Open AccessRabeprazole sodium delayed-release multiparticulates: Effect of enteric coating layers on product performance
Author(s) -
Rakesh N Tirpude,
P. K. Puranik
Publication year - 2011
Publication title -
journal of advanced pharmaceutical technology and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.325
H-Index - 33
eISSN - 2231-4040
pISSN - 0976-2094
DOI - 10.4103/2231-4040.85539
Subject(s) - enteric coating , coating , rabeprazole , pellet , polymer , enteric coated , acrylic acid , materials science , dissolution , chemical engineering , dosage form , chemistry , chromatography , biomedical engineering , composite material , organic chemistry , copolymer , biochemistry , medicine , engineering , proton pump inhibitor
Rabeprazole sodium is one of the most effective proton pump inhibitors (PPIs) used in antiulcer therapy. Like most other PPIs, owing to its acid-labile nature, the drug is formulated as enteric-coated dosage form. Conventional means of producing delayed release multiparticulate dosage forms of PPIs require large quantities of enteric polymer coatings. In the present study, in order to better evaluate the effect of polymeric coating on product performance, the pellet core structure and composition was kept constant. Four different enteric-coating formulations and designs were evaluated. Enteric-coated drug multiparticulates prepared with single polymeric coatings (acrylic or cellulosic) were compared with two different polymeric layer coatings to evaluate the effectiveness of latter coatings in more effectively producing a better rabeprazole sodium delayed-release pellet product. The pH-dependent, enteric acrylic, and cellulosic polymers were used either alone, in combination, or applied one over the other to impart delayed-release properties to the core drug pellets. It was demonstrated that dual delayed-release coating with two different enteric polymers-an inner acrylic coating followed by an outer cellulosic coating-yields the best product that provides all the desired physicochemical and drug dissolution characteristics.