Comparative In Vitro Dissolution Profile of Commercial Azithromycin Dihydrate 500 mg Tablet Preparations in the Philipppines

  • Gerard Q. de Guzman The Graduate School Universiy of Santo Tomas, Espana Blvd., Sampaloc, Manila 1015
  • Aleth Therese L. Dacanay Universiy of Santo Tomas, Espana Blvd., Sampaloc,Manila 1015
  • Raymund S. Erguiza College of Pharmacy, Virgen Milagrosa University Foundation, Martin P. Posadas Ave.,San Carlos City, Pangasinan 2420
  • Rosalyn M. Rosal College of Pharmacy, Virgen Milagrosa University Foundation, Martin P. Posadas Ave.,San Carlos City, Pangasinan 2420
  • Grecebio Jonathan D. Alejandro Universiy of Santo Tomas, Espana Blvd., Sampaloc,Manila 1015
Keywords: Comparative dissolution, azithromycin dihydrate, tablets


This study seeks to compare the in vitro multi-point dissolution profiles between 3 off-patent products azithromycin dihydrate 500 mg and the innovator product. The paddle-type dissolution apparatus was used. This was rotated at a speed of 50 rpm using 0.1-N HCl as media. Random samples were withdrawn after certain time points and assayed for azithromycin dihydrate. Comparision between test samples and the innovator product was done by computing their similarity (f1) and disimilarity (f2) factors and by fitting them to various kinetics of drug release during dissolution. Test samples 1 and 3 were comparable to the innovator product because they complied with f1 and f2 specifications. Test sample 2, however, gave higher f2 values making it non-equivalent with the innovator product. The Higuchi and Korsmeyer-Peppa kinetics of drug release characterized most of the dissolution profiles. This study showed that test samples 1 and 3 are equivalent with the innovator products in terms of comparative in vitro dissolution profiles where extra-Fickian release behaviors was exhibited by all the preparations.


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