-62
14. Lindenberg M, Kopp S, Dressman JB. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the Biopharmaceutics Classification System. Eur J Pharm Biopharm 2004; 58: 265-78
15. Blume HH, Schug BS. The Biopharmaceutics Classification System (BCS): class III drugs. Better candidate for BA/BE waiver? J Pharm Sci 1999; 9: 117-21
16. Polli JE. In vitro-in vivo relationships of several 'immediate' release tablets containing a low permeability drug. Adv Exp Med Biol 1997; 423: 191-8
17. Koch KM, Parr AF, Tomlinson JJ, et al. Effect of sodium acid pyrophosphate on ranitidine bioavailability and gastrointestinal transit time. Pharm Res 1993; 10: 1027-30
18. Adkin DA, Davis SS, Sparrow RA, et al. The effect of mannitol on the oral bioavailability of cimetidine. J Pharm Sci 1995; 84: 1405-9