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ABOUT AUTHORS:
Suresh VV Babu¹, Talasila EGK Murthy²*, Chimakurthy Jithendra^3
1Dept. of Pharmaceutics, Natco Pharma Limited, Hyderabad, Telangana, India.
²Dept. of Pharmaceutics, Bapatla College of Pharmacy, Bapatla, Andhra Pradesh, India.
³Dept. of Pharmacology, Bapatla College of Pharmacy, Bapatla, Andhra Pradesh, India.
*drgkm@bcop.net

ABSTRACT
The present study was to assess the relative bioavailability and pharmacokinetic properties of extended release formulations of Ranolazine 1000 mg in healthy male volunteers usinga randomized, open-label, balanced, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study under fasting conditions. Bioavailability of the test product of Ranolazine extended release tablets 1000 mg was compared with that of the reference product of Ranexa® (Ranolazine extended release tablets 1000mg) of CV Therapeutics Inc., California. The plasma samples were collected at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hours post dose after single administration of Ranolazine 1000mg. The plasma Ranolazine concentrations were estimated by using a validated bioanalytical method by LC-MS/MS. A ten day washout period is followed between two treatments. The formulations were considered to be bioequivalent if the 90% CIs for the log-transformed values were within the predetermined equivalence range 80%–125% for AUC and C_max. For Ranolazine, at 90% confidence intervals C_max, AUC_0-tand AUC _0-∞ were 83.43-113.29, 82.10-102.87 and 80.94-101.85 for log-transformed data respectively.The present results show that the formulation of Ranolazine was bioequivalent to the reference in fasting, healthy, male volunteers.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

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