March 2015

HySynth BioTechnologies is a contract research organization based in Chennai, South India. We provide outsourced development services on a global basis to the pharmaceutical, biotechnology and medical device industries.

Post: Drug Safety Associate - Pharmacovigilance

Gujarat Cancer & Research Institute (GCRI) established in the year 1972, is a functional autonomous body jointly managed by Government of Gujarat and Gujarat Cancer Society, affliated to B J Medical College. It is also a Regional Cancer Centre of Government of India and getting assistance under National Cancer Control Programme. GCRI is a unique example of cooperation between State Government, Central Government, and Non-Government Organization – Gujarat Cancer & Research Institute.

Post: Junior Pharmacist, Research Scientist, Research Coordinator

The University Institute of Pharmaceutical Sciences of the Panjab University is a premier institution of Pharmaceutical Education and Research in the country. The institute has covered a long and glorious journey of 76 years starting from Lahore in 1944 and finally settling to the present campus in Chandigarh at the foothills of Himachal. In its travelogue, the institute crossed multiple milestones and continue to head ahead towards the well-defined goals. The elevation of the status from department to the level of an institute i.e. University Institute of Pharmaceutical Sciences in 1994, and hosting of Indian Pharmaceutical Congress in the same year, two presidential honors of the Indian Pharmaceutical Congresses to its faculty members, a special recognition by the UGC by granting SAP in 1993 and COSIST in 1981 establishment of ICMR Advanced Centre for standardization of Drugs of Indian System of Medicine are some of the major hallmarks on the path treaded so far.

Post: Research Associate: 1 (One)

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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.