Multiparticulate drug delivery system have the several advantage in comparison to single unit dosage form like predictable, reproducible and short gastric residence time, less inter- and intra-subject variability, improve bioavailability, reduced adverse effects, improved tolerability, limited risk of local irritation and no risk of dose dumping. Salt form of carvedilol, such as carvedilol phosphate, with greater aqueous solubility, chemical stability etc., may offer potential benefits for provision of medicinal products containing the drug carvedilol, including the ability to achieve desired or prolonged systemic drug levels by sustaining absorption along the gastro-intestinal tract, particularly in regions of neutral pH where carvedilol has minimal solubility. There exists a need in the art for alternate ways to formulate compositions of carvedilol salts especially extended release compositions. Pulsatile is such a drug delivery system where drug is released of a sudden after well-defined time gap (lag time) according to circadian rhythm of disease states. The diseases recently targeted for pulsatile drug delivery include asthma, arthritis, duodenal ulcer, cancer, cardiovascular diseases, diabetes, hypercholesterolemia and neurological disorders etc. which have good circadian rhythm. In this invention, once daily chronotherapeutic triphasic pulsatile multiparticulate controlled release dosage form of carvedilol phosphate was prepared by combining immediate release (IR) pellets, delayed release (DR) pellets and controlled release (CR) pellets in suitable ratio to deliver carvedilol phosphate in appropriate manner matching circadian rhythm of humans to facilitate once daily administration. The above formulation was evaluated for chemical parameters like assay and in-vitro drug release study.
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