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Abstract

FORMULATION AND EVALUATION OF SPIRONOLACTONE FAST DISSOLVING TABLETS: A STUDY ON RAPID DRUG DELIVERY

Ayesha Naz*1, Syeda Kulsum1, Salma Begum1, Donthula Srilatha2, Amena Samreen1, Mohammed Shaibaz1

1MRM College of Pharmacy, Chintapallyguda, Ibrahimpatnam, Rangareddy, Telangana-501510.
2Brilliant College of Pharmacy, Abdullapurmet, Rangareddy, Telangana-501513, INDIA.

ABSTRACT

Spironolactone is a potassium-sparing diuretic essentially utilized in the therapeutic management of hypertension, congestive heart failure, and oedema. Despite its clinical prevalence, the drug exhibits poor water solubility, which presents significant challenges in developing dosage forms with optimal bioavailability. The present study was aimed at the formulation and evaluation of spironolactone immediate-release tablets to achieve rapid drug release and acceptable physicochemical properties utilizing the direct compression method. Various formulations were prepared using distinct super disintegrants, specifically Cross Povidone, Croscarmellose sodium, and Sodium starch glycolate. The prepared powder blends were subjected to pre-compression evaluation for parameters including bulk density, tapped density, angle of repose, Carr's index, and Hausner's ratio, with results indicating satisfactory flow properties. Subsequently, compressed tablets were evaluated for post-compression quality attributes such as weight variation, hardness, thickness, friability, disintegration time, drug content uniformity, and in vitro dissolution profiles. All evaluated parameters fell within the limits specified by the Indian Pharmacopoeia (IP). Among the developed formulations (F1-F9), formulation F7 was identified as the optimized candidate, exhibiting rapid disintegration and a maximum in vitro drug release of 99.82%, a statistically significant improvement over comparative formulation. These results demonstrate that spironolactone immediate-release tablets with enhanced dissolution characteristics can be successfully formulated via direct compression, potentially improving therapeutic efficacy and patient compliance.

Keywords: Spironolactone, Immediate Release, Direct Compression, Sodium Starch Glycolate, Super disintegrants.


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