Volume : 13, Issue : 09, September – 2026
Title:
DEVELOPMENT AND PHARMACOKINETIC EVALUATION OF AN IMMEDIATE-RELEASE TABLET FORMULATION OF BICALUTAMIDE
Authors :
Enugula Velangini *, Dr. K. Ram Prasad
Abstract :
Bicalutamide is a non-steroidal androgen receptor antagonist widely used in the hormonal management of prostate cancer. The present study aimed to develop and evaluate an immediate-release tablet formulation of Bicalutamide with improved pharmaceutical performance and systemic exposure. Preformulation studies included solubility, UV spectrophotometric analysis, DSC, FTIR, particle-size analysis, and powder-flow evaluation. Bicalutamide showed low aqueous solubility of 0.023 mg/mL in water and 0.030 mg/mL in phosphate buffer pH 6.8, while higher solubility was observed in methanol and acetonitrile. The analytical method showed linearity over 50–250 µg/mL at 271 nm. DSC and FTIR studies confirmed satisfactory drug–excipient compatibility. Nine formulations (BF1–BF9) were prepared using lactose monohydrate, sodium starch glycolate, PVP, and magnesium stearate. BF4 exhibited the highest dissolution, whereas BF6 was selected as the optimized formulation based on overall formulation criteria. BF6 showed higher Cmax and AUC than the comparator, indicating enhanced systemic exposure. Accelerated stability testing for 3 months demonstrated satisfactory stability. Overall, BF6 showed promising pharmaceutical and pharmacokinetic performance.
Keywords: Bicalutamide; Immediate-release tablet; Dissolution; Pharmacokinetics; Preformulation; Stability.
Cite This Article:
Please cite this article in press Enugula Velangini et al., Development And Pharmacokinetic Evaluation Of An Immediate-Release Tablet Formulation Of Bicalutamide.,. Indo Am. J. P. Sci, 2026; 13(10).
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