FORMULATION DEVELOPMENT AND IN-VITRO CHARACTERIZATION OF PULSATILE DRUG DELIVERY SYSTEM FOR SPIRONOLACTONE

C. Sadak Vali*, Abdullah Khan, S. Siva Prasad, Reddy Nazemoon, Fatima Sultana, Mare Prathibha Bharathi, Survi Swathi Goud, Pasupuleti Shyamala, T. Narasimha Rao

spironolactone is a steroid-based aldosterone antagonist belonging to the spirolactone class and is widely prescribed as an adjunct therapy in Chronic Heart Failure (CHF) and hypertension, particularly in patients with aldosterone-mediated resistant hypertension.[1] The present investigation aimed to formulate and evaluate press-coated tablets of spironolactone using polymers such as ethyl cellulose and hydroxypropyl methylcellulose (HPMC) for achieving pulsatile drug release. Based on consistent and reproducible experimental outcomes obtained from both core and press-coated tablets, formulation F6 of the core tablet and E2f6 of the press-coated tablet demonstrated a lag time of approximately 6 hours followed by a rapid burst release during the 7th hour and maximum drug release by the end of the 8th hour. Hence, these formulations were identified as optimized systems suitable for pulsatile drug delivery design. The findings confirm that press-coated spironolactone tablets can be effectively used as a time-controlled chronopharmaceutical dosage form.[2-5]