The presented work describes the formulation and characterization of modified\nrelease glassy solid dosage forms (GSDFs) containing an amorphous nifedipine, as a model\nBCS (Biopharmaceutical Classification System) class II drug. The GSDFs were prepared by\nmelting nifedipine together with octaacetyl sucrose. Dissolution profiles, measured under\nstandard and biorelevant conditions, were compared to those obtained from commercially\navailable formulations containing nifedipine such as modified release (MR) tablets and\nosmotic release oral system (OROS). The results indicate that the dissolution profiles of the\nGSDFs with nifedipine are neither affected by the pH of the dissolution media, type and\nconcentration of surfactants, nor by simulated mechanical stress of biorelevant intensity.\nFurthermore, it was found that the dissolution profiles of the novel dosage forms were similar\nto the profiles obtained from the nifedipine OROS. The formulation of GSDFs is relatively\nsimple, and the dosage forms were found to have favorable dissolution characteristics.
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