Andhra Pradesh

National Institute of Pharmaceutical Education and Research (NIPER) is the first national level institute in pharmaceutical sciences with a proclaimed objective of becoming a centre of excellence for advanced studies and research in pharmaceutical sciences. The Government of India has declared NIPER as an 'Institute of National Importance'. It is an autonomous body set up under the aegis of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. The Institute is conceived to provide leadership in pharmaceutical sciences and related areas not only within the country, but also to the countries in South East Asia, South Asia and Africa. NIPER is a member of Association of Indian Universities and Association of Commonwealth Universities.

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A medical device MNC based in Hyderabad, R&D center based in hyderabad. Leading manufactureres of medical devices in the globe

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Sree Vaageswari Educational society was established in 2003 and started Vaageswari College of Pharmacy with B.Pharmacy course in 2004 to honor SARASWATHI, the goddess of Education. We are working with a mission to provide the quality education in the field of Pharmacy profession and also to promote highest quality professional pharmacy education at all levels, to produce competent pharmacists, with entrepreneurship and innovative skills. We also wish to educate people regarding drugs, drug products, health and population control and also to create a model pharmacy in the institution to strengthen the relation between public and pharmacy.

Indian Institute of Chemical Technology (IICT), Hyderabad, a constituent of CSIR is a leading research Institute in the area of chemical sciences. The core strength of IICT lies in Organic Chemistry, and it continues to excel in this field for over six decades. The research efforts during these years have resulted in the development of several innovative processes for a variety of products necessary for human welfare such as drugs, agrochemicals, food, organic intermediates, adhesives etc.

Indian Pharmaceutical Association (IPA) is the premier professional association of pharmaceutical professionals in India. IPA is affiliated with international pharmaceutical associations, like Federation of Asian Pharmaceutical Associations (FAPA), Commonwealth Pharmaceutical Association (CPA), Asia Pacific Pharmaceutical Symposium (APPS), World Health Organization (WHO) & International Pharmaceutical Students’ Federation (IPSF) for carrying out various collaborative professional activities.

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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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Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.

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