Abstract
Ranitidine is an antisecretory drug with H2 antagonist action useful in treating gastric and duodenal disorders. The dissolution test is used to obtain and compare dissolution profiles and establish similarities of pharmaceutical forms. The aim of this study was to compare the dissolution profiles of 150-mg coated ranitidine tablets of a reference drug (product A) and a generic (product B) and a similar (product C) drug marketed in Bahia, Brazil using a simple, fast and inexpensive ultraviolet method. Dissolution was determined using a USP type 2 apparatus at 50 rpm with 900 mL of distilled water at 37.0 ± 0.5 oC for 1h. The dissolution test was performed in compliance with the American Pharmacopoeia (USP-32). Dissolution efficiency and difference (f1) and similarity (f2) factors were calculated and evaluated. The proposed quantification methodology for drug dissolution test was validated, presenting accuracy, linearity and precision within the acceptance criteria. Products A, B and C showed dissolution efficiency values of 59.29, 73.59 and 66.67%, respectively. Factors f1 and f2 were calculated and showed that the profiles of products A, B and C were dissimilar. However, all the products released ranitidine satisfactorily, with at least 80% of the drug dissolved within 30 min.
Highlights
Ranitidine is an antisecretory drug from the H2-antagonist pharmacological class
Ranitidine is highly soluble in water and little cell membrane permeable (Coelho, 2007), being classified as a class III drug according to the Biopharmaceutical Classification System (BCS) proposed by the Food and Drug Administration (FDA)
This study aims to compare the dissolution profiles of 150-mg ranitidine coated tablets of reference, generic and similar drugs marketed in Bahia, Brazil using a simple, fast and inexpensive ultraviolet method
Summary
Ranitidine is an antisecretory drug from the H2-antagonist pharmacological class. It is used in the treatment of gastric and duodenal disorders, such as gastroesophageal reflux disease (GERD), gastritis, peptic ulcer disease, Zollinger-Ellison, among others (Costa, 2004; Mincis, Mincis, 2009; Xue et al, 2001; Grant et al, 1989; Moraes, 1999). Ranitidine has a bioavailability of approximately 50%. About 6% of the dose is excreted in urine as N-oxide, 2% as S-oxide, and 2% as desmethyl ranitidine, such as furoic acid analogues (Hoogerwerf, Pasricha, 2006). Ranitidine is highly soluble in water and little cell membrane permeable (Coelho, 2007), being classified as a class III drug according to the Biopharmaceutical Classification System (BCS) proposed by the Food and Drug Administration (FDA). Class I (high solubility and high permeability) and some Class III (high solubility and low permeability) drugs can be assessed for bioequivalence by dissolution test alone (Bonamici, 2009)
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