Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies
- 5 January 2010
- journal article
- research article
- Published by Informa UK Limited in Drug Development and Industrial Pharmacy
- Vol. 36 (2), 180-189
- https://doi.org/10.3109/03639040903468811
Abstract
Formulation of proton pump inhibitors (PPIs) into oral solid dosage forms is challenging because the drug molecules are acid-labile. The aim of this study is to evaluate different formulation strategies (monolithic and multiparticulates) for three PPI drugs, that is, rabeprazole sodium, lansoprazole, and esomeprazole magnesium, using delayed release film coating applications. The core tablets of rabeprazole sodium were prepared using organic wet granulation method. Multiparticulates of lansoprazole and esomeprazole magnesium were prepared through drug layering of sugar spheres, using powder layering and suspension layering methods, respectively. Tablets and drug-layered multiparticulates were seal-coated, followed by delayed release film coating application, using Acryl-EZE(R), aqueous acrylic enteric system. Multiparticulates were then filled into capsules. The final dosage forms were evaluated for physical properties, as well as in vitro dissolution testing in both compendial acid phase, 0.1N HCl (pH 1.2), and intermediate pH, acetate buffer (pH 4.5), followed by phosphate buffer, pH 6.8. The stability of the delayed release dosage forms was evaluated upon storage in accelerated conditions [40 degrees C/75% relative humidity] for 3 months. All dosage forms demonstrated excellent enteric protection in the acid phase, followed by rapid release in their respective buffer media. Moreover, the delayed release dosage forms remained stable under accelerated stability conditions for 3 months. Results showed that Acryl-EZE enteric coating systems provide excellent performance in both media (0.1N HCl and acetate buffer pH 4.5) for monolithic and multiparticulate dosage forms.Keywords
This publication has 15 references indexed in Scilit:
- Evaluation of new rosin derivatives for pharmaceutical coatingInternational Journal of Pharmaceutics, 2003
- An Overview of Proton Pump InhibitorsGastroenterology Nursing, 2003
- Anatomical and physiological parameters affecting gastrointestinal absorption in humans and ratsFood and Chemical Toxicology, 2001
- The proton-pump inhibitors: Similarities and differencesClinical Therapeutics, 2000
- Tableting of coated pelletsEuropean Journal of Pharmaceutics and Biopharmaceutics, 1997
- Multiparticulate Oral Drug DeliveryDrugs and the Pharmaceutical Sciences, 1994
- An in vivo investigation into the suitability of pH dependent polymers for colonic targetingInternational Journal of Pharmaceutics, 1993
- Kinetics of Release from Enteric-Coated TabletsPharmaceutical Research, 1988
- Study of Rosin and Rosin esters as coating materialsInternational Journal of Pharmaceutics, 1985
- Correlation of surface characteristics with ease of production and in vitro release of sodium salicylate from various enteric coated microcapsules prepared by pan coatingJournal of Microencapsulation, 1984