DESIGN AND INVITRO EVALUATION OF PULSATILE DRUG DELIVERY SYSTEMS OF FLUVASTATIN SODIUM

Pulsatile Drug Delivery Systems (PDDS) are advanced drug delivery techniques that have been developed to release the drug after a definite lag time followed by a sudden release of the drug, which is in accordance with the circadian rhythm of the body. In the case of hyperlipidemia, which is a major risk factor for the development of cardiovascular diseases, the circadian rhythm of cholesterol synthesis is observed. In this case, the production of cholesterol is maximum in the early morning. In conventional drug delivery systems, the drug is released without synchronization with the circadian rhythm, which might affect the therapeutic response and side effects of the drug. In the current study, a pulsatile drug delivery system of Fluvastatin sodium, a competitive inhibitor of HMG-CoA Reductase, used in the treatment of hypercholesterolemia and prevention of cardiovascular diseases, is designed and evaluated. Fluvastatin, due to its short half-life, low bioavailability, and extensive metabolism through the liver, is a good candidate for a chronotherapeutic pulsatile drug delivery system. It is to be administered before sleep, and the drug is released at a particular time to coincide with the peak hepatic cholesterol synthesis, which is between 12 a.m. and 4 a.m.