Telangana

BIOEQUIVALENCE AND PHARMACOKINETIC STUDY OF RANAZOLINE IN HEALTHY MALE VOLUNTEERS: AN OPEN LABEL, RANDOMIZED, SINGLE-DOSE, TWO-WAY CROSSOVER STUDY

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ABOUT AUTHORS:
Suresh VV Babu1, Talasila EGK Murthy2*, Chimakurthy Jithendra3
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 Cmax. For Ranolazine, at 90% confidence intervals Cmax, AUC0-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.

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A CASE STUDY ON HEMOLYTIC UREMIC SYNDROME- LEADING TO ACUTE RENAL FAILURE

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ABOUT AUTHORS:
Jiguru Prasant*, Mohammad Kaleemullah Quraishi, Amer Khan
Department of Doctor of Pharmacy,
Krishna Institute of Medical Sciences and Bharat Institute of Technology (Pharmacy),
Hyderabad, Telangana, India
Prashant7792@gmail.com

ABSTRACT
A 65 yrs female patient was presented with  complaints of vomiting,  loose stools, pain,  fever, high grade chills,  giddiness, loss of appetite acute renal failure, hemolytic anemia and thrombocytopenia She was diagnosed with Escherichia coli  associated hemolytic-uremic syndrome and treated with plasmapheresis and other medications for 3 weeks. She recovered without sequelae.

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