Abiraterone Advantages

Possible Advantages of the Physicochemical Properties

The active ingredient of the drug is the acetyl ester of abiraterone. Abiraterone acetate is a white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (cLog P) and is practically insoluble in water (U. S. Food and Drug Administration/Center for Drug Evaluation and Research, 2012). Based on its physicochemical properties, abiraterone can be made into tablets and consuming with water without or trace solubility before reaching the stomach for further absorption, which increases the bioavailability for the drug. With a cLog P value

The active substance abiraterone acetate will be converted into abiraterone in the body and inhibits the biosynthesis of androgen by inhibiting the enzyme 17 α-hydroxylase/C17,20-lyase (CYP17) expressed in testicular, adrenal, and prostatic tumor tissues (Potter et al., 1995). Without this enzyme, androgen cannot be made by the body, therefore the serum testosterone level can be lowered and the growth of tumor can be slowed down or even shrink in size after the treatment (U. S. Food and Drug Administration/Center for Drug Evaluation and Research,

According to the existing non-clinical and clinical studies for abiraterone acetate drugs, such as Zytiga, a risk management plan should be filed in details of safety concern, agreed pharmacovigilance activities, and agreed risk minimization activities. For instance, the major identified risks for abiraterone drugs are hypertension, hypokalaemia, fluid retention, hepatotoxicity, and cardiac disorders. When these side effects occur, company should follow the pharmacovigilance routine, including long-term trial extensions and follow-up with reporters in order to determine the next action to minimize the risk activities. If the adverse reactions are anticipated as pharmacodynamic consequences, actions such as co-administration with other drugs, reduction of doses, and guidance provided by physicians will step in to minimize or eliminate the side effects (Kluetz et al., 2013). Other potential risks, such as osteoporosis, cataract, drug-drug interaction, and increased exposure with food, are also observed in certain populations and the risk minimize actions should follow the risk management plan same as