World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
World Journal of Pharmaceutical and Life Sciences (WJPLS) has indexed with various reputed international bodies like : Google Scholar, Index Copernicus, Indian Science Publications, SOCOLAR, China, Cosmos Impact Factor, Research Bible, Fuchu, Tokyo. JAPAN, Scientific Indexing Services (SIS), Jour Informatics (Under Process), UDLedge Science Citation Index, Global Impact Factor (In Process), International Impact Factor Services, International Scientific Indexing, UAE, International Society for Research Activity (ISRA) Journal Impact Factor (JIF), Science Library Index, Dubai, United Arab Emirates, International Innovative Journal Impact Factor (IIJIF), Scientific Journal Impact Factor (SJIF), Eurasian Scientific Journal Index (ESJI), Indian citation Index (ICI), IFSIJ Measure of Journal Quality, International Scientific Indexing, UAE (ISI), Web of Science Group (Under Process), Directory of Research Journals Indexing, 

Abstract

QUALIFICATION FOR BIOWAIVER AND BIOEQUIVALENCE STUDY ON SEVEN BRANDS OF METFORMIN HYDROCHLORIDE TABLETS EXISTING IN SUDAN MEDICINE MARKET

Dr. Abdrhman Mahmoud Gamil* and Dr. Yuvaraj D. Mandavkar

ABSTRACT

Metformin HCl is the drug of choice for obese diabetic patients. It can be used alone with diet control or in combination with other antidiabetic remedies. It is one of the two antidiabetic medicines listed in the WHO list of essential medicines. Being classified in class 3 in the biopharmaceutical classification system, it is highly soluble with low permeability. Many Metformin brands exist in the Sudan Medicine market, some of them are locally manufactured and others are imported including the originator brand, Glucophage, of Merck Serono – France. To evaluate these brands in respect to the similarity with the originator and qualification for biowaiver study, seven brands were subjected to dissolution testing to study their dissolution profile using apparatus type 2 in a simulating intestinal medium using spectrophotometric method at 233 nm. One imported and two locally manufactured brands were found to show adequate similarity of the dissolution profile with the originator but they were disqualified for biowaiver study for class 3 of the BCS as they failed to exhibit 85% dissolution in 15 mins. The other two locally manufactured brands were dissimilar to the originator but they showed more than 85% dissolution in 15 mins which qualifies them for biowaiver study for class 3. One imported brand being dissimilar and disqualified for biowaiver study. It is recommended that DRA should set regulations for interchangeability and international harmonized specification for similarity, qualification for biowaiver study and the pharmacopeia specifications will be valuable.

[Full Text Article]

BEST PAPER AWARDS

World Journal of Pharmaceutical and life sciences Will give best paper award in every issue in the from of money along with certificate to promote research .

Best Article of current issue

Download Article : Click here