Disintegration/dissolution profiles of copies of Fosamax (alendronate)

References

• Videau J-Y. Making medicines safe. Bull World Health Org 2001;79:87
   PubMed Web of Science ®Google Scholar
• Rägo L. Ensuring access to drug products that are of acceptable quality. WHO Pilot Procurement Quality and Sourcing (‘pre-qualification’) project. World Health Organization Web site. Available at: http://www.who.int/medicines/organization/par/briefing/9prequalification.ppt Accessed September 4, 2003
   Google Scholar
• Schnitzer TJ. Update on alendronate for osteoporosis: once-weekly dosing. Expert Opin Pharmacother 2001;2:1461–72
   PubMedGoogle Scholar
• Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995;333:1437–43
   PubMed Web of Science ®Google Scholar
• Devogelaer JP, Broll H, Correa-Rotter R, Cumming DC, De Deuxchaisnes CN, Geusens P, et al. Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis. Bone 1996;18: 141–50
   PubMed Web of Science ®Google Scholar
• Tonino RP, Meunier PJ, Emkey R, Rodriguez-Portales JA, Menkes CJ, Wasnich RD, et al. Skeletal benefits of alendronate: 7 year treatment of postmenopausal osteoporotic women. J Clin Endocrinol Metab 2000;85: 3109–15
   PubMed Web of Science ®Google Scholar
• Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996;348:1535–41
   PubMed Web of Science ®Google Scholar
• Karpf DB, Shapiro DR, Seeman E, Ensrud KE, Johnston CC, Adami S, et al. Prevention of nonvertebral fractures by alendronate. A meta-analysis. JAMA 1997;277:1159–64
   PubMed Web of Science ®Google Scholar
• Cranney A, Wells G, Willan A, Griffith L, Zytaruk N, Robinson V, et al. Meta-analyses of therapies for postmenopausal osteoporosis. II. Meta-analysis of alendronate for the treatment of postmenopausal women. Endocrine Rev 2002;23:508–16
   PubMed Web of Science ®Google Scholar
• Cummings SR, Black DM, Thompson DE, Applegate WB, Barret-Connor E, Musliner TA, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: Results from the Fracture Intervention Trial. JAMA 1998;280:2077–82
   PubMed Web of Science ®Google Scholar
• Fosamax Prescribing Information. Physicians’ Desk Reference, 55th edn. Montvale, NJ: Medical Economics Co; 2001:1930–6
   Google Scholar
• Cryer R, Bauer DC. Oral bisphosphonates and upper gastrointestinal tract problems: what is the evidence? Mayo Clin Proc 2002;77:1031–43
   PubMed Web of Science ®Google Scholar
• Watts N, Freedholm D, Daifotis A. The clinical tolerability profile of alendronate. Int J Clin Pract 1999;101(Suppl):51–61
   Google Scholar
• de Groen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, et al. Esophagitis associated with the use of alendronate. N Engl J Med 1996;335:1016–21
   PubMed Web of Science ®Google Scholar
• Greenspan S, Field-Munves E, Tonino R, Smith M, Petruschke R, Wang L, et al. Tolerability of once-weekly alendronate in patients with osteoporosis: a randomized, double-blind, placebo-controlled study. Mayo Clin Proc 2002;77:1044–52
   PubMed Web of Science ®Google Scholar
• Rizzoli R, Greenspan SL, Bone G 3rd, Schnitzer TJ, Watts NB, Adami S, et al., for the Alendronate Once-Weekly Study Group. Two-year results of once-weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. J Bone Miner Res 2002;17: 1988–96
   PubMed Web of Science ®Google Scholar
• United States Pharmacopeia, Chapter 701 24th edn. 2000: 1941
   Google Scholar
• De Marco JD, Biffar SE, Reed D, Brooks M. J Pharm Biomed Anal 1989;7:1719–27
   PubMed Web of Science ®Google Scholar
• Gertz BJ, Holland SD, Kline WF, Matuszewski BK, Freeman A, Quan H, et al. Studies of the oral bioavailability of alendronate. Clin Pharmacol Ther 1995;58:288–98
   PubMed Web of Science ®Google Scholar
• Porras AG, Holland SD, Gertz BJ. Pharmacokinetics of alendronate. Clin Pharmacokinet 1999;36:315–28
   PubMed Web of Science ®Google Scholar
• Castell DO. Editorial. ‘Pill esophagitis’ – the case of alendronate. N Engl J Med 1996;335:1058–9
   PubMed Web of Science ®Google Scholar
• Ovartlarnporn B, Kulwichit W, Hiranniramol S. Medication-induced esophageal injury: report of 17 cases with endoscopic documentation. Am J Gastroenterol 1991; 86:748–50
   PubMed Web of Science ®Google Scholar
• Drake WM, Worsley DF, Lentle BC, Kendler DL. Monitoring esophageal transit of wax-polished alendronate in healthy postmenopausal women: a new technique for the study of pill transit time. Curr Ther Res Clin Exp 2002;63:103–9
   Web of Science ®Google Scholar
• Siris ES, Chines AA, Altman RD, et al. Risedronate in the treatment of Paget’s disease of bone: an open label, multicenter study. J Bone Miner Res 1998;13:1032–7
   PubMed Web of Science ®Google Scholar
• Channer KS, Virjee JP. The effect of size and shape of tablets on their esophageal transit. J Clin Pharmacol 1986;26:141–6
   PubMed Web of Science ®Google Scholar
• Bailey RT Jr, Bonavina L, McChesney L, Spires KJ, Muilenberg MI, McGill JE, et al. Factors influencing the transit of a gelatin capsule in the esophagus. Drug Intell Clin Pharm 1987;21:282–5
   PubMedGoogle Scholar
• Channer KS, Virjee JP. The effect of formulation on oesophageal transit. J Pharm Pharmacol 1985;37:126–9
   PubMed Web of Science ®Google Scholar
• Perkins AC, Wilson CG, Blackshaw PE, Vincent RM, Dansereau RJ, Juhlin KD, et al. Impaired oesophageal transit of capsule versus tablet formulations in the elderly. Gut 1994;35:1363–7
   PubMed Web of Science ®Google Scholar
• Marvola M, Vahervuo K, Sothmann A, Marttila E, Rajaniemi M. Development of a method for study of the tendency of drug products to adhere to the esophagus. J Pharm Sci 1982; 71:975–7
   PubMed Web of Science ®Google Scholar
• Lufkin EG, Argueta R, Whitaker MD, Cameron AL, Wong VH, Egan KS, et al. Pamidronate: an unrecognized problem in gastrointestinal tolerability. Osteoporos Int 1994;4:320–2
   PubMed Web of Science ®Google Scholar