EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

EVALUATION OF THE PHYSICOCHEMICAL PROPERTIES AND QUALITY INDICES OF MULTISOURCE FLUOXETINE CAPSULES MARKETED IN NIGERIA

Ukwueze S.E.*, Andrew-Kekii L.P., Nwoke E.A. and Odigie J.

ABSTRACT

The need to constantly evaluate the quality of multisource drugs to ascertain their pharmaceutical equivalence and interchangeability cannot be overemphasized. Fluoxetine, a selective serotonin re-uptake inhibitor antidepressant, is one of the commonly utilized multisource psychotropic agents in many parts of the globe, with an equally great potential for abuse. This study examined the extent to which commonly available brands of fluoxetine hydrochloride in Nigeria comply with quality and safety standards. Different brands of fluoxetine hydrochloride capsules obtained from retail pharmacies located in some parts of Nigeria were assessed using official BP and USP and unofficial methods. Tests for uniformity of weight, disintegration, dissolution, content of active ingredients and similarity factor determination for capsules were employed. The content of active ingredient test was carried out using UV-spectrophotometer at a wavelength of 241 nm for fluoxetine. The innovator brand (Prozac®) was used as primary standard. The results showed that all the brands passed the uniformity of weight (< 5 mg), disintegration (< 10 min), and dissolution tests (> 85% after 30 min). However, one sample failed the assay for active ingredient (75%), while only one brand had a similarity factor greater than 50. Thus, only one brand was found to be interchangeable with the innovator brand. Therefore, the random therapeutic use of multisource fluoxetine in Nigeria can potentially affect therapeutic outcome.

Keywords: Substandard, Counterfeit, Fluoxetine, Interchangeability, Multisource medicines.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI )