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Evaluation of the Effect of Dissolution Conditions on the Release Profiles of Felodipine from the Extended Release Push-Pull Osmotic Tablets

Abstracr: In this study, the bilayered push–pull osmotic tablets of 5mg felodipine were prepared by the double compression method, then the core tablets were coated with cellulose acetate as a semipermeable membrane. One releasing orifice was drilled by laser on the drug side of the tablets. The osmotic tablets used felodipine containing low molecular weight PEO (200,000) as the primary component in the drug layer, high molecular weight PEO (5,000,000) as a swelling agent in the push layer and natri chloride as osmotic agent in both drug and push layers, with a semi-permeable membrane coated with a weight gain of 8.5 % and a drilled release orifice of 0.8 mm. The influence of dissolution conditions on the release profiles of felodipine from the extended release push-pull osmotic tablets was studied in pH media with different stirring speeds and osmotic pressures. The study results show that the drug release profile was not affected by the media’s pH and stirring speeds. However, felodipine released from the osmotic tablets was inversely proportional to the osmotic pressure of the dissolution medium. Therefore, the drug release from the osmotic tablets was independent of the media’s pH and stirring speeds, but dependent on the osmotic pressure of the dissolution medium.