In vitro disintegration and dissolution and in vivo bioequivalence of two alendronate once-weekly formulations

Arzneimittel-Forschung/Drug Research

Volumn 56, Issue 2, 2006, Pages 84-89

  Almeida, Susana ^a,b   Almeida, Ana ^a   Filipe, Augusto ^a   Penedo, Clarisse ^a   Rocha, Alexandre ^a   Lainesse, Audrey ^c   Vallée, François ^c  

^a Tecnimede Group   (Portugal)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c SFBC Anapharm   (Canada)

Author keywords

Alendronate, bioequivalence, disintegration, dissolution; Antiosteoporotic drugs; Bisphosphonates; CAS 121268 17 5

Indexed keywords

ALENDRONIC ACID; HYDROCHLORIC ACID; PAMIDRONIC ACID; WATER;

ADULT; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COVARIANCE; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG SOLUBILITY; DRUG TOLERABILITY; DRUG URINE LEVEL; FEMALE; FLUORESCENCE ANALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET DISINTEGRATION; TABLET FORMULATION; UNSPECIFIED SIDE EFFECT; URINALYSIS;

EID: 33645109511     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296706     Document Type: Article

References (15)

1. Porras, A. G., Holland, D., Gertz, B. J., Pharmacokinetics of alendronate. Clin. Pharmacokinet. 36, 315 (1999)
2. Sharpe, M., Noble, S., Spencer, C. M., Alendronate: an update of its use in osteoporosis. Drugs 61, 999 (2001)
3. Epstein, S., Cryer, B., Ragi, S. et al., Disintegration/dissolution profiles of copies of Fosamax (alendronate). Curr. Med. Res. Opin. 19, 781 (2003)
4. CPMP (Committee for Proprietary Medicinal Products), Note for Guidance on the Investigation of Bioavailability and Bioequivalence (2001)
5. International Conference on Harmonisation, Good Clinical Practice Consolidated Guideline, E6 (1996)
6. Blume, H. H., Schug, B. S., The biopharmaceutics classification system [BCS): class III drugs - better candidates for BA/BE waiver? Eur. J. Pharm. Sci. 9, 117 (1999)
7. Cheng, C. L., Yu, L. X., Lee, H. L. et al., Biowaiver extension potential to BCS Class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet. Eur. J. Pharm. Sci. 22, 297 (2004)
8. Kortejarvi, H., Yliperttula, M., Dressman, J. B. et al., Biowaiver monographs for immediate release solid oral dosage forms: Ranitidine hydrochloride. J. Pharm. Sci. 94, 1617 (2005)
9. Wu, C. Y., Benet, L. Z., Predicting drug disposition via application of BCS: transport / absorption / elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm. Res. 22, 11 (2005)
10. Lainesse, A., Ozalp, Y., Wong, H. et al., Bioequivalence studies on bisphosphonates: the example of alendronate. Arzneim.-Forsch./Drug Res. 54, 569 (2004)
11. Roldán, E. J. A., Quattrocchi, O., Zanetti, D. et al., In vitro and in vivo equivalence studies of alendronate monosodium tablets. Arzneim.-Forsch./Drug Res. 55, 93 (2005)
12. Tothfalusi, L., Endrenyi, L., Midha, K. K., Scaling or wider bioequivalence limits for highly variable drugs and for the special case of C(max). Int. J. Clin. Pharmacol. Ther. 41, 217 (2003)
13. Tothfalusi, L., Endrenyi, L., Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharm. Res. 20, 382 (2003)
14. Tothfalusi, L., Endrenyi, L., Midha, K. K. et al., Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharm. Res. 18, 728 (2001)
15. Boddy, A. W., Snikeris, F. C., Kringle, R. O. et al., An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharm. Res. 12, 1865 (1995)