Nifedipine 20 mg Brands' Bioequivalency and Bioavailability in Healthy Human Subjects

Ajay kumar shukla

Institute of Pharmacy, Dr Rammanohar Lohia Avadh University Ayodhya, Uttar Pradesh, India

Refer this article

Ajay Kumar Shukla. Nifedipine 20 mg Brands' Bioequivalency and Bioavailability in Healthy Human Subjects. International journal of therapeutic innovation, Jan-Feb 2024, V 2 - I 1, Pages - 0089 – 0093. Doi: https://doi.org/10.55522/ijti.V2I1.0021.

ABSTRACT

Bioavailability and bioequivalence study for developing new drug product and for generating its alternatives these parameters plays a major role in this phase. Nifedipine (NFDP) is an orally active calcium channel blocker, antihypertensive property which reduces the risk of cardiovascular diseases. The goal of the current study is to assess in healthy human subjects the bioavailability and bioequivalency of NFDP 20 mg formulations following a single dosage administered while fasting. As a result, an open label, balanced, randomized, three-period single dose bioequivalency study of various NFDP tablet brands with a minimum seven-day wash-out interval was designed. All twelve subjects stayed at the study site for 24 hours prior to dosing, and study formulations were given following a 10-hour overnight fast in each phase. Blood samples were obtained in accordance with the schedule for pharmacokinetic analysis. HPLC analysis was used to determine the plasma concentration. If the 90% CI for the test 1 /reference and test2/reference ratios' bioequivalence fell between 0.80 and 1.25, the test, test2, and reference formulations were deemed bioequivalent. For test1/reference and test2/reference in this investigation, the 90% confidence intervals (CI) were 1.0027 & 1.0055 for Cmax, 0.9815 & 1.0013 for AUC0-t, and 0.9835 & 1.0016 for AUC0-∞:.9992 & 1.0047 for Cmax 9900 & 1.0008 for AUC0-t, and.9905 & 1.0010 for AUC0-∞. Thus, it can be observed that, in accordance with the CDSCO bio-equivalency criterion, all of the parameters fall within 0.8 and 1.25. Therefore it can be calculated that generic drugs are as safe as branded drugs and have same efficacy as branded drugs. Due to expiry of patent of drug many of the generic drugs come in the market for the same branded drug. It leads no competition between different companies and for selling their generic drug these companies reduced the cost of their generic drug. Due to this generics become the preferred alternatives.

Keywords:

Nifedipine, Bioequivalence, Bioavailability and Pharmacokinetic, HPLC