Bicalutamide is a non-steroidal anti-androgen used primarily in the treatment of prostate cancer. It functions by blocking androgen receptors, thereby inhibiting the stimulatory effects of androgens (like testosterone) on prostate cancer cells. Bicalutamide is typically used in combination with luteinizing hormone-releasing hormone (LHRH) analogs or surgical castration as part of androgen deprivation therapy.
Indications include:
∙ Advanced prostate cancer (as monotherapy or combined therapy)
∙ Locally advanced prostate cancer (as adjuvant treatment)
∙ Off-label uses in hormone-sensitive conditions (under clinical supervision)
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Parent: Bicalutamide
Impurities in bicalutamide result from its multi-step organic synthesis, including amide bond formation, chlorination, and aromatic substitutions, as well as oxidative degradation. These impurities must be controlled per ICH Q3A/B and pharmacopoeial guidelines (USP, EP), especially considering its chronic use and narrow therapeutic margin.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
It is used to treat prostate cancer, especially in combination with LHRH analogs or orchiectomy, to reduce androgen stimulation of cancer cells.
Bicalutamide competitively inhibits androgen receptors, blocking the effects of testosterone and dihydrotestosterone (DHT) in prostate tissue.
Yes, but it is more effective when used in combination with LHRH analogs or as adjuvant therapy post-surgery or radiation.
Bicalutamide is generally stable under normal storage conditions, but should be protected from light and moisture. It should be stored at controlled room temperature in tightly sealed containers.
