XML Template (2009) [5.9.2009–2:48pm] [1–4]
{TANDF_FPP}CMO/CMO_A_365060(NEW).3d (CMO) [First Proof]
Current Medical Research and Opinion
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Volume 25, Number 2 2008
disintegration of the generic alendronate sodium tablets
3. Bone HG, Hosking D, Devogelaer JP, et al. Ten years’ experience with alen-
available in the United States have been shown to be
dronate for osteoporosis in postmenopausal women. N Engl J Med
2004;350:1189-99
similar to some of the rapidly disintegrating generic tablets
4. Lufkin EG, Argueta R, Whitaker MD, et al. Pamidronate: an
available in Canada and Europe. The rapid disintegration
unrecognized problem in gastrointestinal tolerability. Osteoporosis Int 1994;
may resultindrug exposure inthemouth and/oresophagus 4:320-2
during swallowing with potential iatrogenic complica-
5. deGroen PC, Lubbe DF, Hirsch LJ, et al. Esophagitis associated with the use of
tions. Since there is not an established disintegration
alendronate. N Engl J Med 1996;335:1016-21
6. Kikendall JW, Friedman AC, Oyewole MA, et al. Pill-induced esophageal
time for alendronate sodium tablets there is no guarantee
injury: case reports and review of the medical literature. Dig Dis Sci
that the generic tablets are equivalent in terms of
1983;28:174-82
esopahgeal drug exposure to that of the innovator 7. Kikendall J. Pill-induced esophageal injury. Gastroenterol Clin North Am
product, however an in vitro/in vivo correlation has not
1991;20:835-46
been established.
8. Spiller R. 1986. Where do all the tablets go? Gut 1986;27:879-85
9. Perkins AC, Wilson CG, Frier M, et al. Esophageal transit of risedronate
cellulose-coated tablet and gelatin capsule formulations. Int J Pharm
1999;186:169-75
Acknowledgment
10. Ferriolli E, Dantas RO, Oliveira RB, et al. The influence of ageing on oeso-
phageal motility after ingestion of liquids with different viscosities. Eur J
Declaration of interest
Gatoenterol Hepatol 1996;8:793-8
11. United States Pharmacopeia. Alendronate Sodium and Alendronic Acid
This study was supported by Procter & Gamble Pharmaceuticals,
Tablets, 30th edn, United States Pharmacopeial Convention, Inc., 12601
Cincinnati, OH, USA and Sanofi-Aventis, Paris, France. A. C.
Twinbrook Parkway, Rockville, MD 20852, USA, 2007:1318-19
P. is a paid consultant for Procter & Gamble.
12. Dansereau R, Crail D, Perkins AC. In vitro disintegration and dissolution
studies of once-weekly copies of alendronate sodium tablets (70 mg) and
in vivo implications. Curr Med Res Opin 2008;24:1137-45
13. United States Pharmacopeia. Disintegration, 30th edn, United States
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In vitro disintegration studies of weekly generic alendronate sodium Dansereau et al.
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