Document Detail

In vitro determination of the release of alendronic acid from alendronate tablets of different brands during deglutition.
MedLine Citation:
PMID:  19630066     Owner:  NLM     Status:  MEDLINE    
Alendronic acid, a frequently applied compound for the treatment of different forms of diseases of bone metabolism, is a strong acid with a high solubility in water. In connection with the oral administration this exhibits a potential health risk for the upper gastrointestinal tract. The in vitro release of tablets containing alendronic acid of different brands (Stada, ratiopharm, interpharm, Fosamax) was determined by dissolution tests for the time period required for oral intake. The effect of rotation speed, temperature, and solvent volume on the release rate of alendronic acid was determined for the used dissolution apparatus. Analysis of alendronic acid was performed by a validated HPLC method. The highest rate of release was found for the original brand. The dissolution rate of the generic formulations was significantly lower in the early stage of dissolution. Over the complete range of dissolution, more than 85% of the claimed amount was dissolved within 4 min. Dissolution profiles were compared by calculation of the similarity factor f(2) showing equal products with the exception of one generic product, whose dissolution rate was lower.
Guenther Lamprecht
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of pharmaceutical sciences     Volume:  98     ISSN:  1520-6017     ISO Abbreviation:  J Pharm Sci     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-08-31     Completed Date:  2010-01-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985195R     Medline TA:  J Pharm Sci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3575-81     Citation Subset:  IM    
Institute of Analytical Chemistry and Food Chemistry, University of Vienna, Waehringerstrasse 38, A-1090 Vienna, Austria.
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MeSH Terms
Alendronate / analysis*,  chemistry*,  pharmacokinetics
Bone Density Conservation Agents / analysis*,  chemistry*,  pharmacokinetics
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Diphosphonates / analysis
Drugs, Generic
Indicators and Reagents
Therapeutic Equivalency
Reg. No./Substance:
0/Bone Density Conservation Agents; 0/Diphosphonates; 0/Drugs, Generic; 0/Indicators and Reagents; 0/Solvents; 0/Tablets; 40391-99-9/pamidronate; 66376-36-1/Alendronate

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