Upper Gastrointestinal Tract Transit Times of Tablet and Drinkable Solution Formulations of Alendronate: A Bioequivalence and a Quantitative, Randomized Study using Video DeglutitionReportar como inadecuado




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Calcified Tissue International

, Volume 91, Issue 5, pp 325–334

First Online: 26 August 2012Received: 03 April 2012Accepted: 12 July 2012

Abstract

The bioequivalence and upper digestive tract transit time of a drinkable solution of 70 mg-100 mL alendronate was compared to reference tablets. A randomized, single- dose, two-way crossover study of the rate of urinary recovery of alendronate during 36 h AE0–36 h by HPLC, in 104 healthy young male volunteers, showed that AE0–36 h and the maximum excretion rate Rmax were within the accepted range of bioequivalence 81.8–105.7 and 81.7–106.2, respectively. To characterize the oesophageal passage time of the two alendronate formulations, we performed a randomized, controlled study, in 24 healthy men and women mean 52 years old, who took the formulations standing or lying down, by an X-ray video deglutition system. When taken in the standing position, both formulations had equal mean transit times from mouth to stomach and tablet disintegration but data dispersion was significantly smaller with the liquid form. When taken in lying position, drinkable alendronate had shorter and less variable median transit times compared to the tablets. These results show that the drinkable alendronate formulation is bioequivalent to the tablets and may be advantageous in patients in whom the transit or disintegration of the tablets is impaired.

KeywordsAlendronate Bioequivalence Digestive transit Liquid formulation C. Gómez Acotto has a consultant-advisory role to the Universidad Maimónides. E. J. A. Roldán has received remuneration from Gador SA. D. Flynn and D. McDaid have received remuneration and have stock ownership in Xeolas Pharmaceuticals. All other authors have stated that they have no conflict of interest.

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Autor: Claudia Gómez Acotto - Carlos Antonelli - Damien Flynn - Dennis McDaid - Emilio J. A. Roldán

Fuente: https://link.springer.com/







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