DEVELOPMENT AND ASSESSMENT OF RAPID-DISSOLVING ENALAPRIL MALEATE TABLETS UTILIZING CO-PROCESSED SUPER DISINTEGRANTS

Enalapril maleate, a maleate salt of the amino acid derivative enalapril, functions as an angiotensin-converting enzyme (ACE) inhibitor. This medication effectively lowers blood pressure by diminishing peripheral vascular resistance without significantly impacting cardiac output, heart rate, or contractility. It is particularly beneficial for treating all grades of essential hypertension, especially in patients with diabetes and chronic renal conditions such as glomerulosclerosis. Additionally, enalapril maleate is indicated for managing heart failure. With a half-life of approximately 11 hours, the bioavailability of enalapril maleate tablets is around 55%, and food intake does not significantly influence absorption. To enhance the formulation of fast-dissolving tablets (FDT) of enalapril maleate, a study was conducted using the direct compression technique with co-processed superdisintegrants, specifically Crospovidone and Croscarmellose sodium, in various ratios. The formulated tablets were evaluated for essential pharmaceutical properties, including hardness, friability, weight variation, and drug content, alongside in-vitro dissolution profiles. The findings indicated that employing the direct compression method with co-processed superdisintegrants significantly improved the solubility of enalapril maleate. Characterization through Fourier Transform Infrared Spectroscopy (FTIR) confirmed the integrity of the drug within the formulations. The results for hardness, friability, weight variation, and drug content adhered to the specifications outlined in the Indian Pharmacopoeia (I.P).Tablets containing Crospovidone and Croscarmellose sodium exhibited rapid disintegration and enhanced capillary action, resulting in quick drug release. Notably, formulations SB 3 and CPS 6 achieved 99% drug release within 20 minutes. Stability studies further indicated no significant changes in physical properties, hardness, drug content, or in-vitro dissolution profiles, confirming the stability of the formulations. In summary, the direct compression technique utilizing co-processed superdisintegrants proved effective in enhancing the solubility and overall performance of enalapril maleate tablets.