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Original Article

In vitro disintegration and dissolution studies of once-weekly copies of alendronate sodium tablets (70  mg) and in vivo implications

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Pages 1137-1145 | Accepted 20 Mar 2008, Published online: 20 Feb 2008

References

  • Liberman UA, Weiss SR, Broll J, 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
  • Black DM, Cummings SR, Karpf D, et al. Randomised trial effects of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trail Research Group. Lancet 1996;348:1535–41
  • Bone HG, Hosking D, Devogelaer JP, et al. Ten years experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004;350:1189–99
  • Lufkin EG, Argueta R, Whitaker MD, et al. Pamidronate: An unrecognized problem in gastrointestinal tolerability. Osteoporosis Int 1994;4:320–2
  • deGroen PC, Lubbe DF, Hirsch LJ, et al. Esophagitis associated with the use of alendronate. N Engl J Med 1996;335: 1016–21
  • Kikendall JW, Friedman AC, Oyewole MA, et al. Pill-induced esophageal injury: Case reports and review of the medical literature. Dig Dis Sci 1983;28:174–82
  • Kikendall JW. Pill-induced esophageal injury. Gastroenterol Clin North Am 1991;20:835–46
  • Spiller RC. 1986. Where do all the tablets go? Gut 1986;27: 879–85
  • 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
  • Ferriolli E, Dantas RO, Oliveira RB, Braga FJ. The influence of ageing on oesophageal motility after ingestion of liquids with different viscosities. Eur J Gatoenterol Hepatol 1996;8: 793–98
  • United States Pharmacopeia. Alendronate Sodium and Alendronic Acid Tablets, 30th edn, United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, 2007:1318–19
  • Epstein S, Geusens P, Fisher JE, et al. Disintegration and esophageal irritation profiles of alendronate formulations: Implications for clinical safety and efficacy. J Applied Res 2005;5:253–64
  • Epstein S, Cryer B, Gagi S, et al. Disintegration/dissolution profiles of copies of Fosamax (alendronate). Curr Med Res Opin 2003;19:781–9
  • United States Pharmacopeia. Disintegration, 30th edn, United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, 2007:276–7
  • United States Pharmacopeia. Dissolution, 30th edn, United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, 2005:2412–4
  • United States Pharmacopeia. 30th edn, United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, 2007:2142
  • Hanson W. Overall consideration in Handbook of Dissolution Testing, 2nd edn Revised, Chapter 1. Eugene, Oregon: Aster Publishing Company, 1991:2–12
  • European Pharmacopoeia. General Notices, 5th edn, Volume 1, 2005:627
  • Dobetti L. Fast-Melting tablets: Developments and technologies. Pharm Tech Suppl 2001;44–50
  • Dor JM, Fix JA, Johnson MI. A new In vitro method to measure the disintegration time of a fast disintegration tablet. Proceed Int Symp Control Rel Bioact Mater. Controlled Release Society 1999;939–40
  • Bi Y, Sunada H, Yonezawa Y, et al. Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity. Chem Pharm Bull 1996;44:2121–7
  • Harada T, Narazaki R, Nagira S, et al. Evaluation of the disintegration properties of commercial famotidine 20 mg orally disintegrating tablets using a simple new test and human sensory test. Chem Pharm Bull 2006;58:1072–5
  • Klancke J. Dissolution testing of orally disintegrating tablets. Dissolution Technol 2003;5:6–8
  • 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
  • Prescribing information. Fosamax (alendronate sodium) tablets and oral solution. Merck & Co., Inc, Whitehouse Station NJ; May 2007. Available at: www.merck.com/products/usa/pi_ circulars/f/products_f.html (Last accessed 17 December 2007)
  • Prescribing information. Actonel (risedronate sodium tablets). Procter & Gamble Pharmaceuticals Inc, Cincinnati, OH, May 2007. Available at: www.Actonel.com/prescribinginformaion. jsp (Last accessed 17 2007 December 2007)
  • Ezra A, Golomb G. Administration routes and delivery systems of bisphosphonates for the treatment of bone resorption. Advanced Drug Deliv Rev 2000;42:175–95

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