ABSTRACT

The objective of the present study, was to develop a pulsatile capsule of Fluvastatin sodium to reduce plasma cholesterol levels. The microspheres formulations of Fluvastatin sodium were prepared by emulsion solvent evaporation process by changing polymer: drug ratio. Weighed amount of drug (Fluvastatin sodium) and polymer (Eudragit RL100) in 1:1 ratio was dissolved in 10 ml of acetone. The Pulsi cap was similar in appearance to a hard gelatin capsule, but the main body was water insoluble. Fluvastatin sodium microspheres were placed into the formaldehyde treated bodies by hand filling. The capsules containing the microspheres were then plugged with prepared hydrogel plug. The joint of the capsule body and cap was sealed with a small amount of the 5% ethyl cellulose ethanolic solution. The sealed capsules were completely coated by dip coating method with 5% cellulose acetate phthalate in 8:2 (v/v) mixture of acetone: ethanol plasticized with dibutyl phthalate (0.75%), to prevent variable gastric emptying. Results: Optimized microsphere formulation(F20) were selected based on dissolution studies. Dissolution studies of pulsatile capsule device in media with different pH (1.2, 7.4 and 6.8) showed that drug release in colon could be modulated by optimizing the concentration of polymers in the microspheres. Conclusion: Among all the formulations Fluvastatin sodium microspheres prepared (F20) with Eudragit RS100 in 1:3 ratio shown prolonged release for a period of 12 hours. The obtained results showed the good stability and capability of the system in delaying drug release for a programmable period and to deliver the drug in the early morning hours when cholesterol synthesis is more prevalent. Keywords: Fluvastatin sodium, pulsatile, hydrogel plug
Publication date: 01/12/2022

https://ijbpas.com/pdf/2022/December/MS_IJBPAS_2022_6687.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.12.6687